Medical Device Manufacturer · US , Ayer , MA

Sofradim Production

41 submissions · 41 cleared · Since 1999
41
Total
41
Cleared
0
Denied

Sofradim Production — FDA 510(k) Submissions

Sofradim Production has submitted 41 FDA 510(k) premarket notifications since 1999, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mesh, Surgical, Polymeric, Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, Mesh, Surgical, Absorbable, Abdominal Hernia, Laparoscope, General & Plastic Surgery . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
Parietene? Macroporous Mesh (PPM5050 )
K250869 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2025 30d
ProGrip? Self-Gripping Polypropylene Mesh
K243315 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jan 2025 87d
Transorb? Self-Gripping Resorbable Mesh
K233661 · OWT Mesh, Surgical,... · General & Plastic Surgery
Feb 2024 90d
Progrip? Self-Gripping Polypropylene Mesh
K232373 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jan 2024 163d
Parietene Macroporous Mesh
K223218 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Dec 2022 46d
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
K220586 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2022 113d
Dextile Anatomical Mesh
K192443 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Dec 2019 91d
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)
K173796 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2018 85d
Duatene bilayer mesh
K172395 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Feb 2018 177d
Parietene DS Composite Mesh
K163212 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2017 225d
Versatex Monofilament Mesh
K150091 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
May 2015 130d
Progrip Laparoscopic Self-Fixating Mesh
K143386 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2015 107d
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh
K142908 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Nov 2014 39d
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh
K142900 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Oct 2014 22d
PARIETENE MACROPOROUS MESH
K142091 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Oct 2014 77d
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
May 2014 23d
SYMBOTEX(TM) COMPOSITE MESH
K131969 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Aug 2013 55d
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Dec 2012 28d
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2012 95d
PARIETEX COMPOSITE VENTRAL PATCH
K120506 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Jun 2012 113d
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Aug 2011 156d
PARIETEX OPTIMIZED COMPOSTIE MESH
K110815 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2011 26d
PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
K110816 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Apr 2011 26d
PARIETEX PROGRIP
K103682 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Mar 2011 77d
PARIETEX PLUG AND PATCH
K101519 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery
Nov 2010 156d
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