BEUDAMED
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    Xeleris 4.0 Processing and Review Workstation

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100332·BARRAQUER INFANT WIRE SPECULUM

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111058141·SKLHN LISTER BAND SCISS 5 1/2"

    BTI INTERNA DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    GDC 360 DETEACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    SPRINT QUATTRO SECURE S

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

    SWIFT LOCK ANCHOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 30, 2011

    WALLSTENT RX BILIARY ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code FGE·September 5, 2008

    FUSION ENT NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·February 2, 2021

    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