FDA Updates Guidance on Third-Party 510(k) Review Program
The FDA issued updated guidance on the 510(k) Third Party Review Program and EUA Review, clarifying expectations, processes, and criteria.
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FDA Approves Canady Flex RoboWrist Robotic Surgery Device
The Canady Flex RoboWrist is a fully articulating motorized, 5mm hand-held surgical instrument available with a variety of end effectors.
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FDA Updates Guidance on Third-Party 510(k) Review Program
The FDA issued updated guidance on the 510(k) Third Party Review Program and EUA Review, clarifying expectations, processes, and criteria.