Panels › General, Plastic Surgery › Product code OJU · Class 1
Skin Prep Tray
Regulation 878.4800
0510(k)s in 12 months (1 all time)
4recalls in 12 months (21 all time)
0recalls that name a 510(k)
Top companies in OJU
| Company | 510(k)s | Recalls |
|---|---|---|
| Medline Industries Inc | 0 | 6 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 6 |
| Centurion Medical Products Corporation | 0 | 3 |
| Carefusion 2200 Inc | 0 | 2 |
| American Contract Systems | 0 | 1 |
| American Optisurgical Inc | 0 | 1 |
| CareFusion 213, LLC | 0 | 1 |
| MEDLINE INDUSTRIES, LP - SPT | 0 | 1 |
| Pharmaseal Div., Baxter Healthcare Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 8, 1978 | K781797 | PREP TRAY, PREOPERATIVE SKIN Pharmaseal Div., Baxter Healthcare Corp. | OJU |
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