FTM · Class II · 21 CFR 878.3300

FDA Product Code FTM: Mesh, Surgical

Leading manufacturers include Cook Biotech, Inc., Tei Biosciences, Inc. and Bio-Vascular, Inc..

164
Total
164
Cleared
111d
Avg days
1982
Since
164 devices
73–96 of 164
Cleared Oct 17, 2007
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K070405
Cook Biotech, Inc.
General & Plastic Surgery · 247d
Cleared Sep 04, 2007
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K071016
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 147d
Cleared Aug 06, 2007
ORTHOMEND SOFT TISSUE MATRIX
K071807
Tei Biosciences, Inc.
General & Plastic Surgery · 35d
Cleared Jun 20, 2007
MESOSFOL SURGICAL FILM
K062558
Biomet Manufacturing Corp
General & Plastic Surgery · 294d
Cleared Apr 05, 2007
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K070738
Cook Biotech, Inc.
General & Plastic Surgery · 20d
Cleared Nov 21, 2006
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K063178
C.R. Bard, Inc.
General & Plastic Surgery · 33d
Cleared Oct 13, 2006
SURGISIS, SURGISIS ES
K062696
Cook Biotech, Inc.
General & Plastic Surgery · 32d
Cleared Oct 10, 2006
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K062729
Cook Biotech, Inc.
General & Plastic Surgery · 27d
Cleared Oct 02, 2006
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K062320
Cook Biotech, Inc.
General & Plastic Surgery · 54d
Cleared May 17, 2006
COSMATRIX
K060829
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared May 17, 2006
XENFORM SOFT TISSUE REPAIR MATRIX
K060984
Tei Biosciences, Inc.
General & Plastic Surgery · 37d
Cleared May 15, 2006
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K060989
Tei Biosciences, Inc.
General & Plastic Surgery · 35d
Cleared Apr 10, 2006
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K052322
C.R. Bard, Inc.
General & Plastic Surgery · 228d
Cleared Feb 03, 2006
TENDON WRAP TENDON PROTECTOR
K053655
Integra LifeSciences Corporation
General & Plastic Surgery · 35d
Cleared Oct 05, 2005
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K051879
Synthes (Usa)
General & Plastic Surgery · 86d
Cleared Sep 23, 2005
SURGISIS STAPLE LINE REINFORCEMENT II
K051048
Cook Biotech, Inc.
General & Plastic Surgery · 151d
Cleared Aug 15, 2005
BIOBLANKET SURGICAL MESH
K043259
Kensey Nash Corp.
General & Plastic Surgery · 264d
Cleared Aug 05, 2005
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
K043388
Pegasus Biologics, Inc.
General & Plastic Surgery · 239d
Cleared May 19, 2005
SIS DERMAL AUGMENTATION STRAND
K050246
Cook Biotech, Inc.
General & Plastic Surgery · 106d
Cleared Mar 09, 2005
SIS FISTULA PLUG
K050337
Cook Biotech, Inc.
General & Plastic Surgery · 27d
Cleared Nov 02, 2004
CUFFPATCH
K042809
Organogenesis, Inc.
General & Plastic Surgery · 21d
Cleared Oct 27, 2004
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
K041669
Synovis Surgical Innovations
General & Plastic Surgery · 128d
Cleared Sep 08, 2004
BIOBLANKET
K041923
Kensey Nash Corp.
General & Plastic Surgery · 54d
Cleared Jul 14, 2004
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K040756
Implex Corp.
General & Plastic Surgery · 112d