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N6.5B Tips PK100

OTODYNAMICS LIMITED · Model T-N6.5B · UDI-DI 05060396172267

510(k) clearances

Adverse events

Recalls

Facilities

Description

Probe Ear Tip, neonate, N6.5B, Green (pack of 100). For DPOAE and TEOAE testing. Appropriate for larger newborns and first year infants with approx. 6.5mm (0.26") ear canal. The N6.5B probe tip is to be used with X-series probes (via Neonate Tip Holder). NB: Otodynamics probe tips are latex-free. Recommended for single use.

Recalls

Date	Firm	Reason
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16	Cardinal Health, Inc	GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor

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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.