BEUDAMED
    15 results · 26ms · Sources: EU EUDAMED, US FDA

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    ETIII SA Fixture System (O3.2mm)

    FDA 510(k)
    FDA Class 2 ·Dental

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222021·

    BREATH ALCOHOL TEST SYSTEM, MODEL AL 2500

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    APTUS ULNA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    CAPSURE Z

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

    STRAUMANN BONE CERAMIC

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code LYC·June 30, 2011

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 5, 2008

    Artis zee biplane, Model Number 10094141

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

    Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·June 19, 2013

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Artis zee biplane, Model Number 10094141

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

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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·July 1, 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