Panels › General Hospital › Product code OUG · Class 1
Medical Device Data System
Regulation 880.6310
0510(k)s in 12 months (1 all time)
0recalls in 12 months (24 all time)
0recalls that name a 510(k)
Top companies in OUG
| Company | 510(k)s | Recalls |
|---|---|---|
| Beckman Coulter Inc. | 0 | 4 |
| BioMerieux SA | 0 | 2 |
| Merge Healthcare, Inc. | 0 | 2 |
| Pentax of America Inc | 0 | 2 |
| Radiometer Medical ApS | 0 | 2 |
| CareFusion 209 Inc. | 0 | 1 |
| ENDOTRONIX | 0 | 1 |
| Horiba Instruments Inc | 0 | 1 |
| Intel-GE Care Innovations LLC | 0 | 1 |
| Maquet Cardiovascular Us Sales, Llc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 22, 2013 | K122361 | T:CONNECT DATA MANAGEMENT SYSTEM Tandem Diabetes Care, Inc. | OUG |
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