K000195

Substantially Equivalent

CRANIAL DRILL

Applicant: Image-Guided Neurologics, Inc.
Product code: HBB
Advisory panel: Neurology
Date received: 2000-01-21
Decision date: 2000-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.