Compact II
Avante · Model 60132II · UDI-DI 00815871020299
1
510(k) clearances
37
Adverse events (1 deaths)
4
Recalls
18
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl |
| 2019-09-11 | Pacific Medical Group Inc. | Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse cl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.