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 )

View 43 510(k) Devices ↓

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sofradim Production Gastroenterology & Urology ✕

2 devices

1-2 of 2

Cleared May 17, 2004

URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM

Gastroenterology & Urology · 12d

Cleared Oct 04, 2001

URETEX SUP PUBOURETHRAL SLING

Gastroenterology & Urology · 30d