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Accessory Box AB08
PATH medical GmbH · Model 100734-P · UDI-DI 04260223146138
GWJ
Prescription
10
510(k) clearances
119
Adverse events
4
Recalls
58
Facilities
Description
Accessory box Content: 1. Box. AN101329 2. Ear Tip PM007H 7 mm mushroom. AN100765-PH 3. Ear Tip PM009H 9 mm mushroom. AN100767-PH 4. Ear Tip PM010H 10 mm mushroom. AN100768-PH 5. Ear Tip PM011H 11 mm mushroom. AN100769-PH 6. Ear Tip PM012H 12 mm mushroom. AN100770-PH 7. Ear Tip PM013H 13 mm mushroom. AN100771-PH 8. Ear Tip PM014H 14 mm mushroom. AN100772-PH 9. Ear Tip PM016H 16 mm mushroom. AN100773-PH 10. Ear Tip PM018H 18 mm mushroom. AN100774-PH
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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Get your free API keyRead the docsData 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.