FTM · Class II · 21 CFR 878.3300

FDA Product Code FTM: Mesh, Surgical

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

164
Total
164
Cleared
111d
Avg days
1982
Since
164 devices
97–120 of 164
Cleared Jul 07, 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140
Acell, Inc.
General & Plastic Surgery · 68d
Cleared Jun 30, 2004
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K040364
Porex Surgical, Inc.
General & Plastic Surgery · 138d
Cleared Jun 04, 2004
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K040868
Genzyme Corp.
General & Plastic Surgery · 63d
Cleared Apr 14, 2004
ACELL UBM SURGICAL MESH
K040621
Acell, Inc.
General & Plastic Surgery · 36d
Cleared Feb 18, 2004
SIS PLASTIC SURGERY MATRIX
K034039
Cook Biotech, Inc.
General & Plastic Surgery · 51d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 32d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332
C.R. Bard, Inc.
General & Plastic Surgery · 17d
Cleared Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 41d
Cleared Jun 12, 2002
DERMMATRIX SURGICAL MESH
K021160
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 62d
Cleared Apr 03, 2002
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K020455
Tei Biosciences, Inc.
General & Plastic Surgery · 51d
Cleared Dec 27, 2000
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K001738
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 203d
Cleared Oct 06, 2000
TUTOPATCH
K991296
Tutogen Medical U.S., Inc.
General & Plastic Surgery · 540d
Cleared Feb 22, 2000
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
K992537
Bio-Vascular, Inc.
General & Plastic Surgery · 208d
Cleared Jul 14, 1999
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K991567
Shelhigh, Inc.
General & Plastic Surgery · 70d
Cleared Oct 09, 1998
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
K983162
Bio-Vascular, Inc.
General & Plastic Surgery · 29d
Cleared Sep 25, 1998
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K982330
Depuy, Inc.
General & Plastic Surgery · 85d
Cleared May 28, 1998
SURGISIS
K980431
Cook Biotech, Inc.
General & Plastic Surgery · 113d
Cleared Sep 25, 1997
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
K973379
S. Jackson, Inc.
General & Plastic Surgery · 17d
Cleared May 09, 1997
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048
Bio-Vascular, Inc.
General & Plastic Surgery · 49d
Cleared Sep 23, 1996
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
K963175
Glycar, Inc.
General & Plastic Surgery · 40d
Cleared Jun 13, 1996
SUPPLE PERI-GUARD PERICARDIUM
K961810
Bio-Vascular, Inc.
General & Plastic Surgery · 34d
Cleared Jun 13, 1996
PERI-GUARD PERICARDIUM
K961811
Bio-Vascular, Inc.
General & Plastic Surgery · 34d
Cleared May 02, 1994
PERI-STRIPS
K940205
Bio-Vascular, Inc.
General & Plastic Surgery · 108d
Cleared Dec 21, 1992
SUPPLE PERI-GUARD
K923657
Bio-Vascular, Inc.
General & Plastic Surgery · 208d