IBED WIRELESS WITH IBED AWARENESS— 510(k) K103536

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K103536 for IBED WIRELESS WITH IBED AWARENESS, Substantially Equivalent on 2010-12-16. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code FNL
Advisory panel: General Hospital
Date received: 2010-12-01
Decision date: 2010-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.