Gainor Medical
US
Gainor Medical appears in FDA device records in US. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Gainor Medical between 1984 and 1987. The busiest year on record is 1984, with 9. The most recent is 1987, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 9 |
| 1985 | 1 |
| 1987 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K850100 | BLOOD LANCET | FMK | Substantially Equivalent | |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | FMK | Substantially Equivalent | |
| K844306 | GAINOR MEDICAL SYRINGE | FMF | Substantially Equivalent | |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | FMI | Substantially Equivalent | |
| K840951 | FIRST AID BANDAGE | KGX | Substantially Equivalent | |
| K840950 | ZINC OXIDE TAPE | KGX | Substantially Equivalent | |
| K840945 | SKIN CLOSURE | FPX | Substantially Equivalent | |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | KGX | Substantially Equivalent | |
| K840947 | CLOTH-HYPOALLERGENIC | KGX | Substantially Equivalent | |
| K840946 | MICROPOROUS HYPOALLERGENIC | KGW | Substantially Equivalent | |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | GKX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain