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
49–72 of 81
Cleared Jun 24, 1997
DEGANIA SILICONE SIL-K
K971482
Degania Silicone , Ltd.
General & Plastic Surgery · 64d
Cleared Jun 10, 1997
SCAR HEAL
K971468
Specialty Systems, Inc.
General & Plastic Surgery · 49d
Cleared May 12, 1997
SPECTRUM DESIGNS SPECTRAGEL
K970702
Spectrum Designs, Inc.
General & Plastic Surgery · 75d
Cleared Feb 12, 1997
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Dec 05, 1996
NOVAGEL SILICONE GEL SHEETING
K963128
Brennen Medical, Inc.
General & Plastic Surgery · 115d
Cleared Sep 03, 1996
DURASIL (MODIFICATION)
K961410
The S. F. Group, Inc.
General & Plastic Surgery · 175d
Cleared Aug 22, 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013
Mentor Corp.
General & Plastic Surgery · 91d
Cleared Apr 02, 1996
SILGEL TOPICAL GEL SHEET
K960254
Rofil Medical USA, Inc.
General & Plastic Surgery · 76d
Cleared Feb 28, 1996
STERILIZED TRI BLOCK POLYMER GEL SHEET
K955664
Silipos, Inc.
General & Plastic Surgery · 77d
Cleared Nov 29, 1995
KELOCOTE
K954413
Allied Biomedical Corp.
General & Plastic Surgery · 69d
Cleared Nov 22, 1995
DURASIL
K952612
The S. F. Group, Inc.
General & Plastic Surgery · 168d
Cleared Sep 26, 1995
SILK*SKIN SCAR TREATMENT
K953420
Silk*Skin Care Co.
General & Plastic Surgery · 78d
Cleared Aug 07, 1995
SILON SILICONE TEXTILE COMPOSITE
K952546
Bio Med Sciences, Inc.
General & Plastic Surgery · 66d
Cleared Jul 13, 1995
SILON SILICONE FOAM SHEETING
K946362
Bio Med Sciences, Inc.
General & Plastic Surgery · 217d
Cleared Mar 03, 1995
SILON(R) SILICONE THERMOPLASTIC SHEETING
K945892
Bio Med Sciences, Inc.
General & Plastic Surgery · 91d
Cleared Nov 28, 1994
SKIN NEUVEAU SCAR TREATMENT
K942339
Puritas Health Care, Inc.
General & Plastic Surgery · 196d
Cleared Nov 10, 1994
TRI BLOCK POLUMER GEL SHEETING
K942695
Silipos, Inc.
General & Plastic Surgery · 156d
Cleared Aug 11, 1994
SILK*SKIN SCAR TREATMENT
K941197
Puritas Health Care, Inc.
General & Plastic Surgery · 150d
Cleared Jun 13, 1994
EPI-DERM SILICONE GEL SHEETING
K942156
Biodermis Corp.
General & Plastic Surgery · 41d
Cleared May 31, 1994
NOVAGEL SILICONE GEL SHEETING
K941125
Brennen Medical, Inc.
General & Plastic Surgery · 83d
Cleared May 12, 1994
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST
K933811
Pitt Enterprises (Silicone) , Ltd.
General & Plastic Surgery · 281d
Cleared Apr 04, 1994
JOBSKIN CONTINUING CARE
K925583
Jobst Institute, Inc.
General & Plastic Surgery · 515d
Cleared Feb 10, 1994
PMT SILICONE SHEETING
K935499
Pmt Corp.
General & Plastic Surgery · 86d
Cleared Feb 03, 1994
HASKON MEDICAL GRADE SHEETING
K934829
Haskon Intl., Inc.
General & Plastic Surgery · 118d