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GN Otometrics A/S

Natus Medical Denmark ApS · Model 1096, SA,CLINI W/ PRIN, CLAS US · UDI-DI 05713315005657

ETY
10
510(k) clearances
6
Adverse events
1
Recalls
14
Facilities

Recalls

DateFirmReason
2005-06-27Natus Medical IncInternal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.