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Epistat

MEDTRONIC XOMED, INC. · Model 1527031 · UDI-DI 00763000340353

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

Description

CATHETER 1527031 EPISTAT NASAL

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.