PATH
FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
- Device recalls: 5
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Nov 6, 2025 | MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)Class II · Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus | Device recalls |
| Sep 26, 2023 | SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-SClass II · Affected lots of product may experience technical distortions to a greater extent than expected. | Device recalls |
| Sep 26, 2023 | SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2Class II · Affected lots of product may experience technical distortions to a greater extent than expected. | Device recalls |
| Sep 26, 2023 | SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098Class II · Affected lots of product may experience technical distortions to a greater extent than expected. | Device recalls |
| Sep 26, 2023 | AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUPClass II · Affected lots of product may experience technical distortions to a greater extent than expected. | Device recalls |
Canada and Imports
Matched by company name- FDA import refusals since 2024
- 1 shipment lines, through Oct 23, 2026
Names and Identifiers
- Appears as
- Website
- path.org
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built