MODIFICATION TO AUTOFUSER— 510(k) K090300

Substantially Equivalent

Ace Medical Us, LLC

FDA 510(k) clearance K090300 for MODIFICATION TO AUTOFUSER, Substantially Equivalent on 2009-04-30. Applicant: Ace Medical Us, LLC.

Clearance details

Applicant: Ace Medical Us, LLC
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2009-02-06
Decision date: 2009-04-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Powell, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.