Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

44 results for "Sofradim Production"
1–24 of 44
Search insights Median review: 77d Cleared: 100% Top manufacturer: Sofradim Production Lead specialty: General & Plastic Surgery
Cleared Oct 16, 2026
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
K262443 · OWT
Sofradim Production
General & Plastic Surgery · 92d
Cleared May 21, 2026
ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015,...
K253956 · FTL
Sofradim Production
General & Plastic Surgery · 162d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d
Cleared Apr 23, 2025
Parietene™ Macroporous Mesh (PPM5050 )
K250869 · FTL
Sofradim Production
General & Plastic Surgery · 30d
Cleared Jan 17, 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · FTL
Sofradim Production
General & Plastic Surgery · 87d
Cleared Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
K233661 · OWT
Sofradim Production
General & Plastic Surgery · 90d
Cleared Jan 18, 2024
Progrip™ Self-Gripping Polypropylene Mesh
K232373 · FTL
Sofradim Production
General & Plastic Surgery · 163d
Cleared Dec 02, 2022
Parietene Macroporous Mesh
K223218 · FTL
Sofradim Production
General & Plastic Surgery · 46d
Cleared Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex...
K220586 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Cleared Dec 06, 2019
Dextile Anatomical Mesh
K192443 · FTL
Sofradim Production
General & Plastic Surgery · 91d
Cleared Mar 09, 2018
Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical...
K173796 · FTL
Sofradim Production
General & Plastic Surgery · 85d
Cleared Feb 01, 2018
Duatene bilayer mesh
K172395 · FTL
Sofradim Production
General & Plastic Surgery · 177d
Cleared Jun 29, 2017
Parietene DS Composite Mesh
K163212 · FTL
Sofradim Production
General & Plastic Surgery · 225d
Cleared May 26, 2015
Versatex Monofilament Mesh
K150091 · FTL
Sofradim Production
General & Plastic Surgery · 130d
Cleared Mar 13, 2015
Progrip Laparoscopic Self-Fixating Mesh
K143386 · FTL
Sofradim Production
General & Plastic Surgery · 107d
Cleared Nov 14, 2014
Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh),...
K142908 · FTL
Sofradim Production
General & Plastic Surgery · 39d
Cleared Oct 28, 2014
Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh),...
K142900 · FTL
Sofradim Production
General & Plastic Surgery · 22d
Cleared Oct 17, 2014
PARIETENE MACROPOROUS MESH
K142091 · FTL
Sofradim Production
General & Plastic Surgery · 77d
Cleared May 07, 2014
PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH
K140941 · FTL
Sofradim Production
General & Plastic Surgery · 23d
Cleared Aug 22, 2013
SYMBOTEX(TM) COMPOSITE MESH
K131969 · FTL
Sofradim Production
General & Plastic Surgery · 55d
Cleared Dec 11, 2012
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH
K123479 · FTL
Sofradim Production
General & Plastic Surgery · 28d
Cleared Jun 29, 2012
PROGRIP LAPARSCOPIC SELF-FIXATING MESH
K120897 · FTL
Sofradim Production
General & Plastic Surgery · 95d
Cleared Jun 13, 2012
PARIETEX COMPOSITE VENTRAL PATCH
K120506 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Cleared Aug 11, 2011
PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)
K110663 · FTL
Sofradim Production
General & Plastic Surgery · 156d