BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Biomet Spine Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Genesis

    FDA UDI
    KEYSTONE DENTAL, INC.·D768K156950·Ratchet

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100622·KATENA DOUBLE-X SPECULUM V-WIRE

    ELLIPSE PRECICE TRAUMA NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREPEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ADAPTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 8, 2013

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

    Artis zee biplane, Model Number 10094141

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

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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

    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