MDA · Class I · 21 CFR 878.4025

FDA Product Code MDA: Elastomer, Silicone, For Scar Management

Leading manufacturers include Bio Med Sciences, Inc., Biodermis Corp. and Pmt Corp..

81
Total
81
Cleared
122d
Avg days
1985
Since

FDA 510(k) Cleared Elastomer, Silicone, For Scar Management Devices (Product Code MDA)

81 devices
1–24 of 81
Cleared Sep 29, 2011
NEODYNE DRESSING
K112131
Neodyne Biosciences, Inc.
General & Plastic Surgery · 65d
Cleared Sep 22, 2011
CORELEADER SCAR-DIMMER
K111733
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 93d
Cleared Jan 26, 2009
BEAU RX SCAR CARE GEL
K083718
Beau RX Solutions, LLC
General & Plastic Surgery · 42d
Cleared Apr 14, 2006
KELO-COTE SPRAY
K053481
Advanced Bio-Technologies, Inc.
General & Plastic Surgery · 121d
Cleared Oct 17, 2005
NEWGEL AND NEWGEL PLUS E
K041704
Newmedical Technology, Inc.
General & Plastic Surgery · 481d
Cleared Aug 12, 2004
HANSON SCAR ADE
K040307
Hanson Medical, Inc.
General & Plastic Surgery · 185d
Cleared Jun 18, 2003
CURAD SCAR THERAPY
K024057
Beiersdorf, Inc.
General & Plastic Surgery · 191d
Cleared Mar 17, 2003
NEOSPORIN SCAR SOLUTION
K024160
Warner-Lambert Co.
General & Plastic Surgery · 90d
Cleared Jan 23, 2003
DIMISIL SCAR GEL
K023678
Aesthetic and Reconstructive Technologies, Inc.
General & Plastic Surgery · 83d
Cleared Oct 16, 2002
OLEEVA FABRIC
K023136
Bio Med Sciences, Inc.
General & Plastic Surgery · 26d
Cleared Feb 14, 2002
MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030.
K014036
Medtrade Products , Ltd.
General & Plastic Surgery · 69d
Cleared Feb 07, 2002
GELZONE
K013732
Implantech Associates, Inc.
General & Plastic Surgery · 90d
Cleared Oct 24, 2001
CONFORM SHEETING, MODEL IGEL
K012419
Implantech Associates, Inc.
General & Plastic Surgery · 86d
Cleared May 30, 2001
ENSIL FABRIC
K010675
Gottfried Medical, Inc.
General & Plastic Surgery · 85d
Cleared Apr 25, 2001
ACTIVHEAL SCAR MANAGEMENT DRESSING
K010245
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 90d
Cleared Mar 19, 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979
Medtrade Products , Ltd.
General & Plastic Surgery · 87d
Cleared Jan 29, 2001
EPI-DERM SILICONE GEL SHEETING
K003948
Biodermis Corp.
General & Plastic Surgery · 39d
Cleared Jan 05, 2001
KELO-COTE TOPICAL GEL
K002488
Advanced Bio-Technologies, Inc.
General & Plastic Surgery · 144d
Cleared Aug 31, 2000
OLEEVA FOAM
K002109
Bio Med Sciences, Inc.
General & Plastic Surgery · 50d
Cleared Jul 25, 2000
BLAINE SCARCARE PATCH
K001608
Blaine Labs, Inc.
General & Plastic Surgery · 62d
Cleared Oct 26, 1999
SPECTRUM DESIGNS SPECTRAGEL
K992522
Spectrum Designs, Inc.
General & Plastic Surgery · 90d
Cleared Oct 25, 1999
SCAREASE SHEETS & SCAREASE GEL
K991970
Pillar Surgical
General & Plastic Surgery · 136d
Cleared Aug 20, 1999
SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING
K991312
Library Medical, Inc.
General & Plastic Surgery · 126d
Cleared Aug 13, 1999
SKIN 2 FORTE SILICONE SHEETING
K990651
United Hospital Technologies, Inc.
General & Plastic Surgery · 165d

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