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 |
|---|---|---|---|
| Aug 5, 1994 | K935407 | STICKIT E.M. Innovations, Inc. | FMI |
| Jun 24, 1994 | K933601 | FLIPTIP SAFETY NEEDLE Syntuition, Inc. | FMI |
| Jun 15, 1994 | K942323 | ONGARD 2 GALLON SHARPS CONTAINER Ongard Systems, Inc. | FMI |
| Jun 3, 1994 | K935843 | BE-SAFE Mathis-Koolpe, Inc. | FMI |
| May 16, 1994 | K933674 | ONGARD 2 GALLON CHEMO SHARPS CONTAINER Ongard Systems, Inc. | FMI |
| May 16, 1994 | K933274 | ONGARD 3 QUART SHARPS CONTAINER Ongard Systems, Inc. | FMI |
| May 9, 1994 | K925086 | AUTOMATIC NEEDLE DISCONECT (A.N.D.) Post Medical, Inc. | FMI |
| Apr 29, 1994 | K925816 | SHARPS CONTAINMENT SYSTEM Post Medical, Inc. | FMI |
| Mar 28, 1994 | K936235 | NEEDLESAFE II & NEEDLEGARD II Ingenious Technologies Corp. | FMI |
| Mar 10, 1994 | K936261 | CATHETER INSERTION TRAY Medcare Custom Packaging, Inc. | FMI |
| Feb 28, 1994 | K935777 | SHARPSAFE, CAT. NO. 4125 Smiths Industries Medical Systems, Inc. | FMI |
| Feb 28, 1994 | K935776 | SHARPSAFE, CAT. NO. 4126 Smiths Industries Medical Systems, Inc. | FMI |
| Feb 28, 1994 | K930217 | BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE Baxter Healthcare Corp | FMI |
| Feb 16, 1994 | K934591 | CLAVE VIAL ACCESS SPIKE Icu Medical, Inc. | FMI |
| Feb 14, 1994 | K933751 | LIFESHIELD BLOOD COLLECTION DEVICE Sherwood Medical Co. | FMI |
| Feb 10, 1994 | K935514 | VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER Kawasumi Laboratories Co., Ltd., JP | FMI |
| Feb 4, 1994 | K936029 | NON-CORNING (HUBER) NEEDLE Therex Corp. | FMI |
| Feb 4, 1994 | K935628 | SHARPSAFE CAT. NO. 4127 Smiths Industries Medical Systems, Inc. | FMI |
| Feb 4, 1994 | K934404 | MONOJECT VERTICAL ENTRY SHARPS CONTAINER Sherwood Medical Co. | FMI |
| Feb 3, 1994 | K935506 | MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION Kawasumi Laboratories Co., Ltd., JP | FMI |
| Feb 3, 1994 | K935505 | WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER Kawasumi Laboratories Co., Ltd., JP | FMI |
| Feb 3, 1994 | K934088 | AUTO SUTURE SHARPS CONTAINER United States Surgical, A Division of Tyco Healthc | FMI |
| Jan 28, 1994 | K935480 | MEDICAL SPECIALTIES NON-CORING NEEDLE ADMIN SETS Evans Medical, Inc. | FMI |
| Nov 19, 1993 | K925234 | BEDSIDE CADDY Researched, Novel Medical Devices (Rn/Md) | FMI |
| Oct 19, 1993 | K924793 | HAN-D-AID Salmon Ent. | FMI |
| Oct 18, 1993 | K931019 | BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Oct 5, 1993 | K924820 | HYPOGRIP(TM) Collett Products | FMI |
| Jul 29, 1993 | K925446 | BARD SAFE SAMPLING DEVICE C.R. Bard, Inc. | FMI |
| Jul 2, 1993 | K922179 | CATHETER INSERTION TRAY Medcare Custom Packaging, Inc. | FMI |
| Jun 7, 1993 | K921950 | SURGICAL DYNAMICS DISCOGRAPHY SYSTEM Surgical Dynamics, Inc. | FMI |
| Apr 29, 1993 | K923127 | NEEDLE-PRO CARTRIDGE Concord/Portex | FMI |
| Mar 18, 1993 | K924070 | B-D PEN NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Feb 12, 1993 | K924439 | BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Dec 15, 1992 | K920737 | LIFESHIELD VIAL ADAPTER Abbott Laboratories | FMI |
| Jul 21, 1992 | K922158 | PROTECTOR SYRINGE SAFETY CAP SYSTEM Injectimed, Inc. | FMI |
| Apr 22, 1992 | K920717 | NEEDLEGARD II Ingenious Technologies Corp. | FMI |
| Mar 4, 1992 | K915409 | INTRAOSSEOUS ACCESS NEEDLE Cook, Inc. | FMI |
| Mar 4, 1992 | K913258 | DISPOSABLE INTROSSEOUS INFUSION NEEDLES Cook, Inc. | FMI |
| Jan 10, 1992 | K913386 | CHEMO-PORT Hdc Corp. | FMI |
| Dec 13, 1991 | K913885 | RINN E-Z CAPPER Rinn Corp. | FMI |
| Nov 27, 1991 | K913498 | MX927 BLOOD TRANSFER DEVICE Medex, Inc. | FMI |
| Oct 31, 1991 | K913317 | MEGA ARTHROGRAM KIT Mega Medical, Inc. | FMI |
| Oct 17, 1991 | K913141 | MEGA MYELOGRAM KIT Megadyne Medical Products, Inc. | FMI |
| Oct 8, 1991 | K913914 | PROGUARDII(TM) BLOOD COLLECTION DEVICE Care Medical Devices, Inc. | FMI |
| Sep 4, 1991 | K910667 | STERI-STAT REUSABLE SYRINGE David Craig Marketing, Inc. | FMI |
| Aug 23, 1991 | K913329 | V-ACCI-GUARD(TM) REUSABLE HOLDER Medical Safety Products, Inc. | FMI |
| Jul 26, 1991 | K911597 | THE NEEDLE NABBER J. Simmons Instrument , Ltd. | FMI |
| Jul 1, 1991 | K911436 | SHARPS PIN CUSHION(TM) CONTAINER Catalyst, Inc. | FMI |
| Jun 6, 1991 | K910733 | MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE Medisystems Corp. | FMI |
| Jun 6, 1991 | K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE Gainor Medical Europe, Ltd. | FMI |
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