510(k) K180443— Tumark Vision

Substantially Equivalent

Somatex Medical Technologies GmbH

Clearance details

Applicant: Somatex Medical Technologies GmbH
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2018-02-20
Decision date: 2018-03-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Teltow, DE

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.