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OSSEOUS
EON MEDITECH PRIVATE LIMITED · Model E7180-O · UDI-DI 08904428722020
EMX
Prescription
10
510(k) clearances
102
Adverse events (2 deaths)
4
Recalls
53
Facilities
Description
Standard Nasal Dressings sponges are designed to be placed inside the nasal cavities for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and allowing smooth septum ventilation to ensure patient comfort. The device in invasive with respect to body orifice.
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.
