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Mesh, Surgical

FDA product code FTM · 152 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3300
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1982-05-14 – 2026-08-12

FTM 2004-10-27

VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD

Applicant Synovis Surgical Innovations

K number K041669

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FTM 2004-09-08

BIOBLANKET

Applicant Kensey Nash Corp.

K number K041923

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FTM 2004-07-14

THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX

Applicant Implex Corp.

K number K040756

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FTM 2004-07-07

ACELL UBM SURGICAL MESH ML AND MLPLUS

Applicant Acell, Inc.

K number K041140

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FTM 2004-06-30

MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH

Applicant Porex Surgical, Inc.

K number K040364

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FTM 2004-06-15

PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16

Applicant Pm Devices, Inc.

K number K040835

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FTM 2004-06-04

SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH

Applicant Genzyme Corp.

K number K040868

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FTM 2004-06-04

PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10

Applicant Pm Devices, Inc.

K number K033985

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FTM 2004-04-14

ACELL UBM SURGICAL MESH

Applicant Acell, Inc.

K number K040621

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FTM 2004-03-17

PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION

Applicant Synovis Surgical Innovations

K number K040119

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FTM 2004-02-18

SIS PLASTIC SURGERY MATRIX

Applicant Cook Biotech, Inc.

K number K034039

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FTM 2003-07-28

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Applicant DePuy Orthopaedics, Inc.

K number K031969

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FTM 2003-05-15

BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH

Applicant C.R. Bard, Inc.

K number K031332

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FTM 2003-04-21

SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL

Applicant W. L. Gore & Associates, Inc.

K number K030782

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FTM 2003-03-18

XYLOS SURGICAL MESH

Applicant Xylos Corporation

K number K023237

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FTM 2002-10-31

PERMACOL

Applicant Tissue Science Laboratories, Plc

K number K021056

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FTM 2002-06-12

DERMMATRIX SURGICAL MESH

Applicant Carbon Medical Technologies, Inc.

K number K021160

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FTM 2002-05-15

FORTAFLEX SURGICAL SLING

Applicant Organogenesis, Inc.

K number K021107

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FTM 2002-05-10

FORTAFLEX SURGICAL MESH

Applicant Organogenesis, Inc.

K number K021105

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FTM 2002-04-03

TISSUEMEND SOFT TISSUE REPAIR MATRIX

Applicant Tei Biosciences, Inc.

K number K020455

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FTM 2002-03-18

FORTAFLEX SURGICAL MESH

Applicant Organogenesis, Inc.

K number K020049

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FTM 2002-01-17

PERMACOL

Applicant Tissue Science Laboratories, Plc

K number K013625

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FTM 2001-08-24

FORTAFLEX SURGICAL MESH

Applicant Organogenesis, Inc.

K number K011025

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FTM 2001-05-30

FORTAFLEX SURGICAL SLING

Applicant Organogenesis, Inc.

K number K011027

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FTM 2000-12-27

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Applicant DePuy Orthopaedics, Inc.

K number K001738

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FTM 2000-10-06

TUTOPATCH

Applicant Tutogen Medical U.S., Inc.

K number K991296

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FTM 2000-02-22

PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED

Applicant Bio-Vascular, Inc.

K number K992537

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FTM 1999-07-14

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.

Applicant Shelhigh, Inc.

K number K991567

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FTM 1998-10-09

PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC

Applicant Bio-Vascular, Inc.

K number K983162

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FTM 1998-09-25

DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Applicant Depuy, Inc.

K number K982330

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FTM 1998-05-28

SURGISIS

Applicant Cook Biotech, Inc.

K number K980431

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FTM 1997-09-25

STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS

Applicant S. Jackson, Inc.

K number K973379

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FTM 1997-05-09

PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT

Applicant Bio-Vascular, Inc.

K number K971048

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FTM 1996-09-23

GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING

Applicant Glycar, Inc.

K number K963175

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FTM 1996-06-13

PERI-GUARD PERICARDIUM

Applicant Bio-Vascular, Inc.

K number K961811

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FTM 1996-06-13

SUPPLE PERI-GUARD PERICARDIUM

Applicant Bio-Vascular, Inc.

K number K961810

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FTM 1994-05-02

PERI-STRIPS

Applicant Bio-Vascular, Inc.

K number K940205

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FTM 1993-01-12

TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER

Applicant Ti-Mesh, Inc.

K number K922308

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FTM 1992-12-21

SUPPLE PERI-GUARD

Applicant Bio-Vascular, Inc.

K number K923657

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FTM 1992-03-02

PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH

Applicant ETHICON, Inc.

K number K915774

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FTM 1990-05-07

COATED NOVAFIL, POLYBUTESTER, MESH

Applicant American Cyanamid Co.

K number K896946

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FTM 1989-10-10

GORE-TEX SURGICAL TAPE

Applicant W. L. Gore & Associates, Inc.

K number K894580

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FTM 1985-06-11

NYLAMID MESH PAD FULL & HALF

Applicant S. Jackson, Inc.

K number K852011

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FTM 1985-05-21

VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH

Applicant ETHICON, Inc.

K number K851086

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FTM 1985-01-24

PDS POLYDIOXANONE MESH

Applicant ETHICON, Inc.

K number K844228

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FTM 1984-11-14

LINK ACETABULAR MESH

Applicant Waldemar Link GmbH & Co. KG

K number K844225

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FTM 1983-08-16

FOIL IN 3 FORMS-NON-STERILE SHEETS

Applicant S. Jackson, Inc.

K number K831725

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FTM 1983-08-12

QUARTER GLOBE CAPS

Applicant S. Jackson, Inc.

K number K831727

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FTM 1983-08-12

SUPRAMID EXTRA SURGICAL MESH

Applicant S. Jackson, Inc.

K number K831723

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FTM 1983-08-11

EYE MUSCLE SLEEVES

Applicant S. Jackson, Inc.

K number K831726

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FTM 1983-05-09

DEXON 'S' POLYGLYCOLIC ACID MESH

Applicant Davis & Geck, Inc.

K number K830889

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FTM 1982-05-14

MECRON(R) ACETABULAR NETS TM

Applicant Serrano Intl.

K number K820619

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