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AMBLER SURGICAL CORP. · Model Farrior ear speculum · UDI-DI 00190660178048

EPY Prescription
10
510(k) clearances
10
Adverse events
2
Recalls
231
Facilities

Description

Farrior ear speculum, oval, oblique ends, set of 11 includes sizes #1 - #11 (86-210, 86-211, 86-212, 86-213, 86-214, 86-215, 86-216, 86-217, 86-218, 86-219, and 86-220), black ceramic finish

Recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2024-02-23MEDLINE INDUSTRIES, LP - NorthfieldProduct may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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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.