Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
General, Plastic Surgery · 21 CFR 878.3300
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Recent MDR events
33 adverse event reports on file
- SURGIMEND MATRIX - UNSPECIFIEDSep 5, 2025InjuryTei Biosciences Inc3004170064-2025-00004
- SURGIMEND PRS MESHED 20CM X 10CM X 1MMMar 6, 2025MalfunctionTei Biosciences Inc3004170064-2025-00001
- SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTLNov 24, 2020MalfunctionTei Biosciences Inc3004170064-2020-00017
- SURGIMEND PRS MESHED 20CM X 10CM X 1MM INTLJul 16, 2020MalfunctionTei Biosciences Inc3004170064-2020-00002
- GENTRIX SURGICAL MATRIX THICKOct 17, 2018InjuryAcell, Inc.3005920706-2018-00017
- GENTRIX SURGICAL MATRIX THICKAug 21, 2018InjuryAcell, Inc.3005920706-2018-00011
- MESO BIOMATRIXJan 25, 2018InjuryDsm Biomedical2530154-2017-00005
- ARTHREX DX MATRIXAug 9, 2017InjuryDsm Biomedical2530154-2017-00004
- XCM BIOLOGICJul 12, 2017InjuryDsm Biomedical2530154-2017-00003
- ARTHREX DX MATRIXJun 22, 2017InjuryDsm Biomedical2530154-2017-00002
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
50 firms currently registered for this product code
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Acell, Inc.
Columbia, MD, US
Bard Shannon Limited
Humacao, PR, US
Synergy Health Ast, Llc
Saxonburg, PA, US
Sterigenics Belgium Fleurus Sa
Fleurus Hainaut, BE
Integra Lifesciences Corporation
Princeton, NJ, US
Boston Scientific Corporation
Roswell, GA, US
Cook Biotech, Inc.
West Lafayette, IN, US
Lifecell Corp
Branchburg, NJ, US
Integra Lifesciences Braintree Inc.
Braintree, MA, US
Kerecis Ehf
Isafjordur Vestfiroir, IS
Tribe Medical Group
London Ontario, CA
Lifecell Corp.
BRANCHBURG, NJ, US
Sterigenics Radiation Technologies Canada, Inc
PORT COQUITLAM British Columbia, CA
Depuy Orthopaedics
BRIDGEWATER, MA, US
Tutogen Medical Gmbh
Neunkirchen am Brand Bavaria, DE
Cook Incorporated
ELLETTSVILLE, IN, US
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Davol Inc., Sub. C.r. Bard, Inc.
Warwick, RI, US
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Synergy Health Ast, Llc
Petaluma, CA, US
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
510(k) clearances
5 clearances for this product code
- Kerecis LimitedJul 15, 2025
K251844 · Kerecis SurgiBind (50241)
- Kerecis LimitedMay 2, 2021
K202430 · Kerecis Reconstruct
- Integra Lifesciences Corporation (Owner of Tei Biosciences)Jun 7, 2017
K171357 · SurgiMend PRS Meshed, Revize-X
- Miromatrix Medical, Inc.Jun 8, 2016
K160400 · Miromatrix Biological Mesh
- Miromatrix Medical, Inc.May 12, 2015
K150341 · Miromatrix Biological Mesh RS