MDA · Class I · 21 CFR 878.4025

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

Leading manufacturers include Implantech Associates, Inc., Smith & Nephew, Inc. and Beiersdorf, Inc..

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 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 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 Jul 30, 1999
CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL.
K991968
Smith & Nephew, Inc.
General & Plastic Surgery · 49d
Cleared Jul 20, 1999
CICACARE MANAGEMENT FOR SCARS
K991957
Smith & Nephew, Inc.
General & Plastic Surgery · 40d
Cleared Feb 12, 1997
IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING
K964846
Implantech Associates, Inc.
General & Plastic Surgery · 71d
Cleared Aug 22, 1996
MENTOR H/S SILICONE GEL SHEETING FOR SCAR MANAGEMENT
K962013
Mentor Corp.
General & Plastic Surgery · 91d
Cleared Feb 03, 1994
CICA-CARE SILICONE GEL SHEET
K935803
Smith & Nephew United, Inc.
General & Plastic Surgery · 63d

About Product Code MDA - Regulatory Context