Sofradim Production FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)510(k)May 21, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	May 21, 2026
Parietene Macroporous Mesh (PPM5050 )510(k)Apr 23, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Apr 23, 2025
ProGrip Self-Gripping Polypropylene Mesh510(k)Jan 17, 2025General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 17, 2025
Transorb Self-Gripping Resorbable Mesh510(k)Feb 13, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Feb 13, 2024
Progrip Self-Gripping Polypropylene Mesh510(k)Jan 18, 2024General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jan 18, 2024
Parietene Macroporous Mesh510(k)Dec 2, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Dec 2, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh510(k)Jun 22, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Special)	Jun 22, 2022