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OtoClear® Irrigation Tips

Bionix, LLC · Model 7200ST · UDI-DI 00859911004870

KCP Prescription
4
510(k) clearances
26
Adverse events
1
Recalls
143
Facilities

Description

OtoClear Irrigation Tips, bulk 5,000

Recalls

DateFirmReason
2003-04-30Medegen Medical Products, LLCFinished products were not sterilized.

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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.