Panels › General Hospital › Product code FMI · Class 2
Needle, Hypodermic, Single Lumen
Regulation 880.5570
13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
Top companies in FMI
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2016 | K152334 | Sungshim Insulin Pen Needle Sung Shim Medicare Co., Ltd., KR | FMI |
| Mar 7, 2016 | K152824 | MEDT PEN NEEDLE Shandong Caremed Medical Products Co., Ltd., CN | FMI |
| Mar 2, 2016 | K152050 | Pencylcap B.Braun Melsungen AG, DE | FMI |
| Feb 10, 2016 | K151311 | Safe Block Pen Needle Artsana S.P.A, IT | FMI |
| Feb 2, 2016 | K152410 | Top Fine Pen Needle Medexel Co.,Ltd, KR | FMI |
| Nov 18, 2015 | K152514 | Clickfine AutoProtect Pen Needle Ypsomed AG, CH | FMI |
| Nov 2, 2015 | K152183 | EXELINT SecureTouch Safety Hypodermic Needle Exelint International, Co. | FMI |
| Oct 16, 2015 | K152362 | Terumo SurGuard 3 Safety Hypodermic Needle Terumo (Philippines) Corporation, PH | FMI |
| Oct 14, 2015 | K151571 | Mini Needle Ocujet, LLC | FMI |
| Aug 20, 2015 | K151341 | Turbo High-Flow Non-coring Needle Norfolk Medical | FMI |
| Aug 11, 2015 | K142765 | TM SAFETY NEEDLE Thinkmed Medical Technology Co., Ltd., CN | FMI |
| Jun 25, 2015 | K151398 | K-Pack II Needle - 29G x 5/16 Thin Wall Terumo Europe N.V., BE | FMI |
| Jun 25, 2015 | K143437 | Droplet Pen Needles Htl-Strefa S.A, PL | FMI |
| Jun 9, 2015 | K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) Ypsomed AG, CH | FMI |
| Apr 1, 2015 | K150263 | K-Pack II Needle-21G x 2 Terumo Europe N.V., BE | FMI |
| Aug 28, 2014 | K142086 | NIO -INTRAOSSEOUS DEVICE Waismed, Ltd. | FMI |
| Aug 5, 2014 | K140516 | Terumo Pen Injector Needle 34 Kofu Factory of Terumo Corp. | FMI |
| Jul 29, 2014 | K141749 | CAREFINE PEN NEEDLE FAMILY INCLUDING QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC | FMI |
| Jul 22, 2014 | K130097 | MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS American Medical Manufacturing, Inc./ Advanced Med | FMI |
| Jul 8, 2014 | K141117 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare, LLC | FMI |
| Jun 17, 2014 | K133635 | EASYPOINT NEEDLE Retractable Technologies, Inc. | FMI |
| Jun 3, 2014 | K132557 | EWNL SAFETY SYRINGE WITH NEEDLE Jiamei-Un Co., Ltd., TW | FMI |
| May 29, 2014 | K131954 | MEDI PEN NEEDLE Shanghai Carelife International Trading Co. , Ltd., CN | FMI |
| May 21, 2014 | K133738 | NOVOFINE PLUS 32G 4 MM Novo Nordisk, Inc. | FMI |
| May 13, 2014 | K140568 | CAREFINE PEN NEEDLE WITH QUINTAPOINT AND SUPERPOINT Facet Technologies, LLC | FMI |
| Feb 25, 2014 | K133059 | INSULIN PEN NEEDLE Wenzhou Beipu Science & Technology Co., Ltd., CN | FMI |
| Feb 25, 2014 | K133058 | INSULIN PEN NEEDLE Wenzhou Wuzhou Import & Export Co., Ltd., CN | FMI |
| Feb 11, 2014 | K132583 | EZ-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
| Jan 23, 2014 | K133100 | CAREFINE PEN NEEDLE Facet Technologies | FMI |
| Nov 20, 2013 | K130212 | SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE Wuxi Yushou Medical Applicances Co., Ltd., CN | FMI |
| Nov 13, 2013 | K132552 | U&U STERILE HYPODERMIC NEEDLE U&U Medical Technology Co, Ltd., CN | FMI |
| Sep 6, 2013 | K132233 | K-PACK II NEEDLE - 27G X 3/4 THIN WALL Terumo Europe N.V., BE | FMI |
| Aug 20, 2013 | K131842 | STERICAN CANNULA B.Braun Medical, Inc. | FMI |
| Jul 16, 2013 | K131358 | BD PEN NEEDLE Becton, Dickinson & CO | FMI |
| Jul 15, 2013 | K131040 | EXTAVIPRO STERICAN 30G B.Braun Melsungen AG, DE | FMI |
| Jul 5, 2013 | K131125 | CLICKFINE PEN NEEDLE Ypsomed AG, CH | FMI |
| Jul 5, 2013 | K131123 | CLICKFINE AUTOPROTECT PEN NEEDLE Ypsomed AG, CH | FMI |
| Jun 25, 2013 | K130487 | FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE Pyng Medical Corp., CA | FMI |
| May 8, 2013 | K123684 | SOL-CARE SAFETY NEEDLE Sol-Millennium Medical | FMI |
| Jan 18, 2013 | K123300 | BD PEN NEEDLE Becton, Dickinson & CO | FMI |
| Nov 8, 2012 | K121607 | TERUMO(R) NEEDLE Terumo (Philippines) Corporation | FMI |
| Oct 25, 2012 | K122971 | CLICKFINE PEN NEEDLE P/L Biomedical | FMI |
| Oct 25, 2012 | K122969 | CLICKFINE PEN NEEDLE P/L Biomedical | FMI |
| Oct 18, 2012 | K120420 | STERILE BLUNT FOR SINGLE USE Shanghai Double Dove Industrial Co., Ltd., CN | FMI |
| Oct 18, 2012 | K113469 | NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE Nipro Medical Corporation | FMI |
| Aug 28, 2012 | K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE Terumo (Philippines) Corporation | FMI |
| Aug 10, 2012 | K121632 | COMFORT EZ Simple Diagnostics, Inc. | FMI |
| Jul 25, 2012 | K121908 | SAFETY INFUSION SET Greiner Bio-One North America, Inc. | FMI |
| Jun 22, 2012 | K120690 | INSULIN PEN NEEDLE Tiger Medical Products, Ltd., CN | FMI |
| Jun 3, 2012 | K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE Vidacare Corporation | FMI |
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