BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    KREATIV MODEL KV-1

    FDA 510(k)
    FDA Class 2 ·Dental

    ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Celsio Flexible Cryocatheter System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·April 22, 2014

    ON-Q PAIN PUMP

    FDA Adverse Event
    Injury ·I-FLOW, LLC·Product code MEB·January 31, 2013

    SHORT PORT BTT W/CDC SEAL, 5 PACK

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code GCJ·December 22, 2010

    PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014