Medical Device Manufacturer · US , Fall River , MA

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

9 submissions · 8 cleared · Since 1998

9

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Genzyme Surgical Product (Genzyme Biosurgery) General & Plastic Surgery ✕

7 devices

1-7 of 7

Cleared Nov 13, 2000

NEXTSTITCH CARDIOVASCULAR VALVE SUTURE

General & Plastic Surgery · 189d

Cleared Jun 12, 2000

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE...

General & Plastic Surgery · 35d

Cleared Sep 03, 1999

BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

General & Plastic Surgery · 74d

Cleared Jul 20, 1999

ENDOSCOPIC CAMERA

General & Plastic Surgery · 88d

Cleared Jun 22, 1999

BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE

General & Plastic Surgery · 75d

Cleared Mar 30, 1999

General & Plastic Surgery · 81d

Cleared Jul 07, 1998

CUTALON NYLON POLYAMIDE SURGICAL SUTURE

General & Plastic Surgery · 88d