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BioWorld - Tuesday, February 3, 2026
Home » ​FDA releases second advisory under early alert program​
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​FDA releases second advisory under early alert program​

Dec. 23, 2024
By Mark McCarty
The U.S. FDA posted another early advisory, this time for the Mini PCNL devices by Trokamed GmbH. The agency noted that these devices should not be used for suction and irrigation of surgical sites, a use for which the device was not cleared in the first place.
Medical technology Regulatory U.S. FDA

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