# Genzyme Corp.

- Location (FDA's records): Cambridge, MA
- FDA decisions: 35 (1991–2011): 33 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Genzyme Corp. (29); Genzyme Corporation (6)
- Product codes: JFJ (4), FTL (3), LBS (3), PSZ (3), LBR (3), MRR (3), LCP (2), GGT (2), LYA (1), KHJ (1), FTM (1), LLH (1)
- Predicates its devices cite: 28 (8 its own); citations of its devices by later devices: 56 (8 its own)
- Recalls linked to its devices: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Xomed, Inc.: 2 (https://510kreport.com/company/xomed)
- C.R. Bard, Inc.: 2 (https://510kreport.com/company/cr-bard)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Davis & Geck, Inc.: 2 (https://510kreport.com/company/davis-geck)
- Quidel Corp.: 2 (https://510kreport.com/company/quidel)
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)
- Boston Medical Products, Inc.: 1 (https://510kreport.com/company/boston-medical-products)
- Walter Lorenz Surgical, Inc.: 1 (https://510kreport.com/company/walter-lorenz-surgical)

## Firms that cite its devices most
- C.R. Bard, Inc.: 6 (https://510kreport.com/company/cr-bard)
- Davol Inc., Sub. C. R. Bard, Inc.: 3 (https://510kreport.com/company/davol-sub-c-r-bard)
- Carbylan Biosurgery: 2 (https://510kreport.com/company/carbylan-biosurgery)
- Denka Seiken Co., Ltd.: 2 (https://510kreport.com/company/denka-seiken)
- Schiapparelli Biosystems, Inc.: 2 (https://510kreport.com/company/schiapparelli-biosystems)
- Teleflexmedical, Inc.: 2 (https://510kreport.com/company/teleflexmedical)
- Horiba Abx: 2 (https://510kreport.com/company/horiba-abx)
- Elitechgroup Seppim S.A.S.: 2 (https://510kreport.com/company/elitechgroup-seppim)

## Its most-cited devices
- K021019: Cottony II, Silky II Polydek & Tevdek II Polyester Suture (2002), cited by 12
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator (2002), cited by 7
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set (1997), cited by 7
- K012532: Sepragel Sinus (2001), cited by 6
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh (2004), cited by 5
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh (2005), cited by 4

## Recent decisions
- P110003: LEGOO (Sep 28, 2011)
- K102242: Osom C. Difficile Toxin a/B Test (Dec 21, 2010)
- K092633: Osom Influenza a&B Test , Model PN190 (Sep 25, 2009)
- K080662: Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator (May 15, 2008)
- K063739: Sepramesh, Model 5959-1214 (Jan 17, 2007)
- K061508: Osom Influenza a&B Test (Jun 12, 2006)
- K051244: Genzyme Osom Influenza a & B Test (Feb 21, 2006)
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh (Dec 19, 2005)

Source page: https://510kreport.com/company/genzyme