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

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    COLOR LCD MONITOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 9, 2015

    SIEMENS 1.5T TXRX 15 CH KNEE

    FDA Adverse Event
    Other ·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011

    HARDYDISK NETILMICIN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

    FDA 510(k)
    FDA Class 2 ·Radiology

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 3, 2015

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

    Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

    FDA Recall
    Open, Classified ·Datex-Ohmeda Inc·Product code BTM·May 8, 2026

    Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda Inc·June 24, 2026

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    LIGASURE IMPACT

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·April 28, 2011

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP COMBO KIT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DRS·July 21, 2008

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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