Data / Medical devices / United States / Genzyme Corporation
Genzyme Corporation: FDA-registered device maker in Ridgefield, NJ, United States, 1 PMA approval
Genzyme Corporation is registered with the FDA (registration 3039908023) in Ridgefield, NJ, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated August 8, 1997. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039908023
- Address
- 1125 Pleasantview Terrace, Ridgefield, NJ, United States, 07657
- Owner or operator
- GENZYME CORPORATION (9002116)
- Roles
- Specification developer
- First device listed
- June 30, 2003
- Registered through
- 2026
- Brand names listed
- Synvisc/SynviscOne
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Hyaluronic, Intraarticular | MOZ | 3 | Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 8, 1997 | P940015 | SYNVISC ONE | MOZ | 51 | January 2, 2025 | accessdata.fda.gov |
Compare with other makers
Updated January 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.