Product Code: FMF FDA class 2 21 CFR 880.5860

Syringe, Piston

General Hospital

The Piston Syringe is a general-purpose medical syringe with a piston mechanism used to aspirate or inject fluids in clinical care settings, including irrigation and medication administration. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMF, regulated under 21 CFR 880.5860 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

739

FEI Numbers

553

Registration Numbers

553

Unique Applicants

480

Years Active

Basic Information

Product Code: FMF
Device Class: FDA class 2
Regulation Number: 880.5860
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 739 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250733	3DOSE 1ml Syringe	Jul 03, 2025	Substantially Equivalent	Bimed Teknik Aletler Sanayi & Ticaret A.S.
K251648	GPS Advanced; GPS Advanced Cannula	Jun 24, 2025	Substantially Equivalent	Prosidyan, Inc.
K250262	GO-PEN®	Apr 24, 2025	Substantially Equivalent	GO-Pen ApS
K243580	GraftGun Universal Graft Delivery System (GDS)	Feb 05, 2025	Substantially Equivalent	SurGenTec, LLC.
K242434	Insulin Syringes	Dec 24, 2024	Substantially Equivalent	CHIRANA T. Injecta
K241856	Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)	Dec 23, 2024	Substantially Equivalent	HLB LifeScience Co., Ltd.
K242099	Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle	Oct 22, 2024	Substantially Equivalent	Sol-Millennium Medical Inc.
K241821	Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle	Sep 20, 2024	Substantially Equivalent	Sol-Millennium Medical Inc.
K231095	Tamper Evident Cap	Sep 04, 2024	Substantially Equivalent	International Medical Industries, Inc.
K240961	Disposable Pen Injector Assembly	Aug 15, 2024	Substantially Equivalent	Wuxi NEST Biotechnology Co., Ltd.
K241426	GPS Advanced; 5 cc GPS Advanced Cannula	Jul 10, 2024	Substantially Equivalent	Prosidyan, Inc.
K233368	Allograft Delivery Device (OFAC-C)	Jun 25, 2024	Substantially Equivalent	Bioventus LLC
K240774	Pen Injector	Jun 18, 2024	Substantially Equivalent	Wuxi NEST Biotechnology Co., Ltd.
K232950	Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle	Jun 12, 2024	Substantially Equivalent	Perfect Medical Industry (VN) Co., Ltd.
K234024	HWJECT Auto-disable syringe	Mar 19, 2024	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd
K233794	Insulin Syringe	Mar 06, 2024	Substantially Equivalent	SPM Medicare Pvt. Ltd.
K230235	Medline Luer Lock Syringes	Feb 16, 2024	Substantially Equivalent	Medline Industries, LP
K231558	SMB Luer lock disposable syringe	Jan 12, 2024	Substantially Equivalent	SMB Corporation of India
K231877	NavaClick Injection System	Nov 30, 2023	Substantially Equivalent	Lineage Biomedical, Inc.
K230061	Insulin Syringe	Nov 30, 2023	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K231519	Revital Cady	Nov 06, 2023	Substantially Equivalent	Revital Healthcare (EPZ) Limited
K233056	EpiZact	Nov 02, 2023	Substantially Equivalent	GuideStar Medical Devices
K221777	Disposable Sterile Syringe	Oct 06, 2023	Substantially Equivalent	Weihai Shengjie Medical Technology Co., Ltd
K231792	VeriSafe Safety sterile syringes	Sep 28, 2023	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K231888	BD Texium Needle-Free Syringe	Sep 25, 2023	Substantially Equivalent	Carefusion
K231727	Sterile Auto-Disable Syringes with/without Needle for Single Use	Sep 08, 2023	Substantially Equivalent	Wepon Medical Technology Co., Ltd.
K230447	Sterile Syringe Bulk Tray	Aug 16, 2023	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd
K231900	A-TAP (previously called Arthrotap)	Jul 25, 2023	Substantially Equivalent	Elcam Medical ACAL
K222925	Hypodermic Syringes & Needle	Jul 18, 2023	Substantially Equivalent	Lifelong Meditech Private Limited
K231456	Avitus® DragonWing Large Volume Autograft Delivery System	Jul 17, 2023	Substantially Equivalent	Avitus Orthopaedics, Inc.
K230492	Avitus® Precision Autograft Delivery System	Jun 26, 2023	Substantially Equivalent	Avitus Orthopaedics, Inc.
K212857	Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use	May 09, 2023	Substantially Equivalent	Jiangsu Zhiyu Medical Instrument Co, Ltd.
K220713	Sol-Guard Auto-disable Syringe	May 04, 2023	Substantially Equivalent	Sol-Millennium Medical Inc.
K221974	EpiFinder	Apr 16, 2023	Substantially Equivalent	Omeq Medical Ltd.
K212207	Sterile Hypodermic Syringe for Single Use	Mar 23, 2023	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.
K222672	Disposable Insulin Syringe	Mar 06, 2023	Substantially Equivalent	Hantech Medical Device Co., Ltd.
K223453	Insulin Syringe	Mar 02, 2023	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K221702	CompuFlo Epidural Computer Controlled Anesthesia System	Feb 25, 2023	Substantially Equivalent	Milestone Scientific, Inc.
K212635	Sofjec	Feb 13, 2023	Substantially Equivalent	Hwajin Medical Co.,Ltd.
K223678	Sterile Syringes for Single Use	Feb 09, 2023	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd.
K203211	Insulin syringe with integrated needle DL	Feb 09, 2023	Substantially Equivalent	DLP Medical Products, Corp.
K213054	Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe	Dec 09, 2022	Substantially Equivalent	Medline Industries, Inc.
K212764	Medwell Technology Ltd Syringes, various sizes	Nov 04, 2022	Substantially Equivalent	Medwell Technology Ltd
K221045	Insulin Syringes without needle	Nov 03, 2022	Substantially Equivalent	Berpu Medical Technology Co., Ltd
K221308	Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle	Oct 17, 2022	Substantially Equivalent	Jiangxi Maidikang Medical Devices Co., Ltd
K222744	Sol-M Luer Lock Syringe	Oct 11, 2022	Substantially Equivalent	Sol-Millennium Medical Inc.
K221079	Sterile Hypodermic Syringes for Single Use	Oct 04, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221068	Sterile Hypodermic Syringes for Single Use with Needles	Oct 04, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K212846	Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use	Aug 30, 2022	Substantially Equivalent	Jiangsu Jichun Medical Devices Co., Ltd.
K212033	Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle	Aug 17, 2022	Substantially Equivalent	Shandong Zhushi Pharmaceutical Group Co., Ltd
K221737	InstaFill Graft Delivery System, SIGNIFY Bioactive	Aug 11, 2022	Substantially Equivalent	Globus Medical Inc.
K220184	Pump Alignment Syringe	Jul 21, 2022	Substantially Equivalent	Jiangsu Caina Medical Co., Ltd.
K213158	Syringe with permanently attached needle	Jul 21, 2022	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K220204	Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle	Jul 14, 2022	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.
K213811	Sterile Hypodermic Syringes for Single Use	May 12, 2022	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K212677	aboNT SYRINGE	Apr 15, 2022	Substantially Equivalent	Nipro Medical Corporation
K213560	Verifine Safety Syringe with Fixed Needle	Apr 05, 2022	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K203738	Qitexio	Mar 14, 2022	Substantially Equivalent	Medex
K212920	Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use	Mar 11, 2022	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.
K212499	BD Insulin Syringe (0.3mL)	Mar 09, 2022	Substantially Equivalent	Becton, Dickinson and Company
K210848	Sure-Fine Insulin Syringes	Mar 01, 2022	Substantially Equivalent	Shina Med Corporation
K213632	Instylla Delivery Kit	Feb 10, 2022	Substantially Equivalent	Instylla, Inc.
K211210	Sterile Auto-Disable Syringes with/without Needle for Single Use	Jan 27, 2022	Substantially Equivalent	Azur Medical Company Inc.
K211482	Disposable Syringe with Needle	Jan 24, 2022	Substantially Equivalent	Shandong Qinkai Medical Industry Co., Ltd.
K201044	CHIRANA Insulin Syringes	Jan 18, 2022	Substantially Equivalent	CHIRANA T. Injecta
K210914	Sterile Syringe for Single Use	Dec 17, 2021	Substantially Equivalent	Jiangsu Suyun Medical Material Co., Ltd.
K212544	MiniLoad Syringe	Oct 13, 2021	Substantially Equivalent	OcuJect, LLC
K211211	Sterile syringes for single use with/without needle	Oct 07, 2021	Substantially Equivalent	Azur Medical Company Inc.
K211728	Sterile hypodermic syringes for single use	Oct 05, 2021	Substantially Equivalent	Jiangsu Kangyou Medical Instrument Co., Ltd.
K210818	TrueCare Biomedix Tamper Evident Cap	Sep 15, 2021	Substantially Equivalent	US Infusion Inc. D/B/A Truecare Biomedix-USA
K210227	Sterile syringe for single use with/without needle	Sep 10, 2021	Substantially Equivalent	Zhejiang Kangkang Medical-Devices CO., Ltd.
K211242	Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes	Sep 09, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K210712	Verifine Mechanical Safety Insulin Syringe	Sep 08, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K210997	PreferX Delivery System	Sep 07, 2021	Substantially Equivalent	MD3 LLC
K210991	Disposable Sterile Syringe, Disposable Sterile Syringe with Needle	Aug 26, 2021	Substantially Equivalent	Guangdong Antmed Co., Ltd.
K210464	Auto Disable Syringe	Aug 24, 2021	Substantially Equivalent	Anhui Tiankang Medical Technology Co.,Ltd.
K203359	BD Flu+ Syringe	Jul 28, 2021	Substantially Equivalent	Becton, Dickinson and Company
K210103	SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX	Jul 16, 2021	Substantially Equivalent	Lifelong Meditech Private Limited
K210200	1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock	May 14, 2021	Substantially Equivalent	Set Medikal Sanayi Ve Ticaret Anonim Sirketi
K203264	MicroDose Injector	Apr 26, 2021	Substantially Equivalent	MedOne Surgical, Inc.
K202432	MiniLoad Syringe	Feb 19, 2021	Substantially Equivalent	OcuJect, LLC
K203453	BD Hypodermic Syringe	Jan 25, 2021	Substantially Equivalent	Becton Dickinson and Company
K201930	Nanum Syringe	Jan 17, 2021	Substantially Equivalent	Nanum Company Co., Ltd
K202544	Instylla Delivery Kit	Jan 07, 2021	Substantially Equivalent	Instylla, Inc.
K193273	Insulin Syringe	Jan 05, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K192770	S dispensing line	Dec 17, 2020	Substantially Equivalent	AEA srl
K201284	Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use	Dec 14, 2020	Substantially Equivalent	Set Medikal Sanayi Ve Ticaret Anonim Sirketi
K201816	ARTHROTAP	Oct 16, 2020	Substantially Equivalent	Accuro Technologies Inc.
K201900	3D GraftRasp System	Sep 03, 2020	Substantially Equivalent	SurGenTec
K193526	Syringe with safety needle, Safety needle	Jul 17, 2020	Substantially Equivalent	Jiangsu Caina Medical Co., Ltd
K201234	BD SoloShot Mini Syringe/ BD Auto Disable Syringe	Jul 15, 2020	Substantially Equivalent	Becton, Dickinson, and Company
K200325	Orbit Subretinal Delivery System	Jul 14, 2020	Substantially Equivalent	Orbit Biomedical
K201338	Allograft MIS Delivery System	Jul 13, 2020	Substantially Equivalent	LifeNet Health
K200629	Aspire Mechanical Aspirator G	May 29, 2020	Substantially Equivalent	Control Medical Technology
K200431	3D GraftRasp System	May 18, 2020	Substantially Equivalent	SurGenTec
K200606	O-Genesis Graft Delivery System	May 01, 2020	Substantially Equivalent	Orthofix, Inc.
K193101	Omnifix Low Dead Space Luer Lock Syringe	Mar 05, 2020	Substantially Equivalent	B. Braun Medical Inc.
K192674	Mixing and Delivery System	Feb 18, 2020	Substantially Equivalent	Bone Solutions, Inc.
K193192	Tamper Evident Cap	Jan 31, 2020	Substantially Equivalent	International Medical Industries Inc.
K191642	TK Sterile Piston Syringe without Needle	Jan 06, 2020	Substantially Equivalent	Anhui Tiankang Medical Technology Co.,Ltd.
K190054	BD Insulin Syringe	Oct 21, 2019	Substantially Equivalent	Becton Dickinson and Company
K191659	Instylla Delivery Kit	Oct 10, 2019	Substantially Equivalent	Instylla, Inc.
K191359	Nipro Syringe	Oct 09, 2019	Substantially Equivalent	Nipro Medical Corporation
K192421	EpiFaith Syringe	Sep 27, 2019	Substantially Equivalent	Flat Medical Co., Ltd
K190002	Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use	Sep 12, 2019	Substantially Equivalent	Shanghai Kohope Medical Devices Co., Ltd
K191531	Sure-Fine Insulin Syringes	Sep 06, 2019	Substantially Equivalent	Shina Med Corporation
K182765	5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe	Sep 03, 2019	Substantially Equivalent	TOP Corporation
K190996	Bonus Therapeutics Mixing and Delivery System	Jul 28, 2019	Substantially Equivalent	Bonus Therapeutics Ltd.
K190427	Immucise	Jul 18, 2019	Substantially Equivalent	Terumo Corporation
K182268	EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)	Apr 05, 2019	Substantially Equivalent	Flat Medical Co., Ltd.
K182589	BD Plastipak Syringe	Mar 14, 2019	Substantially Equivalent	Becton, Dickinson and Company
K182387	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	Dec 17, 2018	Substantially Equivalent	Novo Nordisk Inc.
K182274	Orbit Subretinal Delivery System	Nov 20, 2018	Unknown	Orbit Biomedical, Inc.
K182279	Merit Syringe	Nov 06, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K182216	Merit Syringe	Nov 06, 2018	Substantially Equivalent	Merit Medical Systems, Inc
K172670	BD Single Use, Hypodermic Syringe	Oct 23, 2018	Substantially Equivalent	Becton, Dickinson and Company
K180937	Graftgun Universal Graft Delivery System	May 10, 2018	Substantially Equivalent	Surgentec, LLC
K173029	Nipro Syringe	Mar 30, 2018	Substantially Equivalent	Nipro Medical Corporation
K173601	Merit Syringe	Jan 31, 2018	Substantially Equivalent	Merit Medical Systems, Inc.
K173385	Graft Delivery, DePuy Synthes	Nov 30, 2017	Substantially Equivalent	Micromedics, Inc. (d/b/a Nordson MEDICAL)
K170900	DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories	Nov 09, 2017	Substantially Equivalent	INTERVENE Group Ltd
K171131	MHC Standard and NRFit Tip Syringes	Nov 08, 2017	Substantially Equivalent	Mazza Healthcare, LLC.
K171805	Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml	Sep 08, 2017	Substantially Equivalent	ConceptoMed AS
K171362	Merit Syringe	Aug 07, 2017	Substantially Equivalent	Merit Medical Systems, Inc.
K170675	Graftgun Universal Graft Delivery System	Jul 19, 2017	Substantially Equivalent	Surgentec, LLC
K161883	CompuFlo Epidural Computer Controlled Anesthesia System	Jun 09, 2017	Substantially Equivalent	MILESTONE SCIENTIFIC, INC.
K170386	BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine needle and BD Insulin Syringes with Micro-Fine IV Needle	Apr 12, 2017	Substantially Equivalent	Becton, Dickinson & Company
K161812	Freedom Syringe	Mar 27, 2017	Substantially Equivalent	Procedure Products, Inc.
K163161	Sterile Single-use Syringe with Needle	Mar 20, 2017	Substantially Equivalent	JiangXi HongDa Medical Equipment Group Ltd.
K170218	Vesco Medical NRFit Tip Syringes	Feb 24, 2017	Substantially Equivalent	Vesco Medical, LLC
K161606	Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH	Feb 10, 2017	Substantially Equivalent	TERUMO EUROPE N.V.
K162057	ConceptoMed Luer-Jack Slip 10ml	Jan 11, 2017	Substantially Equivalent	ConceptoMed AS
K162180	Disposable Insulin Syringe	Dec 29, 2016	Substantially Equivalent	BERPU MEDICAL TECHNOLOGY CO., LTD
K162081	BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe	Dec 19, 2016	Substantially Equivalent	Becton, Dickinson and Company
K162602	NovoPen Echo	Oct 18, 2016	Substantially Equivalent	Novo Nordisk Inc.
K161568	Bone Solutions Mixing and Delivery System	Sep 16, 2016	Substantially Equivalent	BONE SOLUTIONS, INC.
K152879	Sure-Fine Insulin Syringes	Sep 09, 2016	Substantially Equivalent	SHINA MED CORPORATION
K160629	InPen	Jul 26, 2016	Substantially Equivalent	COMPANION MEDICAL, INC.
K152803	SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE	Jul 12, 2016	Substantially Equivalent	SUNG SHIM MEDICARE CO., LTD.
K160978	LITe BIO Delivery System	Jul 08, 2016	Substantially Equivalent	STRYKER CORPORATION
K151870	BD U-500 INSULIN SYRINGE	Jul 08, 2016	Substantially Equivalent	BECTON, DICKINSON AND COMPANY
K153537	Sol-M Insulin Syringe, Sol-M TB Syringe	Jun 17, 2016	Substantially Equivalent	SOL-MILLENNIUM MEDICAL, INC.
K160668	HumaPen Savvio	Jun 03, 2016	Substantially Equivalent	Eli Lilly and Company, Inc.
K153553	SiO2 Coated syringe 3 ml	May 17, 2016	Substantially Equivalent	SiO2 Medical Products
K151686	HumanPen Ergo II	Dec 30, 2015	Substantially Equivalent	ELI LILLY AND COMPANY, INC.
K152783	Merit 20 mL Syringe	Dec 07, 2015	Substantially Equivalent	Merit Medical Systems, Inc.
K151949	Disposable Insulin Syringe	Oct 02, 2015	Substantially Equivalent	JIANGYIN CAINA TECHNOLOGY CO., LTD.
K151777	Intradermal Adapter	Sep 29, 2015	Substantially Equivalent	WEST PHARMACEUTICAL SERVICES INC.
K151766	BD Single Use, Hypodermic Syringe	Sep 02, 2015	Substantially Equivalent	BECTON, DICKINSON AND COMPANY
K150874	NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)	Jul 31, 2015	Substantially Equivalent	NOVO NORDISK INC.
K151543	Graft Delivery Device with Integrated Stylet	Jul 07, 2015	Substantially Equivalent	Micromedics Inc. (d/b/a Nordson Medical)
K150758	Safety Disposable Insulin Syringe	Jun 18, 2015	Substantially Equivalent	JIANGYIN CAINA TECHNOLOGY CO., LTD
K142518	HumaPen Luxura	Jun 05, 2015	Substantially Equivalent	ELI LILLY AND COMPANY
K142535	ConMed Mixing and Delivery Kit	Apr 23, 2015	Substantially Equivalent	CONMED CORPORATION
K143757	ANUTRA Feedback Aspiration Syringe	Jan 08, 2015	Substantially Equivalent	ANUTRA MEDICAL, INC.
K143488	InFill Graft Delivery System	Dec 17, 2014	Substantially Equivalent	PINNACLE SPINE GROUP, LLC
K142661	Bi-Portal Bone Graft Delivery Device	Dec 11, 2014	Substantially Equivalent	Spinal Surgical Strategies, LLC
K142636	Merit 10mL Syringe	Oct 17, 2014	Substantially Equivalent	Merit Medical Systems, Inc.
K140710	BIOMET GRAFT DELIVERY SYRINGES	Sep 04, 2014	Substantially Equivalent	BIOMET SPINE (AKA EBI, LLC)
K141762	PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM	Aug 27, 2014	Substantially Equivalent	BIOMET, INC.
K141359	HARD PACK SYRINGE	Jul 25, 2014	Substantially Equivalent	JIANGYIN CAINA TECHNOLOGY CO., LTD
K141245	ETEX MIXING AND DELIVERY SYSTEM	Jul 09, 2014	Substantially Equivalent	ETEX CORPORATION
K140194	NAMIC RCS SYRINGE	Apr 14, 2014	Substantially Equivalent	NAVILYST MEDICAL, INC.
K133493	SINGLE USE STERILE SYRINGE WITH NEEDLE	Mar 27, 2014	Substantially Equivalent	JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT
K132011	APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET	Mar 21, 2014	Substantially Equivalent	AEA SRL
K132553	U&U STERILE PISTON SYRINGE WITHOUT NEEDLE	Feb 27, 2014	Substantially Equivalent	U&U MEDICAL TECHNOLOGY CO., LTD
K132321	JMS SYRINGE	Feb 20, 2014	Substantially Equivalent	JMS NORTH AMERICA CORPORATION
K133021	MIXING SYRINGE SYSTEM	Jan 13, 2014	Substantially Equivalent	ZIMMER KNEE CREATIONS, INC.
K132120	WTF SECURA SYRINGE AND NEEDLE	Dec 12, 2013	Substantially Equivalent	BEIJING WANTEFU MEDICAL APPARATUS CO., LTD.
K130230	STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES	Nov 20, 2013	Substantially Equivalent	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
K131661	INFUSION SYRINGE SET	Nov 05, 2013	Substantially Equivalent	INNOVATIVE MEDICAL MANUFACTURING CO.
K131963	TAUTONA INJECTOR DEVICE	Oct 22, 2013	Substantially Equivalent	TAUTONA GROUP, LLC
K124037	JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE	Sep 12, 2013	Substantially Equivalent	JUNG RIM MEDICAL INDUSTRIAL CO., LTD
K131641	MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP)	Aug 28, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K123766	NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN	Aug 15, 2013	Substantially Equivalent	NOVO NORDISK INC.
K130900	EVICEL APPLICATION DEVICE	Aug 13, 2013	Substantially Equivalent	ETHICON INC (ON BEHALF OF OMRIX BIOPHARACEUTICALS
K123710	UNITOX BOTOX SYRINGE	May 09, 2013	Substantially Equivalent	BIO-MED USA INC
K122416	ARTIGLASS L. O.R. GLASS SYRINGE	May 03, 2013	Substantially Equivalent	ARTIGLASS SRL
K123588	INTRADERMAL ADAPTER	Feb 19, 2013	Substantially Equivalent	WEST PHARMACEUTICAL SERVICES, INC.
K130049	MONOJECT 12ML SYRINGE	Feb 14, 2013	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K122787	COMFORT EZ	Dec 06, 2012	Substantially Equivalent	SIMPLE DIAGNOSTICS, INC.
K122122	REGEN SPRAY APPLICATOR,	Nov 09, 2012	Substantially Equivalent	REGEN LAB SA
K122023	MIXJECT WITH SPRAY HEAD	Oct 04, 2012	Substantially Equivalent	MEDIMOP MEDICAL PROJECTS, LTD.
K122373	NEOMED ORAL/ENTERAL SYRINGE	Sep 20, 2012	Substantially Equivalent	NEOMED, INC.
K121476	INFILL GRAFT DELIVERY SYSTEM	Aug 29, 2012	Substantially Equivalent	PINNACLE SPINE GROUP, LLC
K113673	MYSAFETY SYRINGE	Aug 03, 2012	Substantially Equivalent	MEDICALCHAIN INTERNARTIONAL CORPORATION
K121283	BD EMERALD SAF-T SINGLE USE, HYPODERMIC	May 30, 2012	Substantially Equivalent	Becton, Dickinson and Company
K121124	ARTHREX MIXING AND DELIVERY SYSTEM	May 16, 2012	Substantially Equivalent	ARTHREX, INC.
K111841	SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE	Mar 01, 2012	Substantially Equivalent	CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD
K112057	KDL SYRINGES AND NEEDLE	Dec 14, 2011	Substantially Equivalent	SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,
K113241	BD EMERALD SINGLE USE, HYPODERMIC SYRINGE	Nov 28, 2011	Substantially Equivalent	BECTON DICKINSON
K112475	XTRACT SYRINGE KEY SYSTEM	Nov 10, 2011	Substantially Equivalent	XTRACT SOLUTIONS
K113091	SYRINGES AND NEEDLES	Oct 28, 2011	Substantially Equivalent	JIANGYIN CAINA TECHNOLOGY CO., LTD
K110882	IMC INSULIN SYRINGE	Aug 18, 2011	Substantially Equivalent	INTERNATIONAL MEDSURG CONNECTION
K111632	INFILL GRAFT DELIVERY SYSTEM	Aug 11, 2011	Substantially Equivalent	PINNACLE SPINE GROUP, LLC
K103830	JIANGSU SHENLI MEDICAL PRODUCTION CO. LTD. PISTON SYRINGE (5CC LUER LOCK)	Jul 29, 2011	Substantially Equivalent	JIANGSU SHENLI MEDICAL PRODUCTION FACTORY
K110697	TIGER SYRINGES AND NEEDLES	Jul 14, 2011	Substantially Equivalent	TIGER MEDICAL PRODUCTS LTD
K111091	MERIT MEDICAL 20 ML SYRINGE	Jun 24, 2011	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K103736	DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE	Jun 10, 2011	Substantially Equivalent	DMC MEDICAL LTD.
K110771	BD SINGLE USE, HYPODERMIC SYRINGE	May 13, 2011	Substantially Equivalent	Becton, Dickinson and Company
K110421	DISPOSABLE INSULIN SYRINGE	Apr 26, 2011	Substantially Equivalent	WENZHOU WUZHOU IMPORT & EXPORT CO., LTD
K110112	CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE	Apr 20, 2011	Substantially Equivalent	RONGSHAN LI
K103200	PROPEP DELIVERY DEVICE	Apr 12, 2011	Substantially Equivalent	RHYTHMLINK INTERNATIONAL, LLC
K101708	PATIENT SAFE LUER CAP	Feb 24, 2011	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K102192	INDISCAL DIGITAL MANOMETER	Feb 23, 2011	Substantially Equivalent	BAYLIS MEDICAL CO., INC.
K102969	IMC PISTON SYRINGES	Dec 20, 2010	Substantially Equivalent	INTERNATIONAL MEDSURG CONNECTION
K101547	HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)	Nov 22, 2010	Substantially Equivalent	HENKE-SASS WOLF, GMBH.
K102178	EASY TOUCH	Sep 02, 2010	Substantially Equivalent	MHC MEDICAL PRODUCTS
K101359	INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)	Aug 20, 2010	Substantially Equivalent	INVIRO MEDICAL DEVICES, INC.
K100988	HUMAPEN LUXURA HD	Aug 17, 2010	Substantially Equivalent	ELI LILLY AND COMPANY
K100665	MARROMAX B ONE MARROW ASPIRATION NEEDLE KIT, MODELS 50083-XX, 50084-XX	Jun 24, 2010	Substantially Equivalent	NEEDLETECH PRODUCTS, INC.
K100754	GRAFT DELIVERY SYSTEM MODEL SA-6115	Jun 09, 2010	Substantially Equivalent	MICROMEDICS, INC.
K093863	EPIDRUM	May 10, 2010	Substantially Equivalent	EXMOOR PLASTICS LTD.
K093400	1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2	Apr 01, 2010	Substantially Equivalent	UNILIFE MEDICAL SOLUTIONS LIMITED
K091722	COAXIAL APPLICATOR SYSTEM	Mar 12, 2010	Substantially Equivalent	BIOMET, INC.
K092908	NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO	Mar 10, 2010	Substantially Equivalent	NEOMED, INC.
K092986	ACACIA PISTON SYRINGE	Oct 27, 2009	Substantially Equivalent	ACACIA, INC.
K091200	XTRACT SYRINGE KEYS	Aug 21, 2009	Substantially Equivalent	XTRACT SOLUTIONS, LLC
K091279	NIPRO DISPOSABLE SYRINGE	Aug 12, 2009	Substantially Equivalent	NIPRO MEDICAL CORPORATION
K091167	SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES	Aug 06, 2009	Substantially Equivalent	SHINA CORP.
K091474	EASY.TOUCH INSULIN SYRINGE	Jul 09, 2009	Substantially Equivalent	MASTERS HEALTHCARE, LLC.
K091377	BD FLU+ SYRINGE	Jul 02, 2009	Substantially Equivalent	BECTON DICKINSON & CO.
K083686	BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES	Jul 02, 2009	Substantially Equivalent	ANHUI KANGDA MEDICAL PRODUCTS CO., LTD.
K083583	XPRESSE INJECTION SYSTEM	Jun 30, 2009	Substantially Equivalent	NORDSON EFD
K090929	STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE	Jun 12, 2009	Substantially Equivalent	SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
K091315	COVIDIEN EXTENDED TIP APPLICATOR	Jun 05, 2009	Substantially Equivalent	CONFLUENT SURGICAL,INC
K083514	TERUMO SYRINGE WITH/WITHOUT NEEDLE	May 22, 2009	Substantially Equivalent	TERUMO EUROPE N.V.
K090162	EVICEL APPLICATION DEVICE	Feb 20, 2009	Substantially Equivalent	OMRIX BIOPHARMACEUTICALS LTD.
K083457	TACTIPEN	Feb 13, 2009	Substantially Equivalent	HASELMEIER GMBH
K083193	REVAC AUTO RETRACTABLE SAFETY SYRINGE	Feb 13, 2009	Substantially Equivalent	REVOLUTIONS MEDICAL CORPORATION INC
K082674	SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE	Nov 28, 2008	Substantially Equivalent	SPECTRA MEDICAL DEVICES, INC.
K082454	MICROMYST APPLICATOR, MODEL 20-5000	Nov 07, 2008	Substantially Equivalent	COVIDIEN
K081436	INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES	Oct 22, 2008	Substantially Equivalent	INVIRO MEDICAL DEVICES, INC.
K082616	HASELMEIER PEN 8	Sep 26, 2008	Substantially Equivalent	HASELMEIER GMBH
K081547	BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC	Sep 08, 2008	Substantially Equivalent	BIO-MED U.S.A., INC.
K081241	WEIGAO EMPTY CARTRIDGE SYRINGE	Sep 08, 2008	Substantially Equivalent	SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
K081524	SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L	Jul 29, 2008	Substantially Equivalent	SPECTRA MEDICAL DEVICES, INC.
K080989	UNIVERSAL VIAL ACCESS SPIKE	May 02, 2008	Substantially Equivalent	ICU MEDICAL, INC
K072790	CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008	Jan 11, 2008	Substantially Equivalent	CONFLUENT SURGICAL,INC
K072654	PATIENT SAFE SYRINGE	Dec 14, 2007	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K072330	CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM	Dec 06, 2007	Substantially Equivalent	BIOMET, INC.
K070856	ICU MEDICAL SINGLE-USE SYRINGE	Oct 05, 2007	Substantially Equivalent	ICU MEDICAL, INC
K072299	POWRSYRINGE ASPIRATOR	Oct 04, 2007	Substantially Equivalent	PINYONS MEDICAL TECHNOLOGY, INC.
K072345	POWRSYRINGE MONITOR	Sep 21, 2007	Substantially Equivalent	PINYONS MEDICAL TECHNOLOGY, INC.
K072318	POWRSYRINGE INJECTOR	Sep 21, 2007	Substantially Equivalent	PINYONS MEDICAL TECHNOLOGY, INC.
K062865	SMALL VOLUME SYRINGE	Aug 23, 2007	Substantially Equivalent	ALCON LABORATORIES
K071459	B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES	Aug 16, 2007	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K071126	CRYOSEAL FS APPLICATOR SYSTEM	Aug 16, 2007	Substantially Equivalent	THERMOGENESIS CORP.
K071027	TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE	Jul 20, 2007	Substantially Equivalent	TRIBOFILM RESEARCH, INC.
K070936	WELMED HYPODERMIC SYRINGE	Jul 16, 2007	Substantially Equivalent	WELMED INC.
K071630	TERUMO 31G THINPRO INSULIN SYRINGE	Jul 11, 2007	Substantially Equivalent	TERUMO MEDICAL CORP.
K070917	FEEL-JECT INSULIN SYRINGE	Jun 20, 2007	Substantially Equivalent	FEEL TECH
K070633	GENIE, MODEL CH-200	Jun 05, 2007	Substantially Equivalent	ICU MEDICAL, INC
K070814	MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP	May 30, 2007	Substantially Equivalent	CONFLUENT SURGICAL,INC
K070575	EVICEL APPLICATION DEVICE	May 29, 2007	Substantially Equivalent	OMRIX BIOPHARMACEUTICALS LTD.
K070264	50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB	May 29, 2007	Substantially Equivalent	TERUMO EUROPE N.V.
K071108	TEXIUM SYRINGE	May 24, 2007	Substantially Equivalent	CARDINAL HEALTH, ALARIS PRODUCTS
K070100	HASELMEIER PEN	Mar 21, 2007	Substantially Equivalent	HASELMEIER SARL
K063348	TOP FINE INSULIN SYRINGE	Mar 01, 2007	Substantially Equivalent	DAEJIN TECH MEDICAL MANUFACTURING CO., LTD.
K063535	CAPTION APPLICATOR	Feb 26, 2007	Substantially Equivalent	SMITH & NEPHEW, INC.
K062753	FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC, 20CC, 50CC	Feb 08, 2007	Substantially Equivalent	SURGIMED, INC.
K063851	AUTO-FILL SYRINGE KIT, MODEL 7600	Jan 26, 2007	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K063613	MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE	Dec 26, 2006	Substantially Equivalent	TERUMO MEDICAL CORP.
K062986	MEDTRONIC GRAFT DELIVERY SYRINGE	Dec 08, 2006	Substantially Equivalent	MEDTRONIC SOFAMOR DANEK USA, INC.
K062702	ULTICARE DISPOSABLE SYRINGES AND NEEDLES	Nov 29, 2006	Substantially Equivalent	ULTIMED, INC.
K063280	INJEKT SYRINGE	Nov 17, 2006	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K062260	OSTEOBOOST-BMA	Oct 26, 2006	Substantially Equivalent	ORTHOS LIMITED
K062365	ARTHREX ASPIRATE KIT	Sep 29, 2006	Substantially Equivalent	ARTHREX, INC.
K061092	BAXTER DUPLOSPRAY MIS APPLICATOR	Sep 13, 2006	Substantially Equivalent	MICROMEDICS, INC.
K062173	MODIFICATION TO BONE GRAFT SYRINGE	Aug 23, 2006	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K061492	MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE	Aug 03, 2006	Substantially Equivalent	TYCO HEALTHCARE
K061275	MEDLINE SYRINGES, MULTIPLE	Jul 19, 2006	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K061039	AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE	Jun 29, 2006	Substantially Equivalent	AMSINO INTERNATIONAL, INC.
K061183	CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093	Jun 01, 2006	Substantially Equivalent	CONFLUENT SURGICAL,INC
K053563	HUMAPEN MEMOIR	Apr 07, 2006	Substantially Equivalent	ELI LILLY AND COMPANY
K053413	TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES	Apr 06, 2006	Substantially Equivalent	TERUMO EUROPE N.V.
K060211	WUZHOU SYRINGE, WITH/WITHOUT NEEDLE	Feb 10, 2006	Substantially Equivalent	WENZHOU WUZHOU GROUP CO. LTD.
K060095	MODIFICATION TO: VACLOK SYRINGE	Feb 10, 2006	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K052773	B. BRAUN 0.2 MICRON FILTER	Jan 24, 2006	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K052667	ARTSANA PISTON AND INSULIN SYRINGES	Nov 25, 2005	Substantially Equivalent	ARTSANA S.P.A.
K052075	PROCEDUR-10	Nov 09, 2005	Substantially Equivalent	AVANCA MEDICAL DEVICES, INC.
K052173	VITAGEL SURGICAL HEMOSTAT SPRAY SET	Oct 19, 2005	Substantially Equivalent	ORTHOVITA, INC.
K052551	DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE	Sep 30, 2005	Substantially Equivalent	DEVON SAFETY PRODUCTS, INC.
K050999	YI XIN STERILE SYRINGE FOR SINGLE USE	Sep 02, 2005	Substantially Equivalent	JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
K051574	NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE	Aug 26, 2005	Substantially Equivalent	NIPRO MEDICAL CORP.
K052034	TERUMO SYRINGE WITH/WITHOUT NEEDLE	Aug 16, 2005	Substantially Equivalent	TERUMO MEDICAL CORP.
K051930	DRUG ACCESS SPIKE	Aug 16, 2005	Substantially Equivalent	MEDEGEN MEDICAL MANUFACTURING SERVICES
K051720	SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE	Jul 25, 2005	Substantially Equivalent	SYNTHES (USA)
K050998	CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063	Jun 15, 2005	Substantially Equivalent	CONFLUENT SURGICAL,INC
K050753	STRYKER DISCMONITOR	May 18, 2005	Substantially Equivalent	STRYKER INSTRUMENTS
K050495	EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)	May 02, 2005	Substantially Equivalent	BAXTER HEALTHCARE CORP., BIOSCIENCE
K043261	HARVEST GRAFT DELIVERY SYRINGE	Mar 11, 2005	Substantially Equivalent	HARVEST TECHNOLOGIES, CORP.
K042500	DUOPROSS SYRINGES	Feb 22, 2005	Substantially Equivalent	DUOPROSS MEDITECH CORPORATION
K042486	PROCEDUR 10 SYRINGE DEVICE	Jan 21, 2005	Substantially Equivalent	AVANCA MEDICAL DEVICES, INC.
K043172	TRUGRAFT BGS SYRINGE, MODEL 600-041	Jan 07, 2005	Substantially Equivalent	OSTEOBIOLOGICS, INC.
K042588	CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093	Dec 09, 2004	Substantially Equivalent	CONFLUENT SURGICAL,INC
K042547	DRAGON HEART PISTON SYRINGE	Dec 01, 2004	Substantially Equivalent	DRAGON HEART MEDICAL DEVICES CO., LTD.
K042314	SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE	Nov 22, 2004	Substantially Equivalent	BIOGEN
K042934	1BD SOLOSHOT IX SYRINGE	Oct 28, 2004	Substantially Equivalent	BECTON DICKINSON & CO.
K033589	BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR	Oct 04, 2004	Substantially Equivalent	MICROMEDICS, INC.
K041830	MAGELLAN RATIO DISPENSER KIT	Sep 29, 2004	Substantially Equivalent	MEDTRONIC PERFUSION SYSTEMS
K041991	ASPIREX - BONE MARROW ASPIRATE KIT	Sep 16, 2004	Substantially Equivalent	ISOTIS ORTHOBIOLOGICS, INC
K041976	SMITH & NEPHEW GRAFT DELIVERY SYSTEM	Aug 23, 2004	Substantially Equivalent	SMITH & NEPHEW, INC.
K041504	HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01	Aug 06, 2004	Substantially Equivalent	HAEMACURE CORP.
K041344	OPEN BORE SYRINGE	Jul 16, 2004	Substantially Equivalent	ISOTIS NV
K041084	CLIP-ON SPACER 20%; 40%; 50%	Jul 15, 2004	Substantially Equivalent	SERONO, INC.
K033739	PHYSICIAN INDUSTRIES' DURAMETER SYRINGE	Jul 12, 2004	Substantially Equivalent	PHYSICIAN INDUSTRIES, INC.
K041590	AUTODETECT SYRINGE	Jun 23, 2004	Substantially Equivalent	INDIGO ORB, INC.
K033721	VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT	Feb 13, 2004	Substantially Equivalent	VASCULAR SOLUTIONS, INC.
K033794	ULTICARE DISPOSABLE SYRINGE 3 ML/CC	Dec 30, 2003	Substantially Equivalent	ULTIMED, INC.
K033166	KACEY INSULIN SYRINGE	Dec 12, 2003	Substantially Equivalent	KACEY, INC.
K030683	NIPRO DISPOSABLE SYRINGES	Oct 31, 2003	Substantially Equivalent	NIPRO MEDICAL CORP.
K031394	AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE	Jul 25, 2003	Substantially Equivalent	AMERICAN SYRINGE COMPANY
K021993	SHANCHUAN SYRINGE	Jun 03, 2003	Substantially Equivalent	SHANGDONG ZIBO SHANCHUAN MEDICAL INSTRUMENTS CO.
K030208	IMBIBE II SYRINGE	Apr 16, 2003	Substantially Equivalent	ORTHOVITA, INC.
K023074	IMBIBE BONE MARROW ASPIRATION SYRINGE	Mar 11, 2003	Substantially Equivalent	ORTHOVITA, INC.
K024052	MERIT MEDICAL 1-ML SYRINGE	Feb 21, 2003	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K023752	BD INTEGRA SYRINGE	Feb 07, 2003	Substantially Equivalent	BD
K024112	BD INSULIN SYRINGE	Jan 09, 2003	Substantially Equivalent	BECTON DICKINSON & CO.
K023271	TERUMO SYRINGE WITH/WITHOUT NEEDLE	Dec 18, 2002	Substantially Equivalent	TERUMO MEDICAL CORP.
K023108	STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE	Dec 03, 2002	Substantially Equivalent	ATLANTIC PRODUCTS, INC.
K022159	PISTON SYRINGE & HYPODERMIC NEEDLE	Nov 07, 2002	Substantially Equivalent	INTERNATIONAL MEDSURG CONNECTION
K022495	GETTIG DISPOSABLE SYRINGES	Oct 08, 2002	Substantially Equivalent	GETTIG PHARMACEUTICAL INSTRUMENT CO.
K023088	BONE GRAFT SYRINGE, MODEL 8600-00X0	Oct 02, 2002	Substantially Equivalent	WRIGHT MEDICAL TECHNOLOGY, INC.
K022246	MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM	Aug 02, 2002	Substantially Equivalent	DEPUY ACROMED
K021084	LIGHT SABER SPINAL NEEDLE	Jul 03, 2002	Substantially Equivalent	MINRAD, INC.
K021071	PCCS GRAFT DELIVERY SYSTEM	Jul 01, 2002	Substantially Equivalent	BIOMET, INC.
K014114	GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX	Jun 26, 2002	Substantially Equivalent	NIPRO DIABETES SYSTEMS, INC.
K020666	DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML	Jun 24, 2002	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K014088	DUPLOREACH	Jun 07, 2002	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K021197	SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16	Apr 26, 2002	Substantially Equivalent	HOSUK CO., LTD.
K020252	SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2	Apr 05, 2002	Substantially Equivalent	HARVEST TECHNOLOGIES, CORP.
K020147	MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP	Apr 03, 2002	Substantially Equivalent	MEDTRONIC PERFUSION SYSTEMS
K014073	HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE	Feb 13, 2002	Substantially Equivalent	PORTEX, INC.
K012868	MICROMEDICS FIBRIJET AEROSOL APPLICATOR	Oct 29, 2001	Substantially Equivalent	MICROMEDICS, INC.
K011087	ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE	Sep 19, 2001	Substantially Equivalent	ORTHOVITA, INC.
K011176	REUSABLE GLASS SYRINGES	Aug 10, 2001	Substantially Equivalent	LOCKETT MEDICAL CORP.
K011951	EZ SYRINGE	Aug 02, 2001	Substantially Equivalent	OWEN MUMFORD, LTD.
K010692	THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM	Jun 29, 2001	Substantially Equivalent	SPINTECH, INC.
K010708	APPLICATOR TIP/DUAL SPRAYER KIT	Apr 30, 2001	Substantially Equivalent	INTERPORE CROSS INTL.
K010890	BD ULTRA-FINE II INSULIN SYRINGE-MINI NEEDLE, MODEL 30G * 3/16 (5MM)	Apr 19, 2001	Substantially Equivalent	BECTON DICKINSON AND CO.
K010359	INNOVO	Mar 14, 2001	Substantially Equivalent	NOVO NORDISK A/S
K003571	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	Feb 12, 2001	Substantially Equivalent	TERUMO MEDICAL CORP.
K002381	PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES	Jan 11, 2001	Substantially Equivalent	PENTAFERTE S.R.L.
K002717	STERILE PISTON SYRINGE	Jan 08, 2001	Substantially Equivalent	ABBOTT LABORATORIES
K002127	INJECTRITE-C15 AND INJECTRITE-C30	Dec 29, 2000	Substantially Equivalent	STERLING MEDIVATIONS, INC.
K002569	GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES	Dec 12, 2000	Substantially Equivalent	MALGAM ENT., INC.
K003193	DUPLOGRIP	Nov 07, 2000	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K002921	SUREONE INSULIN SYRINGE	Oct 18, 2000	Substantially Equivalent	HOSUK CO., LTD.
K001731	AVID-NIT LOSS OF RESISTANCE SYRINGE	Aug 29, 2000	Substantially Equivalent	AVID MEDICAL, INC.
K981089	TISSOMAT AND SPRAY SET	Jul 05, 2000	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K001474	TERUMO U-100 INSULIN SYRING	Jun 09, 2000	Substantially Equivalent	TERUMO MEDICAL CORP.
K000747	UNIVEC TWO PIECE SYRINGE	Jun 08, 2000	Substantially Equivalent	UNIVEC, INC.
K992404	THE WAND	Jun 06, 2000	Substantially Equivalent	SPINTECH, INC.
K000456	HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2	Jun 01, 2000	Substantially Equivalent	HARVEST TECHNOLOGIES, LLC.
K000438	MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER	May 03, 2000	Substantially Equivalent	BIOSURGICAL CORP.
K994023	HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01	Apr 25, 2000	Substantially Equivalent	HAEMACURE CORP.
K994230	ULTICARE DISPOSABLE SYRINGE	Mar 24, 2000	Substantially Equivalent	ULTIMED, INC.
K993017	PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE	Feb 25, 2000	Substantially Equivalent	SHIN CHANG MEDICAL CO., LTD.
K993995	VEIN ENTRY INDICATOR DEVICE (VEID)	Feb 14, 2000	Substantially Equivalent	VASCULAR TECHNOLOGIES LTD.
K000144	NIPRO INSULIN SYRINGE	Feb 11, 2000	Substantially Equivalent	NIPRO MEDICAL CORP.
K000048	SEALOUETTE FIBRIN SEALANT EXTENDED DROPLET APPLICATOR, MODEL TE-1	Jan 31, 2000	Substantially Equivalent	BIOSURGICAL CORP.
K994253	VACLOK SYRINGE	Jan 05, 2000	Substantially Equivalent	MERIT MEDICAL SYSTEMS, INC.
K993666	DISETRONIC PEN P100	Nov 22, 1999	Substantially Equivalent	DISETRONIC MEDICAL SYSTEMS
K992351	SEALOUETTE FIBRIN SEALANT APPLICATOR	Oct 08, 1999	Substantially Equivalent	BIOSURGICAL CORP.
K992802	TERUMO U-100 INSULIN SYRINGE	Sep 09, 1999	Substantially Equivalent	TERUMO MEDICAL CORP.
K991225	MTI 1 ML SYRINGE	Jul 08, 1999	Substantially Equivalent	MICRO THERAPEUTICS, INC.
K990020	TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC	Jun 24, 1999	Substantially Equivalent	TE ME NA S.A.R.L.
K991758	MONOJECT INSULIN SYRINGE	Jun 14, 1999	Substantially Equivalent	THE KENDAL CO.
K991039	EASYSAFE RETRACTING NEEDLE SYRINGE	May 21, 1999	Substantially Equivalent	SAF-T-MED, INC.
K984017	ALLISON MEDICAL INSULIN SYRINGE (AMIS)	Mar 04, 1999	Substantially Equivalent	ALLISON MEDICAL, INC.
K983430	LITE-TOUCH SYRINGE	Feb 09, 1999	Substantially Equivalent	MEDICORE, INC.
K983994	UNIFINE	Jan 08, 1999	Substantially Equivalent	Owen Mumford USA, Inc.
K983974	OWEN MUMFORD 3ML AUTOPEN	Dec 21, 1998	Substantially Equivalent	Owen Mumford USA, Inc.
K982966	DISETRONIC PEN	Oct 19, 1998	Substantially Equivalent	DISETRONIC MEDICAL SYSTEMS
K980078	PENETREASE	Oct 16, 1998	Substantially Equivalent	P.T. PANCA PUSAKA DELI
K982842	HUMAPEN AND HUMAPEN ERGO	Sep 25, 1998	Substantially Equivalent	ELI LILLY AND CO.
K982018	LIGHT SABER ASPIRATION NEEDLE	Aug 07, 1998	Substantially Equivalent	MINRAD, INC.
K972728	STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)	Jul 15, 1998	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K981140	MINRAD DRTS LIGHT SABER SYRINGE	Jun 25, 1998	Substantially Equivalent	MINRAD, INC.
K980580	BECTON DICKINSON SYRINGES	Jun 25, 1998	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K981797	B-D PEN ULTRA	Jun 12, 1998	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K980987	BECTON DICKINSON SYRINGE	Jun 11, 1998	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K963364	GLASS VAN GLASS SYRINGES	May 01, 1998	Substantially Equivalent	MYCO MEDICAL SUPPLIES, INC.
K980796	TERUMO ALLERGY SYRINGE	Apr 02, 1998	Substantially Equivalent	TERUMO CORP.
K980755	B-D E ML PEN	Apr 02, 1998	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K980181	TERUMO DISPOSABLE HYPODERMC SYRINGE	Apr 02, 1998	Substantially Equivalent	TERUMO MEDICAL CORP.
K972900	ULTRASAFE MODEL T200 INJECTOR	Feb 26, 1998	Substantially Equivalent	SAFETY SYRINGES, INC.
K972877	ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD	Feb 26, 1998	Substantially Equivalent	SAFETY SYRINGES, INC.
K970419	DAXOR MAX100 SYRINGE (MAX100)	Dec 22, 1997	Substantially Equivalent	DAXOR CORPORATION
K973510	DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)	Dec 08, 1997	Substantially Equivalent	IMMUNO-U.S., INC.
K972878	ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300	Oct 30, 1997	Substantially Equivalent	SAFETY SYRINGES, INC.
K964597	BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE	Sep 08, 1997	Substantially Equivalent	BIOSURGICAL CORP.
K971664	RAMY PISTON SYRINGE	Jul 25, 1997	Substantially Equivalent	ALSHIFA MEDICAL SYRINGES MFG. CO., LTD.
K972452	RAMY INTEGRATED NEEDLE SYRINGE	Jul 24, 1997	Substantially Equivalent	ALSHIFA MEDICAL SYRINGES MFG. CO., LTD.
K964230	CORELIFE	Jul 24, 1997	Substantially Equivalent	CORE HEALTHCARE LTD.
K965030	BRANNON ARTERIO-VENOUS PORTSYRINGE	Mar 04, 1997	Substantially Equivalent	VASCULAR LOGICS, INC.
K962084	OMNICAN SYRINGE	Feb 10, 1997	Substantially Equivalent	B. BRAUN MEDICAL AG
K964060	COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE	Dec 24, 1996	Substantially Equivalent	TRAVENOL LABORATORIES (ISRAEL) LTD.
K945410	IRT LOCKING SYRINGE	Dec 19, 1996	Substantially Equivalent	INTERVENTIONAL RESEARCH TECHNOLOGIES
K963260	DRESSING CHANGE TRAYS	Nov 22, 1996	Substantially Equivalent	BUSSE HOSPITAL DISPOSABLES, INC.
K962042	GLASS SYRINGE	Oct 08, 1996	Substantially Equivalent	ISPG, INC.
K962329	GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10	Sep 12, 1996	Substantially Equivalent	GLOBAL MEDICAL PRODS, INC.
K962614	SHIFA STERILE DISPOSABLE SYRINGES	Sep 06, 1996	Substantially Equivalent	INTERNATIONAL REGULATORY CONSULTANTS
K955606	PISTON SYRINGE	Jul 25, 1996	Substantially Equivalent	MEDICAL SURGICAL INTL.
K960882	CONTROL SYRINGE	Jul 08, 1996	Substantially Equivalent	LOUISVILLE LABORATORIES, INC.
K960049	BRANNON PORTSYRINGE	May 24, 1996	Substantially Equivalent	JAMES K. BRANNON
K960047	BRANNON PEDI PORTSYRINGE	May 24, 1996	Substantially Equivalent	JAMES K. BRANNON
K953940	TERUMO RETRACTABLE NEEDLE (RN) SYRINGE	May 21, 1996	Substantially Equivalent	TERUMO MEDICAL CORP.
K955282	THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS	May 06, 1996	Substantially Equivalent	THERMOGENESIS CORP.
K960248	GENERAL PROCEDURE KIT	Apr 12, 1996	Substantially Equivalent	PHYSICIAN INDUSTRIES, INC.
K955164	S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)	Mar 20, 1996	Substantially Equivalent	HABLEY MEDICAL TECHNOLOGY CORP.
K950666	UNIQUE NEEDLE WITH FIRM GRIP SHIELD	Feb 16, 1996	Substantially Equivalent	UNIQUE MANAGEMENT ENT., INC.
K950245	UNIQUE NEEDLE	Dec 06, 1995	Substantially Equivalent	UNIQUE MANAGEMENT ENT., INC.
K953626	SYRINGE MAGNIFIER	Dec 01, 1995	Substantially Equivalent	INNOVATIVE PREMIUMS, INC.
K950969	DISPOSABLE SYRINGE	Nov 29, 1995	Substantially Equivalent	SURGIPLAST LTD.
K954064	BECTON DICKINSON SYRINGSE	Nov 21, 1995	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K954337	GENOTROPIN MIXER	Nov 13, 1995	Substantially Equivalent	PHARMACIA, INC.
K951919	B-D PEN ULTRA	Oct 24, 1995	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K954189	EASI-JECTOR CONTROL SYSTEM	Oct 19, 1995	Substantially Equivalent	NORTH, INC.
K951025	PISTON SYRINGE	Oct 19, 1995	Substantially Equivalent	PHARMACIA, INC.
K952201	PORT-A-CATH ACCESS KIT	Oct 04, 1995	Substantially Equivalent	MEDI-FLEX HOSPITAL PRODUCTS, INC.
K952553	ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE	Oct 03, 1995	Substantially Equivalent	ALPHA MEDICA
K944542	REUSABLE ALL - GLASS SYRINGES	Sep 29, 1995	Substantially Equivalent	TOP SYRINGE MFG. CO.
K951980	COLLAPSIBLE HYPODERMIC SYRINGE	Sep 22, 1995	Substantially Equivalent	ROMAN VLADIMIRSKY
K952918	PTFE SYRINGE FILTER	Sep 15, 1995	Substantially Equivalent	B. BRAUN MEDICAL, INC.
K950824	STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS	Aug 25, 1995	Substantially Equivalent	STRYKER CORP.
K951918	SURGICAL TECHNOLOGIES, INC. SYRINGE	Jul 20, 1995	Substantially Equivalent	SURGICAL TECHNOLOGIES, INC.
K945592	VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE	Jul 14, 1995	Substantially Equivalent	VLV ASSOCIATES, INC.
K951871	PISTON SYRINGE	Jun 21, 1995	Substantially Equivalent	BAXA CORP.
K951619	UNIVEC NONREUSABLE LOCKING SYRINGE	Jun 06, 1995	Substantially Equivalent	UNIVEC, INC.
K945797	STERILE EMPTY PCA SYRINGE	May 19, 1995	Substantially Equivalent	INTL. MEDICATION SYSTEMS, LTD.
K942159	NOVOPEN 1.5	Apr 26, 1995	Substantially Equivalent	NOVO NORDISK PHARMACEUTICALS, INC.
K950133	HYPODERMIC SYRINGE PISTON	Apr 13, 1995	Substantially Equivalent	ISPG, INC.
K946190	DRUG DISPENSING SPIKE	Mar 17, 1995	Substantially Equivalent	GELMAN SCIENCES, INC.
K945715	MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES	Mar 01, 1995	Substantially Equivalent	SHERWOOD MEDICAL CO.
K945588	DISPOSABLE 1CC SYRINGE WITH LUER LOCK	Feb 10, 1995	Substantially Equivalent	INTERVENTIONAL THERAPEUTICS CORP.
K940635	SAFE-1(TM) SYRINGE	Jan 31, 1995	Substantially Equivalent	SAFETY 1ST MEDICAL, INC.
K942394	SAFE VENT SYSTEM	Jan 27, 1995	Substantially Equivalent	INCUTECH, INC.
K945225	DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES	Jan 26, 1995	Substantially Equivalent	MYCO MEDICAL SUPPLIES, INC.
K944920	CG DISPOSABLE SYRINGE	Dec 20, 1994	Substantially Equivalent	FORTUNIQUE MEDICAL PRODUCTS
K936015	DISPOSABLE DISC FILTER	Dec 12, 1994	Substantially Equivalent	MEDI-DOSE, INC.
K944355	NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES	Dec 07, 1994	Substantially Equivalent	NISSHO CORP.
K941589	SYRINGE FILTER DEVICES	Sep 06, 1994	Substantially Equivalent	GELMAN SCIENCES, INC.
K941020	DRUG RECONSTITUTION FILTER DEVICE	Aug 10, 1994	Substantially Equivalent	GELMAN SCIENCES, INC.
K942221	IRRIGATION TRAY WITH PISTON SYRINGE	Aug 05, 1994	Unknown	TRINITY LABORATORIES, INC.
K942615	SYRINGE	Jul 21, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K941095	MEDSAVER SYRINGE	Jun 17, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K935092	CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM	Jun 10, 1994	Unknown	CONTOUR FABRICATORS OF FLORIDA, INC.
K941032	UNKNOWN	May 27, 1994	Substantially Equivalent	GELMAN SCIENCES, INC.
K941657	BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE	May 26, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K941562	1ML LUER-LOK SYRINGE	May 26, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K941545	ADVANTAGE SYRINGE	May 23, 1994	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K925822	CUSTOM SYRIGENE KITS	Apr 22, 1994	Substantially Equivalent	SYRIGENE MEDICAL TECHNOLOGIES, INC.
K933335	RIVER VIAL ADAPTER	Mar 01, 1994	Substantially Equivalent	RIVER MEDICAL, INC.
K931472	CAREJECT DISPOSABLE SYRINGE AND NEEDLE	Feb 22, 1994	Substantially Equivalent	CAREWELL MEDIPRODUCTS, LTD.
K934561	ONE TIME VIAL ACCESS SPIKE	Feb 10, 1994	Substantially Equivalent	ICU MEDICAL, INC.
K920039	MEDIJECT DISPOSABLE SYRINGES	Feb 09, 1994	Substantially Equivalent	P.T. IGAR JAYA
K932001	ALLISON MEDICAL SYRINGE	Jan 21, 1994	Substantially Equivalent	ALLISON MEDICAL, INC.
K932361	BASIC SKIN PREP TRAY	Dec 13, 1993	Unknown	MCBAR INDUSTRIES
K923321	EDGE SYRINGES AND NEEDLES	Sep 28, 1993	Substantially Equivalent	TRICO INTL., INC.
K931095	SPRING LOADED SYRINGE	Sep 16, 1993	Substantially Equivalent	ACACIA, INC.
K931632	I.D.A. SYRINGES	Aug 24, 1993	Substantially Equivalent	PT HASOON CHANDRA
K930791	AMERICAN POWER CONVERSIONS, BACK-UPS 600	Aug 06, 1993	Substantially Equivalent	BIO CLINIC CO.
K924511	MONOJECT(R) 6 CC SAFETY SYRINGE	Jul 29, 1993	Substantially Equivalent	SHERWOOD MEDICAL CO.
K925548	FIBRACOL COLLAGEN-ALGINATE DRESSING	Jul 13, 1993	Substantially Equivalent	JOHNSON & JOHNSON MEDICAL, INC.
K923183	GENESIS SPRAY TIP ATOMIZER	Jul 13, 1993	Substantially Equivalent	MAI
K930847	ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY	Jul 12, 1993	Unknown	SHERWOOD MEDICAL CO.
K921908	NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE	Jun 29, 1993	Substantially Equivalent	NOVO NORDISK PHARMACEUTICALS, INC.
K930321	BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.	May 17, 1993	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K930342	BECTON DICKINSON ARTERIAL BLOOD GAS KITS	Apr 07, 1993	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K926007	ACCESSORY TO PISTON SYRINGE	Feb 23, 1993	Substantially Equivalent	MARTECH MEDICAL PRODUCTS, INC.
K915780	RACK AND SYRINGES	Jan 27, 1993	Substantially Equivalent	NORMECA CORP.
K924072	BECTON DICKINSON SAFETY-LOK SYRINGE	Dec 17, 1992	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K922522	MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES	Nov 25, 1992	Substantially Equivalent	SHERWOOD MEDICAL CO.
K922041	PRIMARY SURGICAL DRESSING TRAY	Nov 06, 1992	Unknown	TRANSIDYNE GENERAL CORP.
K922190	LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER	Oct 23, 1992	Unknown	ADVANCED SURGICAL, INC.
K923645	VISITEC ASPIRATING SYRINGE	Sep 30, 1992	Substantially Equivalent	VISITEC CO.
K921833	ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD	Sep 21, 1992	Unknown	ETHICON, INC.
K915676	SPLATTER SHIELD	Sep 11, 1992	Substantially Equivalent	CHATHAMBOROUGH RESEARCH GROUP, INC.
K912437	IRRIGATING SYRINGE	Jul 13, 1992	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K920422	B-D INTERLINK SYRINGE CANNULA	Apr 29, 1992	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K920321	BECTON DICKINSON SAFETY-LOK SYRINGE	Apr 20, 1992	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K920398	CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT	Apr 15, 1992	Substantially Equivalent	MEDI-FLEX HOSPITAL PRODUCTS, INC.
K913541	NEO-THOR THORACOSTOMY KIT	Apr 09, 1992	Substantially Equivalent	INTL. MEDICAL DEVICES LTD.
K913540	PEDIA-THOR THORACOSTOMY KIT	Apr 09, 1992	Substantially Equivalent	INTL. MEDICAL DEVICES LTD.
K913602	IDEAS' PORT	Jan 02, 1992	Unknown	IDEAL MEDICAL, INC.
K913114	TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT	Jan 02, 1992	Unknown	GERARD MEDICAL ENTERPRISES, INC.
K911440	RAPI-JECT(R) SYRINGE	Dec 30, 1991	Substantially Equivalent	DAVID BULL LABORATORIES, USA, INC.
K913694	PALCO LABS LOADMATIC	Dec 17, 1991	Substantially Equivalent	PALCO LABORATORIES, INC.
K913235	DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH	Oct 31, 1991	Substantially Equivalent	DAVOL, INC.
K912330	B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204	Oct 11, 1991	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K912111	MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE	Oct 08, 1991	Substantially Equivalent	GERARD MEDICAL ENTERPRISES, INC.
K902401	CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM	Oct 08, 1991	Substantially Equivalent	BURRON MEDICAL, INC.
K910731	DISPOSABLE RETRACTABLE NEEDLE SYRINGE	May 07, 1991	Substantially Equivalent	SAFE TECH MEDICAL PRODUCTS, INC.
K910520	SAFETYSNAP SAFETY SYRINGE	Apr 16, 1991	Substantially Equivalent	U.S. MEDICAL INSTRUMENTS, INC.
K905384	DAVID SIMMONDS ANESTHESIA EXTENSION TUBES	Mar 22, 1991	Substantially Equivalent	SPARTA SURGICAL CORP.
K904620	STERAID DISPOSABLE SYRINGE	Mar 15, 1991	Substantially Equivalent	DISPOSABLE MEDI-AIDS LTD.
K902178	YUEFA DISPOSABLE SYRINGE	Dec 21, 1990	Substantially Equivalent	BLUE & RED CORP.
K902157	JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR	Nov 29, 1990	Unknown	JOHNSON & JOHNSON MEDICAL, INC.
K904382	SAFE-T-STIK	Oct 17, 1990	Substantially Equivalent	XIKON TECHNOLOGY
K903426	INSULIN SYRINGE GUIDE	Sep 26, 1990	Substantially Equivalent	BAY STATE ANESTHESIA, INC.
K895980	SHARGHP INSULIN SYRINGES	Sep 07, 1990	Substantially Equivalent	SHARGH PHARMACEUTICAL CO., INC.
K895810	SHARGHP SYRINGES, WITH AND WITHOUT NEEDLE	Sep 07, 1990	Substantially Equivalent	SHARGH PHARMACEUTICAL CO., INC.
K901546	NEEDLEPOINT GUARD	Jul 02, 1990	Substantially Equivalent	NEEDLEPOINT GUARD, INC.
K902346	DISPOSABLE CORONARY CONTROL SYRINGE	Jun 26, 1990	Substantially Equivalent	ADVANCE MEDICAL DESIGNS, INC.
K901508	RETRAX SAFETY SYRINGE	Jun 14, 1990	Substantially Equivalent	RETRAX, INC.
K901203	HYPODERMIC SYRINGE LUER LOK	Jun 06, 1990	Substantially Equivalent	WARE-MEDICS GLASS WORKS, INC.
K900857	NON STERILE PARENTERAL SUPPLY KIT	May 22, 1990	Unknown	INTERMED, INC.
K900687	SYRINGE DISPOSAL SYSTEM	May 18, 1990	Substantially Equivalent	NATIONAL SYRINGE DISPOSAL, INC.
K897105	CHEMO-SHIELD	Mar 19, 1990	Substantially Equivalent	VISION PLASTICS, INC.
K895890	AUTOPEN	Feb 16, 1990	Substantially Equivalent	ULSTER SCIENTIFIC, INC.
K896722	PISTON SYRINGE	Jan 24, 1990	Substantially Equivalent	SAFE TECH MEDICAL PRODUCTS, INC.
K896086	PROGUARD II(TM)	Jan 24, 1990	Substantially Equivalent	SAFETY-JECT, INC.
K893233	DISPOSABLE NEEDLE, ASPIRATION AND INJECTION	Jan 04, 1990	Substantially Equivalent	PIONEER INTL. CO.
K895831	NEEDLEPOINT GUARD	Dec 01, 1989	Substantially Equivalent	NEEDLEPOINT GUARD, INC.
K895419	DISPOSABLE DISC FILTER	Nov 24, 1989	Substantially Equivalent	THE MEDI-DOSE GROUP
K895220	THE ON-GARD RECAPPER	Nov 08, 1989	Substantially Equivalent	ON-GARD SYSTEMS, INC.
K894206	INTOPO	Oct 27, 1989	Substantially Equivalent	ACACIA, INC.
K895203	EN-TRAP SYRINGE	Oct 18, 1989	Substantially Equivalent	THE MEDTECH GROUP, INC.
K894801	30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES	Sep 19, 1989	Substantially Equivalent	ADVANCE MEDICAL DESIGNS, INC.
K894335	MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR	Sep 12, 1989	Substantially Equivalent	MIDMARK CORP.
K894217	SYRINGE TIP ADAPTOR	Sep 12, 1989	Substantially Equivalent	ACACIA, INC.
K894177	NEEDLE*LESS DRUG VIAL ADAPTER	Sep 12, 1989	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K893862	FLEXGARD SYRINGE PROTECTOR	Aug 09, 1989	Substantially Equivalent	DR. GIL DEL CASTILLO
K892430	DISPOSABLE DISC FILTER	Jul 14, 1989	Substantially Equivalent	THE MEDI-DOSE GROUP
K892428	COMBI-CAP	Jul 14, 1989	Substantially Equivalent	THE MEDI-DOSE GROUP
K892405	NEEDLEPOINT GUARD	May 30, 1989	Substantially Equivalent	UROLOGICAL ASSOC. OF GRAND ISLAND, P.C.
K891467	LOKSHOT PISTON SYRINGE	May 24, 1989	Substantially Equivalent	FLP ENT., INC.
K884841	RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR	Apr 21, 1989	Substantially Equivalent	HALL MEDICAL LABORATORIES
K883073	N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM	Feb 28, 1989	Substantially Equivalent	NATIONAL MEDICAL DEVICE CORP.
K890155	MDP DISPOSABLE SYRINGE	Feb 24, 1989	Substantially Equivalent	MEDIPLAS MARKETING
K884921	HEMO-SANITAS SYRINGE	Feb 09, 1989	Substantially Equivalent	HEMO-SANITAS, INC. C/O GREENBERG IRWIN & WEISINGER
K890082	DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN	Jan 31, 1989	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K884233	QUADROJECT(TM)	Jan 30, 1989	Substantially Equivalent	ELLIS PHARMACEUTICAL CONSULTING, INC.
K882975	RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER	Jan 25, 1989	Substantially Equivalent	RICHMANN LABORATORIES
K881791	STERA DISPOSABLE SYRINGES	Dec 22, 1988	Substantially Equivalent	EXCEL U.S.A.
K884985	MODIFIED 10CC SYRINGE CONTROL RING SET	Dec 20, 1988	Substantially Equivalent	PROCEDURE PRODUCTS, INC.
K884497	CONTROL SYRINGE	Dec 12, 1988	Substantially Equivalent	PROFESSIONAL MEDICAL SERVICES
K884589	FRANTZ MEDICAL SHARPS COLLECTOR	Dec 09, 1988	Substantially Equivalent	FRANKLIN MEDICAL USA, INC.
K881454	RETRACTABLE NEEDLE 3CC SYRINGE	Dec 08, 1988	Substantially Equivalent	KENMAR MEDICAL
K881867	NEEDLE EJECTOR	Nov 22, 1988	Substantially Equivalent	HOWARD, HILLS & HARSH
K881866	NEEDLE REMOVER	Nov 14, 1988	Substantially Equivalent	HOWARD, HILLS & HARSH
K883078	INSULIN SYRINGE	Oct 31, 1988	Substantially Equivalent	SELECT SOURCES, INC.
K883033	PISTON SYRINGE WITH NEEDLE	Oct 31, 1988	Substantially Equivalent	SELECT SOURCES, INC.
K883220	EXTRAVAKIT FOR RADIOLOGICAL APPLICATIONS	Oct 20, 1988	Substantially Equivalent	CANCER TECHNOLOGIES, INC.
K883955	SINGLE-FIL(TM) SYRINGE	Oct 17, 1988	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K883242	EXTRAVAKIT FOR DIMETHYLSULFOXIDE (DMSO)	Oct 12, 1988	Substantially Equivalent	CANCER TECHNOLOGIES, INC.
K883227	SKIFA, PLASTIC DISPOSABLE SYRINGE	Sep 29, 1988	Substantially Equivalent	P.T. SETIO HARTO LTD.
K883744	MANAN HUBER STYLE INFUSION NEEDLE	Sep 28, 1988	Substantially Equivalent	MANAN MEDICAL PRODUCTS, INC.
K883614	CYTOGUARD(R)	Sep 15, 1988	Substantially Equivalent	SURVIVAL TECHNOLOGY, INC.
K883311	COUNT-A-DOSE	Sep 15, 1988	Substantially Equivalent	PAVEL JORDAN & ASSOCIATES, INC.
K882536	OPHTHALMIC PAO VALVE	Sep 09, 1988	Substantially Equivalent	LOOK, INC.
K882403	OPHTHALMIC FLUID INJECTOR	Sep 09, 1988	Substantially Equivalent	TREK MEDICAL PRODUCTS, INC.
K882114	AMISCO U-100 INSULIN SYRINGE	Aug 23, 1988	Substantially Equivalent	AMERICAN INTL. MEDICAL SUPPLY CO.
K881775	BD MICROFINE IV PEN INJECTOR	Aug 23, 1988	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K883094	MX350 (SERIES) CONTROL SYRINGE	Aug 10, 1988	Substantially Equivalent	MEDEX, INC.
K882025	MODIFIED EXTRAVAKIT	Jul 27, 1988	Unknown	EXTRAVAKIT, INC.
K881980	RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE	Jun 28, 1988	Substantially Equivalent	HABLEY MEDICAL TECHNOLOGY CORP.
K880963	HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.	Jun 24, 1988	Substantially Equivalent	BUCKMAN CO., INC.
K882335	DISPOSABLE SYRINGE	Jun 16, 1988	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K880693	MEDSURG MYELOGRAM TRAY	May 11, 1988	Unknown	MEDSURG INDUSTRIES, INC.
K875297	JAMES TENDOS (SYRINGE HOLDER)	Apr 19, 1988	Substantially Equivalent	MED-TEXT INTL.
K880894	ALLERGIST SYRINGES	Mar 31, 1988	Substantially Equivalent	ABCO DEALERS, INC.
K880342	UROSTHESIA	Feb 25, 1988	Substantially Equivalent	MEDICAL RESEARCH INNOVATORS, INC.
K880350	YUE/FA DISPOSABLE SYRINGE	Feb 16, 1988	Substantially Equivalent	HONWAY INTERNATIONAL CO.
K875097	DISPOSABLE SYRINGE	Feb 16, 1988	Substantially Equivalent	CALIFORNIA ENT.
K875148	MEDICRAT, HYPODERMIC SYRINGES & NEEDLES	Feb 11, 1988	Substantially Equivalent	KNOWLTECH IND., INC.
K874807	EXTRAVAKIT	Feb 04, 1988	Unknown	CANCER TECHNOLOGIES, INC.
K874747	10CC SYRINGE CONTROL RING SET	Feb 04, 1988	Substantially Equivalent	PROCEDURE PRODUCTS, INC.
K874579	COEUR CONTROL SYRINGE	Jan 19, 1988	Substantially Equivalent	COEUR LABORATORIES, INC.
K872565	DUOFLO DISPENSER	Dec 29, 1987	Substantially Equivalent	HEMAEDICS, INC.
K871616	CUSTOM PROCEDURE TRAYS	Dec 11, 1987	Unknown	MEDICAL CUSTOM PRODUCTS, INC.
K873709	3 RING ATTACHMENT FOR SYRINGES	Nov 03, 1987	Substantially Equivalent	CONDOR MEDICAL
K873588	10CC CONTROL SYRINGE	Oct 23, 1987	Substantially Equivalent	MEDI-PLAST INTL., INC.
K872805	NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM	Oct 09, 1987	Substantially Equivalent	SQUIBB-NOVO, INC.
K872743	BAXA TUBING SETS (FOR PHARMACY PUMP)	Oct 09, 1987	Substantially Equivalent	BAXA CORP., SUB. OF COOK GROUP, INC.
K872944	LOOK SPRING-ASSIST SYRINGES	Sep 04, 1987	Substantially Equivalent	LOOK, INC.
K872820	SAFETY SYRINGE	Sep 04, 1987	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K871965	JMS NEEDLES AND JMS SYRINGES	Sep 04, 1987	Substantially Equivalent	JMS CO., LTD.
K871443	CASANDRA SYRINGE CAP	Aug 18, 1987	Substantially Equivalent	CASANDRA MEDICAL CORP.
K860688	MONOJECT PHARMACY TRAY	Aug 06, 1987	Substantially Equivalent	SHERWOOD MEDICAL CO.
K871007	ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE	Apr 30, 1987	Substantially Equivalent	HABLEY MEDICAL TECHNOLOGY CORP.
K870518	SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT	Apr 29, 1987	Substantially Equivalent	SURGITEK
K870192	DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE	Apr 16, 1987	Substantially Equivalent	CAN-AM SURGICAL CORP.
K870191	DISPOSABLE SYRINGE WITH NEEDLE	Apr 16, 1987	Substantially Equivalent	CAN-AM SURGICAL CORP.
K870190	DISPOSABLE SYRINGE W/O NEEDLE	Apr 16, 1987	Substantially Equivalent	CAN-AM SURGICAL CORP.
K870078	ACCUPEN(R)	Mar 17, 1987	Substantially Equivalent	ULSTER SCIENTIFIC, INC.
K870018	E-Z JECT INSULIN SYRINGE	Feb 04, 1987	Substantially Equivalent	CAN-AM SURGICAL CORP.
K864541	BT HYPODERMIC SYRINGE	Jan 21, 1987	Substantially Equivalent	BARON TECHNOLOGIES, INC.
K861686	NOVOPEN SYSTEM (INSULIN SYRINGE)	Jan 21, 1987	Substantially Equivalent	SQUIBB-NOVO, INC.
K864407	REFILLABLE SYRINGE	Jan 20, 1987	Substantially Equivalent	MEDFUSION SYSTEMS, INC.
K864781	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC	Dec 29, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864779	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC	Dec 29, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864778	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC	Dec 29, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864777	MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC	Dec 29, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864747	VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES	Dec 29, 1986	Substantially Equivalent	JMS CO., LTD.
K864783	MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC	Dec 23, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864782	MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC	Dec 23, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864780	MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC	Dec 23, 1986	Substantially Equivalent	MAC LEE MEDICAL PRODUCTS
K864414	SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)	Dec 18, 1986	Substantially Equivalent	SEAL SYRINGE CORP.
K864761	USI AUTOJECT INSULIN SYRINGE	Dec 16, 1986	Substantially Equivalent	ULSTER SCIENTIFIC, INC.
K864555	3 RING ATTACHMENT	Dec 01, 1986	Substantially Equivalent	PROFESSIONAL MEDICAL SERVICES
K861276	TAMPER PROOF CAP	May 05, 1986	Substantially Equivalent	INTL. MEDICAL INDUSTRIES
K861153	DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES	Apr 23, 1986	Substantially Equivalent	EXEL INTL.
K853450	STERISTORAGE CONTAINER	Mar 18, 1986	Substantially Equivalent	K-SEVEN INDUSTRIES, INC.
K854877	ACU-SYRINGE W/WO NEEDLES	Feb 19, 1986	Substantially Equivalent	ACUDERM, INC.
K854563	DISPOSABLE SYRINGES & NEEDLES	Dec 09, 1985	Substantially Equivalent	MEDELEC INTL. CORP.
K853120	ADDITIVE EXTENSION SYRINGE	Dec 05, 1985	Substantially Equivalent	ABBOTT LABORATORIES
K852503	R.R. PRONTO SIRINGA	Nov 13, 1985	Substantially Equivalent	MEDICAL HOSPITAL EQUIPMENT
K854255	SPAN / AID SYRINGE	Nov 12, 1985	Substantially Equivalent	SPAN-AMERICA MEDICAL SYSTEMS, INC.
K853838	JMS LCC INSULIN SYRINGE	Oct 16, 1985	Substantially Equivalent	JMS CO., LTD.
K852444	ASIK 'ONCE' SYRINGE	Oct 16, 1985	Substantially Equivalent	PHARMA-PLAST USA, INC.
K852443	PHARMA-PLAST CLINIPAK	Oct 16, 1985	Substantially Equivalent	PHARMA-PLAST USA, INC.
K852990	PAO VALUE	Sep 20, 1985	Substantially Equivalent	ACKARD LABORATORIES
K852819	STERILE DISPOSABLE SYRINGE(3 PIECES)	Sep 20, 1985	Substantially Equivalent	FABERSANITAS, S.A.
K852304	SAFE-N-JECT	Sep 20, 1985	Substantially Equivalent	GERSTNER INTL. TRADE
K852818	STERILE DISPOSABLE SYRINGES(2 PIECES)	Jul 29, 1985	Substantially Equivalent	FABERSANITAS, S.A.
K851523	DISPOSABLE PLASTIC SYRINGES	Jul 24, 1985	Substantially Equivalent	TRANSCOJECT GMBH & CO. KG
K852640	MONOJECT STERILE 35CC SYRINGES	Jul 23, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K852607	MONJECT STERILE 20CC SYRINGES	Jul 23, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K852588	MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES	Jul 23, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K852580	MONOJECT STERILE 60CC SYRINGES	Jul 23, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K852544	MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES	Jul 23, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K851464	PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS	Jul 05, 1985	Substantially Equivalent	PULSE MED, INC.
K851519	FORTUNA DISPOSABLE SYRINGES	Jun 17, 1985	Substantially Equivalent	IMPOR-TEX, INTL., INC.
K851090	MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE	Apr 12, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K851089	MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES	Apr 12, 1985	Substantially Equivalent	SHERWOOD MEDICAL CO.
K850958	BLOOD GAS SAMPLER KIT	Apr 10, 1985	Substantially Equivalent	CHURCHILL CORP.
K844475	SPECIMEN COLLECTION & TRANSPORT SYSTEM	Feb 06, 1985	Substantially Equivalent	PORTABLE MEDICAL LABORATORIES, INC.
K844106	SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY	Jan 14, 1985	Substantially Equivalent	ABCO DEALERS, INC.
K844796	MICRO-BETA U100 SYRINGE	Dec 18, 1984	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K843887	IV JET	Dec 07, 1984	Substantially Equivalent	NUCLEAR CONCEPTS, INC.
K843415	TOP HYPODERMIC SYRINGE LUER LOCK	Dec 07, 1984	Substantially Equivalent	TOP SURGICAL MANUFACTURERS CO.
K844306	GAINOR MEDICAL SYRINGE	Nov 30, 1984	Substantially Equivalent	GAINOR MEDICAL
K843473	PHARMA-PLAST INSULIN SYRINGE	Oct 31, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843472	PHARMA-PLAST SYRINGE WITH NEEDLE	Oct 31, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843471	PHARMA-PLAST SYRINGE	Oct 31, 1984	Substantially Equivalent	ZIMMAR CONSULTING LTD.
K843414	TOP HYPODERMIC SYRINGE PISTON	Sep 07, 1984	Substantially Equivalent	TOP SURGICAL MANUFACTURERS CO.
K841949	DOSE RELEASE OF STERILIZATION LOTS	Sep 05, 1984	Substantially Equivalent	MEDCARE DISP PRODUCTS, INC.
K842227	AIMED DISPOSABLE SYRINGE, VARIOUS SIZES	Jul 23, 1984	Substantially Equivalent	TECH-CONS LTD., INTL.
K841566	HESUNG DISPOSABLE SYRINGE	Jul 17, 1984	Substantially Equivalent	AMKOR TRADING CO.
K841931	DISPO. AES DISPOS. SYRINGE W/NEEDLE	Jul 06, 1984	Substantially Equivalent	HIRSCH CHEMIE LTD.
K841810	MARK5 ARTERIAL BLOOD GAS KIT	Jul 06, 1984	Substantially Equivalent	MARTELL MEDICAL PRODUCTS, INC.
K841578	DISPOSABLE SYRINGE	May 07, 1984	Substantially Equivalent	AVA MEDICAL PRODUCTS OF CANADA, INC.
K840490	FLUID REMOVAL ASSEMBLY	Apr 17, 1984	Substantially Equivalent	ACKRAD LABORATORIES
K833706	CLICK-COUNT U100 INSULIN SYRINGE	Apr 05, 1984	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K840924	SYRINGE, PISTON, ARTERIAL BLOOD SAMPL	Mar 23, 1984	Substantially Equivalent	MEDCARE DISP PRODUCTS, INC.
K834256	PBC SYRINGE IRRIGATING	Mar 23, 1984	Substantially Equivalent	PHILADELPHIA BIOLOGICS CENTER
K840192	PISTON SYRINGE DISPOS. STERILE SYRING	Mar 06, 1984	Substantially Equivalent	INTEREXPO CORP.
K834548	HYPODERMIC SYRINGES & NEEDLES	Mar 06, 1984	Substantially Equivalent	CORDIS CORP.
K834368	SURGICAL DISPOSABLE STERILE & NONSTERIL	Mar 05, 1984	Substantially Equivalent	MARBEX, INC.
K840083	STERILE INSULIN DISPOS. NEEDLE/GREEN	Feb 21, 1984	Substantially Equivalent	LEE MEDICAL INTL., INC.
K840082	STERILE INSULIN DISPOS. NEEDLE/SYRINGE	Feb 21, 1984	Substantially Equivalent	LEE MEDICAL INTL., INC.
K833399	SYRINGE	Jan 10, 1984	Substantially Equivalent	I M, INC.
K834165	SYRINGE	Dec 13, 1983	Substantially Equivalent	ELFA TRADING CO.
K833435	MULTI PURPOSE SYRINGE	Dec 12, 1983	Substantially Equivalent	I M, INC.
K833493	DISPOSABLE SYRINGES & NEEDLES	Nov 29, 1983	Substantially Equivalent	ALDRICH CHEMICAL CO., INC.
K833460	SYRINGE,PISTON NEEDLE, HOLLOW LUMEN	Nov 28, 1983	Substantially Equivalent	ALDRICH CHEMICAL CO., INC.
K832605	TRANCOJECT DISPOSABLE SYRINGES	Nov 14, 1983	Substantially Equivalent	HUBORGA, INC.
K832761	AIR FLUID EXCHANGE PUMP	Oct 19, 1983	Substantially Equivalent	INTEK INT'L, INC.
K832621	TOP DISPOSABLE PLASTIC SYRINGES	Oct 14, 1983	Substantially Equivalent	TOP SURGICAL MANUFACTURERS CO.
K832658	DIRECTOR	Oct 04, 1983	Substantially Equivalent	PHARMACIA, INC.
K832101	STERILE DISPOSABLE SYRINGE	Sep 12, 1983	Substantially Equivalent	LEE MEDICAL INTL., INC.
K823521	STERILE HD CVP TRAY	Apr 08, 1983	Substantially Equivalent	BILL DUDE HOSPITAL DISPOSABLES, INC.
K823537	GLUCOSE REAGENT	Apr 06, 1983	Substantially Equivalent	AC BIOCHEMICAL LABORATORIES, INC.
K823527	SUBCLAVIAN INSERTION KIT	Mar 31, 1983	Substantially Equivalent	CUNNINGHAM WOODLAND, INC.
K823056	THE INGLEFIELD MAGIC RING	Nov 03, 1982	Substantially Equivalent	THE INGLEFIELD CO.
K822774	9110 SYRINGE	Nov 03, 1982	Substantially Equivalent	CARDIAC PACEMAKERS, INC.
K822159	ANGIOUROGRAPHY KIT	Nov 03, 1982	Substantially Equivalent	MALLINCKRODT CRITICAL CARE
K822928	DISPOSABLE MICRO-INFUSION SYSTEM	Oct 26, 1982	Substantially Equivalent	ORANGE MEDICAL INSTRUMENTS, INC.
K822185	LARYNGEAL SYRINGE	Oct 18, 1982	Substantially Equivalent	KELLEHER CORP.
K822760	ARTERIAL LINE KIT	Sep 28, 1982	Substantially Equivalent	MARTELL MEDICAL PRODUCTS, INC.
K822420	REPLAM HYDROXYAPATATITE	Sep 28, 1982	Substantially Equivalent	REPLAM CORP.
K822534	NEEDLES(HYPODERMIC)	Sep 17, 1982	Substantially Equivalent	IMPEX LABORATORIES
K822533	SYRINGES(3-PARTS SINGLE USE)	Sep 17, 1982	Substantially Equivalent	IMPEX LABORATORIES
K822532	SYRINGES(2-PARTS SINGLE USE)	Sep 17, 1982	Substantially Equivalent	IMPEX LABORATORIES
K822238	DISPOSABLE TAIYANG SYRINGE	Aug 25, 1982	Substantially Equivalent	S.D. SUNNYLAND ENTERPRISES, INC.
K822083	U-100 INSULIN SYRINGE	Aug 16, 1982	Substantially Equivalent	TERUMO MEDICAL CORP.
K822029	MONOJET 520 20CC SYRINGES W/NEEDLES	Jul 28, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K821671	DISPO. AES.	Jul 28, 1982	Substantially Equivalent	HIRAOKA NEW YORK, INC.
K821528	SYRINGE, PISTON	Jun 09, 1982	Substantially Equivalent	MEDCARE DISP PRODUCTS, INC.
K821537	HENKE DISPOSABLE SYRINGE	May 28, 1982	Substantially Equivalent	C. B. DUMONT COMPANY, INC.
K821233	DISPOSABLE PLASTIC SYRINGE W/NEEDLE	May 14, 1982	Substantially Equivalent	TAIYANG CORP.
K821096	A-LINER	May 14, 1982	Substantially Equivalent	MARTELL MEDICAL PRODUCTS, INC.
K820384	GLASS SYRINGES, DRUG, LUER LOCK	Apr 15, 1982	Substantially Equivalent	PROCEDURE PRODUCTS, INC.
K820716	MONOJECT 512 SYRINGES W/WO NEEDLES	Apr 14, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K813157	COLORLESS DISPOSIBLE PLASTIC SYRINGES	Apr 14, 1982	Substantially Equivalent	SAM JOO INDUSTRIAL CO., LTD.
K820062	DISPOSABLE PLASTIC SYRINGE & NEEDLE	Apr 01, 1982	Substantially Equivalent	MARSHALL DAVIS, INC.
K820294	BOSTON SYRINGE	Mar 23, 1982	Substantially Equivalent	FRISCO PRODUCTS, INC.
K820449	PHARMACEUTICALS MOD. 1CC-1,2,3 THRU 50CC	Mar 12, 1982	Substantially Equivalent	ABEK CORP.
K820454	THE RED CAP	Mar 08, 1982	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K820164	EMPTY STERILE CARPUJECT	Feb 24, 1982	Substantially Equivalent	STERLING DRUG, INC.
K813646	JMS DISPOSABLE SYRINGE	Jan 28, 1982	Substantially Equivalent	PHILADELPHIA BIOLOGICS CENTER
K813647	PBC SYRINGE	Jan 25, 1982	Substantially Equivalent	PHILADELPHIA BIOLOGICS CENTER
K813480	MONOJECT M560 60CC SYRINGES	Jan 05, 1982	Substantially Equivalent	SHERWOOD MEDICAL CO.
K813175	20CC GLASS CONTROL SYRINGE	Nov 27, 1981	Substantially Equivalent	ABCO DEALERS, INC.
K812888	SYRINGE, PISTON	Nov 10, 1981	Substantially Equivalent	FRISCO PRODUCTS, INC.
K812934	MONOJECT PREFILLED SYRINGES	Nov 06, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K812748	MONOJECT M535 35CC SYRINGE	Oct 23, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K812560	MDM ARTERIAL BLOOD GAS SYRINGE	Oct 09, 1981	Substantially Equivalent	MARTELL MEDICAL PRODUCTS, INC.
K812023	MONOJECT STERILE M506 6CC SYRINGES	Jul 28, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K811505	MONOJECT STERILE M503 3CC SYRINGES	Jun 18, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K811009	PREFILLED PULSATOR SYRINGE	Jun 12, 1981	Substantially Equivalent	CONCORD LABORATORIES, INC.
K811167	FOCUS STERILE SYRINGES	May 21, 1981	Substantially Equivalent	STANFORD LABORATORIES
K810995	PREFILLED PULSATOR SYRINGE	May 21, 1981	Substantially Equivalent	CONCORD LABORATORIES, INC.
K811065	PISTON SYRINGE	May 05, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K803302	PREHEPARINZED SYRINGE	Apr 08, 1981	Substantially Equivalent	THE UNIVERSITY OF CHICAGO
K803204	IRRIGATION PISTON	Jan 21, 1981	Substantially Equivalent	WALPAK CO.
K803198	IRRIGATION SET W/PISTON SYRINGE	Jan 15, 1981	Substantially Equivalent	WALPAK CO.
K802406	CYTOTRAN I BONE MARROW ASPIRATION SYSTEM	Jan 15, 1981	Substantially Equivalent	APPLIED MEDICAL DEVICES, INC.
K801430	CONTROL SYRINGE	Jul 08, 1980	Substantially Equivalent	ABCO DEALERS, INC.
K801311	BURRON MULTI-AD SYRINGE CAP	Jun 17, 1980	Substantially Equivalent	BURRON MEDICAL PRODUCTS, INC.
K792520	ANESTHESIA & HOSPITAL SYRINGE HOLDER	Feb 07, 1980	Substantially Equivalent	MEDICAL INNOVATIONS CORP.
K792033	DYNACOR STERILE BLOOD GAS SPECIMEN TRAY	Nov 16, 1979	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K791660	PREPACELL-BONE MARROW SAMPLER	Sep 12, 1979	Substantially Equivalent	APPLIED MEDICAL DEVICES, INC.
K790409	LOW DEAD SPACE INSULIN SYRINGE	Apr 24, 1979	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K781978	PUNCTURE KIT, DISPOSALBE VEIN	Dec 12, 1978	Substantially Equivalent	ARROW INTL., INC.
K781917	MUCUS ASPIRATOR	Dec 04, 1978	Substantially Equivalent	OVUTIME, INC.
K781154	SYRINGE, INSULIN, HYPOTIP	Aug 10, 1978	Substantially Equivalent	NATIONAL PATENT DEVELOPMENT CORP.
K780602	SYRINGE (IRRIGATION)	Apr 19, 1978	Substantially Equivalent	ABCO DEALERS, INC.
K780600	IRRIGATION TRAY	Apr 19, 1978	Substantially Equivalent	ABCO DEALERS, INC.
K780595	MINI-IRRIGATION TRAY	Apr 19, 1978	Substantially Equivalent	ABCO DEALERS, INC.
K780550	STERILE AIR SYRINGE	Apr 19, 1978	Substantially Equivalent	NATIONAL PATENT DEVELOPMENT CORP.
K772338	SYRINGE, BLOOD, SAMPLING, ARTERIAL	Jan 26, 1978	Substantially Equivalent	C.R. BARD, INC.
K771888	SYRINGE, DISPOSABLE	Oct 21, 1977	Substantially Equivalent	ORTHOPEDIC EQUIPMENT CO., INC.
K771584	ARTEOIAL BLOOD SAMPLING KIT 2D9014	Sep 13, 1977	Substantially Equivalent	TRAVENOL LABORATORIES, S.A.
K771272	DISP. SYRINGES: 2,5 & L0 MI.	Sep 12, 1977	Substantially Equivalent	BERMAN, PCP & CONSULTANTS, INC.
K771359	ALLERGIST PACK SYRINGES	Aug 22, 1977	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K770850	TRAY, BLOOD GAS, ARTERIAL, #4014	Jul 15, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K771205	HYPODERMIC SYRINGE	Jul 14, 1977	Substantially Equivalent	TERUMO AMERICA, INC.
K770852	SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015	Jul 14, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770851	SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016	Jul 14, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770361	TRAY, BLOOD GAS, CAT. NO. 4010	Apr 05, 1977	Substantially Equivalent	CONCORD LABORATORIES, INC.
K770238	OVERDOSE KIT	Apr 05, 1977	Substantially Equivalent	AMERICAN HOSPITAL SUPPLY CORP.
K761158	FLUID DISPENSING SYSTEM	Jan 26, 1977	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K760392	SYRINGES	Nov 02, 1976	Substantially Equivalent	B. BRAUN INSTRUMENTS
K760005	SYRINGE, DISPOSABLE, GLASS & PLASTIC	Aug 23, 1976	Substantially Equivalent	STEWART-NAUMANN LABORATORIES
K760004	SYRINGE, DISPOSABLE, ALL PLASTIC	Aug 23, 1976	Substantially Equivalent	STEWART-NAUMANN LABORATORIES

FEI Numbers

This FDA classification entry is associated with 553 FEI numbers. Click on an entry to view related FDA registrations.

1000100754: 1 registration

1000112877: 433 registrations

1000112968: 424 registrations

1000113657: 15 registrations

1000114185: 228 registrations

1000117446: 10 registrations

1000117748: 143 registrations

1000120776: 18 registrations

1000121130: 25 registrations

1000123222: 187 registrations

1000123689: 3 registrations

1000132370: 44 registrations

1000136269: 265 registrations

1000136478: 184 registrations

1000138054: 760 registrations

1000138447: 15 registrations

1000162947: 1 registration

1000174591: 13 registrations

1000208624: 172 registrations

1000219614: 20 registrations

1000219637: 355 registrations

1000220862: 104 registrations

1000232458: 5 registrations

1000268645: 18 registrations

1000306068: 11 registrations

1000306431: 841 registrations

1000307073: 66 registrations

1000307092: 9 registrations

1000312731: 6 registrations

1000359047: 7 registrations

1000442352: 72 registrations

1000512168: 447 registrations

1000514656: 190 registrations

1000518731: 132 registrations

1000563940: 52 registrations

1017294: 217 registrations

1017768: 16 registrations

1018120: 23 registrations

1018470: 468 registrations

1019003: 12 registrations

1035907: 28 registrations

1036836: 105 registrations

1037885: 40 registrations

1043214: 577 registrations

1043534: 280 registrations

1047843: 371 registrations

1048735: 291 registrations

1211998: 70 registrations

1213809: 17 registrations

1216032: 7 registrations

1217052: 54 registrations

1217831: 11 registrations

1219930: 292 registrations

1220246: 388 registrations

1220477: 911 registrations

1221435: 6 registrations

1313700: 18 registrations

1410248: 5 registrations

1416980: 122 registrations

1417485: 72 registrations

1417592: 699 registrations

1419937: 34 registrations

1420054: 89 registrations

1450662: 954 registrations

1450743: 18 registrations

1518293: 14 registrations

1526439: 314 registrations

1526534: 933 registrations

1643817: 565 registrations

1710034: 25 registrations

1720929: 257 registrations

1721504: 249 registrations

1721676: 747 registrations

1819470: 5 registrations

1825034: 773 registrations

1832816: 43 registrations

1911916: 28 registrations

1915484: 30 registrations

1920898: 9 registrations

1921846: 275 registrations

1928237: 782 registrations

1935627: 169 registrations

2011171: 834 registrations

2022435: 80 registrations

2024024: 189 registrations

2025648: 2 registrations

2025816: 30 registrations

2025870: 5 registrations

2027062: 136 registrations

2027754: 95 registrations

2183425: 20 registrations

2183449: 175 registrations

2183744: 663 registrations

2183771: 15 registrations

2243072: 162 registrations

2244771: 11 registrations

2245304: 497 registrations

2246552: 325 registrations

2433012: 92 registrations

2517117: 1 registration

2518902: 138 registrations

2521402: 104 registrations

2523676: 144 registrations

2647898: 1 registration

2648045: 124 registrations

2648666: 61 registrations

2649614: 45 registrations

2650089: 1 registration

2828: 68 registrations

3000126234: 16 registrations

3000191104: 17 registrations

3000203000: 349 registrations

3000204727: 21 registrations

3000206397: 13 registrations

3000206435: 390 registrations

3000210101: 28 registrations

3000215273: 514 registrations

3000247873: 52 registrations

3000268902: 58 registrations

3000779542: 1 registration

3001124136: 59 registrations

3001236277: 474 registrations

3001236616: 9 registrations

3001236905: 677 registrations

3001239292: 7 registrations

3001451660: 9 registrations

3001570557: 22 registrations

3002091543: 7 registrations

3002579136: 169 registrations

3002655329: 5 registrations

3002669612: 3 registrations

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3002682307: 11 registrations

3002763532: 1 registration

3002806436: 43 registrations

3002806460: 8 registrations

3002806469: 63 registrations

3002806482: 2 registrations

3002806588: 27 registrations

3002806773: 74 registrations

3002806863: 26 registrations

3002806901: 14 registrations

3002806934: 112 registrations

3002806953: 17 registrations

3002807111: 309 registrations

3002807170: 54 registrations

3002807172: 124 registrations

3002807305: 32 registrations

3002807315: 100 registrations

3002808169: 29 registrations

3002808190: 15 registrations

3002808227: 54 registrations

3002808269: 693 registrations

3002808374: 14 registrations

3002821504: 174 registrations

3002865793: 11 registrations

3002879021: 31 registrations

3002902735: 417 registrations

3002907620: 375 registrations

3002910717: 11 registrations

3002974635: 25 registrations

3003015552: 444 registrations

3003040625: 290 registrations

3003056094: 19 registrations

3003057578: 5 registrations

3003058448: 327 registrations

3003064967: 54 registrations

3003076831: 367 registrations

3003094851: 292 registrations

3003112432: 122 registrations

3003120666: 37 registrations

3003120897: 290 registrations

3003128516: 389 registrations

3003131673: 10 registrations

3003152976: 14 registrations

3003154916: 41 registrations

3003166194: 49 registrations

3003169040: 3 registrations

3003310007: 7 registrations

3003348846: 15 registrations

3003405786: 16 registrations

3003418325: 774 registrations

3003429569: 13 registrations

3003477135: 383 registrations

3003560965: 24 registrations

3003574398: 69 registrations

3003589279: 4 registrations

3003589911: 5 registrations

3003595336: 5 registrations

3003640911: 18 registrations

3003681915: 10 registrations

3003704957: 46 registrations

3003737899: 262 registrations

3003752255: 6 registrations

3003755939: 58 registrations

3003767808: 2 registrations

3003767881: 72 registrations

3003807466: 54 registrations

3003829571: 12 registrations

3003831320: 27 registrations

3003857949: 5 registrations

3003902955: 9 registrations

3003974574: 28 registrations

3004024955: 118 registrations

3004034544: 24 registrations

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