FDA 510(k) Applications for Medical Device Product Code "FMI"
(Needle, Hypodermic, Single Lumen)

FDA 510(k) Number Applicant Device Name Decision Date
K963351 ABBOTT LABORATORIES LIFESHIELD BLUNT CANNULA 02/26/1997
K972538 ACACIA, INC. FLOW-EZE BLUNT CANNULA (1999BC) 07/15/1998
K220890 Actuated Medical, Inc IO Needle Safety Sheath 10/31/2022
K222681 Altaviz, LLC Altaviz Needle Kit 12/05/2022
K231261 Altaviz, LLC Altaviz Needle Kit II 07/27/2023
K130097 AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS 07/22/2014
K982029 AMERICAN MEDICAL MFG., INC. SHARPS COLLECTION CONTAINER - SAF-T-SHELL 04/06/1999
K222124 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle 11/04/2022
K230043 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Insulin Pen Needle 09/20/2023
K214075 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) 04/12/2022
K191644 Anhui Tiankang Medical Technology Co., Ltd. TK Safety Needle 08/06/2020
K191643 Anhui Tiankang Medical Technology CO.,Ltd TK Sterile Hypodermic Needle 12/19/2019
K180395 Arrow International, Inc. (Subsidiary of Teleflex, Inc.) EZ-IO Intraosseous Vascular Access System 11/09/2018
K071998 ARROW INTL., INC. ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT 09/26/2007
K961088 ARROW INTL., INC. NON-CORING NEEDLE 07/02/1996
K041153 ARROW INTL., INC. SHARPSAWAY II LOCKING DISPOSABLE CUP 07/12/2004
K151311 Artsana S.P.A Safe Block Pen Needle 02/10/2016
K051783 ARTSANA S.P.A. ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES 10/04/2005
K043249 ATRION MEDICAL PRODUCTS, INC. ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE 05/25/2005
K071567 AUTOSAFE-REFELX INC. AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE 09/14/2007
K090117 AUTOSAFE-REFLEX INC. AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET 09/29/2009
K211214 Azur Medical Company Inc. Sterile Hypodermic Needles for Single Use 10/14/2021
K173803 B. Braun Medical Inc. Omnican fine 06/11/2018
K971924 B. BRAUN MEDICAL, INC. BLUNT SYRINGE CANNULA 09/25/1998
K033575 B. BRAUN MEDICAL, INC. ONE.CLICK NEEDLE 02/09/2004
K131842 B. BRAUN MEDICAL, INC. STERICAN CANNULA 08/20/2013
K072247 B. BRAUN MEDICAL, INC. STERICAN HYPODERMIC NEEDLES 11/08/2007
K131040 B. BRAUN MELSUNGEN AG EXTAVIPRO STERICAN 30G 07/15/2013
K152050 B. BRAUN MELSUNGEN AG Pencylcap 03/02/2016
K203193 Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD] BD Intraosseous Infusion System 03/04/2021
K000657 BAXTER HEALTHCARE CORP. LUER ACCESS UNIVERSAL VIAL ADAPTER 03/08/2000
K021475 BD BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET 07/19/2002
K955235 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE 02/12/1996
K970737 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE 03/28/1997
K002938 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 11/29/2000
K003461 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE 02/01/2001
K974363 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON BLUNT PLASTIC CANNULA 06/03/1998
K964654 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON BLUNT PLASTIC CANNULA 04/02/1997
K974006 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON TWINPAK 01/22/1998
K010188 BD MEDICAL SYSTEMS BD ECLIPSE HYPODERMIC NEEDLE 03/01/2001
K060007 BECTON DICKINSON & CO. BD AUTOSHIELD PEN NEEDLE 03/23/2006
K100209 BECTON DICKINSON & CO. BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY 02/19/2010
K070440 BECTON DICKINSON & CO. BD HYPOINT NEEDLE 03/16/2007
K051899 BECTON DICKINSON & CO. BD PEN NEEDLE 09/13/2005
K123300 BECTON DICKINSON & CO. BD PEN NEEDLE 01/18/2013
K131358 BECTON DICKINSON & CO. BD PEN NEEDLE 07/16/2013
K024109 BECTON DICKINSON & CO. BD ULTRA-FINE III PEN NEEDLE 12/30/2002
K011984 BECTON DICKINSON & CO. BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET 08/29/2001
K043397 BECTON DICKINSON & CO. MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE 12/29/2004
K031200 BECTON DICKINSON & CO. MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE 06/24/2003
K212015 Becton Dickinson and Company BD Nano 2nd Gen Pen Needle 11/19/2021
K110105 BECTON DICKINSON AND COMPANY (BD) BD PEN NEEDLE 04/28/2011
K982541 BECTON DICKINSON VACUTAINER SYSTEMS VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 10/28/1998
K223286 Becton, Dickinson and Company BD AutoShield DuoÖ Pen Needle 12/28/2022
K100005 BECTON, DICKINSON AND CO. BD PEN NEEDLE 04/15/2010
K110703 Becton, Dickinson and Company BD AUTOSHIELD DUO PEN NEEDLE 07/27/2011
K182320 Becton, Dickinson and Company BD Contoured Base Pen Needle 12/20/2018
K161170 Becton, Dickinson and Company BD Eclipse Hypodermic Needle 05/27/2016
K213156 Becton, Dickinson and Company BD Nano 2nd Gen Pen Needle 12/08/2021
K162516 BECTON, DICKINSON AND COMPANY BD Pen Needle 12/09/2016
K213478 Becton, Dickinson and Company BD Pen Needle 06/28/2022
K161553 BECTON, DICKINSON AND COMPANY BD SafeAssist 07/06/2016
K170824 Becton, Dickinson and Company BD Vacutainer Eclipse Signal Blood Collection Needle 08/20/2018
K181730 Becton, Dickinson and Company BD Vacutainer Eclipse UltraFill Blood Collection Needle 03/01/2019
K972469 BEECH MEDICAL PRODUCTS, INC. SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE 08/27/1997
K965248 BEMIS MFG. CO. BEMIS TWO GALLON SHARPS CONTAINER 02/14/1997
K020921 BEMIS MFG. CO. NO-POKES NEEDLE SAFETY DEVICE 07/11/2002
K181447 Berpu Medical Technology Co., Ltd Safety insulin needle for single use 03/12/2019
K212514 Berpu Medical Technology Co., Ltd. Safety Pen Needle for Single Use, Insulin Pen Needles 04/29/2022
K981184 BFI- MEDICAL WASTE SYSTEMS SHARPTRACK REUSABLE SHARPS CONTAINER 06/22/1998
K963748 BIO-PLEXUS, INC. BIO-PLEXUS DROP-IT NEEDLE HOLDER 06/06/1997
K960933 BIO-PLEXUS, INC. BIO-PLEXUS NEEDLE DISPOSAL CONTAINER 08/28/1996
K992091 BIO-PLEXUS, INC. PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750 09/09/1999
K961251 BIO-PLEXUS, INC. PUNCTUR-GUARD WINGED SET 06/27/1996
K003827 BIO-PLEXUS, INC. PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION 01/08/2001
K961328 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES BEC SHROUDED PLASTIC CANNULA 05/30/1996
K161255 BIOTEKNE SRL meso-relle (AAL34, AAL36, AM30G) 01/19/2017
K052843 BUSSE HOSPITAL DISPOSABLES, INC. BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE 04/17/2006
K010038 CAMBRIDGE MARKETING, INC. NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE 01/24/2001
K214004 CC Biotechnology Corporation CCBIO ASCPO Needle 12/13/2022
K052725 CERTOL INTERNATIONAL, LLC PROTECTOR NEEDLE SHEATH PROP 12/28/2005
K220614 Chirana T. Injecta MEDOJECT fine Pen Needles 06/15/2022
K962040 CONTOUR FABRICATORS OF FLORIDA, INC. RNS ARTHROGRAM TRAY 06/25/1996
K160887 COOK INCORPORATED Cook Intraosseous Infusion Needles 07/26/2016
K031058 CORD STICK CORP. CORD STICK MULTIPLE DRAW SYSTEM 06/13/2003
K073122 COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE 11/21/2007
K151090 CPL CO., LTD. CPL Insulin Pen Needle 09/21/2016
K970383 CUSTOM MEDICAL PLASTICS, INC. SHARPS CONTAINER 07/03/1997
K970398 CUSTOM MEDICAL PLASTICS, INC. SHARPS CONTAINER 07/03/1997
K963595 CUTTING EDGE TECHNOLOGIES, INC. SERAGARD VASCULAR ACCESS DEVICE 01/06/1997
K063466 DAEJIN TECH MEDICAL MANUFACTURING CO., LTD. TOP FINE 03/02/2007
K980062 DAVIS & GECK, INC. MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE 03/20/1998
K983750 DEROYAL INDUSTRIES, INC. DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER 11/30/1998
K160199 Diabetic Supply of Suncoast, Inc. Advocate Insulin Pen Needles 10/19/2016
K010958 DIASOL, INC. FISTULOK FISTULA NEEDLE PROTECTION 05/18/2001
K011004 DIASOL, INC. NEEDLELOK HYPODERMIC NEEDLE PROTECTION 05/24/2001
K994197 DISETRONIC MEDICAL SYSTEMS DISENTRONIC PENFINE INJECTION PEN NEEDLE 12/29/1999
K973339 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INJECTION PEN NEEDLE 09/24/1997
K982399 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INJECTION PEN NEEDLE 08/06/1998
K013782 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE 11/20/2001
K052445 DUOPROSS MEDITECH CORPORATION DUOPROSS NEEDLE 12/05/2005
K200017 Eclipse MedCorp, LLC Eclipse DermaFlex Cannula 11/05/2020
K211395 Einstein Works LLC NIO-I 07/28/2021
K182770 Einstein Works, L.L.C Adult Intraosseous Infusion Device 04/09/2019
K191258 Einstein Works, L.L.C. Intraosseous infusion device 10/23/2019
K042917 EMERGO GROUP, INC. STAT MEDICAL PEN NEEDLE 04/22/2005
K952837 EMK ENTERPRISES, LLC. DARWIN HYPODERMIC SAFETY SYSTEM (DHSS) 01/30/1996
K963658 EXEL INTL. EXEL AVF SINGLE NEEDLE 05/05/1998
K003627 EXELINT INTERNATIONAL CO. EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET 02/08/2001
K152183 EXELINT INTERNATIONAL CO. EXELINT SecureTouch Safety Hypodermic Needle 11/02/2015
K011757 EXELINT INTL. CO. EXEL COMFORTPOINT INSULIN PEN NEEDLE 01/23/2002
K022406 EXELINT INTL. CO. EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET 09/30/2002
K133100 FACET TECHNOLOGIES CAREFINE PEN NEEDLE 01/23/2014
K141749 FACET TECHNOLOGIES, LLC CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT 07/29/2014
K140568 FACET TECHNOLOGIES, LLC CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT 05/13/2014
K092831 FEEL TECH DISPOSABLE HYPODERMIC NEEDLE 01/14/2010
K080904 FEEL TECH FEEL-FINE INSULIN PEN NEEDLE 06/04/2008
K192464 Gangan Medical Technology Jiangsu Co., Ltd. Injection Pen Needle 08/25/2020
K962035 GE MEDICAL SYSTEMS GE STERILE ARTHROGRAM TRAY 06/25/1996
K170276 Gemtier Medical (Shanghai) Inc. Safety Blood Collection Device for Single Use 12/11/2017
K033409 GETTIG PHARMACEUTICAL INSTRUMENT CO. AMERSHAM HEALTH NEEDLE-GUARD 01/21/2004
K000455 GETTIG PHARMACEUTICAL INSTRUMENT CO. GETTIG GUARD 04/19/2000
K173757 Greiner Bio-One NA Inc VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set 04/19/2018
K160532 GREINER BIO-ONE NA INC. Greiner Holdex 11/03/2016
K180545 Greiner Bio-One NA Inc. VACUETTE SAFELINK Holder with male luer lock 05/21/2018
K072320 GREINER BIO-ONE NORTH AMERICA, INC. GREINER VACUETTE QUICKSHIELD COMPLETE 09/14/2007
K121908 GREINER BIO-ONE NORTH AMERICA, INC. SAFETY INFUSION SET 07/25/2012
K113505 GREINER BIO-ONE NORTH AMERICA, INC. VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER 02/17/2012
K102774 GREINER BIO-ONE NORTH AMERICA, INC. VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER 10/15/2010
K061483 GREINER BIO-ONE NORTH AMERICA, INC. VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES 08/14/2006
K080235 GREINER BIO-ONE VACUETTE NORTH AMERICA SAFETY INFUSION SET 04/24/2008
K033478 GREINER BIO-ONE VACUETTE NORTH AMERICA VACUETTE QUICKSHIELD SAFETY TUBE HOLDER 12/29/2003
K980768 GREINER MEDITECH, INC. VACUETTE HOLDEX 04/09/1998
K973620 GREINER MEDITECH, INC. VACUETTE MULTI-SAMPLE NEEDLE 12/17/1997
K981619 GREINER MEDITECH, INC. VACUETTE MULTIPLE SAMPLE LUER ADAPTER 07/15/1998
K011786 GREINER VACUETTE NORTH AMERICA, INC. VACUETTE SAFETY BLOOD COLLECTION SET 07/12/2001
K003812 GREINER VACUETTE NORTH AMERICA, INC. VACUETTE SPEEDY QUICK-RELEASE HOLDER 04/30/2001
K153388 GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. 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), IM 06/07/2016
K061933 HAGER WORLDWIDE, INC. HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER 11/16/2006
K222739 Hantech Medical Device Co., Ltd. Disposable Insulin Pen Needle 04/06/2023
K220603 Hantech Medical Device Co., Ltd. Disposable Medical Safety Hypodermic Needle 08/23/2022
K983067 HENKE SASS WOLF OF AMERICA, INC. FINE-JECT 10/30/1998
K954500 HOSPITEC, INC. HOSPITEC MEDI-BUTLER 01/18/1996
K211716 HTL STREFA SA DropSafe Safety Pen Needles 01/07/2022
K192082 HTL-Strefa S.A Droplet Pen Needle 34G 04/21/2020
K171982 HTL-STREFA S.A. DROPLET PEN NEEDLE 03/21/2018
K202340 HTL-Strefa S.A. Droplet Pen Needle 30G & 33G 10/15/2020
K143437 HTL-STREFA S.A. Droplet Pen Needles 06/25/2015
K170988 HTL-Strefa S.A. DropSafe Safety Pen Needle 12/12/2017
K002213 HUNTER RESEARCH LABORATORIES, INC. BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID 10/03/2000
K963830 IMAGE MEDICAL, INC. SHARPS CONTAINER MODEL# SC001 02/10/1997
K980003 IMAGINATION MEDICAL, INC. M500-100 SHARPS CONTAINER 03/13/1998
K050505 IMPRINT PHARMACEUTICALS LIMITED DEPOTONE 04/05/2005
K061032 IMPRINT PHARMACEUTICALS LIMITED DEPOTONE 06/21/2006
K003406 INTERNATIONAL MEDICAL DEVICE PARTNERS, INC. GUARDED NEEDLE 2000 01/12/2001
K110656 INTERNATIONAL MEDSURG CONNECTION IMC BLOOD COLLECTION NEEDLE 08/18/2011
K102584 INTERNATIONAL MEDSURG CONNECTION IMC HYPODERMIC NEEDLE 01/14/2011
K071307 INVIRO MEDICAL DEVICES, INC. INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 02/12/2008
K991404 ITL CORPORATION, PTY LTD. PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP) 05/14/1999
K950686 JAMES J. SCHRAMM I.V. START KIT 10/24/1996
K152166 JEESUNG MEDICAL CO LTD JSM Insulin Pen Needle 07/11/2016
K132557 JIAMEI-UN CO., LTD. EWNL SAFETY SYRINGE WITH NEEDLE 06/03/2014
K172938 Jiangsu Caina Medical Co., Ltd. Disposable Sterile Needle 06/14/2018
K230635 Jiangsu Caina Medical Co., Ltd. Pen Needle 06/02/2023
K192677 Jiangsu Caina Medical Co., Ltd. Safety Insulin Pen Needle 02/18/2020
K170846 Jiangsu Caina Technology Co., Ltd. Disposable Insulin Pen Needle 12/13/2017
K163093 Jiangsu Shenli Medical Production Co., Ltd Safety Blood Collection Set 03/14/2017
K180259 Jiangsu Shenli Medical Production Co., Ltd Sterile Hypodermic Needle for Single Use 05/18/2018
K002394 JMS CO., LTD. JMS APHERESIS NEEDLE SET ACCORDION TYPE 09/05/2001
K991904 JMS CO., LTD. MODIFICATION OF JMS NEEDLES AND JMS SYRINGES 08/31/1999
K001690 JOHNSON & JOHNSON MEDICAL, INC. PROTECTIV SAFETY BLOOD COLLECTION NEEDLE 07/31/2000
K952044 KAREN HOLTZ INSULCAP 02/13/1996
K102994 KAWASUMI LABORATORIES, INC. K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR 11/03/2010
K073257 KAWASUMI LABORATORIES, INC. KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR 01/25/2008
K052561 KOFU FACTORY OF TERUMO CORP. TERUMO MICRO TAPERED PEN NEEDLE 11/23/2005
K140516 KOFU FACTORY OF TERUMO CORP. Terumo Pen Injector Needle 34 08/05/2014
K093043 KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD ZIRCONIA SYRINGE NEEDLE 08/20/2010
K022057 KYUNG GI MEDICAL IND. CO., LTD KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX 11/22/2002
K110606 M.V. S.R.L. MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE 09/29/2011
K071088 M&M INDUSTRIES, INC. LIFE LATCH SHARPS & BIOHAZARD CONTAINER 07/05/2007
K962001 MANAN MEDICAL PRODUCTS, INC. MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE 01/10/1997
K003521 MASTER BENEFITS, INC. DISPO-MED 7.6 LITER SHARPS CONTAINER 04/19/2001
K973012 MDC RESEARCH LTD. MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM 11/05/1997
K960698 MED INSTITUTE, INC. NON-CORING NEEDLE 04/15/1996
K000714 MED-PRO TECHNOLOGIES, INC. VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET 12/21/2000
K171144 Medbio LLC. Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel 09/12/2017
K152410 MEDEXEL CO., LTD. Top Fine Pen Needle 02/02/2016
K172095 MedExel Co.,Ltd. Autokeeper 07/24/2018
K180720 Medibio Usa LLC. Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel 06/27/2018
K980227 MEDICAL DEVICE TECHNOLOGIES, INC. MANAN GALACTOGRAPHY KIT 04/23/1998
K082511 MEDIGARD LIMITED MEDIGARD BLOOD COLLECTION DEVICE 01/16/2009
K062984 MEDLINE INDUSTRIES, INC. MEDLINE HYPODERMIC NEEDLES 11/13/2006
K102010 MEDPRO SAFETY PRODUCTS, INC. VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET 11/19/2010
K072602 MEDPRO SAFETY PRODUCTS, INC. VACUETTE PREMIUM SAFETY NEEDLE SYSTEM 06/18/2008
K111424 MEDPRO SAFETY PRODUCTS, INC. VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH 07/29/2011
K000369 MEDPRO TECHNOLOGIES, INC. VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER 03/30/2000
K960641 MEDSCIENCE, INC. RECAP-1 05/17/1996
K001853 MEDTECH SYSTEMS, INC. SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 08/22/2001
K112789 MHC MEDICAL PRODUCTS, LLC EASY TOUCH 12/23/2011
K163578 MHC Medical Products, LLC. EasyTouch Safety Pen Needle 08/03/2018
K173279 MYCO Medical Supplies, Inc. RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder 05/14/2018
K090426 MYCO MEDICAL SUPPLIES, INC. VAKU-8 BLOOD COLLECTION NEEDLES 06/12/2009
K092746 NANOPASS TECHNOLOGIES LTD. MICRONJET 600 02/03/2010
K221178 Ningbo Medsun Medical Co., Ltd. Disposable Insulin Pen Needle 11/17/2022
K992699 NIPRO MEDICAL CORP. NIPRO BLOOD COLLECTION NEEDLE 02/14/2000
K013293 NIPRO MEDICAL CORP. NIPRO HYPODERMIC NEEDLE 12/14/2001
K052474 NIPRO MEDICAL CORP. NIPRO HYPODERMIC NEEDLE 11/10/2005
K992729 NIPRO MEDICAL CORP. NIPRO LUER ADAPTOR 01/13/2000
K113469 NIPRO MEDICAL CORPORATION NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE 10/18/2012
K222852 Nipro Medical Corporation Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle 05/25/2023
K151341 NORFOLK MEDICAL Turbo High-Flow Non-coring Needle 08/20/2015
K001965 NORTH AMERICAN MEDICAL PRODUCTS, INC. SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS 02/02/2001
K062500 NOVO NORDISK INC. FLEXPEN NEEDLE 11/21/2006
K090111 NOVO NORDISK INC. FLEXPEN NEEDLE 02/01/2010
K210258 Novo Nordisk Inc. NovoFine 06/23/2021
K053470 NOVO NORDISK INC. NOVOFINE 32G TIP 12/21/2005
K173479 Novo Nordisk Inc. NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) 01/17/2018
K050106 NOVO NORDISK INC. NOVOFINE AUTOCOVER 30G X 8MM 03/30/2005
K133738 NOVO NORDISK INC. NOVOFINE PLUS 32G 4 MM 05/21/2014
K202005 Novo Nordisk Inc. NovoFine Plus 32G Tip x 4 mm 12/19/2020
K231255 Novo Nordisk Inc. NovoFine« Plus 08/25/2023
K093109 NOVO NORDISK INC. NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') 06/18/2010
K002403 NOVO NORODISK PHARMACEUTICALS, INC. NOVOFINE 31 DISPOSABLE NEEDLE 12/08/2000
K170768 OcuJect, LLC Mini Needle 07/10/2017
K212805 OcuJect, LLC SteriCap Mini Needle and Standard Needles 09/30/2021
K230959 OcuJect, LLC VitreJect« Needle; OcuSafe« Needle 09/14/2023
K151571 OCUJET, LLC Mini Needle 10/14/2015
K183016 OcuJet, LLC SteriCap Mini Needle 05/07/2019
K010887 OHANA NEEDLE CO. INSULIN PEN NEEDLE ADAPTER 06/08/2001
K030032 OMRIX BIOPHARMACEUTICALS, INC. CROSSEAL APPLICATION DEVICE 03/21/2003
K960963 OSBORN MEDICAL CORP. CORD WRAP WITH NEEDLE RESHEATHER 05/06/1996
K152339 OWEN MUMFORD LTD Unifine Pentips/ Unifine Pentips Plus 06/24/2016
K210399 Owen Mumford Ltd Unifine SafeControl 09/17/2021
K173881 Owen Mumford Ltd Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G 07/11/2018
K973899 Owen Mumford USA, Inc. UNIFINE PENTIPS 12/04/1997
K122969 P/L Biomedical CLICKFINE PEN NEEDLE 10/25/2012
K122971 P/L Biomedical CLICKFINE PEN NEEDLE 10/25/2012
K042907 PDMP, INC. NEEDLE INCAPACITATOR (NEEDLE GUARD) 12/22/2004
K932889 PERRY SPECIALTIES DESIGN, INC. PERRY SPECIALTIES DESIGNS NEEDLE GUARD 05/28/1996
K203792 Pikdare S.p.A Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle 01/20/2023
K223353 Pikdare SpA DropSafeTM SicuraTM 12/02/2022
K191976 Piper Access, LLC Piper GO-IO Intraosseous Infusion System 11/13/2019
K001175 PLATINUM SERVICES, INC. SERAGARD VASCULAR ACCESS PATCH 09/18/2000
K192222 POONGLIM Pharmatech Inc. EZ-Inject Single use Needle 05/12/2020
K172483 Poonglim Pharmatech Inc. Kopac Sterile Needle 06/21/2018
K000085 PORTSETT, INC. PORTSETT 03/17/2000
K990371 POST MEDICAL, INC. DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 04/21/1999
K972536 POST MEDICAL, INC. SYRINGE NEEDLE REMOVER (S.N.R.) 08/15/1997
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K980179 ROTONICS MFG., INC. SHARPS PLUS 5 GALLON SHARPS CONTAINER 04/13/1998
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K152824 SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD. MEDT PEN NEEDLE 03/07/2016
K073705 SHANDONG QIAOPAI GROUP CO., LTD MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE 03/24/2008
K073127 SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G 12/20/2007
K102328 SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA 05/13/2011
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K113186 SHINA CORP. STERILE INSULIN PEN NEEDLE 04/12/2012
K071947 SHINA CORP. VACU-MED BLOOD COLLECTION NEEDLES 10/12/2007
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K112777 SOL-MILENNIUM MEDICAL, INC. SOL-M EXCHANGEABLE NEEDLES 02/24/2012
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K202492 Teleflex Medical EZ-IO Intraosseous Vascular Access System 03/22/2021
K180588 Teleflex Medical FAST1Ö Intraosseous Infusion System; FASTResponderÖ Sternal Intraosseous Device 04/17/2018
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K181369 Terumo Corporation Immucise Intradermal Injection System 11/13/2018
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K082820 TERUMO EUROPE N.V. K-PACK II NEEDLE - 29G THIN WALL 10/23/2008
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K212095 Terumo Europe N.V. SurGuard3 Safety Hypodermic Needle 08/22/2022
K012646 TERUMO MEDICAL CORP. TERUMO 30 GAUGE HYPODERMIC NEEDLE 08/27/2001
K000387 TERUMO MEDICAL CORP. TERUMO NEEDLE WITH LOCKING SHEATH 03/02/2000
K031453 TERUMO MEDICAL CORP. TERUMO SURGUARD 2 SAFETY NEEDLE 07/08/2003
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K120690 TIGER MEDICAL PRODUCTS LTD INSULIN PEN NEEDLE 06/22/2012
K032141 TIGER MEDITECH INCORPORATED SECUMAX BLOOD COLLECTION SYSTEM 01/28/2004
K970370 TSK LABORATORY, JAPAN TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE 04/10/1997
K955772 TTK BIOMED, LTD. CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES 07/08/1996
K112332 TWOBIENS CO., LTD. FINE JECT INSULIN PEN NEEDLE 01/10/2012
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K063567 VIDACARE CORPORATION EZ-MIO STERNAL 01/26/2007
K062956 VIDACARE CORPORATION EZ-MIO, EZ-IO DISTAL TIBIA 12/05/2006
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K063142 VIDACARE CORPORATION MANUAL PD-IO; POWERED PD-IO 12/08/2006
K043490 VIDACARE CORPORATION PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE 02/18/2005
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K051992 VIDACARE CORPORATION POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM 10/20/2005
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K133059 WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. INSULIN PEN NEEDLE 02/25/2014
K133058 WENZHOU WUZHOU IMPORT & EXPORT CO., LTD INSULIN PEN NEEDLE 02/25/2014
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K082908 WEST PHARMACEUTICAL SERVICES, INC. NOVAGUARD, MODEL 3611001 04/24/2009
K961878 WINFIELD INDUSTRIES SHARPS-TAINER 06/27/1996
K982097 WORLDWIDE MEDICAL TECHNOLOGIES, LLC WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD 06/25/1998
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K110312 YPSOMED AG CLICKFINE AUTOPROTECT PEN NEEDLE 01/26/2012
K131123 YPSOMED AG CLICKFINE AUTOPROTECT PEN NEEDLE 07/05/2013
K100436 YPSOMED AG CLICKFINE PEN NEEDLE 04/30/2010
K102108 YPSOMED AG CLICKFINE PEN NEEDLE 11/23/2010
K131125 YPSOMED AG CLICKFINE PEN NEEDLE 07/05/2013
K171984 Ypsomed AG Clickfine Pen Needle, Penfine Classic Pen Needle 10/11/2017
K150662 YPSOMED AG Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) 06/09/2015
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K181069 Zhejiang Kindly Medical Devices Co. Ltd Disposable Insulin Pen Needle 08/28/2018
K213183 Zhejiang Kindly Medical Devices Co. Ltd Safety Insulin Pen Needles 10/14/2022
K223334 Zhejiang kindly Medical Devices Co., Ltd. Sterile Hypodermic Needles for Single Use 12/16/2022


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