Genzyme Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Genzyme Corporation - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Genzyme Corporation has 6 FDA 510(k) cleared medical devices. Based in Cambridge, US.
Historical record: 6 cleared submissions from 2005 to 2010.
Browse the FDA 510(k) cleared devices submitted by Genzyme Corporation Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Genzyme Corporation
6 devices
Cleared
Dec 21, 2010
OSOM C. DIFFICILE TOXIN A/B TEST
Microbiology
134d
Cleared
Sep 25, 2009
OSOM INFLUENZA A&B TEST , MODEL PN190
Microbiology
29d
Cleared
May 15, 2008
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
Chemistry
66d
Cleared
Jan 17, 2007
SEPRAMESH, MODEL 5959-1214
General & Plastic Surgery
30d
Cleared
Dec 19, 2005
SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
General & Plastic Surgery
48d
Cleared
Jul 11, 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
Ear, Nose, Throat
250d