BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    ELUMI 810 + 980 Soft Tissue Laser

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127308·2.0 X 32mm Cannulated Headless Screw, T7

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707014126·CALIBRA 1ST MOL BANDS W/G8325-02 n.UR 32

    Ni-Lock® Anterior Cervical Plate System

    FDA UDI
    Spine Wave, Inc.·10840642102994·Plate 32mm 2 Level

    PHILIPS CPAP DEVICE

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·April 8, 2024

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161111520320·Femoral Head, SIZE 36mm, (M) CoCr Alloy

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 26, 2024

    KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    8FR TURBO - TANDEM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    AXIOM ICONUS R200

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC·Product code KXJ·November 2, 2006

    ORTHO PROVUE

    FDA Adverse Event
    Malfunction ·Product code KSZ·October 8, 2014

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 7, 2011

    OPTITORQUE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·Product code DQO·January 20, 2021

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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