510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MDAClass I

Elastomer, Silicone, For Scar Management

21 CFR 878.4025 / General, Plastic Surgery
FDA source (opens on fda.gov)

MDA is the FDA product code for Elastomer, Silicone, For Scar Management, a class I device type, regulated under 21 CFR 878.4025. As of , FDA records hold 81 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MDA
Device name
Elastomer, Silicone, For Scar Management
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
81
Ingested recalls
0

Clearances, product code MDA

By decision year
81 clearances under product code MDA with a decision year between 1985 and 2011, 1999 the highest year at 14.
Show the numbers
510(k) clearances under FDA product code MDA by decision year
YearClearances
19851
19902
19911
19921
19931
199412
19956
19965
19979
19989
199914
20002
20016
20023
20033
20041
20051
20061
20091
20112

Applicants with the most clearances

Product code MDA
Applicants holding the most 510(k) clearances under product code MDA
ApplicantClearances
Bio Med Sciences, Inc.7
Biodermis LLC4
Implantech Associates Inc3
PMT Corp.3
Silipos, Inc.3
Advanced Bio-Technologies, Inc.2
Allied Biomedical Corp.2
Brennen Medical, Inc.2
Capital Marketing Technologies, Inc.2
Crown Delta Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 189 companies shown, in name order