Medical Device Manufacturer · US , Ayer , MA

Sofradim Production - FDA 510(k) Cleared Devices

42 submissions · 42 cleared · Since 1999

Recent clearances: ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), Parietene™ Macroporous Mesh (PPM5050 ), ProGrip™ Self-Gripping Polypropylene Mesh

42
Total
42
Cleared
0
Denied

Sofradim Production has 42 FDA 510(k) cleared general & plastic surgery devices. Based in Ayer, US.

Latest FDA clearance: May 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, LLC, Covidien and Coviden.

FDA 510(k) Regulatory Record - Sofradim Production

42 devices
1-12 of 42

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