510(k) K951005— KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

Substantially Equivalent

Kenex , Ltd.

Clearance details

Applicant: Kenex , Ltd.
Product code: Code IZQ
Advisory panel: Cardiovascular
Date received: 1995-02-15
Decision date: 1995-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

Adverse events under product code IZQ

product code IZQ

Death: 7
Total: 7

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.