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 |
|---|---|---|---|
| Nov 3, 1987 | K873569 | BLOOD NEEDLE HOLDER Sage Products, Inc. | FMI |
| Oct 23, 1987 | K873957 | NON-CORING HUBER TYPE NEEDLES Advantage Medical Systems, Inc. | FMI |
| Aug 25, 1987 | K872566 | MULTIPLE NEEDLE, INJECTION, DISPOSABLE Cotran Corp. | FMI |
| Aug 13, 1987 | K872580 | HR (TM) COLLECTION SYSTEM Icu Medical, Inc. | FMI |
| Jun 29, 1987 | K871142 | ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP) Peachtree Medical, Inc. | FMI |
| May 8, 1987 | K870863 | FNA THYROID BIOPSY KIT Flint Laboratories Div. Travenol | FMI |
| Feb 27, 1987 | K870193 | A+MED DISPOSABLE NEEDLE Can-Am Surgical Corp. | FMI |
| Feb 4, 1987 | K862610 | ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Jan 20, 1987 | K864310 | RYMCO STERILE SINGLE-USE NEEDLE/SINGLE USE SYRINGE Rymco Ltda | FMI |
| Dec 18, 1986 | K863606 | BUTTERFLY NON-CORING NEEDLE SET Cormed, Inc., Sub. C.R.Bard, Inc. | FMI |
| Sep 25, 1986 | K863514 | PROMEDICOR Terra Marketing Assoc. | FMI |
| Jul 17, 1986 | K861390 | DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET Baxter Healthcare Corp | FMI |
| May 12, 1986 | K861560 | MEDIPOINT MULTI-SAMPLE BLOOD COLLECTING NEEDLE Medi Point, Inc. | FMI |
| May 6, 1986 | K861406 | NON-KOR WINGED INFUSION SETS Creative Care Systems, Inc. | FMI |
| May 6, 1986 | K861152 | EXEL VACUUM BLOOD COLLECTING SYSTEM Exel Intl. | FMI |
| May 6, 1986 | K860781 | ICU MEDICAL NEEDLE, LOPEZ NEEDLE Icu Medical, Inc. | FMI |
| May 2, 1986 | K861318 | DISPOSABLE NEEDLE COUNTER (20-720) Anago, Inc. | FMI |
| Apr 9, 1986 | K861081 | DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH Perkins & Perkins, Inc. | FMI |
| Mar 21, 1986 | K852615 | R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE Medical Hospital Equipment | FMI |
| Feb 26, 1986 | K855248 | BLOOD COLLECTING NEEDLE Churchill Corp. | FMI |
| Feb 4, 1986 | K854549 | MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU Sherwood Medical Co. | FMI |
| Feb 4, 1986 | K854548 | MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES Sherwood Medical Co. | FMI |
| Feb 4, 1986 | K854547 | MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE Sherwood Medical Co. | FMI |
| Nov 12, 1985 | K853604 | ACE-KYLE DYE INJECTION NEEDLE P/N 14082 Today'S Machining & Design, Inc. | FMI |
| Oct 18, 1985 | K853731 | HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX Gish Biomedical, Inc. | FMI |
| Sep 20, 1985 | K852442 | PHARMA-PLAST NEEDLE Pharma-Plast USA, Inc., CA | FMI |
| Sep 19, 1985 | K852831 | NON-KOR ACCESS KITS Creative Care Systems, Inc. | FMI |
| Jul 16, 1985 | K851103 | VASCULAR IMPLANT ACCESS NEEDLE SET Baxter Healthcare Corp | FMI |
| Apr 29, 1985 | K845043 | JMS NEEDLES & JMS SYRINGES Jms Co., Ltd., JP | FMI |
| Apr 24, 1985 | K850420 | CHURCHILL HABER POINT NEEDLE ADMIN. SET Churchill Corp. | FMI |
| Jan 22, 1985 | K844313 | INFUSET W/HUBER NEEDLE Med Fusion Systems, Inc. | FMI |
| Dec 17, 1984 | K843264 | MONOJECT MENGHINI SOFT TISSUE BIOPSY Sherwood Medical Co. | FMI |
| Nov 30, 1984 | K844305 | GAINOR MEDICAL FLOWMAX NEEDLES Gainor Medical | FMI |
| Aug 20, 1984 | K842542 | AMER. PHARMASEAL CHEMONUCLEOLYSIS TRAY American Pharmaseal Div. Ahsc | FMI |
| Jul 23, 1984 | K842756 | BUTTERFLY II PN INFUSION NEEDLE Cosmetic Sciences, Inc. | FMI |
| Jul 17, 1984 | K841565 | HESUNG'S HYPERDERMIC NEEDLES Amkor Trading Co. | FMI |
| Jul 6, 1984 | K842012 | UMI CURVED CHEMONUCLEOLYSIS NEEDLE Universal Medical Instrument Corp. | FMI |
| Jul 6, 1984 | K841742 | NON-CORING NEEDLE Creative Care Systems, Inc. | FMI |
| Jun 28, 1984 | K841704 | THINWALL PUNCTURE NEEDLE Meadox Surgimed, Inc. | FMI |
| Jun 4, 1984 | K841306 | HEPARIN LOCK FLUSH SOLUTION USP KIT,100 Solo Pak Laboratories | FMI |
| Jun 4, 1984 | K841305 | HEPARIN LOCK FLUSH SOLUTION USP KIT Solo Pak Laboratories | FMI |
| Jun 4, 1984 | K841166 | HEPARIN LOCK FLUSH PROCEDURE PACK Solo Pak Laboratories | FMI |
| May 9, 1984 | K833705 | BETAJECT BD U100 Orange Medical Instruments, Inc. | FMI |
| May 7, 1984 | K841577 | HYPODERMIC NEEDLES Ava Medical Products of Canada, Inc. | FMI |
| Apr 27, 1984 | K841217 | PICKER MYELOGRAM TRAY-PMS MYELOGRAM Professional Medical Systems | FMI |
| Apr 13, 1984 | K840944 | INFUSION NEEDLE IIPN Medi Tex, Inc. | FMI |
| Apr 13, 1984 | K840334 | CHEMONUCLEOLYSIS/DISCOGRAPHY TRAY Applied Medical Devices, Inc. | FMI |
| Apr 5, 1984 | K840033 | HYPODERMIC NEEDLES & STYLETS Microvasive | FMI |
| Mar 30, 1984 | K832904 | INTRAVENOUS NEEDLE Yolan R. Guttman | FMI |
| Mar 23, 1984 | K840967 | OHIO HEAT REFLECTING PATCH Ohio Medical Products | FMI |
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