Company ยท US
Gainor Medical
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1995. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KGX | Tape And Bandage, Adhesive | 4 |
| FMI | Needle, Hypodermic, Single Lumen | 2 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 2 |
| FMF | Syringe, Piston | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| FPX | Strip, Adhesive, Closure, Skin | 1 |
| GKX | Instrument, Automated Platelet Counting | 1 |
| KGW | Ring (Wound Protector), Drape Retention, Internal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 1995 | K950159 | SURESHARP Gainor Medical U.S.A., Inc. | FMI |
| Mar 29, 1995 | K944824 | SUREWING Gainor Medical U.S.A., Inc. | FPA |
| Jan 29, 1987 | K850100 | BLOOD LANCET Gainor Medical | FMK |
| Feb 21, 1985 | K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED Gainor Medical | FMK |
| Nov 30, 1984 | K844306 | GAINOR MEDICAL SYRINGE Gainor Medical | FMF |
| Nov 30, 1984 | K844305 | GAINOR MEDICAL FLOWMAX NEEDLES Gainor Medical | FMI |
| Oct 31, 1984 | K840951 | FIRST AID BANDAGE Gainor Medical | KGX |
| Oct 31, 1984 | K840950 | ZINC OXIDE TAPE Gainor Medical | KGX |
| Oct 31, 1984 | K840945 | SKIN CLOSURE Gainor Medical | FPX |
| Aug 17, 1984 | K840949 | CLEAR PLASTIC-HYPOALLERGENIC Gainor Medical | KGX |
| Aug 17, 1984 | K840947 | CLOTH-HYPOALLERGENIC Gainor Medical | KGX |
| Aug 17, 1984 | K840946 | MICROPOROUS HYPOALLERGENIC Gainor Medical | KGW |
| Aug 14, 1984 | K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC Gainor Medical | GKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||