Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Sanofi. FDA records under its name, each linked to the record. See the Sanofi group view.
As of Nov 15, 2026, FDA's public records list Genzyme Biosurgery with 9 510(k) clearances. The most recent is a 510(k) clearance dated Nov 13, 2000: NEXTSTITCH CARDIOVASCULAR VALVE SUTURE.
| Nov 13, 2000 | NEXTSTITCH CARDIOVASCULAR VALVE SUTUREK001440 · GAT | 510(k) clearances |
| Jun 12, 2000 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREK001434 · GAT | 510(k) clearances |
| Sep 3, 1999 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK992088 · GAM | 510(k) clearances |
| Jul 20, 1999 | ENDOSCOPIC CAMERAK991416 · GCJ | 510(k) clearances |
| Jun 22, 1999 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREK991191 · GAM | 510(k) clearances |
| Mar 30, 1999 | SAPHLIFTK990062 · MDM | 510(k) clearances |
| Dec 18, 1998 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250K982712 · CAC | 510(k) clearances |
| Aug 7, 1998 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEK980016 · MOP | 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
