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Apparatus, Vestibular Analysis

FDA product code LXV · Class U · Unknown

5
Registered devices
2
Adverse events
2
Recalls
22
510(k) clearances

Devices with this code

Korebalance Mobile — Diversified Healthcare Development, LLCK-D Balance — King-Devick Test, Inc.Interacoustics — Interacoustics A/SKorebalance Premiere — Diversified Healthcare Development, LLCSway — HEALTHY ROSTER LLC

Recent recalls

DateFirmReason
2009-07-24Neuro KineticsMarketed without a 510k or PMA submission to include the normative data display.
2008-07-09Acacia Engineered Products LLCThe firm distributed an unapproved medical device.

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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.