MDA · Class I · 21 CFR 878.4025

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

Leading manufacturers include Implantech Associates, Inc., Pmt Corp. and Medtrade Products , Ltd..

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 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 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 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 Mar 19, 2001
MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD
K003979
Medtrade Products , Ltd.
General & Plastic Surgery · 87d
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
Cleared Aug 05, 1999
SILGEL STC-S
K984029
Nagor , Ltd.
General & Plastic Surgery · 266d
Cleared Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Jul 30, 1999
SCARAID SILICONE GEL SHEETING
K992146
Biodermis Corp.
General & Plastic Surgery · 36d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Jun 21, 1999
TENDER TOUCH SILICONE GEL PADS
K991478
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 54d
Cleared Jun 11, 1999
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET
K991630
Advanced Medical Solutions Group Plc
General & Plastic Surgery · 31d
Cleared Jun 09, 1999
EPI-FOAM SILICONE SHEETING
K991604
Biodermis Corp.
General & Plastic Surgery · 30d
Cleared Jun 01, 1999
AVOGEL
K981353
Avocet Polymer Technologies, Inc.
General & Plastic Surgery · 413d
Cleared Apr 14, 1999
NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS
K984213
Capital Marketing Technologies, Inc.
General & Plastic Surgery · 141d
Cleared Feb 12, 1999
SCAREASE & SCAREASE ADHESIVE GEL
K984115
Scarease, Inc.
General & Plastic Surgery · 87d

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