510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Path

Germering Bavaria, DE

PATH appears in FDA device records in Germering Bavaria, DE. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
5
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Path, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30081112283008111228PATHLandsberger Strasse 65, Germering Bavaria 82110 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0940-2026MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses and may result in a false PASS outcome.Class IIOpen, Classified
Z-0404-2024SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-SAffected lots of product may experience technical distortions to a greater extent than expected.Class IIOpen, Classified
Z-0403-2024AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUPAffected lots of product may experience technical distortions to a greater extent than expected.Class IIOpen, Classified
Z-0402-2024SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2Affected lots of product may experience technical distortions to a greater extent than expected.Class IIOpen, Classified
Z-0401-2024SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098Affected lots of product may experience technical distortions to a greater extent than expected.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain