TRAUMA TABLE— 510(k) K853535

Substantially Equivalent

Xre Corp.

FDA 510(k) clearance K853535 for TRAUMA TABLE, Substantially Equivalent on 1985-09-11. Applicant: Xre Corp..

Clearance details

Applicant: Xre Corp.
Product code: Code GDC
Advisory panel: General, Plastic Surgery
Date received: 1985-08-23
Decision date: 1985-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

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Adverse events under product code GDC

product code GDC

Malfunction: 791
Total: 791

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.