FDA 510(k) Applications for Medical Device Product Code "MEG"
(Syringe, Antistick)

FDA 510(k) Number Applicant Device Name Decision Date
K211555 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd Hypodermic Safety Needle; Hypodermic Safety Needle with Syringe 10/18/2021
K190183 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe 10/04/2019
K131531 ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE 05/12/2014
K191639 Anhui Tiankang Medical Technology Co.,Ltd. TK Insulin Syringe with/without Saftey Retractable Device 09/11/2020
K010477 AUTO-LOCK AUTO-LOCK 10/09/2001
K042487 AVANCA MEDICAL DEVICES, INC. PROCEDUR SF SAFETY SYRINGE DEVICE 01/21/2005
K011103 BD BD SPRING BASED SYRINGE 06/13/2001
K992734 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON SYRINGE 10/01/1999
K180417 BERPU MEDICAL TECHNOLOGY CO., LTD 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 08/09/2018
K220061 Berpu Medical Technology Co., Ltd. Safety Insulin Syringes 08/23/2022
K031909 BETEC MEDICAL SCIENCE CO., LTD. BETEC RETRACTABLE SAFETY SYRINGE (5ML) 10/07/2003
K032747 BIOTOP TECHNOLOGY CO., LTD. BIOTOP DJT-A SAFETY SYRINGE 05/11/2004
K043038 BIOTOP TECHNOLOGY CO., LTD. BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML 12/22/2004
K041970 BIOTOP TECHNOLOGY CO., LTD. BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML 08/03/2004
K062318 BIOTOP TECHNOLOGY CO., LTD. BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML 01/03/2007
K223376 Cardinal Health 200, LLC 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) 06/21/2023
K060668 DEVON SAFETY PRODUCTS, INC. SAFE TIP SYRINGE 06/12/2006
K070117 DOLOMITE BIOTECH SDN BHD SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC 08/06/2007
K003348 ENSI-MED INTERNATIONAL PTY. LTD. E.N.S.I. RETRACTABLE SAFETY SYRINGE 01/12/2001
K052103 EXELINT INTL. CO. EXEL SECURE TOUCH II SAFETY SYRINGE 10/19/2005
K011754 EXELINT INTL. CO. EXEL SECURETOUCH PTP SYRINGE 01/22/2003
K050134 FORMOSA MEDICAL DEVICES, INC. ICC INSULIN SAFEPRO SAFETY SYRINGE 04/05/2005
K031830 FORMOSA MEDICAL DEVICES, INC. SAFEPRO PLUS SAFETY SYRINGE 08/05/2003
K022063 FORMOSA MEDICAL DEVICES, INC. SAFEPRO SAFETY SYRINGE 08/29/2002
K023323 FUTURA MEDICAL TECHNOLOGY 1CC FUTURA SAFETY SYRINGE 10/29/2002
K212652 Gemtier Medical (Shanghai) Inc. Sterile Syringe with Fixed Safety Needle for Single Use 03/02/2022
K192679 Gemtier Medical (Shanghai) Inc. Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use 04/10/2020
K120641 GLOBAL MEDI PRODUCTS GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE 10/17/2012
K141349 GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD Disposable sterile needle retractable safety syringe 04/10/2015
K143497 GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD Safety Auto-Disable Syrine with Needle (Auto-Lock) 11/04/2015
K212949 Henan Nursecare Biotechnology Co., Ltd 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 02/24/2022
K012726 HOU-SE MEDICAL INC PROSAFE SAFETY SYRINGE 10/18/2001
K051800 IN6 INCUVESTOR INC. IN6 SAFETY SYRINGE, MODEL 3ML 10/21/2005
K040036 INVIRO MEDICAL INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905 03/18/2004
K032780 INVIRO MEDICAL INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC 09/24/2003
K092430 INVIRO MEDICAL DEVICES, INC. 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES 09/04/2009
K092413 INVIRO MEDICAL DEVICES, INC. INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES 09/04/2009
K070203 INVIRO MEDICAL DEVICES, INC. INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 04/23/2007
K152606 JEESUNG MEDICAL CO LTD Jeesung Safety Syringe and Single Use Needles 06/28/2016
K212518 JeeSung Medical Co., Ltd. Jeesung Safety Syringe and Single Use Needles 08/18/2022
K192551 Jiangsu Caina Medical Co., Ltd. 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle 08/10/2020
K191490 Jiangsu Caina Medical Co., Ltd. Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe 10/03/2019
K193022 Jiangsu Caina Medical Co.,Ltd. Retractable Safety Insulin Syringe 07/20/2020
K211329 Jiangsu Kangbao Medical Equipment Co., Ltd Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle 11/15/2021
K221247 Jiangsu Kangbao Medical Equipment Co., Ltd. Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle 11/01/2022
K202570 Jiangsu Micsafe Medical Technology Co., Ltd Insulin Syringe, Insulin Syringe with Safety Retractable 07/02/2021
K183665 Jiangsu Micsafe Medical Technology Co., Ltd. Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use 09/06/2019
K143070 Jiangsu Yile Medical Article Co.,Ltd. Disposable Safety Self-destructive Syringes, 5 ML 07/07/2015
K163162 JiangXi HongDa Medical Equipment Group Ltd. Sterile Hypodermic Safety Syringes for Single Use 03/20/2017
K211753 Jiangxi Hongda Medical Equipment Group Ltd. Sterile Syringe With Safety Needle 10/14/2021
K042102 JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP YIXIN SAFETY SYRINGE 03/08/2005
K030976 LIFE-SHIELD PRODUCTS, INC CAREO RETRACTABLE SAFETY SYRINGE 05/30/2003
K052397 LIFE-SHIELD PRODUCTS, INC CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) 12/22/2005
K060208 LIFE-SHIELD PRODUCTS, INC CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, 03/10/2006
K061055 LIFE-SHIELD PRODUCTS, INC CAREO SAFETY SYRINGE FOR U-100 INSULIN 07/10/2006
K072037 LIFE-SHIELD PRODUCTS, INC CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML 08/08/2007
K034031 M.K. MEDITECH CO. LTD. 10 ML BAK'SNAP DUOPROSS RETRACTABLE SAFETY SYRINGE 01/21/2004
K031594 M.K. MEDITECH CO. LTD. BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY 06/06/2003
K020623 M.K. MEDITECH CO. LTD. DUOPRO SAFETY SYRINGE (DUOPROSS) 05/02/2002
K022806 M.K. MEDITECH CO. LTD. DUOPRO SAFETY SYRINGE (DUOPROSS) 09/19/2002
K050131 M.K. MEDITECH CO. LTD. INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE 04/05/2005
K043419 MEDEXEL MEDICAL MFG. CO., LTD. P&P SAFETY SYRINGE 04/15/2005
K051694 MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE 12/21/2005
K062780 MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. CLICKZIP, MODEL U-100 INSULIN SAFETY SYRINGE 01/05/2007
K973888 MEDICAL INNOVATION LTD. SMARTLOCK SAFETY SYRINGE 06/03/1998
K111734 MEDICALCHAIN INTL. CORP. MYSAFETY SYRINGE 09/06/2011
K971077 MEDISYS TECHNOLOGIES, INC. COVERTIP SAFETY SYRINGE 05/15/1998
K101560 MEDLINE INDUSTRIES, INC. MEDLINE RETRACTABLE SAFETY SYRINGE 03/25/2011
K060772 MEDSAFE ASA MANUEL SAFTEY SYRINGE PARTS 1 & 2 10/16/2006
K032517 MEDSAFE TECHNOLOGIES LLC. MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE 05/18/2004
K150562 Nemera Safe'n'Sound Staked Passive Delivery System - Plajex version 06/02/2015
K010819 NEW MEDICAL TECHNOLOGY LTD. 3CC NMT SAFETY SYRINGE 11/08/2001
K982431 NEW MEDICAL TECHNOLOGY LTD. NMT SAFETY SYRINGE 11/18/1998
K060971 OMI MANUFACTURING PTY., LTD. OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS 10/24/2006
K040545 OTTER (CHINA) TECHNOLOGY CO., LTD. OTTER SAFETY SYRINGE 04/22/2004
K013006 OVUS SYSTEMS OVUS CAPLESS SAFETY NEEDLE 02/06/2002
K030604 PERFECT MEDICAL INDUSTRY CO., LTD. PERFECT SAFETY SYRINGE 04/30/2004
K970803 RETRACTABLE TECHNOLOGIES, INC. ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE 05/29/1997
K973301 RETRACTABLE TECHNOLOGIES, INC. ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE 11/07/1997
K980069 RETRACTABLE TECHNOLOGIES, INC. VANISHPOINT SYRINGE 02/12/1998
K001017 RETRAX SAFETY SYSTEMS, INC. RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC 06/02/2000
K112936 REXAM CONSUMMER PLASTICS INC.D/B/A REXAM PHARMA SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM 01/20/2012
K141664 REXAM HEALTHCARE SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION 10/02/2014
K101233 REXAM PHARMA SAFE'N'SOUND PASSIVE DELIVERY SYSTEM 02/18/2011
K060002 RITRACT LTD. RITRACT SAFETY SYRINGE 06/02/2006
K221981 Roncadelle Operations srl SafeR Syringe and SafeR Sting 12/29/2022
K973792 SAF-T-MED, INC. EASYSAFE RETRACTING NEEDLE SYRINGE 01/29/1998
K012121 SAFEGARD MEDICAL PRODUCTS, INC. SECUREGUARD RETRACTABLE SAFETY SYRINGE 10/24/2001
K993609 SAFEGUARD MEDICAL PRODUCTS, INC. SOLOGUARD LOCKING PLUS SYRINGE 03/17/2000
K063340 SAFETY MEDICAL INTERNATIONAL, INCORPORATED SAF-T-SYRINGE- 0.5 AND 1ML/CC 03/06/2007
K051762 SAFETY MEDICAL INTERNATIONAL, INCORPORATED SAF-T-SYRINGE/SAF-T-NEEDLE 09/23/2005
K060743 SAFETY SYRINGES, INC. MODIFICATION TO: TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM, ULTRASAFE PASSIVE DELIVERY SYSTEM (X-SERIES) 04/28/2006
K042712 SAFETY SYRINGES, INC. TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM 10/15/2004
K013801 SAFETY SYRINGES, INC. ULTRASAFE DENTAL INJECTION SYSTEM 12/13/2001
K122558 SAFETY SYRINGES, INC. ULTRASAFE PASSIVE NEEDLE GUARD 09/20/2012
K011369 SAFETY SYRINGES, INC. ULTRASAFE PASSIVE X-SERIES, NEEDLE GUARD SYRINGE, PISTON (ACCESSORY) 05/29/2001
K123743 SAFETY SYRINGES, INC. ULTRASAFE PLUS PASSIVE NEEDLE GUARD 03/26/2013
K173743 Sang-A Frontec Co., Ltd Greenmedi Safety Filter Syringe 01/28/2019
K073206 SCHREINER MEDIPHARM NEEDLE-TRAP/NEEDLE SAFETY LABEL 01/16/2008
K990208 SCIENCE INCORPORATED PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT 03/25/1999
K031163 SEZ CORPORATION SEZ SAFETY SYRINGE 07/08/2003
K072739 SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. JIERUI SYRINGES AND NEEDLES 03/21/2008
K221416 Shanghai Kindly Enterprise Development Group Co., Ltd Sterile Safety Syringes for Single Use 08/31/2022
K220183 Shanghai Kindly Enterprise Development Group Co., Ltd Sterile Safety Syringes for Single Use (Retractable) 07/21/2022
K220185 Shanghai Kindly Enterprise Development Group Co., Ltd. Sterile Safety Insulin Syringes for Single Use 07/11/2022
K113587 SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) 02/24/2012
K141640 SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE 11/19/2014
K210216 Shantou Wealy Medical Instrument CO.,Ltd Disposable Automatically Retractable Insulin Safety Syringe 03/04/2022
K222452 Shantou Wealy Medical Instrument CO.,Ltd. Disposable Automatically Retractable Safety Syringes (with detachable needle) 11/23/2022
K000860 SHEILA W. PICKERING FUTURA SAFETY SYRINGE 06/30/2000
K220057 Shinva Ande Healthcare Apparatus Co., Ltd. Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization 10/07/2022
K211484 Shinva Ande Healthcare Apparatus Co., Ltd. DisposableáSterileáSyringeáwitháSafetyáNeedle; DisposableáSterileáSyringeáwitháNeedle; DisposableáSterileáSyringe; DisposableáSafetyáNeedles 03/01/2022
K221073 Sichuan Prius Biotechnology Co., Ltd. Sterile Hypodermic Syringes for Single Use with Safety Needles 10/04/2022
K142436 Sincere Medical Device Co., Ltd. 3S Safety Insulin Syringe 02/19/2015
K142435 Sincere Medical Device Co., Ltd. 3S Safety Syringe with/without Needle 02/20/2015
K072482 SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY 11/29/2007
K063755 SMITHS MEDICAL ASD, INC. PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE 02/27/2007
K061194 SMITHS MEDICAL ASD, INC. PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 08/24/2006
K162030 SOL-MILLENNIUM MEDICAL, INC 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle 08/19/2016
K132681 SOL-MILLENNIUM MEDICAL, INC. SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE 05/22/2014
K003555 SPECTRUM BIOTECH, INC. SOLO-SAFE SAFETY SYRINGE, SIZE-3CC 08/29/2001
K093176 STA-MED, LLC MED-LOK 04/06/2010
K103781 STA-MED, LLC MED-LOK SAFETY NEEDLE 02/08/2011
K121637 SUNWELL BIOTECH CO., LTD AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE 10/25/2012
K031065 SYRINGEX MEDICAL, INC. SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5 06/23/2003
K042426 TAIJECT MEDICAL DEVICE CO., LTD. TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) 09/22/2004
K031062 TAIJECT MEDICAL DEVICE CO., LTD. TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN) 05/02/2003
K022278 TAIJECT MEDICAL DEVICE CO., LTD. TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) 09/12/2002
K023458 TAIJECT MEDICAL DEVICE CO., LTD. TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) 11/07/2002
K051865 TERUMO MEDICAL CORP. TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR 09/27/2005
K024249 TERUMO MEDICAL CORP. TERUMO SURGUARD SAFETY SYRINGE 02/21/2003
K000572 TRI-JECT INTL. CORP. E.N.S.I. SYRINGE 02/24/2000
K990831 U.S. SAFETY SYRINGES CO., INC. SUPERGUARD SAFETY SYRINGE 03/08/2000
K032247 U.S. TECHNOLOGIES, INC. U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE 09/30/2003
K152808 U&U Medical Technology Co., Ltd U&U Insulin Syringe with/without Safety Retractable Device 03/25/2016
K103011 ULTI-MED INTL., INC. ULTICARE SAFETY INSULIN SYRINGE 02/02/2011
K140949 ULTIMED INCORPORATED ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE 02/09/2015
K080600 ULTIMED, INC. ULTIMED ULTICARE SAFETY SYRINGE 06/25/2008
K100998 UNILIFE MEDICAL SOLUTIONS LIMITED 1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1 08/30/2010
K080877 UNILIFE MEDICAL SOLUTIONS LIMITED 1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2 10/21/2008
K050116 UNIQSAFE BIOMEDITECH CO., LTD. UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES 05/09/2005
K993996 UNIVEC, INC. UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE 07/17/2000
K933469 UNIVEC, INC. UNIVEC NON-REUSABLE SYRINGE 04/18/1996
K220114 Vault Paragon Group, Inc. PowerPAK Syringe 01/25/2023
K060109 VITALCARE GROUP, INC. OMI RETRACTABLE SAFETY SYRINGE 05/05/2006
K141464 WEST PHARMACEUTICAL SERVICES NOVAGUARD S A SAFETY SYSTEM 09/10/2014
K163511 WEST PHARMACEUTICAL SERVICES, INC. NovaGuard SA Pro Safety System 02/02/2017
K053519 WUXI YUSHOU MEDICAL APPLICANCES CO., LTD SAFETY SYRINGE 08/11/2006
K170651 Yangzhou Medline Industry Co., Ltd. Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle 08/02/2017
K040105 YUE PFONG INTERNATIONAL INDUSTRIAL CO., LTD. YUE PFONG SAFETY SYRINGE (3ML) 04/07/2004
K210229 Zhejiang Kangkang Medical-Devices CO., Ltd. Sterile Auto-Disable Syringes with/without Needle for Single Use 02/15/2022
K213077 Zhejiang Lingyang Medical Apparatus Co., Ltd. Automatically Retractable Safety Syringe 04/27/2022
K212226 Zhuhai DR Medical Instruments Co., Ltd DR Safety Syringe, Sterile Hypodermic needle for Single use 09/29/2021


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