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

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    PillCam COLON 2 Capsule Endoscopy System

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

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111078880·SKLARHONE POTTS-SMITH 45DEG 7"

    FORMATK MAGMA PLATFORM LASER

    FDA Adverse Event
    Injury ·FORMATK SYSTEMS LTD.·Product code GEX·December 19, 2019

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 9, 2022

    HSINER RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARTHREX UNIVERS II SHOULDER PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FORMATK MAGMA PLATFORM

    FDA Adverse Event
    Malfunction ·FOMATK SYSTEMS, LTD·Product code GEX·January 8, 2020

    CAPSUREFIXNOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 8, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTQ·June 21, 2011

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019