TRANSTHORACIC/TRANSABDOMINAL-TRAY— 510(k) K833720

Substantially Equivalent

Applied Medical Devices, Inc.

FDA 510(k) clearance K833720 for TRANSTHORACIC/TRANSABDOMINAL-TRAY, Substantially Equivalent on 1984-05-30. Applicant: Applied Medical Devices, Inc..

Clearance details

Applicant
Applied Medical Devices, Inc.
Product code
Code GDM
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GDM

product code GDM
Death
2
Total
2

Source: openFDA MAUDE database, through . 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.