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 |
|---|---|---|---|
| Jan 25, 2008 | K073257 | KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROTECTOR Kawasumi Laboratories, Inc. | FMI |
| Dec 20, 2007 | K073127 | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G Shandong Weigao Group Medical Polymer Co., Ltd., CN | FMI |
| Nov 21, 2007 | K073122 | MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE Covidien Lp, Formerly Registered AS Tyco Healthcar | FMI |
| Nov 8, 2007 | K072247 | STERICAN HYPODERMIC NEEDLES B.Braun Medical, Inc. | FMI |
| Nov 1, 2007 | K072059 | GRIPPER MICRO NEEDLE Smiths Medical MD, Inc. | FMI |
| Oct 12, 2007 | K071947 | VACU-MED BLOOD COLLECTION NEEDLES Shina Corp. | FMI |
| Sep 26, 2007 | K071998 | ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT Arrow Intl., Inc. | FMI |
| Sep 14, 2007 | K072320 | GREINER VACUETTE QUICKSHIELD COMPLETE Greiner Bio-One North America, Inc. | FMI |
| Sep 14, 2007 | K071567 | AUTOSAFE-REFLEX SAFETY NEEDLE, AUTOSAFE ADVANTAGE SAFETY NEEDLE Autosafe-Refelx, Inc. | FMI |
| Aug 23, 2007 | K070988 | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) Shinchang Medical Co., Ltd. | FMI |
| Aug 2, 2007 | K071785 | HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE Smiths Medical Asd, Inc. | FMI |
| Jul 5, 2007 | K071088 | LIFE LATCH SHARPS & BIOHAZARD CONTAINER M&M Industries, Inc. | FMI |
| Mar 16, 2007 | K070440 | BD HYPOINT NEEDLE Becton, Dickinson & CO | FMI |
| Mar 2, 2007 | K063466 | TOP FINE Daejin Tech Medical Manufacturing Co., Ltd. | FMI |
| Jan 26, 2007 | K063567 | EZ-MIO STERNAL Vidacare Corporation | FMI |
| Jan 25, 2007 | K063450 | PORTEX HYPODERMIC NEEDLE- PRO EDGE SAFETY DEVICE, 18GX1, 401810, 19GX1, 401910, 20GX1,402010, 21GX1402110 Smiths Medical Asd, Inc. | FMI |
| Dec 22, 2006 | K062940 | BONE INJECTION GUN (B.I.G.) Waismed, Ltd. | FMI |
| Dec 8, 2006 | K063142 | MANUAL PD-IO; POWERED PD-IO Vidacare Corporation | FMI |
| Dec 5, 2006 | K062956 | EZ-MIO, EZ-IO DISTAL TIBIA Vidacare Corporation | FMI |
| Nov 21, 2006 | K062500 | FLEXPEN NEEDLE Novo Nordisk, Inc. | FMI |
| Nov 16, 2006 | K061933 | HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER Hager Worldwide, Inc. | FMI |
| Nov 13, 2006 | K062984 | MEDLINE HYPODERMIC NEEDLES Medline Industries, Inc. | FMI |
| Nov 7, 2006 | K062422 | HUMERAL HEAD, MANUAL DRIVER Vidacare Corporation | FMI |
| Sep 15, 2006 | K062608 | 29G AND 30G K-PACK II NEEDLE Terumo Europe N.V., BE | FMI |
| Aug 14, 2006 | K061483 | VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES Greiner Bio-One North America, Inc. | FMI |
| Jun 21, 2006 | K061032 | DEPOTONE Imprint Pharmaceuticals Limited, GB | FMI |
| Apr 17, 2006 | K052843 | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE Busse Hospital Disposables, Inc. | FMI |
| Mar 23, 2006 | K060007 | BD AUTOSHIELD PEN NEEDLE Becton, Dickinson & CO | FMI |
| Dec 28, 2005 | K052725 | PROTECTOR NEEDLE SHEATH PROP Certol International, LLC | FMI |
| Dec 21, 2005 | K053470 | NOVOFINE 32G TIP Novo Nordisk, Inc. | FMI |
| Dec 5, 2005 | K052445 | DUOPROSS NEEDLE Duopross Meditech Corporation | FMI |
| Nov 23, 2005 | K052561 | TERUMO MICRO TAPERED PEN NEEDLE Kofu Factory of Terumo Corp., JP | FMI |
| Nov 17, 2005 | K052408 | EZ-IO Vidacare Corporation | FMI |
| Nov 10, 2005 | K052474 | NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. | FMI |
| Nov 2, 2005 | K052195 | EZ-MIO MANUAL DRIVER Vidacare Corporation | FMI |
| Oct 20, 2005 | K051992 | POWERED PD-IO INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
| Oct 4, 2005 | K051783 | ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES Artsana S.P.A | FMI |
| Sep 13, 2005 | K051899 | BD PEN NEEDLE Becton, Dickinson & CO | FMI |
| May 25, 2005 | K043249 | ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE Atrion Medical Products, Inc. | FMI |
| May 11, 2005 | K050464 | ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2 Ultimed, Inc. | FMI |
| Apr 22, 2005 | K042917 | STAT MEDICAL PEN NEEDLE Emergogroup, Inc. | FMI |
| Apr 5, 2005 | K050505 | DEPOTONE Imprint Pharmaceuticals Limited, GB | FMI |
| Mar 30, 2005 | K050106 | NOVOFINE AUTOCOVER 30G X 8MM Novo Nordisk, Inc. | FMI |
| Feb 18, 2005 | K043490 | PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Vidacare Corporation | FMI |
| Dec 29, 2004 | K043397 | MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE Becton, Dickinson & CO | FMI |
| Dec 22, 2004 | K042907 | NEEDLE INCAPACITATOR (NEEDLE GUARD) Pdmp, Inc. | FMI |
| Dec 1, 2004 | K043019 | VASCULAR SOLUTIONS SCLERO-KIT Vascular Solutions, Inc. | FMI |
| Sep 13, 2004 | K041941 | SAFE T RETRACTABLE BLOOD COLLECTION DEVICE Safe T Medical Devices, Ltd. | FMI |
| Jul 28, 2004 | K041399 | HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE Smiths Medical Asd, Inc. | FMI |
| Jul 12, 2004 | K041153 | SHARPSAWAY II LOCKING DISPOSABLE CUP Arrow Intl., Inc. | FMI |
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