Medical Device Manufacturer · US , Fall River , MA

Genzyme Surgical Product (Genzyme Biosurgery) - FDA 510(k) Cleared De...

9 submissions · 8 cleared · Since 1998

Recent clearances: NEXTSTITCH CARDIOVASCULAR VALVE SUTURE, 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE, BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

View 9 510(k) Devices ↓

9

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genzyme Surgical Product (Genzyme Biosurgery) Cardiovascular ✕

1 devices

1-1 of 1

Cleared Aug 07, 1998

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

Cardiovascular · 217d