VMI 1000 SURGICAL PACEOMETER— 510(k) K951145

Substantially Equivalent

Vision Medical Instruments, Inc.

FDA 510(k) clearance K951145 for VMI 1000 SURGICAL PACEOMETER, Substantially Equivalent on 1995-06-19. Applicant: Vision Medical Instruments, Inc..

Clearance details

Applicant: Vision Medical Instruments, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1995-03-13
Decision date: 1995-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chagrin Falls, OH, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.