510(k) K112167— SOYALA SILKGEL FULL FACE MASK

Substantially Equivalent

Weinmann Gerate Fur Medizin GmbH + Co. KG

Clearance details

Applicant: Weinmann Gerate Fur Medizin GmbH + Co. KG
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2011-07-28
Decision date: 2011-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Hamburg, DE

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.