Sofradim Production - FDA 510(k) Cleared Devices
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
FDA 510(k) Regulatory Record - Sofradim Production General & Plastic Surgery ✕
38 devices
Cleared
May 21, 2026
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015,...
General & Plastic Surgery
162d
Cleared
Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
General & Plastic Surgery
30d
Cleared
Jan 17, 2025
ProGrip™ Self-Gripping Polypropylene Mesh
General & Plastic Surgery
87d
Cleared
Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
General & Plastic Surgery
90d
Cleared
Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
General & Plastic Surgery
163d
Cleared
Dec 02, 2022
Parietene Macroporous Mesh
General & Plastic Surgery
46d
Cleared
Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex...
General & Plastic Surgery
113d
Cleared
Dec 06, 2019
Dextile Anatomical Mesh
General & Plastic Surgery
91d
Cleared
Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical...
General & Plastic Surgery
85d
Cleared
Feb 01, 2018
Duatene bilayer mesh
General & Plastic Surgery
177d
Cleared
Jun 29, 2017
Parietene DS Composite Mesh
General & Plastic Surgery
225d
Cleared
May 26, 2015
Versatex Monofilament Mesh
General & Plastic Surgery
130d
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