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

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    Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser model YSD

    FDA Recall
    Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

    Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V

    FDA Recall
    Open, Classified ·YAMAHA MOTOR CORPORATION·Product code RGA·April 17, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code HAW·November 9, 2021

    Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

    FDA Recall
    Open, Classified ·Bayer Medical Care, Inc.·Product code FRN·November 30, 2022

    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DYB·February 20, 2024

    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code JCW·September 24, 2020

    HYDRATOME RX 49-30MM/260CM Material Number: M00583010

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    DREAMTOME 49-20MM/260CM Material Number: M00584000

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    HYDRATOME RX 44-30MM/450CM Material Number: M00583070

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME RX 49-30-260-035 Material Number: M00573020

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME RX 44-20-260-035 Material Number: M00573040

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME RX 39-30-260-025 Material Number: M00573100

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    DREAMTOME 49-30MM/450CM Material Number: M00584030

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021

    JAGTOME RX 39-20-450-025 Material Number: M00573090

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code KNS·December 22, 2021