Panels › General, Plastic Surgery › Product code NAD · Class 1
Dressing, Wound, Occlusive
Regulation 878.4020
1510(k)s in 12 months (107 all time)
0recalls in 12 months (19 all time)
8recalls that name a 510(k)
Top companies in NAD
| Company | 510(k)s | Recalls |
|---|---|---|
| COVIDIEN LLC | 0 | 9 |
| Chesebrough-Pond'S U.S.A. Co. | 5 | 0 |
| Smith & Nephew, Inc. | 5 | 0 |
| The Bfgoodrich Co. | 4 | 0 |
| Convatec, A Division of E.R. Squibb & Sons | 4 | 0 |
| Dermatec, Inc. | 4 | 0 |
| Fraass Survival Systems, Inc. | 4 | 0 |
| Acme United Corp. | 3 | 0 |
| ConvaTec, Inc | 0 | 3 |
| Kendall Healthcare Products Co | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 8, 1983 | K830089 | BURN DRESSING Action Medical Systems, Inc. | NAD |
| Oct 15, 1982 | K822080 | ADHESIVE WOUND COVER FILM Hollister, Inc. | NAD |
| Sep 16, 1980 | K802021 | PEDIBAND CAT.#195-197 Pollak (Intl.), Ltd. | NAD |
| Sep 9, 1980 | K801840 | SURGICAL BANDAGES/SUNLEEP DX Martin'S Maine Exchange | NAD |
| May 20, 1980 | K800953 | FIXOMULL STERILE Beiersdorf, Inc. | NAD |
| Aug 28, 1979 | K791369 | AIRSTRIP THEATRE WARD DRESSING Acme United Corp. | NAD |
| Jan 6, 1977 | K761093 | BANDAGE Paco Pharmaceutical Services, Inc. | NAD |
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