K051734

Substantially Equivalent

GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955

Applicant: Ge Healthcare Technologies
Product code: HAW
Advisory panel: Neurology
Date received: 2005-06-28
Decision date: 2005-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrence, MA, US

Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

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.