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

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    CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMAGINE H.E. PRESS DESIGN-CERAMIC

    FDA 510(k)
    FDA Class 2 ·Dental

    AVL HINGE KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 6, 2011

    OT ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 26, 2013

    ENDEAVOR RESOLUTE RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 23, 2008

    PEEK CAGE, UNKNOWN TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·February 9, 2021

    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 2110. 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