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
81 devices
25–48 of 81
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
Cleared Aug 06, 1998
SILON SCAR STRIPS
K982036
Bio Med Sciences, Inc.
General & Plastic Surgery · 57d
Cleared Aug 05, 1998
KELOCATE SHEETING
K982051
Allied Biomedical Corp.
General & Plastic Surgery · 55d
Cleared Jun 25, 1998
SPENCO SILICONE GEL SHEET
K981902
Spenco Medical Corp.
General & Plastic Surgery · 24d
Cleared Jun 10, 1998
EVANESCE SCAR MANAGEMENT SYSTEM
K981387
Medical Scientific, Inc.
General & Plastic Surgery · 55d
Cleared May 20, 1998
SKAR-KARE SHEET
K980563
Life Medical Sciences, Inc.
General & Plastic Surgery · 96d
Cleared Apr 03, 1998
REJUVENESS
K974380
Rejuveness Pharamceuticals, Inc.
General & Plastic Surgery · 164d
Cleared Mar 30, 1998
SILGEL TOPICAL GEL SHEET
K974172
Nagor , Ltd.
General & Plastic Surgery · 145d
Cleared Mar 27, 1998
KMC NEWSKIN
K974143
Kmc Intl. Co.
General & Plastic Surgery · 144d
Cleared Mar 05, 1998
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE
K974354
Sca Molnlycke
General & Plastic Surgery · 106d
Cleared Nov 19, 1997
SKAR-KARE
K973271
Target Health, Inc.
General & Plastic Surgery · 78d
Cleared Oct 21, 1997
KELOCOTE SCAR GEL AND KELOCOTE LASER GEL
K973572
Hanson Medical, Inc.
General & Plastic Surgery · 32d
Cleared Oct 01, 1997
PMT NEW BEGINNINGS GELSHAPES & AMEND
K972597
Pmt Corp.
General & Plastic Surgery · 82d
Cleared Jul 29, 1997
SCAR CARE
K971009
Target Health, Inc.
General & Plastic Surgery · 131d
Cleared Jul 29, 1997
MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
K971916
Medical Z, S.A.
General & Plastic Surgery · 67d