SIDE RAIL PADS— 510(k) K823821

Substantially Equivalent

Danek Medical, Inc.

FDA 510(k) clearance K823821 for SIDE RAIL PADS, Substantially Equivalent on 1983-01-21. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code FNJ
Advisory panel: General Hospital
Date received: 1982-12-17
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.