NERVE INTEGRITY MONITOR-2 (NIM-2 XL)— 510(k) K934426

Substantially Equivalent

Xomed-Treace, Inc.

FDA 510(k) clearance K934426 for NERVE INTEGRITY MONITOR-2 (NIM-2 XL), Substantially Equivalent on 1994-05-13. Applicant: Xomed-Treace, Inc..

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 1993-09-10
Decision date: 1994-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.