K220698

Substantially Equivalent

Bambino 3, S3 and S3 Swing, U3 and U3 Light, X

Applicant: Panthera AB
Product code: IOR
Advisory panel: Physical Medicine
Date received: 2022-03-09
Decision date: 2023-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.