STRYKER 5000— 510(k) K935949

Substantially Equivalent

Stryker Medical

FDA 510(k) clearance K935949 for STRYKER 5000, Substantially Equivalent on 1994-06-17. Applicant: Stryker Medical.

Clearance details

Applicant: Stryker Medical
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1993-12-13
Decision date: 1994-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

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.