MEDELA THOPAZ+— 510(k) K141553

Substantially Equivalent

Medela AG

FDA 510(k) clearance K141553 for MEDELA THOPAZ+, Substantially Equivalent on 2014-08-25. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2014-06-11
Decision date: 2014-08-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Baar, Zug, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.