Medical Device Manufacturer · US , Cambridge , MA

Genzyme Corp. - FDA 510(k) Cleared Devices

27 submissions · 27 cleared · Since 1991
27
Total
27
Cleared
0
Denied

Genzyme Corp. was an American biotechnology company headquartered in Cambridge, Massachusetts. The company specialized in diagnostic and surgical medical devices across multiple therapeutic areas.

Genzyme received 27 FDA 510(k) clearances from 27 total submissions between 1991 and 2006. The company's cleared devices spanned chemistry devices, microbiology diagnostics, and surgical implants including wound closure systems and bioresorbable barriers. This regulatory track record reflects the company's broad portfolio across diagnostic and surgical specialties.

Genzyme was acquired by Sanofi in 2011 and operated as a fully owned subsidiary until 2022, when it was integrated into Sanofi's corporate structure. At its peak, Genzyme was the world's third-largest biotechnology company with a global presence in approximately 65 countries and manufacturing facilities worldwide. The company received the National Medal of Technology in 2005, recognizing its innovation leadership.

Explore the complete regulatory history of Genzyme's FDA 510(k) cleared devices, including product names, device codes, and clearance dates in the database.

FDA 510(k) cleared devices by Genzyme Corp.

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