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FMI

691 FDA 510(k) clearances · Product code

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RecordFirmDate
Adult Intraosseous Infusion Device (K182770)Einstein Works, LLC2019-04-09
Safety insulin needle for single use (K181447)Berpu Medical Technology Co., Ltd.2019-03-12
BD Vacutainer Eclipse UltraFill Blood Collection Needle (K181730)Becton, Dickinson and Company2019-03-01
U&U Blood Collection Sets (K181508)U&U Medical Technology Co, Ltd.2019-02-13
BD Contoured Base Pen Needle (K182320)Becton, Dickinson and Company2018-12-20
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set (K182146)Sol-Millennium Medical, Inc.2018-12-03
Immucise Intradermal Injection System (K181369)Terumo Corporation2018-11-13
EZ-IO Intraosseous Vascular Access System (K180395)Arrow International, Inc. (Subsidiary of Teleflex, Inc.)2018-11-09
Disposable Insulin Pen Needle (K181069)Zhejiang Kindly Medical Devices Co., Ltd.2018-08-28
BD Vacutainer Eclipse Signal Blood Collection Needle (K170824)Becton, Dickinson and Company2018-08-20
EasyTouch Safety Pen Needle (K163578)Mhc Medical Products, LLC2018-08-03
Autokeeper (K172095)Medexel Co.,Ltd2018-07-24
Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (K173881)Owen Mumford, Ltd.2018-07-11
Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel (K180720)Medibio USA, LLC2018-06-27
Kopac Sterile Needle (K172483)Poonglim Pharmatech, Inc.2018-06-21
Disposable Sterile Needle (K172938)Jiangsu Caina Medical Co.,Ltd2018-06-14
Omnican fine (K173803)B.Braun Medical, Inc.2018-06-11
VACUETTE SAFELINK Holder with male luer lock (K180545)Greiner Bio-One Na, Inc.2018-05-21
Sterile Hypodermic Needle for Single Use (K180259)Jiangsu Shenli Medical Production Co., Ltd.2018-05-18
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder (K173279)Myco Medical Supplies, Inc.2018-05-14
VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set (K173757)Greiner Bio-One Na, Inc.2018-04-19
FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device (K180588)Teleflex Medical2018-04-17
DROPLET PEN NEEDLE (K171982)Htl-Strefa S.A2018-03-21
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) (K173479)Novo Nordisk, Inc.2018-01-17
DropSafe Safety Pen Needle (K170988)Htl-Strefa S.A2017-12-12
Safety Blood Collection Device for Single Use (K170276)Gemtier Medical (Shanghai), Inc.2017-12-11
Clickfine Pen Needle, Penfine Classic Pen Needle (K171984)Ypsomed AG2017-10-11
Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel (K171144)Medbio, LLC2017-09-12
Mini Needle (K170768)Ocuject, LLC2017-07-10
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (K161950)Promisemed Hangzhou Meditech Co., Ltd.2017-05-11
Safety Blood Collection Set (K163093)Jiangsu Shenli Medical Production Co., Ltd.2017-03-14
meso-relle (AAL34, AAL36, AM30G) (K161255)Biotekne Srl2017-01-19
BD Pen Needle (K162516)Becton, Dickinson and Company2016-12-09
Greiner Holdex (K160532)Greiner Bio-One Na, Inc.2016-11-03
Advocate Insulin Pen Needles (K160199)Diabetic Supply of Suncoast, Inc.2016-10-19
CPL Insulin Pen Needle (K151090)Cpl Co., Ltd.2016-09-21
CareSens Pen Needle, Softip Pen Needle (K160575)Yidobio, Inc.2016-09-07
Insulin Pen Needle (K153706)SteriLance Medical (Suzhou), Inc.2016-08-29
Cook Intraosseous Infusion Needles (K160887)Cook Incorporated2016-07-26
JSM Insulin Pen Needle (K152166)Jeesung Medical Co., Ltd.2016-07-11
BD SafeAssist (K161553)Becton, Dickinson and Company2016-07-06
Unifine Pentips/ Unifine Pentips Plus (K152339)Owen Mumford, Ltd.2016-06-24
NIO-P (K160805)Waismed, Ltd.2016-06-23
ProteXsure Safety Capsule System (K152597)Starcap Medical, LLC ( Dba Prism Medical & Design)2016-06-08
SureFine Pen Needle (K152877)Shina Med Corporation2016-06-07
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), IMPROVACUTER Multi Sample Needle (K153388)Guangzhou Improve Medical Instruments Co., Ltd.2016-06-07
BD Eclipse Hypodermic Needle (K161170)Becton, Dickinson and Company2016-05-27
Sungshim Insulin Pen Needle (K152334)Sung Shim Medicare Co., Ltd.2016-03-17
MEDT PEN NEEDLE (K152824)Shandong Caremed Medical Products Co., Ltd.2016-03-07
Pencylcap (K152050)B.Braun Melsungen AG2016-03-02
Safe Block Pen Needle (K151311)Artsana S.P.A2016-02-10
Top Fine Pen Needle (K152410)Medexel Co.,Ltd2016-02-02
Clickfine AutoProtect Pen Needle (K152514)Ypsomed AG2015-11-18
EXELINT SecureTouch Safety Hypodermic Needle (K152183)Exelint International, Co.2015-11-02
Terumo SurGuard 3 Safety Hypodermic Needle (K152362)Terumo (Philippines) Corporation2015-10-16
Mini Needle (K151571)Ocujet, LLC2015-10-14
Turbo High-Flow Non-coring Needle (K151341)Norfolk Medical2015-08-20
TM SAFETY NEEDLE (K142765)Thinkmed Medical Technology Co., Ltd.2015-08-11
Droplet Pen Needles (K143437)Htl-Strefa S.A2015-06-25
K-Pack II Needle - 29G x 5/16 Thin Wall (K151398)Terumo Europe N.V.2015-06-25
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) (K150662)Ypsomed AG2015-06-09
K-Pack II Needle-21G x 2 (K150263)Terumo Europe N.V.2015-04-01
NIO -INTRAOSSEOUS DEVICE (K142086)Waismed, Ltd.2014-08-28
Terumo Pen Injector Needle 34 (K140516)Kofu Factory of Terumo Corp.2014-08-05
CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT (K141749)Facet Technologies, LLC2014-07-29
MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS (K130097)American Medical Manufacturing, Inc./ Advanced Med2014-07-22
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K141117)Vidacare, LLC2014-07-08
EASYPOINT NEEDLE (K133635)Retractable Technologies, Inc.2014-06-17
EWNL SAFETY SYRINGE WITH NEEDLE (K132557)Jiamei-Un Co., Ltd.2014-06-03
MEDI PEN NEEDLE (K131954)Shanghai Carelife International Trading Co. , Ltd.2014-05-29
NOVOFINE PLUS 32G 4 MM (K133738)Novo Nordisk, Inc.2014-05-21
CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT (K140568)Facet Technologies, LLC2014-05-13
INSULIN PEN NEEDLE (K133058)Wenzhou Wuzhou Import & Export Co., Ltd.2014-02-25
INSULIN PEN NEEDLE (K133059)Wenzhou Beipu Science & Technology Co., Ltd.2014-02-25
EZ-IO INTRAOSSEOUS INFUSION SYSTEM (K132583)Vidacare Corporation2014-02-11
CAREFINE PEN NEEDLE (K133100)Facet Technologies2014-01-23
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE (K130212)Wuxi Yushou Medical Applicances Co., Ltd.2013-11-20
U&U STERILE HYPODERMIC NEEDLE (K132552)U&U Medical Technology Co, Ltd.2013-11-13
K-PACK II NEEDLE - 27G X 3/4 THIN WALL (K132233)Terumo Europe N.V.2013-09-06
STERICAN CANNULA (K131842)B.Braun Medical, Inc.2013-08-20
BD PEN NEEDLE (K131358)Becton, Dickinson & CO2013-07-16
EXTAVIPRO STERICAN 30G (K131040)B.Braun Melsungen AG2013-07-15
CLICKFINE PEN NEEDLE (K131125)Ypsomed AG2013-07-05
CLICKFINE AUTOPROTECT PEN NEEDLE (K131123)Ypsomed AG2013-07-05
FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE (K130487)Pyng Medical Corp.2013-06-25
SOL-CARE SAFETY NEEDLE (K123684)Sol-Millennium Medical2013-05-08
BD PEN NEEDLE (K123300)Becton, Dickinson & CO2013-01-18
TERUMO(R) NEEDLE (K121607)Terumo (Philippines) Corporation2012-11-08
CLICKFINE PEN NEEDLE (K122969)P/L Biomedical2012-10-25
CLICKFINE PEN NEEDLE (K122971)P/L Biomedical2012-10-25
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE (K113469)Nipro Medical Corporation2012-10-18
STERILE BLUNT FOR SINGLE USE (K120420)Shanghai Double Dove Industrial Co., Ltd.2012-10-18
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE (K122249)Terumo (Philippines) Corporation2012-08-28
COMFORT EZ (K121632)Simple Diagnostics, Inc.2012-08-10
SAFETY INFUSION SET (K121908)Greiner Bio-One North America, Inc.2012-07-25
INSULIN PEN NEEDLE (K120690)Tiger Medical Products, Ltd.2012-06-22
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE (K120661)Vidacare Corporation2012-06-03
PUSH-ON NEEDLE 30GX8MM (K120191)Scandinavian Health Limited2012-05-23
STERILE INSULIN PEN NEEDLE (K113186)Shina Corp.2012-04-12
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE (K113422)Terumo (Philippines) Corporation2012-03-05
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