BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DELTA PUNCTUM PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    Sure Lok Mini Posterior Cervical/Upper Thoracic System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code MWH·May 8, 2015

    NELLCOR OXIMAX N-65

    FDA Adverse Event
    Malfunction ·SANMINA-SCI SYSTEMS·Product code DQA·February 11, 2014

    TITANIUM POWERPORT 8 FR CHRONOFLEX ATTACHA

    FDA Adverse Event
    Death ·C. R. BARD INC. (BASD)·Product code LJT·November 16, 2012

    SIGMA STAB XLK INS 4 10MM

    FDA Adverse Event
    Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·September 28, 2010

    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·November 13, 2013

    The LifeCare Pump Model 4200 PCA Infuser makes possible the practical implementation of patient-controlled analgesia. The health care professional sets the prescribed dose, rates, and limits for the drug to be infused. The infuser can be set to operate in one of three modes: PCA Mode, Continuous Mode, and PCA + Continuous Mode. The LifeCare Pump Model 4200 PCA Infuser is designed with a number of mechanical, electrical, and software safeguards that prevent patient injury or drug abuse.

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·July 20, 2016

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023