Medical Device Manufacturer · US , Ayer , MA

Sofradim Production - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1999

Recent clearances: Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030), ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), Parietene™ Macroporous Mesh (PPM5050 )

43
Total
43
Cleared
0
Denied

Sofradim Production has 43 FDA 510(k) cleared general & plastic surgery devices. Based in Ayer, US.

Latest FDA clearance: Oct 2026. Active since 1999.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Covidien, Covidien, LLC and Surgical Devices, A Global Business Unit of Covidien.

FDA 510(k) Regulatory Record - Sofradim Production

43 devices
1-12 of 43

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