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Integra® Miltex®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 19-21 · UDI-DI 10381780418993

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

Description

Integra® Miltex® Gruber Ear Specula set of 4, Long Oval, Includes: (REF #'s 19-22, 19-23, 19-24, & 19-25)

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.