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

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

21 CFR 878.4022 / General, Plastic Surgery
FDA source (opens on fda.gov)

NAE is the FDA product code for Dressing, Wound, Hydrogel Without Drug And/Or Biologic, a class I device type, regulated under 21 CFR 878.4022. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
NAE
Device name
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Regulation
21 CFR 878.4022
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
29
Ingested recalls
6

Clearances, product code NAE

By decision year
29 clearances under product code NAE with a decision year between 1980 and 2009, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code NAE by decision year
YearClearances
19801
19811
19911
19925
19933
19946
19954
19961
19972
19992
20082
20091

Applicants with the most clearances

Product code NAE
Applicants holding the most 510(k) clearances under product code NAE
ApplicantClearances
Brady Medical Products Co.4
Smith & Nephew United, Inc.3
Gorbec Pharmaceutical Services, Inc.2
Medtronic, Inc.2
Ndm Acquisition Corp.2
Bioderm, Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
Convatec, A Division of E.R. Squibb & Sons1
Dermaphylyx, Inc.1
DeRoyal Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 291 companies shown, in name order