Natus
XLTEK · Model 10442 · UDI-DI 00382830000000
IKN
Prescription
1
510(k) clearances
111
Adverse events (2 deaths)
1
Recalls
69
Facilities
Description
Xltek NeuroMax 2 Channel Headbox with cable
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-01-29 | SpineMatrix Inc | A 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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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.