K152670

Substantially Equivalent

DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables

Applicant: Medos International SARL
Product code: GWM
Advisory panel: Neurology
Date received: 2015-09-17
Decision date: 2016-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Locle, CH

Adverse events under product code GWM

product code GWM

Death: 21
Injury: 732
Malfunction: 2,063
Other: 1
Total: 2,817

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.