Genzyme Surgical Product (Genzyme Biosurgery)

FDA Regulatory Profile

Genzyme Surgical Product (Genzyme Biosurgery) appears in FDA public data with 0 recalls, 9 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on November 13, 2000.

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTURENovember 13, 2000
K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREJune 12, 2000
K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURESeptember 3, 1999
K991416ENDOSCOPIC CAMERAJuly 20, 1999
K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREJune 22, 1999
K990062SAPHLIFTMarch 30, 1999
K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250December 18, 1998
K980016MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEAugust 7, 1998
K981322CUTALON NYLON POLYAMIDE SURGICAL SUTUREJuly 7, 1998