ANODYNE CC— 510(k) K963481

Substantially Equivalent

Heyer America, Inc.

FDA 510(k) clearance K963481 for ANODYNE CC, Substantially Equivalent on 1997-08-11. Applicant: Heyer America, Inc..

Clearance details

Applicant: Heyer America, Inc.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 1996-09-03
Decision date: 1997-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarpon Springs, FL, US

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.