Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Sofradim Production

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories2
Latest Approval2025-04-23
TypeNumberDevice NameCodeDate
510(k) K250869 Parietene™ Macroporous Mesh (PPM5050 ) FTL 2025-04-23 View
510(k) K243315 ProGrip™ Self-Gripping Polypropylene Mesh FTL 2025-01-17 View
510(k) K233661 Transorb™ Self-Gripping Resorbable Mesh OWT 2024-02-13 View
510(k) K232373 Progrip™ Self-Gripping Polypropylene Mesh FTL 2024-01-18 View
510(k) K223218 Parietene Macroporous Mesh FTL 2022-12-02 View
510(k) K220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh FTL 2022-06-22 View
510(k) K192443 Dextile Anatomical Mesh FTL 2019-12-06 View
510(k) K173796 Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) FTL 2018-03-09 View
510(k) K172395 Duatene bilayer mesh FTL 2018-02-01 View
510(k) K163212 Parietene DS Composite Mesh FTL 2017-06-29 View