STRYKER ARIA PNEUMATIC SYSTEM— 510(k) K061725

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K061725 for STRYKER ARIA PNEUMATIC SYSTEM, Substantially Equivalent on 2006-10-26. Applicant: Stryker Instruments.

Clearance details

Applicant: Stryker Instruments
Product code: Code HBB
Advisory panel: Neurology
Date received: 2006-06-19
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.