ANOLIFT - PORTABLE & ANOLIFT - GANTRY— 510(k) K902141

Substantially Equivalent

Anodyne Corp.

FDA 510(k) clearance K902141 for ANOLIFT - PORTABLE & ANOLIFT - GANTRY, Substantially Equivalent on 1990-09-12. Applicant: Anodyne Corp..

Clearance details

Applicant: Anodyne Corp.
Product code: Code FSA
Advisory panel: General Hospital
Date received: 1990-05-15
Decision date: 1990-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brighton, MI, US

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Adverse events under product code FSA

product code FSA

Death: 101
Injury: 767
Malfunction: 1,173
Other: 1
Total: 2,042

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.