BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    COBAS LITHIUM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PERCUSSIVENEB, MODEL PN-2001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDO II TAPER INSERT STD 0MM T

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWL·March 21, 2022

    ENDO II MOD ENDO HEAD SZ 53

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWL·March 21, 2022

    Citrine Triple Quad Mass Spectrometer, Part Number 5063684

    FDA Recall
    Open, Classified ·AB Sciex, LLC·Product code DOP·August 30, 2023

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

    EPIDURAL CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INT'L., INC.·Product code CAZ·June 20, 2008

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 19, 2011

    Citrine Triple Quad Mass Spectrometer, Part Number 5063684

    FDA Enforcement
    Class II ·Ongoing·AB Sciex, LLC·October 11, 2023

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022