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 Kells Medical, Inc. with 12 510(k) clearances. The most recent is a 510(k) clearance dated Nov 8, 1993: CPR PLUS.
| Nov 8, 1993 | CPR PLUSK926333 · LIX | 510(k) clearances |
| Jul 24, 1989 | PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890093 · KNT | 510(k) clearances |
| May 24, 1989 | PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095 · KPE | 510(k) clearances |
| May 24, 1989 | EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890094 · KPE | 510(k) clearances |
| Jun 27, 1986 | DERMISTRIPK861972 · NAD | 510(k) clearances |
| Jan 8, 1985 | DERMIDRESSK844463 · KGX | 510(k) clearances |
| Nov 5, 1984 | DERMIZIP SKIN CLOSURE DEVICEK844072 · | 510(k) clearances |
| Mar 7, 1984 | PHONATORY FUNCTION ANALYZER PS-77K832678 · BXP | 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
