Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Gainor Medical with 11 510(k) clearances. The most recent is a 510(k) clearance dated Jan 29, 1987: BLOOD LANCET.
| Jan 29, 1987 | BLOOD LANCETK850100 · FMK | 510(k) clearances |
| Feb 21, 1985 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MEDK850150 · FMK | 510(k) clearances |
| Nov 30, 1984 | GAINOR MEDICAL SYRINGEK844306 · FMF | 510(k) clearances |
| Nov 30, 1984 | GAINOR MEDICAL FLOWMAX NEEDLESK844305 · FMI | 510(k) clearances |
| Oct 31, 1984 | ZINC OXIDE TAPEK840950 · KGX | 510(k) clearances |
| Oct 31, 1984 | SKIN CLOSUREK840945 · FPX | 510(k) clearances |
| Oct 31, 1984 | FIRST AID BANDAGEK840951 · KGX | 510(k) clearances |
| Aug 17, 1984 | CLEAR PLASTIC-HYPOALLERGENICK840949 · KGX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
