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

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    New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated

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

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704285215·IRIS SCISSORS RIBBON TYPE 3 3/4" CURVED

    OrthoMedFlex, LLC

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121532650·Crossbar Acetabular Reamer - 65mm

    MICRUS GUIDE WIRE, WATUSI 0.014

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NHANES WHOLE BODY DXA REFERENCE DATABASE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    UNKNOWN ZIMMER RHK KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·June 30, 2011

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·September 5, 2008

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015

    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

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024