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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 21, 1994 | K930759 | CP & S STERILE BURN SHEET Consolidated Products & Services, Inc. | FPY |
| Apr 20, 1993 | K926290 | BURN SHEET Gam Industries, Inc. | FPY |
| Apr 20, 1993 | K921471 | BURNSHIELD TRAUMA DRESSING Levtrade Intl. (Pty) , Ltd., ZA | FPY |
| Apr 20, 1993 | K921470 | BURNSHIELD FIRE BLANKET Levtrade Intl. (Pty) , Ltd., ZA | FPY |
| Jul 3, 1990 | K900443 | BURNS CASUALTY SHEET LIMB WRAP Pilgrim Medical Services, GB | FPY |
| Jul 3, 1990 | K900442 | BURNS CASUALTY SHEET BURN ROLL Pilgrim Medical Services, GB | FPY |
| Jul 3, 1990 | K900441 | BURNS CASUALTY SHEET Pilgrim Medical Services, GB | FPY |
| Jun 9, 1987 | K871740 | LYOSHEET SURGICAL SHEET FOR BURNS Acme United Corp. | FPY |
| Aug 30, 1985 | K853145 | KENDALL CURITY BURN PAD The Kendal Co. | FPY |
| Aug 14, 1984 | K841898 | FIRST RESPONSE EMERG. MEDICSL - BURNS Reed Products, Inc. | FPY |
| May 13, 1982 | K820994 | ABSORB FURN SHEET American Convertors Div., American Pharmaseal | FPY |
| Mar 25, 1980 | K800064 | WATER JEL FIRE BLANKET Trilling Resources, Ltd. | FPY |
| Dec 20, 1979 | K792433 | TEMPORARY BURN SHEET WITH PERFORATED American Medical Disposable, Inc. | FPY |
| Dec 20, 1979 | K792432 | TEMPORARY BURN SHEET WITH PERFORATED American Medical Disposable, Inc. | FPY |
| Apr 10, 1978 | K780418 | BURN DRESSING PAD The Owenby Co. | FPY |
| Aug 11, 1976 | K760365 | BLANKET, BURN Winn Hirsch & Assoc. | FPY |
| Aug 11, 1976 | K760210 | BLANKET, WATER-JEL FIRE American Safety | FPY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.