BEUDAMED
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    LEICA M844 F40

    FDA Adverse Event
    Injury ·LEICA MICROSYSTEMS (SCHWEIZ) AG·Product code EPT·November 30, 2012

    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product Usage: The Arobella Medical AR1000 Wound Therapy System is interned for the selective dissection and fragmentation of tissue, wound debridement ( of acute and chronic wounds, burns, and diseased or necrotic tissue), and cleansing irrigation of the wound site for the removal of debris, exudates, fragments, and other matter.

    FDA Enforcement
    Class II ·Terminated·Arobella Medical, LLC·December 26, 2012