BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    MANDREL GUIDEWIRES OR M-WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099648·MAX 1ST MOLAR RT&LT 100 BANDS

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604664·Toboggan Arm & Leg Guard Pad, Large

    Symmetry Malis®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482140307·Symmetry® Bipolar Forceps; Hardy Bayonet; Strai...

    AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SIEMENS INFINITY SC 6002XL MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIPRO INSULIN SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·April 6, 2011

    UNKNOWN DEPUY TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·July 18, 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