Genzyme Corp.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000007947 FEI 3039908023
Genzyme Corp. is a medical device manufacturer based in the United States, with 47 devices listed in 4 registries (FDA Class I, II and III; EU Class III) and 9 FDA recalls as of 13 Nov 2026.
- Devices
- 47
- Registrations
- EUDAMEDFDA
- FDA recalls
- 9
Registry facts
- Registries
- FDA 510(k) 27
- FDA GUDID 16
- EUDAMED 2
- FDA PMA 2
- Device classes
- FDA Class I 18
- FDA Class II 17
- FDA Class III 10
- EU Class III 2
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000007947
- FDA FEI 3039908023
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Genzyme Corp. makes
Genzyme Corp. manufactures assay development analyte-specific reagents for in vitro diagnostics, surgical anti-adhesion materials that are implantable, bioabsorbable, and non-medicated, and synovial fluid supplementation media. These include products such as Seprafilm® and its variants (Procedure Pack, Small Incision, Single Site, 4-section), Synvisc® and Synvisc-One®, and various diagnostic reagents like OLIPUDASE, ALDURAZYME, CEREZYME, NEOGAA AVALGLUCO, and GAA-1 ANTIBODY.
The company's portfolio includes devices classified as Class I, II, and III, and is listed in regulatory registries including Eudamed, FDA 510(k), FDA PMA, and FDA UDI. Genzyme Corp. is based in the United States.
Catalogue
Search and filter all 47 devicesCompany details
- EUDAMED SRN
- US-MF-000007947
- FDA FEI number
- 3039908023
- EU VAT number
- 06-1047163
- EUDAMED status
- Active
- EUDAMED registered name
- Genzyme Corporation
- Registered address
- 1125, Pleasant View Terrace, 07657, Ridgefield, United States
- Phone
- +1 570 390 9072
- PRRC contact
- Sandra Ahern
FDA recalls
FDA recall records list 9 recalls initiated by Genzyme Corp., the earliest on 2008-04-10 and the most recent on 2012-06-13. By recorded status: 9 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 13 Jun 2012 Z-1855-2012 Class II Terminated Sterility of product may be compromised due to packaging defect
- 13 Jun 2012 Z-1856-2012 Class II Terminated Sterility of product may be compromised due to packaging defect
2010
- 13 Jul 2010 Z-2310-2010 Unclassified (pre-2012) Terminated Revised Labeling of Carticel Essentials Kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
2008
- 14 Apr 2008 Z-2148-2008 Unclassified (pre-2012) Terminated Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- 14 Apr 2008 Z-2149-2008 Unclassified (pre-2012) Terminated Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- 14 Apr 2008 Z-2150-2008 Unclassified (pre-2012) Terminated Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- 14 Apr 2008 Z-2151-2008 Unclassified (pre-2012) Terminated Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- 10 Apr 2008 Z-1647-2008 Unclassified (pre-2012) Terminated Sterility may be compromised
- 10 Apr 2008 Z-1648-2008 Unclassified (pre-2012) Terminated Sterility may be compromised
Frequently asked questions
How many devices does Genzyme Corp. have in the registry?
The registry currently lists 47 devices for Genzyme Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genzyme Corp.'s devices?
Among its 47 most recently registered devices, Genzyme Corp. has devices listed in EUDAMED (2 devices), FDA 510(k) (27 devices), FDA PMA (2 devices) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Genzyme Corp.'s devices fall under?
Among its 47 most recently registered devices, the classes recorded for Genzyme Corp.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Genzyme Corp.?
FDA recall records list 9 recalls initiated by Genzyme Corp., the most recent initiated on 13 Jun 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Genzyme Corp. in the registry?
The most recently registered devices listed for Genzyme Corp. include Seprafilm® 4301-02, Seprafilm® Procedure Pack 5086-02, LeGoo® LG250 and Seprafilm® Small Incision 6642-01.