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FMI

691 FDA 510(k) clearances · Product code

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RecordFirmDate
SOL-M EXCHANGEABLE NEEDLES (K112777)Sol-Milennium Medical, Inc.2012-02-24
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER (K113505)Greiner Bio-One North America, Inc.2012-02-17
CLICKFINE AUTOPROTECT PEN NEEDLE (K110312)Ypsomed AG2012-01-26
FINE JECT INSULIN PEN NEEDLE (K112332)Twobiens Co., Ltd.2012-01-10
EASY TOUCH (K112789)Mhc Medical Products, LLC2011-12-23
MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE (K110606)M.V.S.R.L.2011-09-29
27 G X 1/2 K-PACK SURSHIELD NEEDLE (K111797)Terumo Europe N.V.2011-09-22
IMC BLOOD COLLECTION NEEDLE (K110656)International Medsurg Connection2011-08-18
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH (K111424)Medpro Safety Products, Inc.2011-07-29
BD AUTOSHIELD DUO PEN NEEDLE (K110703)Becton, Dickinson and Company2011-07-27
K-PACK II NEEDLE- 27G & 30G THIN WALL (K110850)Terumo Europe N.V.2011-06-09
K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE (K110527)Terumo Europe N.V.2011-06-06
BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA (K102328)Shandong Weigao Group Medical Polymer Co., Ltd.2011-05-13
BD PEN NEEDLE (K110105)Becton, Dickinson and Company (BD)2011-04-28
DISPOSABLE BLLOD COLLECTION NEEDLE (K103587)Weihai Hongyu Medical Devices Co., Ltd.2011-04-06
IMC HYPODERMIC NEEDLE (K102584)International Medsurg Connection2011-01-14
CLICKFINE PEN NEEDLE (K102108)Ypsomed AG2010-11-23
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET (K102010)Medpro Safety Products, Inc.2010-11-19
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR (K102994)Kawasumi Laboratories, Inc.2010-11-03
VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER (K102774)Greiner Bio-One North America, Inc.2010-10-15
FASTX STERNAL INTRAOSSEOUS DEVICE (K100124)Pyng Medical Corp.2010-08-31
ZIRCONIA SYRINGE NEEDLE (K093043)Kuo Tai Hospital Managements & Consultant Co., Ltd.2010-08-20
POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO (K101026)Vidacare Corporation2010-07-27
NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') (K093109)Novo Nordisk, Inc.2010-06-18
ULTICARE DISPOSABLE PEN NEEDLES (K100812)Ultimed, Inc.2010-06-03
CLICKFINE PEN NEEDLE (K100436)Ypsomed AG2010-04-30
BD PEN NEEDLE (K100005)Becton, Dickinson and Co.2010-04-15
BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY (K100209)Becton, Dickinson & CO2010-02-19
MICRONJET 600 (K092746)Nanopass Technologies , Ltd.2010-02-03
FLEXPEN NEEDLE (K090111)Novo Nordisk, Inc.2010-02-01
DISPOSABLE HYPODERMIC NEEDLE (K092831)Feel Tech2010-01-14
EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO (K091140)Vidacare Corporation2009-10-14
SUPER-FINE PEN NEEDLE (K092016)Stat Medical Devices, Inc.2009-10-02
AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET (K090117)Autosafe-Reflex, Inc.2009-09-29
ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 (K090156)Wcm Waste & Compliance Management, Inc.2009-09-01
VAKU-8 BLOOD COLLECTION NEEDLES (K090426)Myco Medical Supplies, Inc.2009-06-12
NOVAGUARD, MODEL 3611001 (K082908)West Pharmaceutical Services, Inc.2009-04-24
MEDIGARD BLOOD COLLECTION DEVICE (K082511)Medigard Limited2009-01-16
K-PACK II NEEDLE - 29G THIN WALL (K082820)Terumo Europe N.V.2008-10-23
VACUETTE PREMIUM SAFETY NEEDLE SYSTEM (K072602)Medpro Safety Products, Inc.2008-06-18
FEEL-FINE INSULIN PEN NEEDLE (K080904)Feel Tech2008-06-04
FAST1 INTRAOSSEOUS INFUSION SYSTEM (K080865)Pyng Medical Corp.2008-04-24
SAFETY INFUSION SET (K080235)Greiner Bio-One Vacuette North America2008-04-24
MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE (K073705)Shandong Qiaopai Group Co., Ltd.2008-03-24
FAST1 INTRAOSSEOUS INFUSION SYSTEM (K072487)Pyng Medical Corp.2008-02-13
INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 (K071307)Inviro Medical Devices, Inc.2008-02-12
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE (K073188)Smiths Medical Asd, Inc.2008-02-08
KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR (K073257)Kawasumi Laboratories, Inc.2008-01-25
BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G (K073127)Shandong Weigao Group Medical Polymer Co., Ltd.2007-12-20
MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE (K073122)Covidien Lp, Formerly Registered AS Tyco Healthcar2007-11-21
STERICAN HYPODERMIC NEEDLES (K072247)B.Braun Medical, Inc.2007-11-08
GRIPPER MICRO NEEDLE (K072059)Smiths Medical MD, Inc.2007-11-01
VACU-MED BLOOD COLLECTION NEEDLES (K071947)Shina Corp.2007-10-12
ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT (K071998)Arrow Intl., Inc.2007-09-26
AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE (K071567)Autosafe-Refelx, Inc.2007-09-14
GREINER VACUETTE QUICKSHIELD COMPLETE (K072320)Greiner Bio-One North America, Inc.2007-09-14
SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) (K070988)Shinchang Medical Co., Ltd.2007-08-23
HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE (K071785)Smiths Medical Asd, Inc.2007-08-02
LIFE LATCH SHARPS & BIOHAZARD CONTAINER (K071088)M&M Industries, Inc.2007-07-05
BD HYPOINT NEEDLE (K070440)Becton, Dickinson & CO2007-03-16
TOP FINE (K063466)Daejin Tech Medical Manufacturing Co., Ltd.2007-03-02
EZ-MIO STERNAL (K063567)Vidacare Corporation2007-01-26
PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 (K063450)Smiths Medical Asd, Inc.2007-01-25
BONE INJECTION GUN (B.I.G.) (K062940)Waismed, Ltd.2006-12-22
MANUAL PD-IO; POWERED PD-IO (K063142)Vidacare Corporation2006-12-08
EZ-MIO, EZ-IO DISTAL TIBIA (K062956)Vidacare Corporation2006-12-05
FLEXPEN NEEDLE (K062500)Novo Nordisk, Inc.2006-11-21
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER (K061933)Hager Worldwide, Inc.2006-11-16
MEDLINE HYPODERMIC NEEDLES (K062984)Medline Industries, Inc.2006-11-13
HUMERAL HEAD, MANUAL DRIVER (K062422)Vidacare Corporation2006-11-07
29G AND 30G K-PACK II NEEDLE (K062608)Terumo Europe N.V.2006-09-15
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES (K061483)Greiner Bio-One North America, Inc.2006-08-14
DEPOTONE (K061032)Imprint Pharmaceuticals Limited2006-06-21
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE (K052843)Busse Hospital Disposables, Inc.2006-04-17
BD AUTOSHIELD PEN NEEDLE (K060007)Becton, Dickinson & CO2006-03-23
PROTECTOR NEEDLE SHEATH PROP (K052725)Certol International, LLC2005-12-28
NOVOFINE 32G TIP (K053470)Novo Nordisk, Inc.2005-12-21
DUOPROSS NEEDLE (K052445)Duopross Meditech Corporation2005-12-05
TERUMO MICRO TAPERED PEN NEEDLE (K052561)Kofu Factory of Terumo Corp.2005-11-23
EZ-IO (K052408)Vidacare Corporation2005-11-17
NIPRO HYPODERMIC NEEDLE (K052474)Nipro Medical Corp.2005-11-10
EZ-MIO MANUAL DRIVER (K052195)Vidacare Corporation2005-11-02
POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM (K051992)Vidacare Corporation2005-10-20
ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES (K051783)Artsana S.P.A2005-10-04
BD PEN NEEDLE (K051899)Becton, Dickinson & CO2005-09-13
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (K043249)Atrion Medical Products, Inc.2005-05-25
ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 (K050464)Ultimed, Inc.2005-05-11
STAT MEDICAL PEN NEEDLE (K042917)Emergogroup, Inc.2005-04-22
DEPOTONE (K050505)Imprint Pharmaceuticals Limited2005-04-05
NOVOFINE AUTOCOVER 30G X 8MM (K050106)Novo Nordisk, Inc.2005-03-30
PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE (K043490)Vidacare Corporation2005-02-18
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE (K043397)Becton, Dickinson & CO2004-12-29
NEEDLE INCAPACITATOR (NEEDLE GUARD) (K042907)Pdmp, Inc.2004-12-22
VASCULAR SOLUTIONS SCLERO-KIT (K043019)Vascular Solutions, Inc.2004-12-01
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE (K041941)Safe T Medical Devices, Ltd.2004-09-13
HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE (K041399)Smiths Medical Asd, Inc.2004-07-28
SHARPSAWAY II LOCKING DISPOSABLE CUP (K041153)Arrow Intl., Inc.2004-07-12
TERUMO SURGUARD2 SAFETY NEEDLE (K040531)Terumo Medical Corp.2004-03-23
VIDAPORT INTRAOSSEOUS INFUSION SYSTEM (K032885)Vidacare Corporation2004-03-10
ONE.CLICK NEEDLE (K033575)B.Braun Medical, Inc.2004-02-09
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