MODEL #310T03500 WRIST COIL— 510(k) K942355

Substantially Equivalent

Medic, Inc.

FDA 510(k) clearance K942355 for MODEL #310T03500 WRIST COIL, Substantially Equivalent on 1994-09-16. Applicant: Medic, Inc..

Clearance details

Applicant: Medic, Inc.
Product code: Code LNH
Advisory panel: Radiology
Date received: 1994-05-17
Decision date: 1994-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, NE, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.