Panels › General Hospital › Product code FPY · Class 1
Sheet, Burn
Regulation 880.5180
0510(k)s in 12 months (17 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FPY
| Company | 510(k)s | Recalls |
|---|---|---|
| Pilgrim Medical Services | 3 | 0 |
| American Medical Disposable, Inc. | 2 | 0 |
| Levtrade Intl. (Pty) , Ltd. | 2 | 0 |
| Acme United Corp. | 1 | 0 |
| American Convertors Div., American Pharmaseal | 1 | 0 |
| American Safety | 1 | 0 |
| Consolidated Products & Services, Inc. | 1 | 0 |
| Dukal Corp. | 0 | 1 |
| Gam Industries, Inc. | 1 | 0 |
| The Kendal Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2017 | Dukal Corp. BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01
Product Usage - May provide a sterile, barrier environment to protect patient from infection. Terminated |
FPY | None listed |
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