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Novatome™
Merit Medical Systems, Inc. · Model C · UDI-DI 00884450392829
DWZ
Prescription
10
510(k) clearances
89
Adverse events (1 deaths)
1
Recalls
24
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-04-12 | Heartport, Inc. | Guidewire is protruding through the film portion of the packages which compromises the sterility of the device. |
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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.