Genzyme Corporation
Genzyme Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2010, with 2 FDA device recalls on record.
Top product codes for Genzyme Corporation
FDA recalls by Genzyme Corporation
- Z-1855-2012 — seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
- Z-1856-2012 — seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Genzyme Corporation
- K102242 — OSOM C. DIFFICILE TOXIN A/B TEST
- K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190
- K080662 — GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
- K063739 — SEPRAMESH, MODEL 5959-1214
- K053066 — SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH
- K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.