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

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    MySpine Pedicle Screw Placement Guides - LP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MYSPINE UNILATERAL LEFT GUIDE S01

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024

    Oticon

    FDA UDI
    Oticon A/S·05707131292186·ALTA2, BTE 13 WL 105 SGR

    SPOTLIGHT ACCESS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

    FDA 510(k)
    FDA Class 2 ·Dental

    ATTAIN ABILITY PLUS

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

    NEXGEN LCCK ART SURFACE W/LOCKING SCREW

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

    EEA XL 25MM STAPLER WITH 3.5MM STAPLES

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GDW·September 8, 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; 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

    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