MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT— 510(k) K912445

Substantially Equivalent

Mega Medical, Inc.

FDA 510(k) clearance K912445 for MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT, Substantially Equivalent on 1991-10-18. Applicant: Mega Medical, Inc..

Clearance details

Applicant: Mega Medical, Inc.
Product code: Code CAZ
Advisory panel: Anesthesiology
Date received: 1991-06-03
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

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.