MATRIX CCM 600— 510(k) K926009

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K926009 for MATRIX CCM 600, Substantially Equivalent on 1993-07-20. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1992-12-02
Decision date: 1993-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangeburg, NY, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.