Z-MED Z-MED II— 510(k) K122012

Substantially Equivalent

NuMED, Inc.

FDA 510(k) clearance K122012 for Z-MED Z-MED II, Substantially Equivalent on 2012-10-04. Applicant: NuMED, Inc..

Clearance details

Applicant: NuMED, Inc.
Product code: Code OZT
Advisory panel: Cardiovascular
Date received: 2012-07-10
Decision date: 2012-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkinton, NY, US

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Adverse events under product code OZT

product code OZT

Death: 20
Other: 2
Total: 22

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.