Product Code: FMI FDA class 2 21 CFR 880.5570

Needle, Hypodermic, Single Lumen

General Hospital

The Single-Lumen Hypodermic Needle is a hollow needle with a single channel used to inject medications subcutaneously, intramuscularly, or intravenously, or to draw blood or other fluids. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMI, regulated under 21 CFR 880.5570 in the General Hospital specialty. This device is eligible for third-party review.

View on FDA

510(k)s

688

FEI Numbers

440

Registration Numbers

440

Unique Applicants

385

Years Active

Basic Information

Product Code: FMI
Device Class: FDA class 2
Regulation Number: 880.5570
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 688 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260855	Profoject Safety Pen Needles	Jun 10, 2026	Substantially Equivalent	CMT Health PTE., Ltd.
K254273	Verisafe Safety Sterile Needles (SSN)	Apr 16, 2026	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K252908	Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle	Mar 25, 2026	Substantially Equivalent	Sandstone Medical (Suzhou), Inc.
K253047	PRESSONE	Mar 24, 2026	Substantially Equivalent	Nipro Medical Corporation
K253622	Safety Pen Needle	Mar 18, 2026	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K252886	Pen Needle	Jan 06, 2026	Substantially Equivalent	Hh Global Technology, Inc.
K250700	Pen Injector Needle 32.5	Nov 21, 2025	Substantially Equivalent	Terumo Corporation
K252631	Profoject Disposable Needle	Oct 16, 2025	Substantially Equivalent	CMT Health PTE., Ltd.
K250724	Intraosseous Infusion Needles	Jul 30, 2025	Substantially Equivalent	Spectrum Vascular
K250284	TSK SELECT Needle	Jul 24, 2025	Substantially Equivalent	Tsk Laboratory, Japan
K251447	K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)	Jul 08, 2025	Substantially Equivalent	Terumo Europe N.V.
K243309	27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)	May 29, 2025	Substantially Equivalent	Terumo Europe N.V.
K240355	FROG (Filter Removal of Glass)	Apr 18, 2025	Substantially Equivalent	Carrtech Corp
K243581	K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)	Apr 04, 2025	Substantially Equivalent	Terumo Europe N.V.
K250658	SureFine Pen Needle	Apr 03, 2025	Substantially Equivalent	Shina Med Corporation
K243806	Safety Winged Blood Collection Sets	Jan 10, 2025	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K242741	ACE Cannula	Jan 08, 2025	Substantially Equivalent	Ace Medical Industry Co., Ltd.
K242632	Verifine® Pen Needles	Sep 26, 2024	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K240915	ZIEN IO Intraosseous Access System	Jul 02, 2024	Substantially Equivalent	Zien Medical Technologies, Inc.
K232165	Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles	Feb 01, 2024	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K233037	Sterile Hypodermic Needles for Single Use	Dec 12, 2023	Substantially Equivalent	Zhejiang Kindly Medical Device Co., Ltd.
K233343	SteriCap Safety Needle; VitreJect Safety Needle	Nov 27, 2023	Substantially Equivalent	Ocuject, LLC
K230070	MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM®	Oct 05, 2023	Substantially Equivalent	Promamedical, Inc.
K230043	Insulin Pen Needle	Sep 20, 2023	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K230959	VitreJect® Needle; OcuSafe® Needle	Sep 14, 2023	Substantially Equivalent	Ocuject, LLC
K231729	Sterile syringes for single use with/without needle	Sep 08, 2023	Substantially Equivalent	Wepon Medical Technology Co., Ltd.
K231723	Sterile Safety Hypodermic Needles for Single Use	Sep 08, 2023	Substantially Equivalent	Wepon Medical Technology Co., Ltd.
K231720	Sterile Hypodermic Needles for Single Use	Sep 08, 2023	Substantially Equivalent	Wepon Medical Technology Co., Ltd.
K231255	NovoFine® Plus	Aug 25, 2023	Substantially Equivalent	Novo Nordisk, Inc.
K231261	Altaviz Needle Kit II	Jul 27, 2023	Substantially Equivalent	Altaviz, LLC
K231924	EZ-IO Intraosseous Vascular Access System	Jul 25, 2023	Substantially Equivalent	Teleflex Medical
K230635	Pen Needle	Jun 02, 2023	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd
K222852	Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle	May 25, 2023	Substantially Equivalent	Nipro Medical Corporation
K222739	Disposable Insulin Pen Needle	Apr 06, 2023	Substantially Equivalent	Hantech Medical Device Co., Ltd.
K222417	Shina Safety Needle	Mar 20, 2023	Substantially Equivalent	Shina Corporation
K223327	Sterile Aesthetic Cannula and Hypodermic Needle	Feb 16, 2023	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd.
K222271	Verisafe Safety sterile needles	Feb 15, 2023	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K203792	Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle	Jan 20, 2023	Substantially Equivalent	Pikdare Spa
K223286	BD AutoShield Duo Pen Needle	Dec 28, 2022	Substantially Equivalent	Becton, Dickinson and Company
K223334	Sterile Hypodermic Needles for Single Use	Dec 16, 2022	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.
K214004	CCBIO ASCPO Needle	Dec 13, 2022	Substantially Equivalent	Cc Biotechnology Corporation
K222681	Altaviz Needle Kit	Dec 05, 2022	Substantially Equivalent	Altaviz, LLC
K223353	DropSafeTM SicuraTM	Dec 02, 2022	Substantially Equivalent	Pikdare Spa
K221178	Disposable Insulin Pen Needle	Nov 17, 2022	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K222124	Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle	Nov 04, 2022	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K220890	IO Needle Safety Sheath	Oct 31, 2022	Substantially Equivalent	Actuated Medical, Inc.
K213183	Safety Insulin Pen Needles	Oct 14, 2022	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.
K221080	Sterile Safety Hypodermic Needles for Single Use	Oct 04, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221066	Sterile Hypodermic Needles for Single Use	Oct 04, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K220129	Promisemed X-Safety Pen Needle	Sep 19, 2022	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K220603	Disposable Medical Safety Hypodermic Needle	Aug 23, 2022	Substantially Equivalent	Hantech Medical Device Co., Ltd.
K212095	SurGuard3 Safety Hypodermic Needle	Aug 22, 2022	Substantially Equivalent	Terumo Europe N.V.
K221176	Insulin Pen Needle	Jul 01, 2022	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K213478	BD Pen Needle	Jun 28, 2022	Substantially Equivalent	Becton, Dickinson and Company
K220614	MEDOJECT fine Pen Needles	Jun 15, 2022	Substantially Equivalent	Chirana T. Injecta
K210748	Well-life TM Pen Needles, Well-life TM Safety Pen Needles	May 25, 2022	Substantially Equivalent	W. L. Med Co., Ltd.
K213535	Sterile Safety Hypodermic Needles for Single Use	May 13, 2022	Substantially Equivalent	Zhejiang Kangkang Medical-Devices Co., Ltd.
K212514	Safety Pen Needle for Single Use, Insulin Pen Needles	Apr 29, 2022	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K214075	Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)	Apr 12, 2022	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K210864	Safety Pen Needle	Feb 17, 2022	Substantially Equivalent	Sandstone Medical (Suzhou), Inc.
K211716	DropSafe Safety Pen Needles	Jan 07, 2022	Substantially Equivalent	Htl Strefa SA
K213407	UltiCare Disposable Pen Needles	Dec 16, 2021	Substantially Equivalent	Ultimed Incorporated
K200932	Blood Collection Needles	Dec 14, 2021	Substantially Equivalent	Vacutest Kima Srl
K213156	BD Nano 2nd Gen Pen Needle	Dec 08, 2021	Substantially Equivalent	Becton, Dickinson and Company
K212015	BD Nano 2nd Gen Pen Needle	Nov 19, 2021	Substantially Equivalent	Becton, Dickinson and Company
K202319	Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)	Nov 12, 2021	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K211214	Sterile Hypodermic Needles for Single Use	Oct 14, 2021	Substantially Equivalent	Azur Medical Company, Inc.
K212805	SteriCap Mini Needle and Standard Needles	Sep 30, 2021	Substantially Equivalent	Ocuject, LLC
K210232	Sterile Hypodermic Needles for Single Use	Sep 23, 2021	Substantially Equivalent	Zhejiang Kangkang Medical-Devices Co., Ltd.
K210399	Unifine SafeControl	Sep 17, 2021	Substantially Equivalent	Owen Mumford, Ltd.
K211634	Hypodermic Needle-Pro EDGE Safety Device	Aug 26, 2021	Substantially Equivalent	Smiths Medical Asd, Inc.
K211395	NIO-I	Jul 28, 2021	Substantially Equivalent	Einstein Works, LLC
K211968	NIO+ Adult	Jul 22, 2021	Substantially Equivalent	Waismed, Ltd.
K210059	Promisemed Insulin Pen Needle	Jul 21, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K211293	Safety Winged Blood Collection Sets	Jun 25, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K210258	NovoFine	Jun 23, 2021	Substantially Equivalent	Novo Nordisk, Inc.
K210065	Verifine Safety Type Insulin Pen Needle	Apr 22, 2021	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K202492	EZ-IO Intraosseous Vascular Access System	Mar 22, 2021	Substantially Equivalent	Teleflex Medical
K193422	Easydrip Pen Needle, Easydrip Plus Pen Needle	Feb 02, 2021	Substantially Equivalent	Sandstone Medical (Suzhou), Inc.
K202681	Promisemed Covered Safety Pen Needle	Dec 31, 2020	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K202005	NovoFine Plus 32G Tip x 4 mm	Dec 19, 2020	Substantially Equivalent	Novo Nordisk, Inc.
K202682	Promisemed Triple Safety Pen Needle	Nov 24, 2020	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K200017	Eclipse DermaFlex Cannula	Nov 05, 2020	Substantially Equivalent	Eclipse Medcorp, LLC
K202340	Droplet Pen Needle 30G & 33G	Oct 15, 2020	Substantially Equivalent	Htl-Strefa S.A
K192464	Injection Pen Needle	Aug 25, 2020	Substantially Equivalent	Gangan Medical Technology Jiangsu Co., Ltd.
K191644	TK Safety Needle	Aug 06, 2020	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.
K192222	EZ-Inject Single use Needle	May 12, 2020	Substantially Equivalent	Poonglim Pharmatech, Inc.
K192082	Droplet Pen Needle 34G	Apr 21, 2020	Substantially Equivalent	Htl-Strefa S.A
K190962	Bella-mu	Feb 03, 2020	Substantially Equivalent	U-Needle B.V.
K191643	TK Sterile Hypodermic Needle	Dec 19, 2019	Substantially Equivalent	Anhui Tiankang Medical Technology Co., Ltd.
K191488	SAM IO Intraosseous Access System	Nov 21, 2019	Substantially Equivalent	Sam® Medical Products, Inc.
K191976	Piper GO-IO Intraosseous Infusion System	Nov 13, 2019	Substantially Equivalent	Piper Access, LLC
K191258	Intraosseous infusion device	Oct 23, 2019	Substantially Equivalent	Einstein Works, LLC
K192057	K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall	Oct 11, 2019	Substantially Equivalent	Terumo Europe N.V.
K190538	NIO-I	Oct 07, 2019	Substantially Equivalent	Waismed, Ltd.
K191853	Dual-Safety Pen Needle	Sep 05, 2019	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K183016	SteriCap Mini Needle	May 07, 2019	Substantially Equivalent	Ocujet, LLC
K182770	Adult Intraosseous Infusion Device	Apr 09, 2019	Substantially Equivalent	Einstein Works, LLC
K181447	Safety insulin needle for single use	Mar 12, 2019	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K181730	BD Vacutainer Eclipse UltraFill Blood Collection Needle	Mar 01, 2019	Substantially Equivalent	Becton, Dickinson and Company
K181508	U&U Blood Collection Sets	Feb 13, 2019	Substantially Equivalent	U&U Medical Technology Co, Ltd.
K182320	BD Contoured Base Pen Needle	Dec 20, 2018	Substantially Equivalent	Becton, Dickinson and Company
K182146	Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set	Dec 03, 2018	Substantially Equivalent	Sol-Millennium Medical, Inc.
K181369	Immucise Intradermal Injection System	Nov 13, 2018	Substantially Equivalent	Terumo Corporation
K180395	EZ-IO Intraosseous Vascular Access System	Nov 09, 2018	Substantially Equivalent	Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
K181069	Disposable Insulin Pen Needle	Aug 28, 2018	Substantially Equivalent	Zhejiang Kindly Medical Devices Co., Ltd.
K170824	BD Vacutainer Eclipse Signal Blood Collection Needle	Aug 20, 2018	Substantially Equivalent	Becton, Dickinson and Company
K163578	EasyTouch Safety Pen Needle	Aug 03, 2018	Substantially Equivalent	Mhc Medical Products, LLC
K172095	Autokeeper	Jul 24, 2018	Substantially Equivalent	Medexel Co.,Ltd
K173881	Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G	Jul 11, 2018	Substantially Equivalent	Owen Mumford, Ltd.
K180720	Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel	Jun 27, 2018	Substantially Equivalent	Medibio USA, LLC
K172483	Kopac Sterile Needle	Jun 21, 2018	Substantially Equivalent	Poonglim Pharmatech, Inc.
K172938	Disposable Sterile Needle	Jun 14, 2018	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd
K173803	Omnican fine	Jun 11, 2018	Substantially Equivalent	B.Braun Medical, Inc.
K180545	VACUETTE SAFELINK Holder with male luer lock	May 21, 2018	Substantially Equivalent	Greiner Bio-One Na, Inc.
K180259	Sterile Hypodermic Needle for Single Use	May 18, 2018	Substantially Equivalent	Jiangsu Shenli Medical Production Co., Ltd.
K173279	RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder	May 14, 2018	Substantially Equivalent	Myco Medical Supplies, Inc.
K173757	VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set	Apr 19, 2018	Substantially Equivalent	Greiner Bio-One Na, Inc.
K180588	FAST1 Intraosseous Infusion System; FASTResponder Sternal Intraosseous Device	Apr 17, 2018	Substantially Equivalent	Teleflex Medical
K171982	DROPLET PEN NEEDLE	Mar 21, 2018	Substantially Equivalent	Htl-Strefa S.A
K173479	NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)	Jan 17, 2018	Substantially Equivalent	Novo Nordisk, Inc.
K170988	DropSafe Safety Pen Needle	Dec 12, 2017	Substantially Equivalent	Htl-Strefa S.A
K170276	Safety Blood Collection Device for Single Use	Dec 11, 2017	Substantially Equivalent	Gemtier Medical (Shanghai), Inc.
K171984	Clickfine Pen Needle, Penfine Classic Pen Needle	Oct 11, 2017	Substantially Equivalent	Ypsomed AG
K171144	Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel	Sep 12, 2017	Substantially Equivalent	Medbio, LLC
K170768	Mini Needle	Jul 10, 2017	Substantially Equivalent	Ocuject, LLC
K161950	Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle	May 11, 2017	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K163093	Safety Blood Collection Set	Mar 14, 2017	Substantially Equivalent	Jiangsu Shenli Medical Production Co., Ltd.
K161255	meso-relle (AAL34, AAL36, AM30G)	Jan 19, 2017	Substantially Equivalent	Biotekne Srl
K162516	BD Pen Needle	Dec 09, 2016	Substantially Equivalent	Becton, Dickinson and Company
K160532	Greiner Holdex	Nov 03, 2016	Substantially Equivalent	Greiner Bio-One Na, Inc.
K160199	Advocate Insulin Pen Needles	Oct 19, 2016	Substantially Equivalent	Diabetic Supply of Suncoast, Inc.
K151090	CPL Insulin Pen Needle	Sep 21, 2016	Substantially Equivalent	Cpl Co., Ltd.
K160575	CareSens Pen Needle, Softip Pen Needle	Sep 07, 2016	Substantially Equivalent	Yidobio, Inc.
K153706	Insulin Pen Needle	Aug 29, 2016	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.
K160887	Cook Intraosseous Infusion Needles	Jul 26, 2016	Substantially Equivalent	Cook Incorporated
K152166	JSM Insulin Pen Needle	Jul 11, 2016	Substantially Equivalent	Jeesung Medical Co., Ltd.
K161553	BD SafeAssist	Jul 06, 2016	Substantially Equivalent	Becton, Dickinson and Company
K152339	Unifine Pentips/ Unifine Pentips Plus	Jun 24, 2016	Substantially Equivalent	Owen Mumford, Ltd.
K160805	NIO-P	Jun 23, 2016	Substantially Equivalent	Waismed, Ltd.
K152597	ProteXsure Safety Capsule System	Jun 08, 2016	Substantially Equivalent	Starcap Medical, LLC ( Dba Prism Medical & Design)
K153388	IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle	Jun 07, 2016	Substantially Equivalent	Guangzhou Improve Medical Instruments Co., Ltd.
K152877	SureFine Pen Needle	Jun 07, 2016	Substantially Equivalent	Shina Med Corporation
K161170	BD Eclipse Hypodermic Needle	May 27, 2016	Substantially Equivalent	Becton, Dickinson and Company
K152334	Sungshim Insulin Pen Needle	Mar 17, 2016	Substantially Equivalent	Sung Shim Medicare Co., Ltd.
K152824	MEDT PEN NEEDLE	Mar 07, 2016	Substantially Equivalent	Shandong Caremed Medical Products Co., Ltd.
K152050	Pencylcap	Mar 02, 2016	Substantially Equivalent	B.Braun Melsungen AG
K151311	Safe Block Pen Needle	Feb 10, 2016	Substantially Equivalent	Artsana S.P.A
K152410	Top Fine Pen Needle	Feb 02, 2016	Substantially Equivalent	Medexel Co.,Ltd
K152514	Clickfine AutoProtect Pen Needle	Nov 18, 2015	Substantially Equivalent	Ypsomed AG
K152183	EXELINT SecureTouch Safety Hypodermic Needle	Nov 02, 2015	Substantially Equivalent	Exelint International, Co.
K152362	Terumo SurGuard 3 Safety Hypodermic Needle	Oct 16, 2015	Substantially Equivalent	Terumo (Philippines) Corporation
K151571	Mini Needle	Oct 14, 2015	Substantially Equivalent	Ocujet, LLC
K151341	Turbo High-Flow Non-coring Needle	Aug 20, 2015	Substantially Equivalent	Norfolk Medical
K142765	TM SAFETY NEEDLE	Aug 11, 2015	Substantially Equivalent	Thinkmed Medical Technology Co., Ltd.
K151398	K-Pack II Needle - 29G x 5/16 Thin Wall	Jun 25, 2015	Substantially Equivalent	Terumo Europe N.V.
K143437	Droplet Pen Needles	Jun 25, 2015	Substantially Equivalent	Htl-Strefa S.A
K150662	Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)	Jun 09, 2015	Substantially Equivalent	Ypsomed AG
K150263	K-Pack II Needle-21G x 2	Apr 01, 2015	Substantially Equivalent	Terumo Europe N.V.
K142086	NIO -INTRAOSSEOUS DEVICE	Aug 28, 2014	Substantially Equivalent	Waismed, Ltd.
K140516	Terumo Pen Injector Needle 34	Aug 05, 2014	Substantially Equivalent	Kofu Factory of Terumo Corp.
K141749	CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT	Jul 29, 2014	Substantially Equivalent	Facet Technologies, LLC
K130097	MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS	Jul 22, 2014	Substantially Equivalent	American Medical Manufacturing, Inc./ Advanced Med
K141117	EZ-IO INTRAOSSEOUS INFUSION SYSTEM	Jul 08, 2014	Substantially Equivalent	Vidacare, LLC
K133635	EASYPOINT NEEDLE	Jun 17, 2014	Substantially Equivalent	Retractable Technologies, Inc.
K132557	EWNL SAFETY SYRINGE WITH NEEDLE	Jun 03, 2014	Substantially Equivalent	Jiamei-Un Co., Ltd.
K131954	MEDI PEN NEEDLE	May 29, 2014	Substantially Equivalent	Shanghai Carelife International Trading Co. , Ltd.
K133738	NOVOFINE PLUS 32G 4 MM	May 21, 2014	Substantially Equivalent	Novo Nordisk, Inc.
K140568	CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT	May 13, 2014	Substantially Equivalent	Facet Technologies, LLC
K133059	INSULIN PEN NEEDLE	Feb 25, 2014	Substantially Equivalent	Wenzhou Beipu Science & Technology Co., Ltd.
K133058	INSULIN PEN NEEDLE	Feb 25, 2014	Substantially Equivalent	Wenzhou Wuzhou Import & Export Co., Ltd.
K132583	EZ-IO INTRAOSSEOUS INFUSION SYSTEM	Feb 11, 2014	Substantially Equivalent	Vidacare Corporation
K133100	CAREFINE PEN NEEDLE	Jan 23, 2014	Substantially Equivalent	Facet Technologies
K130212	SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE	Nov 20, 2013	Substantially Equivalent	Wuxi Yushou Medical Applicances Co., Ltd.
K132552	U&U STERILE HYPODERMIC NEEDLE	Nov 13, 2013	Substantially Equivalent	U&U Medical Technology Co, Ltd.
K132233	K-PACK II NEEDLE - 27G X 3/4 THIN WALL	Sep 06, 2013	Substantially Equivalent	Terumo Europe N.V.
K131842	STERICAN CANNULA	Aug 20, 2013	Substantially Equivalent	B.Braun Medical, Inc.
K131358	BD PEN NEEDLE	Jul 16, 2013	Substantially Equivalent	Becton, Dickinson & CO
K131040	EXTAVIPRO STERICAN 30G	Jul 15, 2013	Substantially Equivalent	B.Braun Melsungen AG
K131125	CLICKFINE PEN NEEDLE	Jul 05, 2013	Substantially Equivalent	Ypsomed AG
K131123	CLICKFINE AUTOPROTECT PEN NEEDLE	Jul 05, 2013	Substantially Equivalent	Ypsomed AG
K130487	FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE	Jun 25, 2013	Substantially Equivalent	Pyng Medical Corp.
K123684	SOL-CARE SAFETY NEEDLE	May 08, 2013	Substantially Equivalent	Sol-Millennium Medical
K123300	BD PEN NEEDLE	Jan 18, 2013	Substantially Equivalent	Becton, Dickinson & CO
K121607	TERUMO(R) NEEDLE	Nov 08, 2012	Substantially Equivalent	Terumo (Philippines) Corporation
K122971	CLICKFINE PEN NEEDLE	Oct 25, 2012	Substantially Equivalent	P/L Biomedical
K122969	CLICKFINE PEN NEEDLE	Oct 25, 2012	Substantially Equivalent	P/L Biomedical
K120420	STERILE BLUNT FOR SINGLE USE	Oct 18, 2012	Substantially Equivalent	Shanghai Double Dove Industrial Co., Ltd.
K113469	NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE	Oct 18, 2012	Substantially Equivalent	Nipro Medical Corporation
K122249	TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE	Aug 28, 2012	Substantially Equivalent	Terumo (Philippines) Corporation
K121632	COMFORT EZ	Aug 10, 2012	Substantially Equivalent	Simple Diagnostics, Inc.
K121908	SAFETY INFUSION SET	Jul 25, 2012	Substantially Equivalent	Greiner Bio-One North America, Inc.
K120690	INSULIN PEN NEEDLE	Jun 22, 2012	Substantially Equivalent	Tiger Medical Products, Ltd.
K120661	THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE	Jun 03, 2012	Substantially Equivalent	Vidacare Corporation
K120191	PUSH-ON NEEDLE 30GX8MM	May 23, 2012	Substantially Equivalent	Scandinavian Health Limited
K113186	STERILE INSULIN PEN NEEDLE	Apr 12, 2012	Substantially Equivalent	Shina Corp.
K113422	TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE	Mar 05, 2012	Substantially Equivalent	Terumo (Philippines) Corporation
K112777	SOL-M EXCHANGEABLE NEEDLES	Feb 24, 2012	Substantially Equivalent	Sol-Milennium Medical, Inc.
K113505	VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER	Feb 17, 2012	Substantially Equivalent	Greiner Bio-One North America, Inc.
K110312	CLICKFINE AUTOPROTECT PEN NEEDLE	Jan 26, 2012	Substantially Equivalent	Ypsomed AG
K112332	FINE JECT INSULIN PEN NEEDLE	Jan 10, 2012	Substantially Equivalent	Twobiens Co., Ltd.
K112789	EASY TOUCH	Dec 23, 2011	Substantially Equivalent	Mhc Medical Products, LLC
K110606	MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE	Sep 29, 2011	Substantially Equivalent	M.V.S.R.L.
K111797	27 G X 1/2 K-PACK SURSHIELD NEEDLE	Sep 22, 2011	Substantially Equivalent	Terumo Europe N.V.
K110656	IMC BLOOD COLLECTION NEEDLE	Aug 18, 2011	Substantially Equivalent	International Medsurg Connection
K111424	VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH	Jul 29, 2011	Substantially Equivalent	Medpro Safety Products, Inc.
K110703	BD AUTOSHIELD DUO PEN NEEDLE	Jul 27, 2011	Substantially Equivalent	Becton, Dickinson and Company
K110850	K-PACK II NEEDLE- 27G & 30G THIN WALL	Jun 09, 2011	Substantially Equivalent	Terumo Europe N.V.
K110527	K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE	Jun 06, 2011	Substantially Equivalent	Terumo Europe N.V.
K102328	BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA	May 13, 2011	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.
K110105	BD PEN NEEDLE	Apr 28, 2011	Substantially Equivalent	Becton, Dickinson and Company (BD)
K103587	DISPOSABLE BLLOD COLLECTION NEEDLE	Apr 06, 2011	Substantially Equivalent	Weihai Hongyu Medical Devices Co., Ltd.
K102584	IMC HYPODERMIC NEEDLE	Jan 14, 2011	Substantially Equivalent	International Medsurg Connection
K102108	CLICKFINE PEN NEEDLE	Nov 23, 2010	Substantially Equivalent	Ypsomed AG
K102010	VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET	Nov 19, 2010	Substantially Equivalent	Medpro Safety Products, Inc.
K102994	K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR	Nov 03, 2010	Substantially Equivalent	Kawasumi Laboratories, Inc.
K102774	VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER	Oct 15, 2010	Substantially Equivalent	Greiner Bio-One North America, Inc.
K100124	FASTX STERNAL INTRAOSSEOUS DEVICE	Aug 31, 2010	Substantially Equivalent	Pyng Medical Corp.
K093043	ZIRCONIA SYRINGE NEEDLE	Aug 20, 2010	Substantially Equivalent	Kuo Tai Hospital Managements & Consultant Co., Ltd.
K101026	POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO	Jul 27, 2010	Substantially Equivalent	Vidacare Corporation
K093109	NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')	Jun 18, 2010	Substantially Equivalent	Novo Nordisk, Inc.
K100812	ULTICARE DISPOSABLE PEN NEEDLES	Jun 03, 2010	Substantially Equivalent	Ultimed, Inc.
K100436	CLICKFINE PEN NEEDLE	Apr 30, 2010	Substantially Equivalent	Ypsomed AG
K100005	BD PEN NEEDLE	Apr 15, 2010	Substantially Equivalent	Becton, Dickinson and Co.
K100209	BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY	Feb 19, 2010	Substantially Equivalent	Becton, Dickinson & CO
K092746	MICRONJET 600	Feb 03, 2010	Substantially Equivalent	Nanopass Technologies , Ltd.
K090111	FLEXPEN NEEDLE	Feb 01, 2010	Substantially Equivalent	Novo Nordisk, Inc.
K092831	DISPOSABLE HYPODERMIC NEEDLE	Jan 14, 2010	Substantially Equivalent	Feel Tech
K091140	EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO	Oct 14, 2009	Substantially Equivalent	Vidacare Corporation
K092016	SUPER-FINE PEN NEEDLE	Oct 02, 2009	Substantially Equivalent	Stat Medical Devices, Inc.
K090117	AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET	Sep 29, 2009	Substantially Equivalent	Autosafe-Reflex, Inc.
K090156	ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000	Sep 01, 2009	Substantially Equivalent	Wcm Waste & Compliance Management, Inc.
K090426	VAKU-8 BLOOD COLLECTION NEEDLES	Jun 12, 2009	Substantially Equivalent	Myco Medical Supplies, Inc.
K082908	NOVAGUARD, MODEL 3611001	Apr 24, 2009	Substantially Equivalent	West Pharmaceutical Services, Inc.
K082511	MEDIGARD BLOOD COLLECTION DEVICE	Jan 16, 2009	Substantially Equivalent	Medigard Limited
K082820	K-PACK II NEEDLE - 29G THIN WALL	Oct 23, 2008	Substantially Equivalent	Terumo Europe N.V.
K072602	VACUETTE PREMIUM SAFETY NEEDLE SYSTEM	Jun 18, 2008	Substantially Equivalent	Medpro Safety Products, Inc.
K080904	FEEL-FINE INSULIN PEN NEEDLE	Jun 04, 2008	Substantially Equivalent	Feel Tech
K080865	FAST1 INTRAOSSEOUS INFUSION SYSTEM	Apr 24, 2008	Substantially Equivalent	Pyng Medical Corp.
K080235	SAFETY INFUSION SET	Apr 24, 2008	Substantially Equivalent	Greiner Bio-One Vacuette North America
K073705	MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE	Mar 24, 2008	Substantially Equivalent	Shandong Qiaopai Group Co., Ltd.
K072487	FAST1 INTRAOSSEOUS INFUSION SYSTEM	Feb 13, 2008	Substantially Equivalent	Pyng Medical Corp.
K071307	INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003	Feb 12, 2008	Substantially Equivalent	Inviro Medical Devices, Inc.
K073188	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE	Feb 08, 2008	Substantially Equivalent	Smiths Medical Asd, Inc.
K073257	KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR	Jan 25, 2008	Substantially Equivalent	Kawasumi Laboratories, Inc.
K073127	BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G	Dec 20, 2007	Substantially Equivalent	Shandong Weigao Group Medical Polymer Co., Ltd.
K073122	MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE	Nov 21, 2007	Substantially Equivalent	Covidien Lp, Formerly Registered AS Tyco Healthcar
K072247	STERICAN HYPODERMIC NEEDLES	Nov 08, 2007	Substantially Equivalent	B.Braun Medical, Inc.
K072059	GRIPPER MICRO NEEDLE	Nov 01, 2007	Substantially Equivalent	Smiths Medical MD, Inc.
K071947	VACU-MED BLOOD COLLECTION NEEDLES	Oct 12, 2007	Substantially Equivalent	Shina Corp.
K071998	ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT	Sep 26, 2007	Substantially Equivalent	Arrow Intl., Inc.
K072320	GREINER VACUETTE QUICKSHIELD COMPLETE	Sep 14, 2007	Substantially Equivalent	Greiner Bio-One North America, Inc.
K071567	AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE	Sep 14, 2007	Substantially Equivalent	Autosafe-Refelx, Inc.
K070988	SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G)	Aug 23, 2007	Substantially Equivalent	Shinchang Medical Co., Ltd.
K071785	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE	Aug 02, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K071088	LIFE LATCH SHARPS & BIOHAZARD CONTAINER	Jul 05, 2007	Substantially Equivalent	M&M Industries, Inc.
K070440	BD HYPOINT NEEDLE	Mar 16, 2007	Substantially Equivalent	Becton, Dickinson & CO
K063466	TOP FINE	Mar 02, 2007	Substantially Equivalent	Daejin Tech Medical Manufacturing Co., Ltd.
K063567	EZ-MIO STERNAL	Jan 26, 2007	Substantially Equivalent	Vidacare Corporation
K063450	PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110	Jan 25, 2007	Substantially Equivalent	Smiths Medical Asd, Inc.
K062940	BONE INJECTION GUN (B.I.G.)	Dec 22, 2006	Substantially Equivalent	Waismed, Ltd.
K063142	MANUAL PD-IO; POWERED PD-IO	Dec 08, 2006	Substantially Equivalent	Vidacare Corporation
K062956	EZ-MIO, EZ-IO DISTAL TIBIA	Dec 05, 2006	Substantially Equivalent	Vidacare Corporation
K062500	FLEXPEN NEEDLE	Nov 21, 2006	Substantially Equivalent	Novo Nordisk, Inc.
K061933	HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER	Nov 16, 2006	Substantially Equivalent	Hager Worldwide, Inc.
K062984	MEDLINE HYPODERMIC NEEDLES	Nov 13, 2006	Substantially Equivalent	Medline Industries, Inc.
K062422	HUMERAL HEAD, MANUAL DRIVER	Nov 07, 2006	Substantially Equivalent	Vidacare Corporation
K062608	29G AND 30G K-PACK II NEEDLE	Sep 15, 2006	Substantially Equivalent	Terumo Europe N.V.
K061483	VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES	Aug 14, 2006	Substantially Equivalent	Greiner Bio-One North America, Inc.
K061032	DEPOTONE	Jun 21, 2006	Substantially Equivalent	Imprint Pharmaceuticals Limited
K052843	BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE	Apr 17, 2006	Substantially Equivalent	Busse Hospital Disposables, Inc.
K060007	BD AUTOSHIELD PEN NEEDLE	Mar 23, 2006	Substantially Equivalent	Becton, Dickinson & CO
K052725	PROTECTOR NEEDLE SHEATH PROP	Dec 28, 2005	Substantially Equivalent	Certol International, LLC
K053470	NOVOFINE 32G TIP	Dec 21, 2005	Substantially Equivalent	Novo Nordisk, Inc.
K052445	DUOPROSS NEEDLE	Dec 05, 2005	Substantially Equivalent	Duopross Meditech Corporation
K052561	TERUMO MICRO TAPERED PEN NEEDLE	Nov 23, 2005	Substantially Equivalent	Kofu Factory of Terumo Corp.
K052408	EZ-IO	Nov 17, 2005	Substantially Equivalent	Vidacare Corporation
K052474	NIPRO HYPODERMIC NEEDLE	Nov 10, 2005	Substantially Equivalent	Nipro Medical Corp.
K052195	EZ-MIO MANUAL DRIVER	Nov 02, 2005	Substantially Equivalent	Vidacare Corporation
K051992	POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM	Oct 20, 2005	Substantially Equivalent	Vidacare Corporation
K051783	ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES	Oct 04, 2005	Substantially Equivalent	Artsana S.P.A
K051899	BD PEN NEEDLE	Sep 13, 2005	Substantially Equivalent	Becton, Dickinson & CO
K043249	ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE	May 25, 2005	Substantially Equivalent	Atrion Medical Products, Inc.
K050464	ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2	May 11, 2005	Substantially Equivalent	Ultimed, Inc.
K042917	STAT MEDICAL PEN NEEDLE	Apr 22, 2005	Substantially Equivalent	Emergogroup, Inc.
K050505	DEPOTONE	Apr 05, 2005	Substantially Equivalent	Imprint Pharmaceuticals Limited
K050106	NOVOFINE AUTOCOVER 30G X 8MM	Mar 30, 2005	Substantially Equivalent	Novo Nordisk, Inc.
K043490	PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE	Feb 18, 2005	Substantially Equivalent	Vidacare Corporation
K043397	MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE	Dec 29, 2004	Substantially Equivalent	Becton, Dickinson & CO
K042907	NEEDLE INCAPACITATOR (NEEDLE GUARD)	Dec 22, 2004	Substantially Equivalent	Pdmp, Inc.
K043019	VASCULAR SOLUTIONS SCLERO-KIT	Dec 01, 2004	Substantially Equivalent	Vascular Solutions, Inc.
K041941	SAFE T RETRACTABLE BLOOD COLLECTION DEVICE	Sep 13, 2004	Substantially Equivalent	Safe T Medical Devices, Ltd.
K041399	HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE	Jul 28, 2004	Substantially Equivalent	Smiths Medical Asd, Inc.
K041153	SHARPSAWAY II LOCKING DISPOSABLE CUP	Jul 12, 2004	Substantially Equivalent	Arrow Intl., Inc.
K040531	TERUMO SURGUARD2 SAFETY NEEDLE	Mar 23, 2004	Substantially Equivalent	Terumo Medical Corp.
K032885	VIDAPORT INTRAOSSEOUS INFUSION SYSTEM	Mar 10, 2004	Substantially Equivalent	Vidacare Corporation
K033575	ONE.CLICK NEEDLE	Feb 09, 2004	Substantially Equivalent	B.Braun Medical, Inc.
K032141	SECUMAX BLOOD COLLECTION SYSTEM	Jan 28, 2004	Substantially Equivalent	Tiger Meditech Incorporated
K033409	AMERSHAM HEALTH NEEDLE-GUARD	Jan 21, 2004	Substantially Equivalent	Gettig Pharmaceutical Instrument Co.
K033478	VACUETTE QUICKSHIELD SAFETY TUBE HOLDER	Dec 29, 2003	Substantially Equivalent	Greiner Bio-One Vacuette North America
K033373	MONOJECT INSULIN SYRINGE	Nov 13, 2003	Substantially Equivalent	Tyco Healthcare
K031453	TERUMO SURGUARD 2 SAFETY NEEDLE	Jul 08, 2003	Substantially Equivalent	Terumo Medical Corp.
K031200	MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE	Jun 24, 2003	Substantially Equivalent	Becton, Dickinson & CO
K031058	CORD STICK MULTIPLE DRAW SYSTEM	Jun 13, 2003	Substantially Equivalent	Cord Stick Corp.
K030032	CROSSEAL APPLICATION DEVICE	Mar 21, 2003	Substantially Equivalent	Omrix Biopharmaceuticals, Inc.
K024109	BD ULTRA-FINE III PEN NEEDLE	Dec 30, 2002	Substantially Equivalent	Becton, Dickinson & CO
K022057	KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX	Nov 22, 2002	Substantially Equivalent	Kyung GI Medical Ind. Co., Ltd.
K022415	BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST	Oct 11, 2002	Substantially Equivalent	Waismed, Ltd.
K022406	EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET	Sep 30, 2002	Substantially Equivalent	Exelint Intl. Co.
K021315	SURE-LOK	Aug 21, 2002	Substantially Equivalent	Vital Signs, Inc.
K021475	BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET	Jul 19, 2002	Substantially Equivalent	Bd
K020921	NO-POKES NEEDLE SAFETY DEVICE	Jul 11, 2002	Substantially Equivalent	Bemis Mfg. Co.
K011757	EXEL COMFORTPOINT INSULIN PEN NEEDLE	Jan 23, 2002	Substantially Equivalent	Exelint Intl. Co.
K013293	NIPRO HYPODERMIC NEEDLE	Dec 14, 2001	Substantially Equivalent	Nipro Medical Corp.
K013782	DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE	Nov 20, 2001	Substantially Equivalent	Disetronic Medical Systems
K012736	MONOJECT SAFETY NEEDLE	Oct 25, 2001	Substantially Equivalent	Tyco Healthcare
K012283	SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE	Oct 01, 2001	Substantially Equivalent	Safegard Medical Products, Inc.
K002394	JMS APHERESIS NEEDLE SET ACCORDION TYPE	Sep 05, 2001	Substantially Equivalent	Jms Co., Ltd.
K011984	BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET	Aug 29, 2001	Substantially Equivalent	Becton, Dickinson & CO
K012646	TERUMO 30 GAUGE HYPODERMIC NEEDLE	Aug 27, 2001	Substantially Equivalent	Terumo Medical Corp.
K001853	SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1	Aug 22, 2001	Substantially Equivalent	Medtech Systems, Inc.
K011925	HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO	Jul 12, 2001	Substantially Equivalent	Sims Portex, Inc.
K011786	VACUETTE SAFETY BLOOD COLLECTION SET	Jul 12, 2001	Substantially Equivalent	Greiner Vacuette North America, Inc.
K010887	INSULIN PEN NEEDLE ADAPTER	Jun 08, 2001	Substantially Equivalent	Ohana Needle Co.
K011004	NEEDLELOK HYPODERMIC NEEDLE PROTECTION	May 24, 2001	Substantially Equivalent	Diasol, Inc.
K010958	FISTULOK FISTULA NEEDLE PROTECTION	May 18, 2001	Substantially Equivalent	Diasol, Inc.
K003812	VACUETTE SPEEDY QUICK-RELEASE HOLDER	Apr 30, 2001	Substantially Equivalent	Greiner Vacuette North America, Inc.
K003381	SHIELDING NEEDLE HOLDER	Apr 23, 2001	Substantially Equivalent	U.S. Safety Syringes Co., Inc.
K003521	DISPO-MED 7.6 LITER SHARPS CONTAINER	Apr 19, 2001	Substantially Equivalent	Master Benefits, Inc.
K003382	SARSTEDT NEEDLE PROTECTOR	Mar 30, 2001	Substantially Equivalent	Sarstedt, Inc.
K010188	BD ECLIPSE HYPODERMIC NEEDLE	Mar 01, 2001	Substantially Equivalent	Bd Medical Systems
K003627	EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET	Feb 08, 2001	Substantially Equivalent	Exelint International, Co.
K001965	SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS	Feb 02, 2001	Substantially Equivalent	North American Medical Products, Inc.
K003461	BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE	Feb 01, 2001	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K010038	NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE	Jan 24, 2001	Substantially Equivalent	Cambridge Marketing, Inc.
K003406	GUARDED NEEDLE 2000	Jan 12, 2001	Substantially Equivalent	International Medical Device Partners, Inc.
K003827	PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION	Jan 08, 2001	Substantially Equivalent	Bio-Plexus, Inc.
K000714	VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET	Dec 21, 2000	Substantially Equivalent	Med-Pro Technologies, Inc.
K002403	NOVOFINE 31 DISPOSABLE NEEDLE	Dec 08, 2000	Substantially Equivalent	Novo Norodisk Pharmaceuticals, Inc.
K002938	B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16	Nov 29, 2000	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K002180	SIMPLICITY DISPOSABLE PEN NEEDLE	Oct 13, 2000	Substantially Equivalent	Sterling Medivations, Inc.
K002213	BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID	Oct 03, 2000	Substantially Equivalent	Hunter Research Laboratories, Inc.
K001175	SERAGARD VASCULAR ACCESS PATCH	Sep 18, 2000	Substantially Equivalent	Platinum Services, Inc.
K001572	NEOLUS NEEDLE	Aug 14, 2000	Substantially Equivalent	Terumo Europe N.V.
K001690	PROTECTIV SAFETY BLOOD COLLECTION NEEDLE	Jul 31, 2000	Substantially Equivalent	Johnson & Johnson Medical, Inc.
K993125	SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM	Jun 20, 2000	Substantially Equivalent	Safety Medical Supply Int,., Inc.
K001098	PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01	May 18, 2000	Substantially Equivalent	Pro. Duct Health, Inc.
K000455	GETTIG GUARD	Apr 19, 2000	Substantially Equivalent	Gettig Pharmaceutical Instrument Co.
K000441	BODYGUARD	Apr 11, 2000	Substantially Equivalent	Vital Signs, Inc.
K000369	VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER	Mar 30, 2000	Substantially Equivalent	Medpro Technologies, Inc.
K000085	PORTSETT	Mar 17, 2000	Substantially Equivalent	Portsett, Inc.
K000657	LUER ACCESS UNIVERSAL VIAL ADAPTER	Mar 08, 2000	Substantially Equivalent	Baxter Healthcare Corp
K000387	TERUMO NEEDLE WITH LOCKING SHEATH	Mar 02, 2000	Substantially Equivalent	Terumo Medical Corp.
K992699	NIPRO BLOOD COLLECTION NEEDLE	Feb 14, 2000	Substantially Equivalent	Nipro Medical Corp.
K992729	NIPRO LUER ADAPTOR	Jan 13, 2000	Substantially Equivalent	Nipro Medical Corp.
K994197	DISENTRONIC PENFINE INJECTION PEN NEEDLE	Dec 29, 1999	Substantially Equivalent	Disetronic Medical Systems
K992626	SURE-WAY REUSABLE SHARPS CONTAINER	Dec 16, 1999	Substantially Equivalent	Sure-Way Systems, Inc.
K992091	PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750	Sep 09, 1999	Substantially Equivalent	Bio-Plexus, Inc.
K991904	MODIFICATION OF JMS NEEDLES AND JMS SYRINGES	Aug 31, 1999	Substantially Equivalent	Jms Co., Ltd.
K984576	K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K	Jun 14, 1999	Substantially Equivalent	Terumo Europe N.V.
K990936	THE VAULT	May 18, 1999	Substantially Equivalent	Stik Stoppers, Inc.
K991404	PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)	May 14, 1999	Substantially Equivalent	Itl Corporation Pty, Ltd.
K990371	DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950	Apr 21, 1999	Substantially Equivalent	Post Medical, Inc.
K982029	SHARPS COLLECTION CONTAINER - SAF-T-SHELL	Apr 06, 1999	Substantially Equivalent	American Medical Mfg., Inc.
K983750	DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER	Nov 30, 1998	Substantially Equivalent	Deroyal Industries, Inc.
K981853	BONE INJECTION GUN (B.I.G.) DEVICE	Nov 17, 1998	Substantially Equivalent	Waismed, Ltd.
K983067	FINE-JECT	Oct 30, 1998	Substantially Equivalent	Henke Sass Wolf of America, Inc.
K982541	VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608	Oct 28, 1998	Substantially Equivalent	Becton Dickinson Vacutainer Systems
K971924	BLUNT SYRINGE CANNULA	Sep 25, 1998	Substantially Equivalent	B.Braun Medical, Inc.
K982399	DISETRONIC PENFINE INJECTION PEN NEEDLE	Aug 06, 1998	Substantially Equivalent	Disetronic Medical Systems
K981619	VACUETTE MULTIPLE SAMPLE LUER ADAPTER	Jul 15, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K972538	FLOW-EZE BLUNT CANNULA (1999BC)	Jul 15, 1998	Substantially Equivalent	Acacia, Inc.
K982097	WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD	Jun 25, 1998	Substantially Equivalent	Worldwide Medical Technologies, LLC
K981184	SHARPTRACK REUSABLE SHARPS CONTAINER	Jun 22, 1998	Substantially Equivalent	Bfi- Medical Waste Systems
K974363	BECTON DICKINSON BLUNT PLASTIC CANNULA	Jun 03, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K963658	EXEL AVF SINGLE NEEDLE	May 05, 1998	Substantially Equivalent	Exel Intl.
K972705	RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC	Apr 30, 1998	Substantially Equivalent	Sage Products, Inc.
K980227	MANAN GALACTOGRAPHY KIT	Apr 23, 1998	Substantially Equivalent	Medical Device Technologies, Inc.
K980179	SHARPS PLUS 5 GALLON SHARPS CONTAINER	Apr 13, 1998	Substantially Equivalent	Rotonics Mfg., Inc.
K980768	VACUETTE HOLDEX	Apr 09, 1998	Substantially Equivalent	Greiner Meditech, Inc.
K980062	MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE	Mar 20, 1998	Substantially Equivalent	Davis & Geck, Inc.
K980003	M500-100 SHARPS CONTAINER	Mar 13, 1998	Substantially Equivalent	Imagination Medical, Inc.
K974006	BECTON DICKINSON TWINPAK	Jan 22, 1998	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K973620	VACUETTE MULTI-SAMPLE NEEDLE	Dec 17, 1997	Substantially Equivalent	Greiner Meditech, Inc.
K973899	UNIFINE PENTIPS	Dec 04, 1997	Substantially Equivalent	Owen Mumford USA, Inc.
K973012	MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM	Nov 05, 1997	Substantially Equivalent	MDC Research , Ltd.
K973911	2 GALLON ALTERNATE CARE SHARPS CONTAINER	Oct 29, 1997	Substantially Equivalent	Sage Products, Inc.
K973339	DISETRONIC PENFINE INJECTION PEN NEEDLE	Sep 24, 1997	Substantially Equivalent	Disetronic Medical Systems
K971487	BKMI DISPOSABLE SYRINGE	Sep 04, 1997	Substantially Equivalent	Sumi Salud C.A.
K972279	SHARPS SHUTTLE	Aug 29, 1997	Substantially Equivalent	Sage Products, Inc.
K972469	SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE	Aug 27, 1997	Substantially Equivalent	Beech Medical Products, Inc.
K971763	BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER	Aug 26, 1997	Substantially Equivalent	Retractable Technologies, Inc.
K972536	SYRINGE NEEDLE REMOVER (S.N.R.)	Aug 15, 1997	Substantially Equivalent	Post Medical, Inc.
K970547	ISOLYSER SDS SHARPS CONTAINER	Jul 18, 1997	Substantially Equivalent	Thantex Specialties, Inc.
K970398	SHARPS CONTAINER	Jul 03, 1997	Substantially Equivalent	Custom Medical Plastics, Inc.
K970383	SHARPS CONTAINER	Jul 03, 1997	Substantially Equivalent	Custom Medical Plastics, Inc.
K964042	EXTRESAFE PHLEBOTOMY	Jun 06, 1997	Substantially Equivalent	Specialized Health Products, Inc.
K963748	BIO-PLEXUS DROP-IT NEEDLE HOLDER	Jun 06, 1997	Substantially Equivalent	Bio-Plexus, Inc.
K963571	VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR	Jun 02, 1997	Substantially Equivalent	Vygon Corp.
K970380	F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM	Apr 25, 1997	Substantially Equivalent	Pyng Medical Corp.
K970370	TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE	Apr 10, 1997	Substantially Equivalent	Tsk Laboratory, Japan
K964654	BECTON DICKINSON BLUNT PLASTIC CANNULA	Apr 02, 1997	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K970737	B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE	Mar 28, 1997	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K963351	LIFESHIELD BLUNT CANNULA	Feb 26, 1997	Substantially Equivalent	Abbott Laboratories
K965248	BEMIS TWO GALLON SHARPS CONTAINER	Feb 14, 1997	Substantially Equivalent	Bemis Mfg. Co.
K963830	SHARPS CONTAINER MODEL# SC001	Feb 10, 1997	Substantially Equivalent	Image Medical, Inc.
K962001	MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE	Jan 10, 1997	Substantially Equivalent	Manan Medical Products, Inc.
K963595	SERAGARD VASCULAR ACCESS DEVICE	Jan 06, 1997	Substantially Equivalent	Cutting Edge Technologies, Inc.
K960982	MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA	Dec 23, 1996	Substantially Equivalent	Sherwood Medical Co.
K950686	I.V. START KIT	Oct 24, 1996	Substantially Equivalent	James J. Schramm
K962149	SAFETY CRADLE	Oct 11, 1996	Substantially Equivalent	Specialized Health Products, Inc.
K960933	BIO-PLEXUS NEEDLE DISPOSAL CONTAINER	Aug 28, 1996	Substantially Equivalent	Bio-Plexus, Inc.
K961877	PISTON SYRINGE	Aug 07, 1996	Substantially Equivalent	Univec, Inc.
K955772	CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES	Jul 08, 1996	Substantially Equivalent	Ttk Biomed, Ltd.
K961088	NON-CORING NEEDLE	Jul 02, 1996	Substantially Equivalent	Arrow Intl., Inc.
K961878	SHARPS-TAINER	Jun 27, 1996	Substantially Equivalent	Winfield Industries
K961251	PUNCTUR-GUARD WINGED SET	Jun 27, 1996	Substantially Equivalent	Bio-Plexus, Inc.
K962040	RNS ARTHROGRAM TRAY	Jun 25, 1996	Substantially Equivalent	Contour Fabricators of Florida, Inc.
K962035	GE STERILE ARTHROGRAM TRAY	Jun 25, 1996	Substantially Equivalent	GE Medical Systems
K961328	BEC SHROUDED PLASTIC CANNULA	May 30, 1996	Substantially Equivalent	Biological & Environmental Control Laboratories
K932889	PERRY SPECIALTIES DESIGNS NEEDLE GUARD	May 28, 1996	Substantially Equivalent	Perry Specialties Design, Inc.
K960641	RECAP-1	May 17, 1996	Substantially Equivalent	Medscience, Inc.
K960963	CORD WRAP WITH NEEDLE RESHEATHER	May 06, 1996	Substantially Equivalent	Osborn Medical Corp.
K960698	NON-CORING NEEDLE	Apr 15, 1996	Substantially Equivalent	Med Institute, Inc.
K955748	DOYLE EXTRACTOR	Mar 14, 1996	Substantially Equivalent	Safetech Intl., Inc.
K942073	SHARPSPRO-TECTOR	Feb 29, 1996	Substantially Equivalent	Superior Diapering Products , Ltd.
K952044	INSULCAP	Feb 13, 1996	Substantially Equivalent	Karen Holtz
K955235	B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE	Feb 12, 1996	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K952837	DARWIN HYPODERMIC SAFETY SYSTEM (DHSS)	Jan 30, 1996	Substantially Equivalent	Emk Enterprises, LLC
K954500	HOSPITEC MEDI-BUTLER	Jan 18, 1996	Substantially Equivalent	Hospitec, Inc.
K940645	KEY-LOK(TM) SYSTEM	Nov 20, 1995	Substantially Equivalent	St. Paul Medical
K935916	LIP GRIP CAP HOLDER	Nov 03, 1995	Substantially Equivalent	Daryl C. Fallas
K954041	G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)	Oct 16, 1995	Substantially Equivalent	Glaxo, Inc.
K951254	SAFETYGLIDE NEEDLE	Oct 07, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K952834	SHROUDED PLASTIC CANNULA	Oct 03, 1995	Substantially Equivalent	Medical Associates Network, Inc.
K952274	CHEMOGUARD, P2 HIRISK	Aug 29, 1995	Substantially Equivalent	Biosafety Systems, Inc.
K944931	BECTON DICKINSON BLUNT STEEL CANNULA	Aug 29, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K950012	DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES	Aug 18, 1995	Substantially Equivalent	International Regulatory Consultants
K952518	SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE	Jul 28, 1995	Substantially Equivalent	Medi-Dose, Inc.
K934435	CAP-STIK	Jul 14, 1995	Substantially Equivalent	Mcshane Medical, Inc.
K943057	CAP SAFE SYSTEM	Jul 12, 1995	Substantially Equivalent	Medical Safety Solutions
K946289	DEVONS POINT LOK NEEDLE PROTECTION DEVICE	Jul 10, 1995	Substantially Equivalent	Devon Industries, Inc.
K943765	SHARPS AWAY	Jul 10, 1995	Substantially Equivalent	Biomedical Waste Systems, Inc.
K942930	CAPCARD	Jul 10, 1995	Substantially Equivalent	Capcard, Inc.
K951736	LOCK-UP	Jul 05, 1995	Substantially Equivalent	Medline
K950899	LABORATORY SHARPS BARREL	Jun 29, 1995	Substantially Equivalent	Biosystems
K946041	CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)	Jun 16, 1995	Substantially Equivalent	Cardico, Inc.
K943626	ISOLYSER SHARPS MANAGEMENT SYSTEM SMS	Jun 16, 1995	Substantially Equivalent	Thantex Specialties, Inc.
K951515	MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER	May 23, 1995	Substantially Equivalent	Sherwood Medical Co.
K946084	VANGUARD	May 17, 1995	Substantially Equivalent	Vanguard Container Corp.
K950466	B-D ULTRA-FINE II PEN NEEDLE	May 11, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K925056	SAFESHARPE (TM) DISPOSAL SYSTEM	Apr 21, 1995	Substantially Equivalent	Life Medical Technologies, Inc.
K950159	SURESHARP	Apr 14, 1995	Substantially Equivalent	Gainor Medical U.S.A., Inc.
K945825	SECURE SAFETY INSERT	Apr 10, 1995	Substantially Equivalent	Syncor Intl. Corp.
K945809	MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)	Mar 15, 1995	Substantially Equivalent	Sherwood Medical Co.
K943771	MEDX REUSABLE SHARPS CONTAINER	Mar 03, 1995	Substantially Equivalent	Bfi- Medical Waste Systems
K944680	SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE	Jan 31, 1995	Substantially Equivalent	Researched, Novel Medical Devices (Rn/Md)
K944121	SHARPS CONTAINER 18 GALLON	Jan 27, 1995	Substantially Equivalent	Bci, Inc.
K946027	BIG PHIL	Jan 26, 1995	Substantially Equivalent	Biomedical Waste Systems, Inc.
K941031	TOHP-CAP	Jan 26, 1995	Substantially Equivalent	Jrm Ent., Inc.
K944757	PISTON SYRINGES	Jan 11, 1995	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K945284	TRUJECT	Dec 29, 1994	Substantially Equivalent	Clive Craig Co.
K945276	PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G	Dec 14, 1994	Substantially Equivalent	Pro-Tec Containers, Inc.
K945275	PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1	Dec 14, 1994	Substantially Equivalent	Pro-Tec Containers, Inc.
K945274	PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80	Dec 14, 1994	Substantially Equivalent	Pro-Tec Containers, Inc.
K945273	PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2	Dec 14, 1994	Substantially Equivalent	Pro-Tec Containers, Inc.
K943794	MX4000	Dec 14, 1994	Substantially Equivalent	Bfi- Medical Waste Systems
K943740	ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)	Dec 14, 1994	Substantially Equivalent	Premium Plastics, Inc.
K943679	UNIVEC NONRESUSABLE LOCKING SYRINGE	Dec 12, 1994	Substantially Equivalent	Univec, Inc.
K944114	PHLEBOTOMY UNIT SHARPS A GATOR	Dec 02, 1994	Substantially Equivalent	Devon Industries, Inc.
K943892	POINT OF USE SHARPS A GATOR	Dec 02, 1994	Substantially Equivalent	Devon Industries, Inc.
K942179	PRO-TEC DISPOSABLE SHARPS CONTAINERS	Dec 02, 1994	Substantially Equivalent	Pro-Tec Containers, Inc.
K943722	CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS	Nov 28, 1994	Substantially Equivalent	Baxter Healthcare Corp
K943139	B-D GUARDIAN ONE PIECE SHARPS COLLECTORS	Nov 28, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K944230	DIAL MEDICAL SUPPLY SHARPS CONTAINER	Nov 07, 1994	Substantially Equivalent	Regulatory & Marketing Services, Inc.
K943141	B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943140	B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943137	B-D/BFI MAIL DISPOSAL SERVICE	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943136	B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943135	MED-SAFE INSULIN SHARPS CONTAINER	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943134	B-D GUARDIAN NESTABLE SHARPS COLLECTORS	Nov 07, 1994	Substantially Equivalent	Med-Safe Systems, Inc.
K943683	B-D SAFE-CLIP	Oct 31, 1994	Substantially Equivalent	Becton Dickinson Consumer Products
K943575	B-D GUARDIAN NESTABLE SHARPS COLLECTORS	Oct 14, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K942903	SHARPS-TAINER SMALL OPENING	Sep 19, 1994	Substantially Equivalent	Winfield Co., Inc.
K942901	SHARPS-TAINER LARGE OPENING	Sep 19, 1994	Substantially Equivalent	Winfield Co., Inc.
K940961	MONOJECT LUER ADAPTER	Sep 14, 1994	Substantially Equivalent	Sherwood Medical Co.
K943485	MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER	Sep 09, 1994	Substantially Equivalent	Sherwood Medical Co.
K943496	MONOJECT TRAY SIZE SHARPS CONTAINER	Aug 29, 1994	Substantially Equivalent	Sherwood Medical Co.
K942937	SHARPSAFE CAT NO. 4105, 4115 AND 4120	Aug 25, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K942624	LOK-ON NEEDLE DISPOSAL CONTAINER	Aug 25, 1994	Substantially Equivalent	Medical Safety Products, Inc.
K943578	MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER	Aug 23, 1994	Substantially Equivalent	Sherwood Medical Co.
K942054	SHARPS-TAINER	Aug 23, 1994	Substantially Equivalent	Winfield Industries
K943605	BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS	Aug 17, 1994	Substantially Equivalent	Baxter Healthcare Corp
K943594	BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS	Aug 17, 1994	Substantially Equivalent	Baxter Healthcare Corp
K935407	STICKIT	Aug 05, 1994	Substantially Equivalent	E.M. Innovations, Inc.
K933601	FLIPTIP SAFETY NEEDLE	Jun 24, 1994	Substantially Equivalent	Syntuition, Inc.
K942323	ONGARD 2 GALLON SHARPS CONTAINER	Jun 15, 1994	Substantially Equivalent	Ongard Systems, Inc.
K935843	BE-SAFE	Jun 03, 1994	Substantially Equivalent	Mathis-Koolpe, Inc.
K933674	ONGARD 2 GALLON CHEMO SHARPS CONTAINER	May 16, 1994	Substantially Equivalent	Ongard Systems, Inc.
K933274	ONGARD 3 QUART SHARPS CONTAINER	May 16, 1994	Substantially Equivalent	Ongard Systems, Inc.
K925086	AUTOMATIC NEEDLE DISCONECT (A.N.D.)	May 09, 1994	Substantially Equivalent	Post Medical, Inc.
K925816	SHARPS CONTAINMENT SYSTEM	Apr 29, 1994	Substantially Equivalent	Post Medical, Inc.
K936235	NEEDLESAFE II & NEEDLEGARD II	Mar 28, 1994	Substantially Equivalent	Ingenious Technologies Corp.
K936261	CATHETER INSERTION TRAY	Mar 10, 1994	Unknown	Medcare Custom Packaging, Inc.
K935777	SHARPSAFE, CAT. NO. 4125	Feb 28, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K935776	SHARPSAFE, CAT. NO. 4126	Feb 28, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K930217	BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE	Feb 28, 1994	Substantially Equivalent	Baxter Healthcare Corp
K934591	CLAVE VIAL ACCESS SPIKE	Feb 16, 1994	Substantially Equivalent	Icu Medical, Inc.
K933751	LIFESHIELD BLOOD COLLECTION DEVICE	Feb 14, 1994	Substantially Equivalent	Sherwood Medical Co.
K935514	VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER	Feb 10, 1994	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K936029	NON-CORNING (HUBER) NEEDLE	Feb 04, 1994	Substantially Equivalent	Therex Corp.
K935628	SHARPSAFE CAT. NO. 4127	Feb 04, 1994	Substantially Equivalent	Smiths Industries Medical Systems, Inc.
K934404	MONOJECT VERTICAL ENTRY SHARPS CONTAINER	Feb 04, 1994	Substantially Equivalent	Sherwood Medical Co.
K935506	MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION	Feb 03, 1994	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K935505	WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER	Feb 03, 1994	Substantially Equivalent	Kawasumi Laboratories Co., Ltd.
K934088	AUTO SUTURE SHARPS CONTAINER	Feb 03, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K935480	MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS	Jan 28, 1994	Substantially Equivalent	Evans Medical, Inc.
K925234	BEDSIDE CADDY	Nov 19, 1993	Substantially Equivalent	Researched, Novel Medical Devices (Rn/Md)
K924793	HAN-D-AID	Oct 19, 1993	Substantially Equivalent	Salmon Ent.
K931019	BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE	Oct 18, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K924820	HYPOGRIP(TM)	Oct 05, 1993	Substantially Equivalent	Collett Products
K925446	BARD SAFE SAMPLING DEVICE	Jul 29, 1993	Substantially Equivalent	C.R. Bard, Inc.
K922179	CATHETER INSERTION TRAY	Jul 02, 1993	Unknown	Medcare Custom Packaging, Inc.
K921950	SURGICAL DYNAMICS DISCOGRAPHY SYSTEM	Jun 07, 1993	Unknown	Surgical Dynamics, Inc.
K923127	NEEDLE-PRO CARTRIDGE	Apr 29, 1993	Substantially Equivalent	Concord/Portex
K924070	B-D PEN NEEDLE	Mar 18, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K924439	BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA	Feb 12, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920737	LIFESHIELD VIAL ADAPTER	Dec 15, 1992	Substantially Equivalent	Abbott Laboratories
K922158	PROTECTOR SYRINGE SAFETY CAP SYSTEM	Jul 21, 1992	Substantially Equivalent	Injectimed, Inc.
K920717	NEEDLEGARD II	Apr 22, 1992	Substantially Equivalent	Ingenious Technologies Corp.
K915409	INTRAOSSEOUS ACCESS NEEDLE	Mar 04, 1992	Substantially Equivalent	Cook, Inc.
K913258	DISPOSABLE INTROSSEOUS INFUSION NEEDLES	Mar 04, 1992	Substantially Equivalent	Cook, Inc.
K913386	CHEMO-PORT	Jan 10, 1992	Unknown	Hdc Corp.
K913885	RINN E-Z CAPPER	Dec 13, 1991	Substantially Equivalent	Rinn Corp.
K913498	MX927 BLOOD TRANSFER DEVICE	Nov 27, 1991	Substantially Equivalent	Medex, Inc.
K913317	MEGA ARTHROGRAM KIT	Oct 31, 1991	Substantially Equivalent	Mega Medical, Inc.
K913141	MEGA MYELOGRAM KIT	Oct 17, 1991	Substantially Equivalent	Megadyne Medical Products, Inc.
K913914	PROGUARDII(TM) BLOOD COLLECTION DEVICE	Oct 08, 1991	Substantially Equivalent	Care Medical Devices, Inc.
K910667	STERI-STAT REUSABLE SYRINGE	Sep 04, 1991	Substantially Equivalent	David Craig Marketing, Inc.
K913329	V-ACCI-GUARD(TM) REUSABLE HOLDER	Aug 23, 1991	Substantially Equivalent	Medical Safety Products, Inc.
K911597	THE NEEDLE NABBER	Jul 26, 1991	Substantially Equivalent	J. Simmons Instrument , Ltd.
K911436	SHARPS PIN CUSHION(TM) CONTAINER	Jul 01, 1991	Substantially Equivalent	Catalyst, Inc.
K910733	MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE	Jun 06, 1991	Substantially Equivalent	Medisystems Corp.
K902422	NEEDLE, ASPIRATION & INJECTION, DISPOSABLE	Jun 06, 1991	Substantially Equivalent	Gainor Medical Europe, Ltd.
K911037	SAFETY NEEDLE SHEATH, MODIFICATION	May 03, 1991	Substantially Equivalent	Concord/Portex
K905664	VIAL ACCESS CANNULA	Mar 15, 1991	Substantially Equivalent	Baxter Healthcare Corp
K910455	IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR	Feb 14, 1991	Substantially Equivalent	Ziehm International, Inc.
K905305	SAFE-SITE NEEDLE COVER	Feb 12, 1991	Substantially Equivalent	North American Medical Products, Inc.
K904198	SAFETY NEEDLE SHEATH	Dec 19, 1990	Substantially Equivalent	Concord/Portex
K904107	CAP-AID	Dec 14, 1990	Substantially Equivalent	Nda Systems
K903490	NORPLANT(R) TROCAR	Nov 28, 1990	Substantially Equivalent	Wyeth-Ayerst Laboratories, Inc.
K904295	PROGUARD(TM) BLOOD COLLECTION NEEDLE	Oct 15, 1990	Substantially Equivalent	Safety-Ject, Inc.
K901162	STERIMATIC(TM) SAFETY NEEDLE	Sep 28, 1990	Substantially Equivalent	Sterimatic Worldwide, Ltd.
K895024	PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE	Sep 21, 1990	Substantially Equivalent	Bio-Plexus, Inc.
K895811	SHARGHP HYPODERMIC NEEDLE	Sep 07, 1990	Substantially Equivalent	Shargh Pharmaceutical Co., Inc.
K900282	NEEDLE-SHIELD	Feb 28, 1990	Substantially Equivalent	Macbrud Corp. Medical Div.
K895771	EXEL SPINAL NEEDLES	Feb 16, 1990	Substantially Equivalent	Exel Intl.
K895769	EXEL HUBER NEEDLE	Feb 16, 1990	Substantially Equivalent	Exel Intl.
K896293	VIRAFREE CORP. EJECTABLE NEEDLE HOLDER	Jan 18, 1990	Substantially Equivalent	Virafree Corp.
K896320	CENTURION KLEEN-NEEDLE SYSTEM	Jan 11, 1990	Substantially Equivalent	Tri-State Hospital Supply Corp.
K895630	B-D PEND NEEDLE	Dec 08, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K895432	SAFE-T-CAP	Nov 03, 1989	Substantially Equivalent	Ausmedics Pty , Ltd.
K895075	ACCI-GUARD REUSABLE HOLDER	Oct 31, 1989	Substantially Equivalent	Medical Safety Products, Inc.
K895705	SHAMROCK SAFETY BLOOD COLLECTION SET	Oct 10, 1989	Substantially Equivalent	Ryan Medical, Inc.
K894374	BLOOD DRAWING NEEDLE	Sep 28, 1989	Substantially Equivalent	Pharma-Plast USA, Inc.
K894372	NIPRO NEEDLE HOLDER	Sep 28, 1989	Substantially Equivalent	Pharma-Plast USA, Inc.
K890926	SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE	Jun 20, 1989	Substantially Equivalent	Meadox Surgimed, Inc.
K891919	INTRAVASCULAR ADMINISTRATION SET	May 05, 1989	Substantially Equivalent	Multi-Med, Inc.
K890473	NEEDLE GUARD(TM)	Apr 03, 1989	Substantially Equivalent	Martech Medical Products, Inc.
K885122	NEEDLE STICK	Mar 14, 1989	Substantially Equivalent	Poncy, Inc.
K890620	STICK-GARD SAFETY NEEDLE	Feb 28, 1989	Substantially Equivalent	Ziehm International, Inc.
K890127	INTRAVASCULAR ADMINISTRATION SET	Feb 03, 1989	Substantially Equivalent	Multi-Med, Inc.
K884792	VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES	Jan 30, 1989	Substantially Equivalent	Infucare Products, Inc.
K884620	ASD SINGLE LUMEN NEEDLE	Nov 21, 1988	Substantially Equivalent	Biosurge, Inc.
K884212	WINGED NON-CORING NEEDLE SET	Oct 17, 1988	Substantially Equivalent	Marquette Medical, Inc.
K884211	STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES	Oct 17, 1988	Substantially Equivalent	Marquette Medical, Inc.
K884139	ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER	Oct 06, 1988	Substantially Equivalent	Medical Safety Products, Inc.
K883009	NON-CORING NEEDLES	Oct 04, 1988	Substantially Equivalent	Quinton, Inc.
K882880	SAFETY, BLOOD COLLECTION TUBE HOLDER	Aug 09, 1988	Substantially Equivalent	Ryan Medical, Inc.
K882064	LO-CORE NEEDLE	Jul 08, 1988	Substantially Equivalent	Device Labs, Inc.
K881654	ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE	Jul 08, 1988	Substantially Equivalent	Medical Safety Products, Inc.
K881671	MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT	Jun 15, 1988	Substantially Equivalent	Manan Medical Devices
K881758	VIGGO VASCUPORT NEEDLE	Jun 03, 1988	Substantially Equivalent	Ohmeda Medical
K881785	N.S. CADEE	May 31, 1988	Substantially Equivalent	First Scientific, Div.
K880746	STERILE NEEDLE FOR BLOOD COLLECTION	May 31, 1988	Substantially Equivalent	Applied Plastics Technology, Inc.
K880892	BLOOD COLLECTING NEEDLE AND HOLDERS	Apr 21, 1988	Substantially Equivalent	Abco Dealers, Inc.
K874602	ASD-BIO ANTI-STICK DEVICE	Feb 19, 1988	Substantially Equivalent	Biosurge, Inc.
K874414	HYPODERMIC NEEDLES, SINGLE LUMEN	Jan 14, 1988	Substantially Equivalent	Harbor Medical Devices, Inc.
K874430	NEEDLE CONTAINER	Jan 04, 1988	Substantially Equivalent	American Medical Technology, Inc.
K873991	LAKE IRRIGATION TRAY	Dec 30, 1987	Substantially Equivalent	Lake Medical Products, Inc.
K873165	CHEMO-PORT NON-CORING NEEDLES	Dec 03, 1987	Substantially Equivalent	Hdc Corp.
K874024	ACU-MICRO-NEEDLE	Nov 23, 1987	Substantially Equivalent	Acuderm, Inc.
K874372	HR(TM) NEEDLE AND SYRINGE	Nov 06, 1987	Substantially Equivalent	Icu Medical, Inc.
K874249	BIFURCATED NEEDLE	Nov 03, 1987	Substantially Equivalent	Allergy Laboratories of Ohio, Inc.
K873569	BLOOD NEEDLE HOLDER	Nov 03, 1987	Substantially Equivalent	Sage Products, Inc.
K873957	NON-CORING HUBER TYPE NEEDLES	Oct 23, 1987	Substantially Equivalent	Advantage Medical Systems, Inc.
K872566	MULTIPLE NEEDLE, INJECTION, DISPOSABLE	Aug 25, 1987	Substantially Equivalent	Cotran Corp.
K872580	HR (TM) COLLECTION SYSTEM	Aug 13, 1987	Substantially Equivalent	Icu Medical, Inc.
K871142	ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP)	Jun 29, 1987	Substantially Equivalent	Peachtree Medical, Inc.
K870863	FNA THYROID BIOPSY KIT	May 08, 1987	Substantially Equivalent	Flint Laboratories Div. Travenol
K870193	A+MED DISPOSABLE NEEDLE	Feb 27, 1987	Substantially Equivalent	Can-Am Surgical Corp.
K862610	ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE	Feb 04, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K864310	RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE	Jan 20, 1987	Substantially Equivalent	Rymco Ltda
K863606	BUTTERFLY NON-CORING NEEDLE SET	Dec 18, 1986	Substantially Equivalent	Cormed, Inc., Sub. C.R.Bard, Inc.
K863514	PROMEDICOR	Sep 25, 1986	Substantially Equivalent	Terra Marketing Assoc.
K861390	DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET	Jul 17, 1986	Substantially Equivalent	Baxter Healthcare Corp
K861560	MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE	May 12, 1986	Substantially Equivalent	Medi Point, Inc.
K861406	NON-KOR WINGED INFUSION SETS	May 06, 1986	Substantially Equivalent	Creative Care Systems, Inc.
K861152	EXEL VACUUM BLOOD COLLECTING SYSTEM	May 06, 1986	Substantially Equivalent	Exel Intl.
K860781	ICU MEDICAL NEEDLE, LOPEZ NEEDLE	May 06, 1986	Substantially Equivalent	Icu Medical, Inc.
K861318	DISPOSABLE NEEDLE COUNTER (20-720)	May 02, 1986	Substantially Equivalent	Anago, Inc.
K861081	DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH	Apr 09, 1986	Substantially Equivalent	Perkins & Perkins, Inc.
K852615	R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE	Mar 21, 1986	Substantially Equivalent	Medical Hospital Equipment
K855248	BLOOD COLLECTING NEEDLE	Feb 26, 1986	Substantially Equivalent	Churchill Corp.
K854549	MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU	Feb 04, 1986	Substantially Equivalent	Sherwood Medical Co.
K854548	MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES	Feb 04, 1986	Substantially Equivalent	Sherwood Medical Co.
K854547	MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE	Feb 04, 1986	Substantially Equivalent	Sherwood Medical Co.
K853604	ACE-KYLE DYE INJECTION NEEDLE P/N 14082	Nov 12, 1985	Substantially Equivalent	Today'S Machining & Design, Inc.
K853731	HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX	Oct 18, 1985	Substantially Equivalent	Gish Biomedical, Inc.
K852442	PHARMA-PLAST NEEDLE	Sep 20, 1985	Substantially Equivalent	Pharma-Plast USA, Inc.
K852831	NON-KOR ACCESS KITS	Sep 19, 1985	Unknown	Creative Care Systems, Inc.
K851103	VASCULAR IMPLANT ACCESS NEEDLE SET	Jul 16, 1985	Substantially Equivalent	Baxter Healthcare Corp
K845043	JMS NEEDLES & JMS SYRINGES	Apr 29, 1985	Substantially Equivalent	Jms Co., Ltd.
K850420	CHURCHILL HABER POINT NEEDLE ADMIN. SET	Apr 24, 1985	Substantially Equivalent	Churchill Corp.
K844313	INFUSET W/HUBER NEEDLE	Jan 22, 1985	Substantially Equivalent	Med Fusion Systems, Inc.
K843264	MONOJECT MENGHINI SOFT TISSUE BIOPSY	Dec 17, 1984	Substantially Equivalent	Sherwood Medical Co.
K844305	GAINOR MEDICAL FLOWMAX NEEDLES	Nov 30, 1984	Substantially Equivalent	Gainor Medical
K842542	AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY	Aug 20, 1984	Substantially Equivalent	American Pharmaseal Div. Ahsc
K842756	BUTTERFLY II PN INFUSION NEEDLE	Jul 23, 1984	Substantially Equivalent	Cosmetic Sciences, Inc.
K841565	HESUNG'S HYPERDERMIC NEEDLES	Jul 17, 1984	Substantially Equivalent	Amkor Trading Co.
K842012	UMI CURVED CHEMONUCLEOLYSIS NEEDLE	Jul 06, 1984	Substantially Equivalent	Universal Medical Instrument Corp.
K841742	NON-CORING NEEDLE	Jul 06, 1984	Substantially Equivalent	Creative Care Systems, Inc.
K841704	THINWALL PUNCTURE NEEDLE	Jun 28, 1984	Substantially Equivalent	Meadox Surgimed, Inc.
K841306	HEPARIN LOCK FLUSH SOLUTION USP KIT,100	Jun 04, 1984	Substantially Equivalent	Solo Pak Laboratories
K841305	HEPARIN LOCK FLUSH SOLUTION USP KIT	Jun 04, 1984	Substantially Equivalent	Solo Pak Laboratories
K841166	HEPARIN LOCK FLUSH PROCEDURE PACK	Jun 04, 1984	Substantially Equivalent	Solo Pak Laboratories
K833705	BETAJECT BD U100	May 09, 1984	Substantially Equivalent	Orange Medical Instruments, Inc.
K841577	HYPODERMIC NEEDLES	May 07, 1984	Substantially Equivalent	Ava Medical Products of Canada, Inc.
K841217	PICKER MYELOGRAM TRAY-PMS MYELOGRAM	Apr 27, 1984	Substantially Equivalent	Professional Medical Systems
K840944	INFUSION NEEDLE IIPN	Apr 13, 1984	Substantially Equivalent	Medi Tex, Inc.
K840334	CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY	Apr 13, 1984	Substantially Equivalent	Applied Medical Devices, Inc.
K840033	HYPODERMIC NEEDLES & STYLETS	Apr 05, 1984	Substantially Equivalent	Microvasive
K832904	INTRAVENOUS NEEDLE	Mar 30, 1984	Substantially Equivalent	Yolan R. Guttman
K840967	OHIO HEAT REFLECTING PATCH	Mar 23, 1984	Substantially Equivalent	Ohio Medical Products
K834407	STERILE DISPOSABLE SPINAL NEEDLES	Mar 19, 1984	Substantially Equivalent	Hydro-Med Products, Inc.
K834436	CHEMONUCLEOLYSIS NEEDLE	Mar 15, 1984	Substantially Equivalent	Universal Medical Instrument Corp.
K834553	INTRADISCAL THERAPY TRAY	Mar 06, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K830568	GUTTMAN INFUSION NEEDLE	Oct 27, 1983	Substantially Equivalent	Cosmetic Sciences, Inc.
K832858	INTRADISCAL THERAPY TRAY	Sep 29, 1983	Substantially Equivalent	Ulti-Med Intl., Inc.
K832556	NEONATAL LUMBAR PUNCTURE TRAY	Sep 12, 1983	Substantially Equivalent	American Pharmaseal Div. Ahsc
K832102	STERILE DISPOSABLE NEEDLES	Sep 01, 1983	Substantially Equivalent	Lee Medical Intl., Inc.
K831063	BUTTON INFUSER	Aug 24, 1983	Substantially Equivalent	Markwell Medical Institute, Inc.
K831395	AVL 0073 MICROSAMPLER	Jul 26, 1983	Substantially Equivalent	Avl Scientific Corp.
K831765	HERAPIN LOCK FLUSH SOLUTION USE KIT	Jul 12, 1983	Substantially Equivalent	Smith & Nephew, Mpl Division
K831610	INTRADISCAL THERAPY NEEDLE	Jul 12, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823899	INFANT CARE SYSTEM	Apr 14, 1983	Substantially Equivalent	Narco Scientific
K830242	MICRO 2 HYPODERMIC NEEDLES	Feb 15, 1983	Substantially Equivalent	Smith & Nephew, Mpl Division
K823693	MYELOGRAPHY NEEDLE	Feb 07, 1983	Substantially Equivalent	Ocean Medical Products, Ltd.
K823696	MICRO Z BLOOD COLLECTING NEEDLES	Jan 26, 1983	Substantially Equivalent	Hospital Products Co.
K823255	NON-STERILE REUSABLE NEEDLES	Nov 22, 1982	Substantially Equivalent	Vertex Medical Corp.
K821529	DISPOSABLE HYPODERMIC NEEDLES	Jun 09, 1982	Substantially Equivalent	Medcare Disp Products, Inc.
K820911	PBC NEEDLE BY NIPRO MED. INDUSTRIES	Apr 15, 1982	Substantially Equivalent	Philadelphia Biologics Center
K813256	HYPODERMIC & SUTURE NEEDLES	Mar 25, 1982	Substantially Equivalent	Needle Industries(Usa), Inc.
K813649	PBC NEEDLE	Jan 28, 1982	Substantially Equivalent	Philadelphia Biologics Center
K813648	JMS NEEDLE & MAC JECT	Jan 28, 1982	Substantially Equivalent	Philadelphia Biologics Center
K813545	HYPOSERMIC NEEDLES	Jan 12, 1982	Substantially Equivalent	Optical Micro Systems, Inc.
K812910	MEDISYSTEMS NEEDLES & SYRINGES	Nov 06, 1981	Substantially Equivalent	Medisystems Corp.
K812404	BUTTERFLY NEEDLE ASSEMBLY	Sep 09, 1981	Substantially Equivalent	Nu Tech Medical Systems
K811966	VISITEC NEEDLE RANGE (GENERAL HOSPITAL)	Jul 23, 1981	Substantially Equivalent	Visitec Co.
K801839	DISPOSABLE HYPODERMIC NEEDLES	Sep 16, 1980	Substantially Equivalent	Martin'S Maine Exchange
K801431	PAN-AM MYELOGRAM TRAY	Aug 12, 1980	Substantially Equivalent	Waters Assoc., Inc.
K801108	DOUBLE ENDED VENTED TRANSFER DEVICE	May 30, 1980	Substantially Equivalent	Burron Medical Products, Inc.
K801107	DOUBLE ENDED FILTERED TRANSFER NEEDLE	May 30, 1980	Substantially Equivalent	Burron Medical Products, Inc.
K792096	2 FR KELMAN CHAMBER MAINTAINER	Nov 16, 1979	Substantially Equivalent	Heyer Schulte Corp.
K791462	HYPERDERMIC NEEDLE WITH SENSOR #514	Sep 24, 1979	Substantially Equivalent	Medtech Intl., Inc.
K791156	AMIPAQUE MYELOGRAM TRAY	Jul 30, 1979	Substantially Equivalent	Pharmaseal Div., Baxter Healthcare Corp.
K790953	BORDISPO BRAND HYPODERMIC NEEDLE	Jun 27, 1979	Substantially Equivalent	Borda Products, Inc.
K790086	NEEDLE, TRUCARE VACUTAINER	Feb 08, 1979	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K780209	DILUTION SPIKE	Apr 10, 1978	Substantially Equivalent	Sterling Drug, Inc.
K771667	BLOOD GAS TRAY #4024	Oct 13, 1977	Substantially Equivalent	Concord Laboratories, Inc.
K771209	TERUFUSION BLOOD ADMIN. SET	Jul 26, 1977	Substantially Equivalent	Terumo America, Inc.
K771207	TERUFUSION DONOR SET	Jul 14, 1977	Substantially Equivalent	Terumo America, Inc.
K771203	DISP. HYPODERMIC NEEDLE	Jul 14, 1977	Substantially Equivalent	Terumo America, Inc.
K770528	NEEDLE, MEMBRANE	Apr 29, 1977	Substantially Equivalent	American Viggo
K770425	NEEDLES, STERILE, AIRWAY	Apr 15, 1977	Substantially Equivalent	Pfizer Pharmaceuticals
K770370	CONVENIENCE TRAY	Mar 16, 1977	Substantially Equivalent	Johannah Medical Services, Inc.
K761098	FILTER DEVICES	Jan 28, 1977	Substantially Equivalent	Arrow Intl., Inc.
K760780	DOUBLE-ENDED NEEDLE	Nov 16, 1976	Substantially Equivalent	Travenol Laboratories, S.A.