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

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    MEDI-TRACE DISPOSABLE DOMES/MONITORING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Manta Ray TDF

    FDA UDI
    Seaspine Orthopedics Corporation·10889981290375·Modular Rasp, 20x15x6mm, 7 Deg

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00810030810742·Hybrid Dual Taper Femoral Broach, Size 6

    CONNEXX LOCKING TIBIA NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AISYS

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

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 19, 1998

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 8, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 7, 2007

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2015

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021