Sofradim Production

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
41
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1523-2018Class IIVersatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporouFebruary 23, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K250869Parietene™ Macroporous Mesh (PPM5050 )April 23, 2025
K243315ProGrip™ Self-Gripping Polypropylene MeshJanuary 17, 2025
K233661Transorb™ Self-Gripping Resorbable MeshFebruary 13, 2024
K232373Progrip™ Self-Gripping Polypropylene MeshJanuary 18, 2024
K223218Parietene Macroporous MeshDecember 2, 2022
K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D AnatomicalJune 22, 2022
K192443Dextile Anatomical MeshDecember 6, 2019
K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex ComposMarch 9, 2018
K172395Duatene bilayer meshFebruary 1, 2018
K163212Parietene DS Composite MeshJune 29, 2017
K150091Versatex Monofilament MeshMay 26, 2015
K143386Progrip Laparoscopic Self-Fixating MeshMarch 13, 2015
K142908Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono November 14, 2014
K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (newOctober 28, 2014
K142091PARIETENE MACROPOROUS MESHOctober 17, 2014
K140941PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESHMay 7, 2014
K131969SYMBOTEX(TM) COMPOSITE MESHAugust 22, 2013
K123479PROGRIP LAPAROSCOPIC SELF-FIXATING MESHDecember 11, 2012
K120897PROGRIP LAPARSCOPIC SELF-FIXATING MESHJune 29, 2012
K120506PARIETEX COMPOSITE VENTRAL PATCHJune 13, 2012