BEUDAMED
    2 results · 19ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).

    FDA Enforcement
    Class II ·Terminated·PROCEPT BIOROBOTICS CORPORATION·April 17, 2019

    AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

    FDA Enforcement
    Class II ·Ongoing·PROCEPT BIOROBOTICS CORPORATION·September 1, 2021