BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    2008K2 Hemodialysis Machine

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111075872·SKLHN OP SCIS CRV SB SER 5 1/2

    FUSION FLAT PANEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025

    CD HORIZON BALLAST SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 8, 2013

    DIGITAL DIAGNOST

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS DMC GMBH·Product code MQB·June 21, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 5, 2008

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Injury ·CONMED UTICA·Product code GEI·May 18, 2023

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    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