DeviceClearance

K001339

Substantially Equivalent

MRI FASTSYSTEM RETRACTOR SYSTEM

Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc.
Product code
GAD
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Minneapolis, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code GAD

product code GAD
Malfunction
504
Total
504

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.