BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Status: Terminated ×

    HiSpeed FX/I (2200997 with Gantry mo. #2200997)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2200997)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997 with Gantry mo. #2200997-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2200997-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed LXI (2200997)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code HAW·July 17, 2009

    HiSpeed LX/l (2200997-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997 with Gantry mo. #2201000)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997 with Gantry mo. #2249696)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2201000)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2201000-2 with Gantry mo. #2200997)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997 with Gantry mo. #2201000-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997 with Gantry mo. #2249696-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2249696)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2201000-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2201000-2 with Gantry mo. #2200997-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    HiSpeed FX/I (2200997-2 with Gantry mo. #2249696-2)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·February 1, 2010

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016