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Madsen
Natus Medical Denmark ApS · Model 1012 OTOflex Cavity set · UDI-DI 05713315009013
ETY
Prescription
1
510(k) clearances
6
Adverse events
1
Recalls
14
Facilities
Description
Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-06-27 | Natus Medical Inc | Internal 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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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.