Medical Device Manufacturer · US , Ayer , MA

Sofradim Production - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1999

Recent clearances: Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030), ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030), Parietene™ Macroporous Mesh (PPM5050 )

View 43 510(k) Devices ↓

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sofradim Production General & Plastic Surgery ✕

39 devices

1-12 of 39

Cleared Oct 16, 2026

Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)

General & Plastic Surgery · 92d

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

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