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

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    HEARTWAY POWER MOBILITY SCOOTER, S9

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Conmed/Linvatec

    FDA UDI
    Provision·00810041066480·

    Conmed/Linvatec

    FDA UDI
    Provision·B504OM50921540·

    K.E.A.T.

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 18, 2016

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    CLEAR CARE

    FDA Adverse Event
    Other ·CIBA VISION·Product code LPN·April 29, 2013

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL ¿ NEUROMODULATION·Product code GZB·September 3, 2014

    FUSION NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 27, 2011

    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems, Inc·Product code LGW·April 23, 2010

    Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·St. Jude Medical·Product code LGW·July 26, 2012

    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code MHY·March 28, 2012

    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

    FDA Recall
    Terminated ·Advanced Neuromodulation Systems Inc.·Product code LGW·December 19, 2011

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024