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OSSEOUS

EON MEDITECH PRIVATE LIMITED · Model E7191-O · UDI-DI 08904428722136

EMX Prescription
10
510(k) clearances
102
Adverse events (2 deaths)
4
Recalls
53
Facilities

Description

Sinus Packs sponges are designed to be placed inside the sinus cavity for use as temporary tamponade or hemostasis device to control blood oozing or persistent bleeding.

Recalls

DateFirmReason
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised

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Data 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.