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 23, 2004 | K040531 | TERUMO SURGUARD2 SAFETY NEEDLE Terumo Medical Corp. | FMI |
| Mar 10, 2004 | K032885 | VIDAPORT INTRAOSSEOUS INFUSION SYSTEM Vidacare Corporation | FMI |
| Feb 9, 2004 | K033575 | ONE.CLICK NEEDLE B.Braun Medical, Inc. | FMI |
| Jan 28, 2004 | K032141 | SECUMAX BLOOD COLLECTION SYSTEM Tiger Meditech Incorporated | FMI |
| Jan 21, 2004 | K033409 | AMERSHAM HEALTH NEEDLE-GUARD Gettig Pharmaceutical Instrument Co. | FMI |
| Dec 29, 2003 | K033478 | VACUETTE QUICKSHIELD SAFETY TUBE HOLDER Greiner Bio-One Vacuette North America | FMI |
| Nov 13, 2003 | K033373 | MONOJECT INSULIN SYRINGE Tyco Healthcare | FMI |
| Jul 8, 2003 | K031453 | TERUMO SURGUARD 2 SAFETY NEEDLE Terumo Medical Corp. | FMI |
| Jun 24, 2003 | K031200 | MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE Becton, Dickinson & CO | FMI |
| Jun 13, 2003 | K031058 | CORD STICK MULTIPLE DRAW SYSTEM Cord Stick Corp. | FMI |
| Mar 21, 2003 | K030032 | CROSSEAL APPLICATION DEVICE Omrix Biopharmaceuticals, Inc. | FMI |
| Dec 30, 2002 | K024109 | BD ULTRA-FINE III PEN NEEDLE Becton, Dickinson & CO | FMI |
| Nov 22, 2002 | K022057 | KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX Kyung GI Medical Ind. Co., Ltd., KR | FMI |
| Oct 11, 2002 | K022415 | BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST Waismed, Ltd., IL | FMI |
| Sep 30, 2002 | K022406 | EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET Exelint Intl. Co. | FMI |
| Aug 21, 2002 | K021315 | SURE-LOK Vital Signs, Inc. | FMI |
| Jul 19, 2002 | K021475 | BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET Bd | FMI |
| Jul 11, 2002 | K020921 | NO-POKES NEEDLE SAFETY DEVICE Bemis Mfg. Co. | FMI |
| Jan 23, 2002 | K011757 | EXEL COMFORTPOINT INSULIN PEN NEEDLE Exelint Intl. Co. | FMI |
| Dec 14, 2001 | K013293 | NIPRO HYPODERMIC NEEDLE Nipro Medical Corp. | FMI |
| Nov 20, 2001 | K013782 | DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE Disetronic Medical Systems | FMI |
| Oct 25, 2001 | K012736 | MONOJECT SAFETY NEEDLE Tyco Healthcare | FMI |
| Oct 1, 2001 | K012283 | SOLOGARD LOCKING PLUS SYRINGE WITH NEEDLE Safegard Medical Products, Inc. | FMI |
| Sep 5, 2001 | K002394 | JMS APHERESIS NEEDLE SET ACCORDION TYPE Jms Co., Ltd., JP | FMI |
| Aug 29, 2001 | K011984 | BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET Becton, Dickinson & CO | FMI |
| Aug 27, 2001 | K012646 | TERUMO 30 GAUGE HYPODERMIC NEEDLE Terumo Medical Corp. | FMI |
| Aug 22, 2001 | K001853 | SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 Medtech Systems, Inc. | FMI |
| Jul 12, 2001 | K011925 | HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIO Sims Portex, Inc. | FMI |
| Jul 12, 2001 | K011786 | VACUETTE SAFETY BLOOD COLLECTION SET Greiner Vacuette North America, Inc. | FMI |
| Jun 8, 2001 | K010887 | INSULIN PEN NEEDLE ADAPTER Ohana Needle Co. | FMI |
| May 24, 2001 | K011004 | NEEDLELOK HYPODERMIC NEEDLE PROTECTION Diasol, Inc. | FMI |
| May 18, 2001 | K010958 | FISTULOK FISTULA NEEDLE PROTECTION Diasol, Inc. | FMI |
| Apr 30, 2001 | K003812 | VACUETTE SPEEDY QUICK-RELEASE HOLDER Greiner Vacuette North America, Inc. | FMI |
| Apr 23, 2001 | K003381 | SHIELDING NEEDLE HOLDER U.S. Safety Syringes Co., Inc. | FMI |
| Apr 19, 2001 | K003521 | DISPO-MED 7.6 LITER SHARPS CONTAINER Master Benefits, Inc. | FMI |
| Mar 30, 2001 | K003382 | SARSTEDT NEEDLE PROTECTOR Sarstedt, Inc. | FMI |
| Mar 1, 2001 | K010188 | BD ECLIPSE HYPODERMIC NEEDLE Bd Medical Systems | FMI |
| Feb 8, 2001 | K003627 | EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET Exelint International, Co. | FMI |
| Feb 2, 2001 | K001965 | SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS North American Medical Products, Inc. | FMI |
| Feb 1, 2001 | K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Jan 24, 2001 | K010038 | NEEDLE BARN STICK STOPPER WITH SAFETY CAP, IN KIT WITH STERILE FIELD DRAPE Cambridge Marketing, Inc. | FMI |
| Jan 12, 2001 | K003406 | GUARDED NEEDLE 2000 International Medical Device Partners, Inc. | FMI |
| Jan 8, 2001 | K003827 | PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION Bio-Plexus, Inc. | FMI |
| Dec 21, 2000 | K000714 | VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET Med-Pro Technologies, Inc. | FMI |
| Dec 8, 2000 | K002403 | NOVOFINE 31 DISPOSABLE NEEDLE Novo Norodisk Pharmaceuticals, Inc. | FMI |
| Nov 29, 2000 | K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Oct 13, 2000 | K002180 | SIMPLICITY DISPOSABLE PEN NEEDLE Sterling Medivations, Inc. | FMI |
| Oct 3, 2000 | K002213 | BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID Hunter Research Laboratories, Inc. | FMI |
| Sep 18, 2000 | K001175 | SERAGARD VASCULAR ACCESS PATCH Platinum Services, Inc. | FMI |
| Aug 14, 2000 | K001572 | NEOLUS NEEDLE Terumo Europe N.V., BE | FMI |
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