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Accessory Box AB01

PATH medical GmbH · Model 100135 · UDI-DI 04260223140716

GWJ Prescription

510(k) clearances

119

Adverse events

Recalls

Facilities

Description

Accessory set including: 5 pcs. 100013 Probe Tip PT-A 1 pcs. 100129 Test Cavity 10 pcs. 100063 Ear Tip ET-03 10 pcs. 100064 Ear Tip ET-10 7 pcs. 100125 Ear Tip ET-11 12 pcs. 100126 Ear Tip Soft ET-S12 7 pcs. 100230 Ear Tip Soft ET-S14 7 pcs. 100144 Ear Tip ET-13 2pcs. 100151 Cleaning Tool CT-01

Recalls

Date	Firm	Reason
2025-11-06	PATH	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
2019-05-28	GN Otometrics	There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock.
2010-06-04	Natus Medical Inc	There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.
2008-10-21	Intelligent Hearing Systems Corp.	This was a marketing correction mandated by the United States Food and Drug Administration (USFDA). USFDA notified Intelligent Hearing Systems that 501(k) premarket notification ap

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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.