BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    OXYGEN CATHETER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Trial Tibial Augment

    FDA UDI
    ADLER ORTHO SPA·08056269044134·TRIAL PANTHEON TIBIAL AUGMENT LM/RL SIZE 6 H5

    ATRIAL BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896070059·HEARTLINE ATRIAL BLADE

    ATRIAL BLADE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09928005060·HEARTLINE ATRIAL BLADE

    Valve Retractor

    FDA UDI
    KOROS U.S.A., INC.·10840199537133·Medium Valve Retractor 30 x 42mm

    MARTIN CHAIR, MODEL C4S1

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOSTENT GRAFTMASTER

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MAF·May 8, 2014

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 22, 2012

    ROTALINK? PLUS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·May 27, 2015

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Recall
    Terminated ·Wexford Labs Inc·Product code LRJ·September 10, 2013

    Cardiosave Rescue IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·March 22, 2021

    Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·March 22, 2021

    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