Product Code: MEG FDA class 2 21 CFR 880.5860

Syringe, Antistick

General Hospital

The antistick syringe is a general hospital device designed with features to prevent accidental needlestick injuries during or after injection procedures, protecting healthcare workers from sharps-related exposure to bloodborne pathogens. It is classified as FDA Class II under 21 CFR 880.5860 within the General Hospital specialty, requiring 510(k) premarket clearance. The product code is MEG and the device is not implanted. Full GMP compliance is required.

View on FDA

510(k)s

164

FEI Numbers

143

Registration Numbers

143

Unique Applicants

120

Years Active

Basic Information

Product Code: MEG
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 164 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K230287	SaviSafe Safety Device	Nov 21, 2023	Substantially Equivalent	Suzhou Savicred Biotechnology Co., Ltd.
K231165	Shina Syringe; Shina Safety Syringe	Oct 27, 2023	Substantially Equivalent	Shina Med Corporation
K231907	Medline Safety Insulin and TB Syringes	Oct 18, 2023	Substantially Equivalent	Medline Industries, LP
K223376	Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)	Jun 21, 2023	Substantially Equivalent	Cardinal Health 200, LLC
K220114	PowerPAK Syringe	Jan 25, 2023	Substantially Equivalent	Vault Paragon Group, Inc.
K221981	SafeR Syringe and SafeR Sting	Dec 29, 2022	Substantially Equivalent	Roncadelle Operations srl
K222452	Disposable Automatically Retractable Safety Syringes (with detachable needle)	Nov 23, 2022	Substantially Equivalent	Shantou Wealy Medical Instrument CO.,Ltd.
K221247	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle	Nov 01, 2022	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd.
K220057	Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization	Oct 07, 2022	Substantially Equivalent	Shinva Ande Healthcare Apparatus Co., Ltd.
K221073	Sterile Hypodermic Syringes for Single Use with Safety Needles	Oct 04, 2022	Substantially Equivalent	Sichuan Prius Biotechnology Co., Ltd.
K221416	Sterile Safety Syringes for Single Use	Aug 31, 2022	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd
K220061	Safety Insulin Syringes	Aug 23, 2022	Substantially Equivalent	Berpu Medical Technology Co., Ltd.
K212518	Jeesung Safety Syringe and Single Use Needles	Aug 18, 2022	Substantially Equivalent	JeeSung Medical Co., Ltd.
K220183	Sterile Safety Syringes for Single Use (Retractable)	Jul 21, 2022	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd
K220185	Sterile Safety Insulin Syringes for Single Use	Jul 11, 2022	Substantially Equivalent	Shanghai Kindly Enterprise Development Group Co., Ltd.
K213077	Automatically Retractable Safety Syringe	Apr 27, 2022	Substantially Equivalent	Zhejiang Lingyang Medical Apparatus Co., Ltd.
K210216	Disposable Automatically Retractable Insulin Safety Syringe	Mar 04, 2022	Substantially Equivalent	Shantou Wealy Medical Instrument CO.,Ltd
K212652	Sterile Syringe with Fixed Safety Needle for Single Use	Mar 02, 2022	Substantially Equivalent	Gemtier Medical (Shanghai) Inc.
K211484	Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles	Mar 01, 2022	Substantially Equivalent	Shinva Ande Healthcare Apparatus Co., Ltd.
K212949	Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use	Feb 24, 2022	Substantially Equivalent	Henan Nursecare Biotechnology Co., Ltd
K210229	Sterile Auto-Disable Syringes with/without Needle for Single Use	Feb 15, 2022	Substantially Equivalent	Zhejiang Kangkang Medical-Devices CO., Ltd.
K211329	Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	Nov 15, 2021	Substantially Equivalent	Jiangsu Kangbao Medical Equipment Co., Ltd
K211555	Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe	Oct 18, 2021	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd
K211753	Sterile Syringe With Safety Needle	Oct 14, 2021	Substantially Equivalent	Jiangxi Hongda Medical Equipment Group Ltd.
K212226	DR Safety Syringe, Sterile Hypodermic needle for Single use	Sep 29, 2021	Substantially Equivalent	Zhuhai DR Medical Instruments Co., Ltd
K202570	Insulin Syringe, Insulin Syringe with Safety Retractable	Jul 02, 2021	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd
K191639	TK Insulin Syringe with/without Saftey Retractable Device	Sep 11, 2020	Substantially Equivalent	Anhui Tiankang Medical Technology Co.,Ltd.
K192551	1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle	Aug 10, 2020	Substantially Equivalent	Jiangsu Caina Medical Co., Ltd.
K193022	Retractable Safety Insulin Syringe	Jul 20, 2020	Substantially Equivalent	Jiangsu Caina Medical Co.,Ltd.
K192679	Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use	Apr 10, 2020	Substantially Equivalent	Gemtier Medical (Shanghai) Inc.
K190183	Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe	Oct 04, 2019	Substantially Equivalent	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
K191490	Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe	Oct 03, 2019	Substantially Equivalent	Jiangsu Caina Medical Co., Ltd.
K183665	Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use	Sep 06, 2019	Substantially Equivalent	Jiangsu Micsafe Medical Technology Co., Ltd.
K173743	Greenmedi Safety Filter Syringe	Jan 28, 2019	Substantially Equivalent	Sang-A Frontec Co., Ltd
K180417	Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use	Aug 09, 2018	Substantially Equivalent	BERPU MEDICAL TECHNOLOGY CO., LTD
K170651	Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle	Aug 02, 2017	Substantially Equivalent	Yangzhou Medline Industry Co., Ltd.
K163162	Sterile Hypodermic Safety Syringes for Single Use	Mar 20, 2017	Substantially Equivalent	JiangXi HongDa Medical Equipment Group Ltd.
K163511	NovaGuard SA Pro Safety System	Feb 02, 2017	Substantially Equivalent	WEST PHARMACEUTICAL SERVICES, INC.
K162030	0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle	Aug 19, 2016	Substantially Equivalent	SOL-MILLENNIUM MEDICAL, INC
K152606	Jeesung Safety Syringe and Single Use Needles	Jun 28, 2016	Substantially Equivalent	JEESUNG MEDICAL CO LTD
K152808	U&U Insulin Syringe with/without Safety Retractable Device	Mar 25, 2016	Substantially Equivalent	U&U Medical Technology Co., Ltd
K143497	Safety Auto-Disable Syrine with Needle (Auto-Lock)	Nov 04, 2015	Substantially Equivalent	GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD
K143070	Disposable Safety Self-destructive Syringes, 5 ML	Jul 07, 2015	Substantially Equivalent	Jiangsu Yile Medical Article Co.,Ltd.
K150562	Safe'n'Sound Staked Passive Delivery System - Plajex version	Jun 02, 2015	Substantially Equivalent	Nemera
K141349	Disposable sterile needle retractable safety syringe	Apr 10, 2015	Substantially Equivalent	GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD
K142435	3S Safety Syringe with/without Needle	Feb 20, 2015	Substantially Equivalent	Sincere Medical Device Co., Ltd.
K142436	3S Safety Insulin Syringe	Feb 19, 2015	Substantially Equivalent	Sincere Medical Device Co., Ltd.
K140949	ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE	Feb 09, 2015	Substantially Equivalent	ULTIMED INCORPORATED
K141640	AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE	Nov 19, 2014	Substantially Equivalent	SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
K141664	SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION	Oct 02, 2014	Substantially Equivalent	REXAM HEALTHCARE
K141464	NOVAGUARD S A SAFETY SYSTEM	Sep 10, 2014	Substantially Equivalent	WEST PHARMACEUTICAL SERVICES
K132681	SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE	May 22, 2014	Substantially Equivalent	SOL-MILLENNIUM MEDICAL, INC.
K131531	TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE	May 12, 2014	Substantially Equivalent	ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD
K123743	ULTRASAFE PLUS PASSIVE NEEDLE GUARD	Mar 26, 2013	Substantially Equivalent	SAFETY SYRINGES, INC.
K121637	AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE	Oct 25, 2012	Substantially Equivalent	SUNWELL BIOTECH CO., LTD
K120641	GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE	Oct 17, 2012	Substantially Equivalent	GLOBAL MEDI PRODUCTS
K122558	ULTRASAFE PASSIVE NEEDLE GUARD	Sep 20, 2012	Substantially Equivalent	SAFETY SYRINGES, INC.
K113587	AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)	Feb 24, 2012	Substantially Equivalent	SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
K112936	SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM	Jan 20, 2012	Substantially Equivalent	REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA
K111734	MYSAFETY SYRINGE	Sep 06, 2011	Substantially Equivalent	MEDICALCHAIN INTL. CORP.
K101560	MEDLINE RETRACTABLE SAFETY SYRINGE	Mar 25, 2011	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K101233	SAFE'N'SOUND PASSIVE DELIVERY SYSTEM	Feb 18, 2011	Substantially Equivalent	REXAM PHARMA
K103781	MED-LOK SAFETY NEEDLE	Feb 08, 2011	Substantially Equivalent	STA-MED, LLC
K103011	ULTICARE SAFETY INSULIN SYRINGE	Feb 02, 2011	Substantially Equivalent	ULTI-MED INTL., INC.
K100998	1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1	Aug 30, 2010	Substantially Equivalent	UNILIFE MEDICAL SOLUTIONS LIMITED
K093176	MED-LOK	Apr 06, 2010	Substantially Equivalent	STA-MED, LLC
K092430	1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES	Sep 04, 2009	Substantially Equivalent	INVIRO MEDICAL DEVICES, INC.
K092413	INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES	Sep 04, 2009	Substantially Equivalent	INVIRO MEDICAL DEVICES, INC.
K080877	1ML UNITRACT INSULIN SYRINGE 27G1/2 , 1ML UNITRACT SYRINGE 29G1/2	Oct 21, 2008	Substantially Equivalent	UNILIFE MEDICAL SOLUTIONS LIMITED
K080600	ULTIMED ULTICARE SAFETY SYRINGE	Jun 25, 2008	Substantially Equivalent	ULTIMED, INC.
K072739	JIERUI SYRINGES AND NEEDLES	Mar 21, 2008	Substantially Equivalent	SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD.
K073206	NEEDLE-TRAP/NEEDLE SAFETY LABEL	Jan 16, 2008	Substantially Equivalent	SCHREINER MEDIPHARM
K072482	HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY	Nov 29, 2007	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K072037	CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML	Aug 08, 2007	Substantially Equivalent	LIFE-SHIELD PRODUCTS, INC
K070117	SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC	Aug 06, 2007	Substantially Equivalent	DOLOMITE BIOTECH SDN BHD
K070203	INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024	Apr 23, 2007	Substantially Equivalent	INVIRO MEDICAL DEVICES, INC.
K063340	SAF-T-SYRINGE- 0.5 AND 1ML/CC	Mar 06, 2007	Substantially Equivalent	SAFETY MEDICAL INTERNATIONAL, INCORPORATED
K063755	PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE	Feb 27, 2007	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K062780	CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE	Jan 05, 2007	Substantially Equivalent	MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
K062318	BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML	Jan 03, 2007	Substantially Equivalent	BIOTOP TECHNOLOGY CO., LTD.
K060971	OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS	Oct 24, 2006	Substantially Equivalent	OMI MANUFACTURING PTY., LTD.
K060772	MANUEL SAFTEY SYRINGE PARTS 1 & 2	Oct 16, 2006	Substantially Equivalent	MEDSAFE ASA
K061194	PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558	Aug 24, 2006	Substantially Equivalent	SMITHS MEDICAL ASD, INC.
K053519	SAFETY SYRINGE	Aug 11, 2006	Substantially Equivalent	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
K061055	CAREO SAFETY SYRINGE FOR U-100 INSULIN	Jul 10, 2006	Substantially Equivalent	LIFE-SHIELD PRODUCTS, INC
K060668	SAFE TIP SYRINGE	Jun 12, 2006	Substantially Equivalent	DEVON SAFETY PRODUCTS, INC.
K060002	RITRACT SAFETY SYRINGE	Jun 02, 2006	Substantially Equivalent	RITRACT LTD.
K060109	OMI RETRACTABLE SAFETY SYRINGE	May 05, 2006	Substantially Equivalent	VITALCARE GROUP, INC.
K060743	MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES)	Apr 28, 2006	Substantially Equivalent	SAFETY SYRINGES, INC.
K060208	CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,	Mar 10, 2006	Substantially Equivalent	LIFE-SHIELD PRODUCTS, INC
K052397	CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)	Dec 22, 2005	Substantially Equivalent	LIFE-SHIELD PRODUCTS, INC
K051694	CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE	Dec 21, 2005	Substantially Equivalent	MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
K051800	IN6 SAFETY SYRINGE, MODEL 3ML	Oct 21, 2005	Substantially Equivalent	IN6 INCUVESTOR INC.
K052103	EXEL SECURE TOUCH II SAFETY SYRINGE	Oct 19, 2005	Substantially Equivalent	EXELINT INTL. CO.
K051865	TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR	Sep 27, 2005	Substantially Equivalent	TERUMO MEDICAL CORP.
K051762	SAF-T-SYRINGE/SAF-T-NEEDLE	Sep 23, 2005	Substantially Equivalent	SAFETY MEDICAL INTERNATIONAL, INCORPORATED
K050116	UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES	May 09, 2005	Substantially Equivalent	UNIQSAFE BIOMEDITECH CO., LTD.
K043419	P&P SAFETY SYRINGE	Apr 15, 2005	Substantially Equivalent	MEDEXEL MEDICAL MFG. CO., LTD.
K050134	ICC INSULIN SAFEPRO SAFETY SYRINGE	Apr 05, 2005	Substantially Equivalent	FORMOSA MEDICAL DEVICES, INC.
K050131	INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE	Apr 05, 2005	Substantially Equivalent	M.K. MEDITECH CO. LTD.
K042102	YIXIN SAFETY SYRINGE	Mar 08, 2005	Substantially Equivalent	JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP
K042487	PROCEDUR SF SAFETY SYRINGE DEVICE	Jan 21, 2005	Substantially Equivalent	AVANCA MEDICAL DEVICES, INC.
K043038	BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML	Dec 22, 2004	Substantially Equivalent	BIOTOP TECHNOLOGY CO., LTD.
K042712	TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM	Oct 15, 2004	Substantially Equivalent	SAFETY SYRINGES, INC.
K042426	TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)	Sep 22, 2004	Substantially Equivalent	TAIJECT MEDICAL DEVICE CO., LTD.
K041970	BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML	Aug 03, 2004	Substantially Equivalent	BIOTOP TECHNOLOGY CO., LTD.
K032517	MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE	May 18, 2004	Substantially Equivalent	MEDSAFE TECHNOLOGIES LLC.
K032747	BIOTOP DJT-A SAFETY SYRINGE	May 11, 2004	Substantially Equivalent	BIOTOP TECHNOLOGY CO., LTD.
K030604	PERFECT SAFETY SYRINGE	Apr 30, 2004	Substantially Equivalent	PERFECT MEDICAL INDUSTRY CO., LTD.
K040545	OTTER SAFETY SYRINGE	Apr 22, 2004	Substantially Equivalent	OTTER (CHINA) TECHNOLOGY CO., LTD.
K040105	YUE PFONG SAFETY SYRINGE (3ML)	Apr 07, 2004	Substantially Equivalent	YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD.
K040036	INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905	Mar 18, 2004	Substantially Equivalent	INVIRO MEDICAL
K034031	10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE	Jan 21, 2004	Substantially Equivalent	M.K. MEDITECH CO. LTD.
K031909	BETEC RETRACTABLE SAFETY SYRINGE (5ML)	Oct 07, 2003	Substantially Equivalent	BETEC MEDICAL SCIENCE CO., LTD.
K032247	U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE	Sep 30, 2003	Substantially Equivalent	U.S. TECHNOLOGIES, INC.
K032780	INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC	Sep 24, 2003	Substantially Equivalent	INVIRO MEDICAL
K031830	SAFEPRO PLUS SAFETY SYRINGE	Aug 05, 2003	Substantially Equivalent	FORMOSA MEDICAL DEVICES, INC.
K031163	SEZ SAFETY SYRINGE	Jul 08, 2003	Substantially Equivalent	SEZ CORPORATION
K031065	SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5	Jun 23, 2003	Substantially Equivalent	SYRINGEX MEDICAL, INC.
K031594	BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY	Jun 06, 2003	Substantially Equivalent	M.K. MEDITECH CO. LTD.
K030976	CAREO RETRACTABLE SAFETY SYRINGE	May 30, 2003	Substantially Equivalent	LIFE-SHIELD PRODUCTS, INC
K031062	TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)	May 02, 2003	Substantially Equivalent	TAIJECT MEDICAL DEVICE CO., LTD.
K024249	TERUMO SURGUARD SAFETY SYRINGE	Feb 21, 2003	Substantially Equivalent	TERUMO MEDICAL CORP.
K011754	EXEL SECURETOUCH PTP SYRINGE	Jan 22, 2003	Substantially Equivalent	EXELINT INTL. CO.
K023458	TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)	Nov 07, 2002	Substantially Equivalent	TAIJECT MEDICAL DEVICE CO., LTD.
K023323	1CC FUTURA SAFETY SYRINGE	Oct 29, 2002	Substantially Equivalent	FUTURA MEDICAL TECHNOLOGY
K022806	DUOPRO SAFETY SYRINGE (DUOPROSS)	Sep 19, 2002	Substantially Equivalent	M.K. MEDITECH CO. LTD.
K022278	TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)	Sep 12, 2002	Substantially Equivalent	TAIJECT MEDICAL DEVICE CO., LTD.
K022063	SAFEPRO SAFETY SYRINGE	Aug 29, 2002	Substantially Equivalent	FORMOSA MEDICAL DEVICES, INC.
K020623	DUOPRO SAFETY SYRINGE (DUOPROSS)	May 02, 2002	Substantially Equivalent	M.K. MEDITECH CO. LTD.
K013006	OVUS CAPLESS SAFETY NEEDLE	Feb 06, 2002	Substantially Equivalent	OVUS SYSTEMS
K013801	ULTRASAFE DENTAL INJECTION SYSTEM	Dec 13, 2001	Substantially Equivalent	SAFETY SYRINGES, INC.
K010819	3CC NMT SAFETY SYRINGE	Nov 08, 2001	Substantially Equivalent	NEW MEDICAL TECHNOLOGY LTD.
K012121	SECUREGUARD RETRACTABLE SAFETY SYRINGE	Oct 24, 2001	Substantially Equivalent	SAFEGARD MEDICAL PRODUCTS, INC.
K012726	PROSAFE SAFETY SYRINGE	Oct 18, 2001	Substantially Equivalent	HOU-SE MEDICAL INC
K010477	AUTO-LOCK	Oct 09, 2001	Substantially Equivalent	AUTO-LOCK
K003555	SOLO-SAFE SAFETY SYRINGE, SIZE-3CC	Aug 29, 2001	Substantially Equivalent	SPECTRUM BIOTECH, INC.
K011103	BD SPRING BASED SYRINGE	Jun 13, 2001	Substantially Equivalent	BD
K011369	ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY)	May 29, 2001	Substantially Equivalent	SAFETY SYRINGES, INC.
K003348	E.N.S.I. RETRACTABLE SAFETY SYRINGE	Jan 12, 2001	Substantially Equivalent	ENSI-MED INTERNATIONAL PTY. LTD.
K993996	UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE	Jul 17, 2000	Substantially Equivalent	UNIVEC, INC.
K000860	FUTURA SAFETY SYRINGE	Jun 30, 2000	Substantially Equivalent	SHEILA W. PICKERING
K001017	RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC	Jun 02, 2000	Substantially Equivalent	RETRAX SAFETY SYSTEMS, INC.
K993609	SOLOGUARD LOCKING PLUS SYRINGE	Mar 17, 2000	Substantially Equivalent	SAFEGUARD MEDICAL PRODUCTS, INC.
K990831	SUPERGUARD SAFETY SYRINGE	Mar 08, 2000	Substantially Equivalent	U.S. SAFETY SYRINGES CO., INC.
K000572	E.N.S.I. SYRINGE	Feb 24, 2000	Substantially Equivalent	TRI-JECT INTL. CORP.
K992734	BECTON DICKINSON SYRINGE	Oct 01, 1999	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K990208	PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT	Mar 25, 1999	Substantially Equivalent	SCIENCE INCORPORATED
K982431	NMT SAFETY SYRINGE	Nov 18, 1998	Substantially Equivalent	NEW MEDICAL TECHNOLOGY LTD.
K973888	SMARTLOCK SAFETY SYRINGE	Jun 03, 1998	Substantially Equivalent	MEDICAL INNOVATION LTD.
K971077	COVERTIP SAFETY SYRINGE	May 15, 1998	Substantially Equivalent	MEDISYS TECHNOLOGIES, INC.
K980069	VANISHPOINT SYRINGE	Feb 12, 1998	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K973792	EASYSAFE RETRACTING NEEDLE SYRINGE	Jan 29, 1998	Substantially Equivalent	SAF-T-MED, INC.
K973301	ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE	Nov 07, 1997	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K970803	ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE	May 29, 1997	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K933469	UNIVEC NON-REUSABLE SYRINGE	Apr 18, 1996	Substantially Equivalent	UNIVEC, INC.
K946219	POP-N-LOK SYRINGE	Dec 28, 1995	Substantially Equivalent	RETRACTABLE TECHNOLOGIES, INC.
K955030	SQUARE ONE SAFETY SYRINGE	Dec 15, 1995	Substantially Equivalent	SQUARE ONE MEDICAL, LP
K933569	PENT NOVA AUTOBLOCK SYRINGE	Jun 09, 1995	Substantially Equivalent	MEDI-HUT CO., INC.
K936225	TS1 TURTLE(TM) SYRINGE	May 16, 1995	Substantially Equivalent	KERSHENSTINE DIAMOND, INC.
K936040	HYPO(R) SAFETY CARTRIDGE SYRINGE	May 01, 1995	Substantially Equivalent	SMITH & NEPHEW, INC.
K944425	ULTRASAFE ASPIRATING SYRINGE	Jan 26, 1995	Substantially Equivalent	SAFETY SYRINGES, INC.
K941450	INVIRO SYRINGE	Dec 12, 1994	Substantially Equivalent	DR. F. ROSS SHARP LTD.
K925039	SAFESNAP SAFETY SYRINGE	Feb 16, 1994	Substantially Equivalent	U.S. MEDICAL INSTRUMENTS, INC.

FEI Numbers

This FDA classification entry is associated with 143 FEI numbers. Click on an entry to view related FDA registrations.

1000138054: 760 registrations

1000219637: 355 registrations

1000306068: 11 registrations

1035907: 28 registrations

1213809: 17 registrations

1217052: 54 registrations

1220477: 911 registrations

1417592: 699 registrations

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1911916: 28 registrations

1915484: 30 registrations

1920898: 9 registrations

1921846: 275 registrations

2183744: 663 registrations

2183771: 15 registrations

2243072: 162 registrations

3000126234: 16 registrations

3001236277: 474 registrations

3001236905: 677 registrations

3001570557: 22 registrations

3002091543: 7 registrations

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3002808190: 15 registrations

3002879021: 31 registrations

3002907620: 375 registrations

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3003560965: 24 registrations

3003681915: 10 registrations

3003737899: 262 registrations

3003829571: 12 registrations

3003902955: 9 registrations

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3004417597: 49 registrations

3004425647: 57 registrations

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3004525092: 13 registrations

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3005202238: 4 registrations

3005246939: 50 registrations

3005405146: 17 registrations

3005670221: 33 registrations

3005798905: 24 registrations

3005841027: 54 registrations

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3006973666: 48 registrations

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3010605677: 176 registrations

3010621964: 59 registrations

3010862763: 91 registrations

3010934635: 12 registrations

3011088743: 53 registrations

3011287770: 10 registrations

3011689956: 141 registrations

3012039263: 7 registrations

3012050423: 50 registrations

3012116434: 21 registrations

3012307300: 358 registrations

3012421607: 606 registrations

3012461436: 20 registrations

3012494290: 762 registrations

3012552122: 8 registrations

3012627824: 85 registrations

3012636179: 178 registrations

3012646696: 2 registrations

3012777736: 53 registrations

3012809732: 34 registrations

3013187142: 23 registrations

3013298431: 204 registrations

3013513377: 17 registrations

3013557562: 654 registrations

3013561886: 55 registrations

3013742844: 8 registrations

3013794253: 18 registrations

3014162214: 3 registrations

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3014315664: 12 registrations

3014389131: 9 registrations

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3016774562: 28 registrations

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3022699058: 22 registrations

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3023339256: 41 registrations

3024508819: 5 registrations

3026408938: 290 registrations

3027338968: 1 registration

3029328631: 3 registrations

3029755538: 2 registrations

3030089798: 3 registrations

3030171742: 3 registrations

3030525551: 4 registrations

3030626857: 33 registrations

3030646120: 24 registrations

3030676235: 1 registration

3033536319: 44 registrations

3034667025: 11 registrations

3036679495: 2 registrations