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 |
|---|---|---|---|
| May 23, 2012 | K120191 | PUSH-ON NEEDLE 30GX8MM Scandinavian Health Limited, TW | FMI |
| Apr 12, 2012 | K113186 | STERILE INSULIN PEN NEEDLE Shina Corp., KR | FMI |
| Mar 5, 2012 | K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE Terumo (Philippines) Corporation, PH | FMI |
| Feb 24, 2012 | K112777 | SOL-M EXCHANGEABLE NEEDLES Sol-Milennium Medical, Inc. | FMI |
| Feb 17, 2012 | K113505 | VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER Greiner Bio-One North America, Inc. | FMI |
| Jan 26, 2012 | K110312 | CLICKFINE AUTOPROTECT PEN NEEDLE Ypsomed AG, CH | FMI |
| Jan 10, 2012 | K112332 | FINE JECT INSULIN PEN NEEDLE Twobiens Co., Ltd. | FMI |
| Dec 23, 2011 | K112789 | EASY TOUCH Mhc Medical Products, LLC | FMI |
| Sep 29, 2011 | K110606 | MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE M.V.S.R.L., IT | FMI |
| Sep 22, 2011 | K111797 | 27 G X 1/2 K-PACK SURSHIELD NEEDLE Terumo Europe N.V., BE | FMI |
| Aug 18, 2011 | K110656 | IMC BLOOD COLLECTION NEEDLE International Medsurg Connection | FMI |
| Jul 29, 2011 | K111424 | VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH Medpro Safety Products, Inc. | FMI |
| Jul 27, 2011 | K110703 | BD AUTOSHIELD DUO PEN NEEDLE Becton, Dickinson and Company | FMI |
| Jun 9, 2011 | K110850 | K-PACK II NEEDLE- 27G & 30G THIN WALL Terumo Europe N.V., BE | FMI |
| Jun 6, 2011 | K110527 | K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE Terumo Europe N.V., BE | FMI |
| May 13, 2011 | K102328 | BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA Shandong Weigao Group Medical Polymer Co., Ltd., CN | FMI |
| Apr 28, 2011 | K110105 | BD PEN NEEDLE Becton, Dickinson and Company (BD) | FMI |
| Apr 6, 2011 | K103587 | DISPOSABLE BLLOD COLLECTION NEEDLE Weihai Hongyu Medical Devices Co., Ltd., CN | FMI |
| Jan 14, 2011 | K102584 | IMC HYPODERMIC NEEDLE International Medsurg Connection | FMI |
| Nov 23, 2010 | K102108 | CLICKFINE PEN NEEDLE Ypsomed AG, CH | FMI |
| Nov 19, 2010 | K102010 | VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET Medpro Safety Products, Inc. | FMI |
| Nov 3, 2010 | K102994 | K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FMI |
| Oct 15, 2010 | K102774 | VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER Greiner Bio-One North America, Inc. | FMI |
| Aug 31, 2010 | K100124 | FASTX STERNAL INTRAOSSEOUS DEVICE Pyng Medical Corp., CA | FMI |
| Aug 20, 2010 | K093043 | ZIRCONIA SYRINGE NEEDLE Kuo Tai Hospital Managements & Consultant Co., Ltd., TW | FMI |
| Jul 27, 2010 | K101026 | POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO Vidacare Corporation | FMI |
| Jun 18, 2010 | K093109 | NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') Novo Nordisk, Inc. | FMI |
| Jun 3, 2010 | K100812 | ULTICARE DISPOSABLE PEN NEEDLES Ultimed, Inc. | FMI |
| Apr 30, 2010 | K100436 | CLICKFINE PEN NEEDLE Ypsomed AG, CH | FMI |
| Apr 15, 2010 | K100005 | BD PEN NEEDLE Becton, Dickinson and Co. | FMI |
| Feb 19, 2010 | K100209 | BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY Becton, Dickinson & CO | FMI |
| Feb 3, 2010 | K092746 | MICRONJET 600 Nanopass Technologies , Ltd. | FMI |
| Feb 1, 2010 | K090111 | FLEXPEN NEEDLE Novo Nordisk, Inc. | FMI |
| Jan 14, 2010 | K092831 | DISPOSABLE HYPODERMIC NEEDLE Feel Tech | FMI |
| Oct 14, 2009 | K091140 | EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO Vidacare Corporation | FMI |
| Oct 2, 2009 | K092016 | SUPER-FINE PEN NEEDLE Stat Medical Devices, Inc. | FMI |
| Sep 29, 2009 | K090117 | AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET Autosafe-Reflex, Inc. | FMI |
| Sep 1, 2009 | K090156 | ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 Wcm Waste & Compliance Management, Inc. | FMI |
| Jun 12, 2009 | K090426 | VAKU-8 BLOOD COLLECTION NEEDLES Myco Medical Supplies, Inc. | FMI |
| Apr 24, 2009 | K082908 | NOVAGUARD, MODEL 3611001 West Pharmaceutical Services, Inc. | FMI |
| Jan 16, 2009 | K082511 | MEDIGARD BLOOD COLLECTION DEVICE Medigard Limited | FMI |
| Oct 23, 2008 | K082820 | K-PACK II NEEDLE - 29G THIN WALL Terumo Europe N.V., BE | FMI |
| Jun 18, 2008 | K072602 | VACUETTE PREMIUM SAFETY NEEDLE SYSTEM Medpro Safety Products, Inc. | FMI |
| Jun 4, 2008 | K080904 | FEEL-FINE INSULIN PEN NEEDLE Feel Tech | FMI |
| Apr 24, 2008 | K080865 | FAST1 INTRAOSSEOUS INFUSION SYSTEM Pyng Medical Corp., CA | FMI |
| Apr 24, 2008 | K080235 | SAFETY INFUSION SET Greiner Bio-One Vacuette North America | FMI |
| Mar 24, 2008 | K073705 | MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE Shandong Qiaopai Group Co., Ltd., CN | FMI |
| Feb 13, 2008 | K072487 | FAST1 INTRAOSSEOUS INFUSION SYSTEM Pyng Medical Corp., CA | FMI |
| Feb 12, 2008 | K071307 | INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 Inviro Medical Devices, Inc. | FMI |
| Feb 8, 2008 | K073188 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE Smiths Medical Asd, Inc. | FMI |
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