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 |
K001098 |
PRO. DUCT HEALTH, INC. |
PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 |
05/18/2000 |
K230070 |
PromaMedical Inc. |
MESORAM« Hypodermic Needle (710301); MESORAM« Hypodermic Needle (710302); MESORAM« Hypodermic Needle (712305); MESORAM« Hypodermic Needle (712315); MESORAM« Hypodermic Needle (710303); MESORAM« Hypodermic Needle (710307); MESORAM« Hypodermic Needle (71030 |
10/05/2023 |
K161950 |
Promisemed Hangzhou Meditech Co., Ltd. |
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle |
05/11/2017 |
K191853 |
Promisemed Hangzhou Meditech Co., Ltd. |
Dual-Safety Pen Needle |
09/05/2019 |
K202681 |
Promisemed Hangzhou Meditech Co., Ltd. |
Promisemed Covered Safety Pen Needle |
12/31/2020 |
K210059 |
Promisemed Hangzhou Meditech Co., Ltd. |
Promisemed Insulin Pen Needle |
07/21/2021 |
K202682 |
Promisemed Hangzhou Meditech Co., Ltd. |
Promisemed Triple Safety Pen Needle |
11/24/2020 |
K220129 |
Promisemed Hangzhou Meditech Co., Ltd. |
Promisemed X-Safety Pen Needle |
09/19/2022 |
K211293 |
Promisemed Hangzhou Meditech Co., Ltd. |
Safety Winged Blood Collection Sets |
06/25/2021 |
K210065 |
Promisemed Hangzhou Meditech Co., Ltd. |
Verifine Safety Type Insulin Pen Needle |
04/22/2021 |
K222271 |
Promisemed Hangzhou Meditech Co., Ltd. |
Verisafe Safety sterile needles |
02/15/2023 |
K970380 |
PYNG MEDICAL CORP. |
F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM |
04/25/1997 |
K072487 |
PYNG MEDICAL CORP. |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
02/13/2008 |
K080865 |
PYNG MEDICAL CORP. |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
04/24/2008 |
K130487 |
PYNG MEDICAL CORP. |
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE |
06/25/2013 |
K100124 |
PYNG MEDICAL CORP. |
FASTX STERNAL INTRAOSSEOUS DEVICE |
08/31/2010 |
K971763 |
RETRACTABLE TECHNOLOGIES, INC. |
BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER |
08/26/1997 |
K133635 |
RETRACTABLE TECHNOLOGIES, INC. |
EASYPOINT NEEDLE |
06/17/2014 |
K980179 |
ROTONICS MFG., INC. |
SHARPS PLUS 5 GALLON SHARPS CONTAINER |
04/13/1998 |
K041941 |
SAFE T MEDICAL DEVICES, LTD. |
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE |
09/13/2004 |
K012283 |
SAFEGARD MEDICAL PRODUCTS, INC. |
SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE |
10/01/2001 |
K955748 |
SAFETECH INTL., INC. |
DOYLE EXTRACTOR |
03/14/1996 |
K993125 |
SAFETY MEDICAL SUPPLY INT,., INC. |
SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM |
06/20/2000 |
K973911 |
SAGE PRODUCTS, INC. |
2 GALLON ALTERNATE CARE SHARPS CONTAINER |
10/29/1997 |
K972705 |
SAGE PRODUCTS, INC. |
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC |
04/30/1998 |
K972279 |
SAGE PRODUCTS, INC. |
SHARPS SHUTTLE |
08/29/1997 |
K191488 |
SAM« Medical Products, Inc. |
SAM IO Intraosseous Access System |
11/21/2019 |
K193422 |
Sandstone Medical (Suzhou) Inc. |
Easydrip Pen Needle, Easydrip Plus Pen Needle |
02/02/2021 |
K210864 |
Sandstone Medical (Suzhou) Inc. |
Safety Pen Needle |
02/17/2022 |
K003382 |
SARSTEDT, INC. |
SARSTEDT NEEDLE PROTECTOR |
03/30/2001 |
K120191 |
SCANDINAVIAN HEALTH LIMITED |
PUSH-ON NEEDLE 30GX8MM |
05/23/2012 |
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 |
K131954 |
SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. |
MEDI PEN NEEDLE |
05/29/2014 |
K120420 |
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
STERILE BLUNT FOR SINGLE USE |
10/18/2012 |
K212972 |
Shanghai Kindly Enterprise Development Group Co., Ltd |
KDL Safety Needles |
08/18/2022 |
K223327 |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Sterile Aesthetic Cannula and Hypodermic Needle |
02/16/2023 |
K960982 |
SHERWOOD MEDICAL CO. |
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA |
12/23/1996 |
K113186 |
SHINA CORP. |
STERILE INSULIN PEN NEEDLE |
04/12/2012 |
K071947 |
SHINA CORP. |
VACU-MED BLOOD COLLECTION NEEDLES |
10/12/2007 |
K222417 |
Shina Corporation |
Shina Safety Needle |
03/20/2023 |
K152877 |
SHINA MED CORPORATION |
SureFine Pen Needle |
06/07/2016 |
K070988 |
SHINCHANG MEDICAL CO., LTD. |
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) |
08/23/2007 |
K221066 |
Sichuan Prius Biotechnology Co., Ltd. |
Sterile Hypodermic Needles for Single Use |
10/04/2022 |
K221080 |
Sichuan Prius Biotechnology Co., Ltd. |
Sterile Safety Hypodermic Needles for Single Use |
10/04/2022 |
K121632 |
SIMPLE DIAGNOSTICS, INC. |
COMFORT EZ |
08/10/2012 |
K011925 |
SIMS PORTEX, INC. |
HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO |
07/12/2001 |
K041399 |
SMITHS MEDICAL ASD, INC. |
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE |
07/28/2004 |
K073188 |
SMITHS MEDICAL ASD, INC. |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE |
02/08/2008 |
K211634 |
Smiths Medical ASD, Inc. |
Hypodermic Needle-Pro EDGE Safety Device |
08/26/2021 |
K071785 |
SMITHS MEDICAL ASD, INC. |
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE |
08/02/2007 |
K063450 |
SMITHS MEDICAL ASD, INC. |
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 |
01/25/2007 |
K072059 |
SMITHS MEDICAL MD, INC. |
GRIPPER MICRO NEEDLE |
11/01/2007 |
K112777 |
SOL-MILENNIUM MEDICAL, INC. |
SOL-M EXCHANGEABLE NEEDLES |
02/24/2012 |
K123684 |
SOL-MILLENNIUM MEDICAL |
SOL-CARE SAFETY NEEDLE |
05/08/2013 |
K182146 |
Sol-Millennium Medical, Inc. |
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set |
12/03/2018 |
K964042 |
SPECIALIZED HEALTH PRODUCTS, INC. |
EXTRESAFE PHLEBOTOMY |
06/06/1997 |
K962149 |
SPECIALIZED HEALTH PRODUCTS, INC. |
SAFETY CRADLE |
10/11/1996 |
K152597 |
StarCap Medical LLC ( DBA Prism Medical & Design) |
ProteXsure Safety Capsule System |
06/08/2016 |
K092016 |
STAT MEDICAL DEVICES, INC. |
SUPER-FINE PEN NEEDLE |
10/02/2009 |
K153706 |
STERILANCE MEDICAL (SUZHOU) INC. |
Insulin Pen Needle |
08/29/2016 |
K002180 |
STERLING MEDIVATIONS, INC. |
SIMPLICITY DISPOSABLE PEN NEEDLE |
10/13/2000 |
K990936 |
STIK STOPPERS, INC. |
THE VAULT |
05/18/1999 |
K971487 |
SUMI SALUD C.A. |
BKMI DISPOSABLE SYRINGE |
09/04/1997 |
K152334 |
SUNGSHIM MEDICARE CO., LTD. |
Sungshim Insulin Pen Needle |
03/17/2016 |
K942073 |
SUPERIOR DIAPERING PRODUCTS LTD. |
SHARPSPRO-TECTOR |
02/29/1996 |
K992626 |
SURE-WAY SYSTEMS, INC. |
SURE-WAY REUSABLE SHARPS CONTAINER |
12/16/1999 |
K231924 |
Teleflex Medical |
EZ-IO Intraosseous Vascular Access System |
07/25/2023 |
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 |
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 |
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 |
K192057 |
Terumo Europe N.V. |
K-Pack II Needle - 27G x 1/2ö Extra Thin Wall, K-Pack II Needle - 27G x 1/2ö Ultra Thin Wall, K-Pack II Needle - 30G x 1/2ö Extra Thin Wall, K-Pack II Needle - 30G x 1/2ö Ultra Thin Wall |
10/11/2019 |
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 |
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 |
K040531 |
TERUMO MEDICAL CORP. |
TERUMO SURGUARD2 SAFETY NEEDLE |
03/23/2004 |
K970547 |
THANTEX SPECIALTIES, INC. |
ISOLYSER SDS SHARPS CONTAINER |
07/18/1997 |
K142765 |
ThinkMed Medical Technology Co., Ltd. |
TM SAFETY NEEDLE |
08/11/2015 |
K221176 |
Tianjin Huahong Technology Co., Ltd. |
Insulin Pen Needle |
07/01/2022 |
K202319 |
Tianjin Huahong Technology Co., Ltd. |
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) |
11/12/2021 |
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 |
K033373 |
TYCO HEALTHCARE |
MONOJECT INSULIN SYRINGE |
11/13/2003 |
K012736 |
TYCO HEALTHCARE |
MONOJECT SAFETY NEEDLE |
10/25/2001 |
K190962 |
U-Needle B.V. |
Bella-mu |
02/03/2020 |
K003381 |
U.S. SAFETY SYRINGES CO., INC. |
SHIELDING NEEDLE HOLDER |
04/23/2001 |
K132552 |
U&U MEDICAL TECHNOLOGY CO., LTD |
U&U STERILE HYPODERMIC NEEDLE |
11/13/2013 |
K181508 |
U&U Medical Technology Co.,Ltd |
U&U Blood Collection Sets |
02/13/2019 |
K050464 |
ULTI MED, INC. |
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 |
05/11/2005 |
K213407 |
UltiMed Incorporated |
UltiCare Disposable Pen Needles |
12/16/2021 |
K100812 |
ULTIMED, INC. |
ULTICARE DISPOSABLE PEN NEEDLES |
06/03/2010 |
K961877 |
UNIVEC, INC. |
PISTON SYRINGE |
08/07/1996 |
K200932 |
Vacutest Kima Srl |
Blood Collection Needles |
12/14/2021 |
K043019 |
VASCULAR SOLUTIONS, INC. |
VASCULAR SOLUTIONS SCLERO-KIT |
12/01/2004 |
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 |
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 |
K210748 |
W. L. Med Co., Ltd. |
Well-life TM Pen Needles, Well-life TM Safety Pen Needles |
05/25/2022 |
K190538 |
WaisMed Ltd |
NIO-I |
10/07/2019 |
K211968 |
WaisMed Ltd |
NIO+ Adult |
07/22/2021 |
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 |
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 |
K231720 |
Wepon Medical Technology Co., Ltd. |
Sterile Hypodermic Needles for Single Use |
09/08/2023 |
K231723 |
Wepon Medical Technology Co., Ltd. |
Sterile Safety Hypodermic Needles for Single Use |
09/08/2023 |
K231729 |
Wepon Medical Technology CO., Ltd. |
Sterile syringes for single use with/without needle |
09/08/2023 |
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 |
K130212 |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE |
11/20/2013 |
K160575 |
YIDOBIO INC. |
CareSens Pen Needle, Softip Pen Needle |
09/07/2016 |
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 |
K210232 |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Sterile Hypodermic Needles for Single Use |
09/23/2021 |
K213535 |
Zhejiang Kangkang Medical-Devices CO., Ltd. |
Sterile Safety Hypodermic Needles for Single Use |
05/13/2022 |
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 |