FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR— 510(k) K932137

Substantially Equivalent

Tecnol Medical Products, Inc.

FDA 510(k) clearance K932137 for FLUIDSHIELD SURGICAL/PROCEDURE MASK/M. WITH VISOR, Substantially Equivalent on 1994-04-15. Applicant: Tecnol Medical Products, Inc..

Clearance details

Applicant: Tecnol Medical Products, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 1993-04-27
Decision date: 1994-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.