K850622

Substantially Equivalent

OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR

Applicant: Oscor Medical Corp.
Product code: LDF
Advisory panel: Cardiovascular
Date received: 1985-02-19
Decision date: 1985-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.