DEFIGARD 2000— 510(k) K854175

Substantially Equivalent

Odam

FDA 510(k) clearance K854175 for DEFIGARD 2000, Substantially Equivalent on 1986-01-13. Applicant: Odam.

Clearance details

Applicant: Odam
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1985-10-15
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wissembourg Cedex, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.