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Natus

XLTEK · Model 104037 · UDI-DI 00382830003155

IKN Prescription
10
510(k) clearances
111
Adverse events (2 deaths)
1
Recalls
69
Facilities

Description

AUDITORY STIMULATION HEADPHONES FOR XLTEK XCALIBUR

Recalls

DateFirmReason
2010-01-29SpineMatrix IncA full design review of the CERSR system was conducted in 7/2009. The audit revealed numerous design verification tests that either did not pass or did not meet the design input r

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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.