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Integra® Miltex®

INTEGRA LIFESCIENCES PRODUCTION CORPORATION · Model 1080 · UDI-DI 10381780357902

FGM Prescription
7
510(k) clearances
20
Adverse events (1 deaths)
1
Recalls
104
Facilities

Description

Integra® Miltex® Grooved Director 5-1/8", with Probe Point and Tongue Tie

Recalls

DateFirmReason
2004-02-06Medtronic Gastroenterology / UrologyThe product's rear panel label could smear during use causing the serial number to be unreadible. This has the remote possibility of resulting in patient data from diagnostic test

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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.