510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Genzyme Surgical Product (Genzyme Biosurgery)

Fall River, MA, US

Genzyme Surgical Product (Genzyme Biosurgery) appears in FDA device records in Fall River, MA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 9 510(k) clearances for Genzyme Surgical Product (Genzyme Biosurgery) between 1998 and 2000. The busiest year on record is 1999, with 4. The most recent is 2000, with 2.

Clearances by year, as a table
510(k) clearance decisions for Genzyme Surgical Product (Genzyme Biosurgery), by decision year
YearClearances
19983
19994
20002
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K001440NEXTSTITCH CARDIOVASCULAR VALVE SUTUREGATSubstantially Equivalent
K001434'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTUREGATSubstantially Equivalent for Some Indications
K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAMSubstantially Equivalent
K991416ENDOSCOPIC CAMERAGCJSubstantially Equivalent
K991191BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGAMSubstantially Equivalent
K990062SAPHLIFTMDMSubstantially Equivalent
K982712RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250CACSubstantially Equivalent
K980016MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEMOPSubstantially Equivalent
K981322CUTALON NYLON POLYAMIDE SURGICAL SUTUREGARSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain