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

FDA 510(k) Number Applicant Device Name Decision Date
K973899 *OWNE MUMFORD USA, INC.** UNIFINE PENTIPS 12/04/1997
K963351 ABBOTT LABORATORIES LIFESHIELD BLUNT CANNULA 02/26/1997
K920737 ABBOTT LABORATORIES LIFESHIELD VIAL ADAPTER 12/15/1992
K880892 ABCO DEALERS, INC. BLOOD COLLECTING NEEDLE AND HOLDERS 04/21/1988
K972538 ACACIA, INC. FLOW-EZE BLUNT CANNULA (1999BC) 07/15/1998
K874024 ACUDERM, INC. ACU-MICRO-NEEDLE 11/23/1987
K873957 ADVANTAGE MEDICAL SYSTEMS, INC. NON-CORING "HUBER TYPE" NEEDLES 10/23/1987
K874249 ALLERGY LABORATORIES OF OHIO, INC. BIFURCATED NEEDLE 11/03/1987
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
K874430 AMERICAN MEDICAL TECHNOLOGY, INC. NEEDLE CONTAINER 01/04/1988
K842542 AMERICAN PHARMASEAL DIV. AHSC AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY 08/20/1984
K832556 AMERICAN PHARMASEAL DIV. AHSC NEONATAL LUMBAR PUNCTURE TRAY 09/12/1983
K770528 AMERICAN VIGGO NEEDLE, MEMBRANE 04/29/1977
K841565 AMKOR TRADING CO. HESUNG'S HYPERDERMIC NEEDLES 07/17/1984
K861318 ANAGO, INC. DISPOSABLE NEEDLE COUNTER (20-720) 05/02/1986
K840334 APPLIED MEDICAL DEVICES, INC. CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY 04/13/1984
K880746 APPLIED PLASTICS TECHNOLOGY, INC. STERILE NEEDLE FOR BLOOD COLLECTION 05/31/1988
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
K761098 ARROW INTL., INC. FILTER DEVICES 01/28/1977
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
K895432 AUSMEDICS PTY LTD. SAFE-T-CAP 11/03/1989
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
K841577 AVA MEDICAL PRODUCTS OF CANADA, INC. HYPODERMIC NEEDLES 05/07/1984
K831395 AVL SCIENTIFIC CORP. AVL 0073 MICROSAMPLER 07/26/1983
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
K930217 BAXTER HEALTHCARE CORP. BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE 02/28/1994
K943594 BAXTER HEALTHCARE CORP. BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS 08/17/1994
K943605 BAXTER HEALTHCARE CORP. BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS 08/17/1994
K943722 BAXTER HEALTHCARE CORP. CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS 11/28/1994
K861390 BAXTER HEALTHCARE CORP. DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET 07/17/1986
K924064 BAXTER HEALTHCARE CORP. INTERLINK UNIVERSAL VIAL ADAPTER 04/21/1993
K000657 BAXTER HEALTHCARE CORP. LUER ACCESS UNIVERSAL VIAL ADAPTER 03/08/2000
K851103 BAXTER HEALTHCARE CORP. VASCULAR IMPLANT ACCESS NEEDLE SET 07/16/1985
K905664 BAXTER HEALTHCARE CORP. VIAL ACCESS CANNULA 03/15/1991
K944121 BCI, INC. SHARPS CONTAINER 18 GALLON 01/27/1995
K021475 BD BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET 07/19/2002
K943575 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D GUARDIAN NESTABLE SHARPS COLLECTORS 10/14/1994
K924070 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D PEN NEEDLE 03/18/1993
K895630 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D PEND NEEDLE 12/08/1989
K955235 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE 02/12/1996
K950466 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC B-D ULTRA-FINE II PEN NEEDLE 05/11/1995
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
K944931 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON BLUNT STEEL CANNULA 08/29/1995
K924439 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA 02/12/1993
K931019 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE 10/18/1993
K974006 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BECTON DICKINSON TWINPAK 01/22/1998
K831610 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC INTRADISCAL THERAPY NEEDLE 07/12/1983
K834553 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC INTRADISCAL THERAPY TRAY 03/06/1984
K790086 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NEEDLE, TRUCARE VACUTAINER 02/08/1979
K944757 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PISTON SYRINGES 01/11/1995
K951254 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SAFETYGLIDE NEEDLE 10/07/1995
K862610 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE 02/04/1987
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
K123300 BECTON DICKINSON & CO. BD PEN NEEDLE 01/18/2013
K051899 BECTON DICKINSON & CO. BD PEN NEEDLE 09/13/2005
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
K110105 BECTON DICKINSON AND COMPANY (BD) BD PEN NEEDLE 04/28/2011
K943683 BECTON DICKINSON CONSUMER PRODUCTS B-D SAFE-CLIP 10/31/1994
K982541 BECTON DICKINSON VACUTAINER SYSTEMS VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 10/28/1998
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
K162516 BECTON, DICKINSON AND COMPANY BD Pen Needle 12/09/2016
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
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
K943771 BFI- MEDICAL WASTE SYSTEMS MEDX REUSABLE SHARPS CONTAINER 03/03/1995
K943794 BFI- MEDICAL WASTE SYSTEMS MX4000 12/14/1994
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
K895024 BIO-PLEXUS, INC. PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE 09/21/1990
K961328 BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES BEC SHROUDED PLASTIC CANNULA 05/30/1996
K946027 BIOMEDICAL WASTE SYSTEMS, INC. BIG PHIL 01/26/1995
K943765 BIOMEDICAL WASTE SYSTEMS, INC. SHARPS AWAY 07/10/1995
K952274 BIOSAFETY SYSTEMS, INC. CHEMOGUARD, P2 HIRISK 08/29/1995
K884620 BIOSURGE, INC. ASD SINGLE LUMEN NEEDLE 11/21/1988
K874602 BIOSURGE, INC. ASD-BIO ANTI-STICK DEVICE 02/19/1988
K950899 BIOSYSTEMS LABORATORY SHARPS BARREL 06/29/1995
K161255 BIOTEKNE SRL meso-relle (AAL34, AAL36, AM30G) 01/19/2017
K790953 BORDA PRODUCTS, INC. "BORDISPO" BRAND HYPODERMIC NEEDLE 06/27/1979
K801107 BURRON MEDICAL PRODUCTS, INC. DOUBLE ENDED FILTERED TRANSFER NEEDLE 05/30/1980
K801108 BURRON MEDICAL PRODUCTS, INC. DOUBLE ENDED VENTED TRANSFER DEVICE 05/30/1980
K052843 BUSSE HOSPITAL DISPOSABLES, INC. BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE 04/17/2006
K925446 C.R. BARD, INC. BARD SAFE SAMPLING DEVICE 07/29/1993
K010038 CAMBRIDGE MARKETING, INC. NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE 01/24/2001
K870193 CAN-AM SURGICAL CORP. A+MED DISPOSABLE NEEDLE 02/27/1987
K942930 CAPCARD, INC. CAPCARD 07/10/1995
K946041 CARDICO, INC. CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.) 06/16/1995
K913914 CARE MEDICAL DEVICES, INC. PROGUARDII(TM) BLOOD COLLECTION DEVICE 10/08/1991
K911436 CATALYST, INC. SHARPS PIN CUSHION(TM) CONTAINER 07/01/1991
K052725 CERTOL INTERNATIONAL, LLC PROTECTOR NEEDLE SHEATH PROP 12/28/2005
K855248 CHURCHILL CORP. BLOOD COLLECTING NEEDLE 02/26/1986
K850420 CHURCHILL CORP. CHURCHILL HABER POINT NEEDLE ADMIN. SET 04/24/1985
K945284 CLIVE CRAIG CO. TRUJECT 12/29/1994
K924820 COLLETT PRODUCTS HYPOGRIP(TM) 10/05/1993
K771667 CONCORD LABORATORIES, INC. BLOOD GAS TRAY #4024 10/13/1977
K904198 CONCORD/PORTEX SAFETY NEEDLE SHEATH 12/19/1990
K911037 CONCORD/PORTEX SAFETY NEEDLE SHEATH, MODIFICATION 05/03/1991
K962040 CONTOUR FABRICATORS OF FLORIDA, INC. RNS ARTHROGRAM TRAY 06/25/1996
K160887 COOK INCORPORATED Cook Intraosseous Infusion Needles 07/26/2016
K913258 COOK, INC. DISPOSABLE INTROSSEOUS INFUSION NEEDLES 03/04/1992
K915409 COOK, INC. INTRAOSSEOUS ACCESS NEEDLE 03/04/1992
K031058 CORD STICK CORP. CORD STICK MULTIPLE DRAW SYSTEM 06/13/2003
K863606 CORMED, INC., SUB. C.R.BARD, INC. BUTTERFLY NON-CORING NEEDLE SET 12/18/1986
K842756 COSMETIC SCIENCES, INC. BUTTERFLY II PN INFUSION NEEDLE 07/23/1984
K830568 COSMETIC SCIENCES, INC. GUTTMAN INFUSION NEEDLE 10/27/1983
K872566 COTRAN CORP. MULTIPLE NEEDLE, INJECTION, DISPOSABLE 08/25/1987
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
K841742 CREATIVE CARE SYSTEMS, INC. NON-CORING NEEDLE 07/06/1984
K852831 CREATIVE CARE SYSTEMS, INC. NON-KOR ACCESS KITS 09/19/1985
K861406 CREATIVE CARE SYSTEMS, INC. NON-KOR WINGED INFUSION SETS 05/06/1986
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
K935916 DARYL C. FALLAS LIP GRIP CAP HOLDER 11/03/1995
K910667 DAVID CRAIG MARKETING, INC. STERI-STAT REUSABLE SYRINGE 09/04/1991
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
K882064 DEVICE LABS, INC. LO-CORE NEEDLE 07/08/1988
K946289 DEVON INDUSTRIES, INC. DEVONS POINT LOK NEEDLE PROTECTION DEVICE 07/10/1995
K944114 DEVON INDUSTRIES, INC. PHLEBOTOMY UNIT SHARPS A GATOR 12/02/1994
K943892 DEVON INDUSTRIES, INC. POINT OF USE SHARPS A GATOR 12/02/1994
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
K982399 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INJECTION PEN NEEDLE 08/06/1998
K973339 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INJECTION PEN NEEDLE 09/24/1997
K013782 DISETRONIC MEDICAL SYSTEMS DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE 11/20/2001
K052445 DUOPROSS MEDITECH CORPORATION DUOPROSS NEEDLE 12/05/2005
K935407 E.M. INNOVATIONS, INC. STICKIT 08/05/1994
K042917 EMERGO GROUP, INC. STAT MEDICAL PEN NEEDLE 04/22/2005
K952837 EMK ENTERPRISES, LLC. DARWIN HYPODERMIC SAFETY SYSTEM (DHSS) 01/30/1996
K935480 EVANS MEDICAL, INC. MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS 01/28/1994
K963658 EXEL INTL. EXEL AVF SINGLE NEEDLE 05/05/1998
K895769 EXEL INTL. EXEL HUBER NEEDLE 02/16/1990
K895771 EXEL INTL. EXEL SPINAL NEEDLES 02/16/1990
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
K881785 FIRST SCIENTIFIC, DIV. N.S. CADEE 05/31/1988
K870863 FLINT LABORATORIES DIV. TRAVENOL FNA THYROID BIOPSY KIT 05/08/1987
K844305 GAINOR MEDICAL GAINOR MEDICAL FLOWMAX NEEDLES 11/30/1984
K902422 GAINOR MEDICAL EUROPE, LTD. NEEDLE, ASPIRATION & INJECTION, DISPOSABLE 06/06/1991
K950159 GAINOR MEDICAL U.S.A., INC. SURESHARP 04/14/1995
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
K853731 GISH BIOMEDICAL, INC. HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX 10/18/1985
K954041 GLAXO, INC. G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) 10/16/1995
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
K874414 HARBOR MEDICAL DEVICES, INC. HYPODERMIC NEEDLES, SINGLE LUMEN 01/14/1988
K913386 HDC CORP. CHEMO-PORT 01/10/1992
K873165 HDC CORP. CHEMO-PORT NON-CORING NEEDLES 12/03/1987
K983067 HENKE SASS WOLF OF AMERICA, INC. FINE-JECT 10/30/1998
K792096 HEYER SCHULTE CORP. 2 FR KELMAN CHAMBER MAINTAINER 11/16/1979
K823696 HOSPITAL PRODUCTS CO. MICRO Z BLOOD COLLECTING NEEDLES 01/26/1983
K954500 HOSPITEC, INC. HOSPITEC MEDI-BUTLER 01/18/1996
K171982 HTL-STREFA S.A. DROPLET PEN NEEDLE 03/21/2018
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
K834407 HYDRO-MED PRODUCTS, INC. STERILE DISPOSABLE SPINAL NEEDLES 03/19/1984
K934591 ICU MEDICAL, INC. CLAVE VIAL ACCESS SPIKE 02/16/1994
K872580 ICU MEDICAL, INC. HR (TM) COLLECTION SYSTEM 08/13/1987
K874372 ICU MEDICAL, INC. HR(TM) NEEDLE AND SYRINGE 11/06/1987
K860781 ICU MEDICAL, INC. ICU MEDICAL NEEDLE, LOPEZ NEEDLE 05/06/1986
K963830 IMAGE MEDICAL, INC. SHARPS CONTAINER MODEL# SC001 02/10/1997
K980003 IMAGINATION MEDICAL, INC. M500-100 SHARPS CONTAINER 03/13/1998
K061032 IMPRINT PHARMACEUTICALS LIMITED DEPOTONE 06/21/2006
K050505 IMPRINT PHARMACEUTICALS LIMITED DEPOTONE 04/05/2005
K884792 INFUCARE PRODUCTS, INC. VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES 01/30/1989
K920717 INGENIOUS TECHNOLOGIES CORP. NEEDLEGARD II 04/22/1992
K936235 INGENIOUS TECHNOLOGIES CORP. NEEDLESAFE II & NEEDLEGARD II 03/28/1994
K922158 INJECTIMED, INC. PROTECTOR SYRINGE SAFETY CAP SYSTEM 07/21/1992
K123987 INNOVATIVE MEDICAL TECHNOLOGIES, INC. IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET 08/27/2013
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
K950012 INTERNATIONAL REGULATORY CONSULTANTS DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES 08/18/1995
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
K911597 J. SIMMONS INSTRUMENT LTD. THE NEEDLE NABBER 07/26/1991
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
K170846 Jiangsu Caina Technology Co., Ltd. Disposable Insulin Pen Needle 12/13/2017
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K945825 SYNCOR INTL. CORP. SECURE SAFETY INSERT 04/10/1995
K933601 SYNTUITION, INC. FLIPTIP SAFETY NEEDLE 06/24/1994
K180588 Teleflex Medical FAST1Ö Intraosseous Infusion System; FASTResponderÖ Sternal Intraosseous Device 04/17/2018
K863514 TERRA MARKETING ASSOC. PROMEDICOR 09/25/1986
K152362 TERUMO (PHILIPPINES) CORPORATION Terumo SurGuard 3 Safety Hypodermic Needle 10/16/2015
K113422 TERUMO (PHILIPPINES) CORPORATION TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE 03/05/2012
K122249 TERUMO (PHILIPPINES) CORPORATION TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE 08/28/2012
K121607 TERUMO (PHILIPPINES) CORPORATION TERUMO(R) NEEDLE 11/08/2012
K771203 TERUMO AMERICA, INC. DISP. HYPODERMIC NEEDLE 07/14/1977
K771209 TERUMO AMERICA, INC. TERUFUSION BLOOD ADMIN. SET 07/26/1977
K771207 TERUMO AMERICA, INC. TERUFUSION DONOR SET 07/14/1977
K181369 Terumo Corporation Immucise Intradermal Injection System 11/13/2018
K111797 TERUMO EUROPE N.V. 27 G X 1/2 K-PACK SURSHIELD NEEDLE 09/22/2011
K062608 TERUMO EUROPE N.V. 29G AND 30G K-PACK II NEEDLE 09/15/2006
K984576 TERUMO EUROPE N.V. K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K 06/14/1999
K132233 TERUMO EUROPE N.V. K-PACK II NEEDLE - 27G X 3/4 THIN WALL 09/06/2013
K082820 TERUMO EUROPE N.V. K-PACK II NEEDLE - 29G THIN WALL 10/23/2008
K151398 TERUMO EUROPE N.V. K-Pack II Needle - 29G x 5/16 Thin Wall 06/25/2015
K110850 TERUMO EUROPE N.V. K-PACK II NEEDLE- 27G & 30G THIN WALL 06/09/2011
K150263 TERUMO EUROPE N.V. K-Pack II Needle-21G x 2 04/01/2015
K110527 TERUMO EUROPE N.V. K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE 06/06/2011
K001572 TERUMO EUROPE N.V. NEOLUS NEEDLE 08/14/2000
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
K040531 TERUMO MEDICAL CORP. TERUMO SURGUARD2 SAFETY NEEDLE 03/23/2004
K970547 THANTEX SPECIALTIES, INC. ISOLYSER SDS SHARPS CONTAINER 07/18/1997
K943626 THANTEX SPECIALTIES, INC. ISOLYSER SHARPS MANAGEMENT SYSTEM SMS 06/16/1995
K936029 THEREX CORP. NON-CORNING (HUBER) NEEDLE 02/04/1994
K142765 ThinkMed Medical Technology Co., Ltd. TM SAFETY NEEDLE 08/11/2015
K120690 TIGER MEDICAL PRODUCTS LTD INSULIN PEN NEEDLE 06/22/2012
K032141 TIGER MEDITECH INCORPORATED SECUMAX BLOOD COLLECTION SYSTEM 01/28/2004
K853604 TODAY'S MACHINING & DESIGN, INC. ACE-KYLE DYE INJECTION NEEDLE P/N 14082 11/12/1985
K760780 TRAVENOL LABORATORIES, S.A. DOUBLE-ENDED NEEDLE 11/16/1976
K896320 TRI-STATE HOSPITAL SUPPLY CORP. CENTURION KLEEN-NEEDLE SYSTEM 01/11/1990
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
K033373 TYCO HEALTHCARE MONOJECT INSULIN SYRINGE 11/13/2003
K012736 TYCO HEALTHCARE MONOJECT SAFETY NEEDLE 10/25/2001
K132552 U&U MEDICAL TECHNOLOGY CO., LTD U&U STERILE HYPODERMIC NEEDLE 11/13/2013
K003381 U.S. SAFETY SYRINGES CO., INC. SHIELDING NEEDLE HOLDER 04/23/2001
K050464 ULTI MED, INC. ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 05/11/2005
K832858 ULTI-MED INTL., INC. INTRADISCAL THERAPY TRAY 09/29/1983
K100812 ULTIMED, INC. ULTICARE DISPOSABLE PEN NEEDLES 06/03/2010
K934088 UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC AUTO SUTURE SHARPS CONTAINER 02/03/1994
K961877 UNIVEC, INC. PISTON SYRINGE 08/07/1996
K943679 UNIVEC, INC. UNIVEC NONRESUSABLE LOCKING SYRINGE 12/12/1994
K834436 UNIVERSAL MEDICAL INSTRUMENT CORP. CHEMONUCLEOLYSIS NEEDLE 03/15/1984
K842012 UNIVERSAL MEDICAL INSTRUMENT CORP. UMI CURVED CHEMONUCLEOLYSIS NEEDLE 07/06/1984
K946084 VANGUARD CONTAINER CORP. VAN"GUARD" 05/17/1995
K043019 VASCULAR SOLUTIONS, INC. VASCULAR SOLUTIONS SCLERO-KIT 12/01/2004
K823255 VERTEX MEDICAL CORP. NON-STERILE REUSABLE NEEDLES 11/22/1982
K052408 VIDACARE CORPORATION EZ-IO 11/17/2005
K132583 VIDACARE CORPORATION EZ-IO INTRAOSSEOUS INFUSION SYSTEM 02/11/2014
K091140 VIDACARE CORPORATION EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO 10/14/2009
K052195 VIDACARE CORPORATION EZ-MIO MANUAL DRIVER 11/02/2005
K063567 VIDACARE CORPORATION EZ-MIO STERNAL 01/26/2007
K062956 VIDACARE CORPORATION EZ-MIO, EZ-IO DISTAL TIBIA 12/05/2006
K062422 VIDACARE CORPORATION HUMERAL HEAD, MANUAL DRIVER 11/07/2006
K063142 VIDACARE CORPORATION MANUAL PD-IO; POWERED PD-IO 12/08/2006
K043490 VIDACARE CORPORATION PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE 02/18/2005
K101026 VIDACARE CORPORATION POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO 07/27/2010
K051992 VIDACARE CORPORATION POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM 10/20/2005
K120661 VIDACARE CORPORATION THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE 06/03/2012
K032885 VIDACARE CORPORATION VIDAPORT INTRAOSSEOUS INFUSION SYSTEM 03/10/2004
K141117 VIDACARE LLC EZ-IO INTRAOSSEOUS INFUSION SYSTEM 07/08/2014
K896293 VIRAFREE CORP. VIRAFREE CORP. EJECTABLE NEEDLE HOLDER 01/18/1990
K811966 VISITEC CO. VISITEC NEEDLE RANGE (GENERAL HOSPITAL) 07/23/1981
K000441 VITAL SIGNS, INC. BODYGUARD 04/11/2000
K021315 VITAL SIGNS, INC. SURE-LOK 08/21/2002
K963571 VYGON CORP. VYGON MULTI-DOSE VIAL ADAPTER & BIONECTOR 06/02/1997
K062940 WAISMED LTD. BONE INJECTION GUN (B.I.G.) 12/22/2006
K981853 WAISMED LTD. BONE INJECTION GUN (B.I.G.) DEVICE 11/17/1998
K022415 WAISMED LTD. BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST 10/11/2002
K142086 WAISMED LTD. NIO -INTRAOSSEOUS DEVICE 08/28/2014
K160805 WAISMED LTD. NIO-P 06/23/2016
K801431 WATERS ASSOC., INC. PAN-AM MYELOGRAM TRAY 08/12/1980
K090156 WCM WASTE & COMPLIANCE MANAGEMENT, INC. ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 09/01/2009
K103587 WEIHAI HONGYU MEDICAL DEVICES CO., LTD. DISPOSABLE BLLOD COLLECTION NEEDLE 04/06/2011
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
K082908 WEST PHARMACEUTICAL SERVICES, INC. NOVAGUARD, MODEL 3611001 04/24/2009
K942901 WINFIELD CO., INC. SHARPS-TAINER LARGE OPENING 09/19/1994
K942903 WINFIELD CO., INC. SHARPS-TAINER SMALL OPENING 09/19/1994
K961878 WINFIELD INDUSTRIES SHARPS-TAINER 06/27/1996
K942054 WINFIELD INDUSTRIES SHARPS-TAINER 08/23/1994
K982097 WORLDWIDE MEDICAL TECHNOLOGIES, LLC WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD 06/25/1998
K130212 WUXI YUSHOU MEDICAL APPLICANCES CO., LTD SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE 11/20/2013
K903490 WYETH-AYERST LABORATORIES, INC. NORPLANT(R) TROCAR 11/28/1990
K160575 YIDOBIO INC. CareSens Pen Needle, Softip Pen Needle 09/07/2016
K832904 YOLAN R. GUTTMAN INTRAVENOUS NEEDLE 03/30/1984
K152514 YPSOMED AG Clickfine AutoProtect Pen Needle 11/18/2015
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
K172763 Zhejiang Kindley medical devices Co.,Ltd Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with 06/04/2018
K181069 Zhejiang Kindley medical devices Co.,Ltd Disposable Insulin Pen Needle 08/28/2018
K910455 ZIEHM INTERNATIONAL, INC. IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR 02/14/1991
K890620 ZIEHM INTERNATIONAL, INC. STICK-GARD SAFETY NEEDLE 02/28/1989


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