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 3, 1991 | K911037 | SAFETY NEEDLE SHEATH, MODIFICATION Concord/Portex | FMI |
| Mar 15, 1991 | K905664 | VIAL ACCESS CANNULA Baxter Healthcare Corp | FMI |
| Feb 14, 1991 | K910455 | IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTOR Ziehm International, Inc. | FMI |
| Feb 12, 1991 | K905305 | SAFE-SITE NEEDLE COVER North American Medical Products, Inc. | FMI |
| Dec 19, 1990 | K904198 | SAFETY NEEDLE SHEATH Concord/Portex | FMI |
| Dec 14, 1990 | K904107 | CAP-AID Nda Systems | FMI |
| Nov 28, 1990 | K903490 | NORPLANT(R) TROCAR Wyeth-Ayerst Laboratories, Inc. | FMI |
| Oct 15, 1990 | K904295 | PROGUARD(TM) BLOOD COLLECTION NEEDLE Safety-Ject, Inc. | FMI |
| Sep 28, 1990 | K901162 | STERIMATIC(TM) SAFETY NEEDLE Sterimatic Worldwide, Ltd., GB | FMI |
| Sep 21, 1990 | K895024 | PUNCTUR-GUARD(TM) BLOOD COLLECTION NEEDLE Bio-Plexus, Inc. | FMI |
| Sep 7, 1990 | K895811 | SHARGHP HYPODERMIC NEEDLE Shargh Pharmaceutical Co., Inc. | FMI |
| Feb 28, 1990 | K900282 | NEEDLE-SHIELD Macbrud Corp. Medical Div. | FMI |
| Feb 16, 1990 | K895771 | EXEL SPINAL NEEDLES Exel Intl. | FMI |
| Feb 16, 1990 | K895769 | EXEL HUBER NEEDLE Exel Intl. | FMI |
| Jan 18, 1990 | K896293 | VIRAFREE CORP. EJECTABLE NEEDLE HOLDER Virafree Corp. | FMI |
| Jan 11, 1990 | K896320 | CENTURION KLEEN-NEEDLE SYSTEM Tri-State Hospital Supply Corp. | FMI |
| Dec 8, 1989 | K895630 | B-D PEND NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic | FMI |
| Nov 3, 1989 | K895432 | SAFE-T-CAP Ausmedics Pty , Ltd. | FMI |
| Oct 31, 1989 | K895075 | ACCI-GUARD REUSABLE HOLDER Medical Safety Products, Inc. | FMI |
| Oct 10, 1989 | K895705 | SHAMROCK SAFETY BLOOD COLLECTION SET Ryan Medical, Inc. | FMI |
| Sep 28, 1989 | K894374 | BLOOD DRAWING NEEDLE Pharma-Plast USA, Inc. | FMI |
| Sep 28, 1989 | K894372 | NIPRO NEEDLE HOLDER Pharma-Plast USA, Inc. | FMI |
| Jun 20, 1989 | K890926 | SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE Meadox Surgimed, Inc. | FMI |
| May 5, 1989 | K891919 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc. | FMI |
| Apr 3, 1989 | K890473 | NEEDLE GUARD(TM) Martech Medical Products, Inc. | FMI |
| Mar 14, 1989 | K885122 | NEEDLE STICK Poncy, Inc. | FMI |
| Feb 28, 1989 | K890620 | STICK-GARD SAFETY NEEDLE Ziehm International, Inc. | FMI |
| Feb 3, 1989 | K890127 | INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc. | FMI |
| Jan 30, 1989 | K884792 | VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES Infucare Products, Inc. | FMI |
| Nov 21, 1988 | K884620 | ASD SINGLE LUMEN NEEDLE Biosurge, Inc. | FMI |
| Oct 17, 1988 | K884212 | WINGED NON-CORING NEEDLE SET Marquette Medical, Inc. | FMI |
| Oct 17, 1988 | K884211 | STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES Marquette Medical, Inc. | FMI |
| Oct 6, 1988 | K884139 | ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER Medical Safety Products, Inc. | FMI |
| Oct 4, 1988 | K883009 | NON-CORING NEEDLES Quinton, Inc. | FMI |
| Aug 9, 1988 | K882880 | SAFETY, BLOOD COLLECTION TUBE HOLDER Ryan Medical, Inc. | FMI |
| Jul 8, 1988 | K882064 | LO-CORE NEEDLE Device Labs, Inc. | FMI |
| Jul 8, 1988 | K881654 | ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE Medical Safety Products, Inc. | FMI |
| Jun 15, 1988 | K881671 | MANAN TABAR-ROTHSCHILD GALACTOGRAPHY KIT Manan Medical Devices | FMI |
| Jun 3, 1988 | K881758 | VIGGO VASCUPORT NEEDLE Ohmeda Medical | FMI |
| May 31, 1988 | K881785 | N.S. CADEE First Scientific, Div. | FMI |
| May 31, 1988 | K880746 | STERILE NEEDLE FOR BLOOD COLLECTION Applied Plastics Technology, Inc. | FMI |
| Apr 21, 1988 | K880892 | BLOOD COLLECTING NEEDLE AND HOLDERS Abco Dealers, Inc. | FMI |
| Feb 19, 1988 | K874602 | ASD-BIO ANTI-STICK DEVICE Biosurge, Inc. | FMI |
| Jan 14, 1988 | K874414 | HYPODERMIC NEEDLES, SINGLE LUMEN Harbor Medical Devices, Inc. | FMI |
| Jan 4, 1988 | K874430 | NEEDLE CONTAINER American Medical Technology, Inc. | FMI |
| Dec 30, 1987 | K873991 | LAKE IRRIGATION TRAY Lake Medical Products, Inc. | FMI |
| Dec 3, 1987 | K873165 | CHEMO-PORT NON-CORING NEEDLES Hdc Corp. | FMI |
| Nov 23, 1987 | K874024 | ACU-MICRO-NEEDLE Acuderm, Inc. | FMI |
| Nov 6, 1987 | K874372 | HR(TM) NEEDLE AND SYRINGE Icu Medical, Inc. | FMI |
| Nov 3, 1987 | K874249 | BIFURCATED NEEDLE Allergy Laboratories of Ohio, Inc. | FMI |
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