K053526
Substantially EquivalentMICROSPEED UNI MOTOR SYSTEM
- Applicant
- Aesculap, Inc.
- Product code
- HBC
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Center Valley, PA, US
Adverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
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.