Integrity V500

Vivosonic Inc · Model V500 · UDI-DI 00627908010018

510(k) clearances

Adverse events

Recalls

Facilities

Description

Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025 B71-10 Bone Conductor: DI 00627908010032 ER-3A-ABR Insert Earphones: DI 00627908010049 HDA 300 EP Headphones: DI 00627908010056 P40-GP OAE Probe: DI 00627908010063 P40-UG OAE Probe: DI 00627908010070

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

Query this across every FDA database — by API.

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

Get your free API key Read the docs

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.