Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)— 510(k) K241311

Substantially Equivalent

Bernhard Förster GmbH

FDA 510(k) clearance K241311 for Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach), Substantially Equivalent on 2024-08-02. Applicant: Bernhard Förster GmbH.

Clearance details

Applicant: Bernhard Förster GmbH
Product code: Code MQC
Advisory panel: Unknown
Date received: 2024-05-09
Decision date: 2024-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pforzheim, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.