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Sofradim Production

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories2
Latest FDA decision2026-05-21
TypeNumberDevice NameCodeDateActions
510(k) K253956 ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL2026-05-21 View
510(k) K250869 Parietene™ Macroporous Mesh (PPM5050 )FTL2025-04-23 View
510(k) K243315 ProGrip™ Self-Gripping Polypropylene MeshFTL2025-01-17 View
510(k) K233661 Transorb™ Self-Gripping Resorbable MeshOWT2024-02-13 View
510(k) K232373 Progrip™ Self-Gripping Polypropylene MeshFTL2024-01-18 View
510(k) K223218 Parietene Macroporous MeshFTL2022-12-02 View
510(k) K220586 Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament MeshFTL2022-06-22 View
510(k) K192443 Dextile Anatomical MeshFTL2019-12-06 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)FTL2018-03-09 View
510(k) K172395 Duatene bilayer meshFTL2018-02-01 View
510(k) K163212 Parietene DS Composite MeshFTL2017-06-29 View
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