MERIDIAN CRANIAL PERFORATOR— 510(k) K121253

Substantially Equivalent

Adeor Medical Technologies GmbH

FDA 510(k) clearance K121253 for MERIDIAN CRANIAL PERFORATOR, Substantially Equivalent on 2012-07-17. Applicant: Adeor Medical Technologies GmbH.

Clearance details

Applicant: Adeor Medical Technologies GmbH
Product code: Code HBF
Advisory panel: Neurology
Date received: 2012-04-25
Decision date: 2012-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pullach, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBF

product code HBF

Injury: 587
Malfunction: 621
Other: 1
Total: 1,209

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.