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Silicone Nasal Epistaxis Balloon
FORTUNE MEDICAL INSTRUMENT CORP. · Model 3103-0930 · UDI-DI 14711182605480
10
510(k) clearances
103
Adverse events (2 deaths)
4
Recalls
52
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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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.