BEUDAMED
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    Family of CoolGlide Aesthetic Lasers

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

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100493·LIEBERMAN SPECULUM K-WIRE

    GENESYS SPINE TILOCK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 28, 2024

    36MM I.D. SIZE E NEUTRAL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·September 16, 2025

    RIATA ACTIVE FIXATION

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

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 7, 2011

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 8, 2013

    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

    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

    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