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MILLENNIUM

Avalign Technologies, Inc. · Model 10-385255 · UDI-DI 00190776351229

KAL Prescription
5
510(k) clearances
15
Adverse events
1
Recalls
123
Facilities

Description

Endaural Retractor

Recalls

DateFirmReason
2023-05-25TELEFLEX LLCThere are incomplete pre-cleaning instructions within the Instructions for Use (IFU).

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.