BEUDAMED
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    LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS

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

    Spherodon - M

    FDA UDI
    SILMET LTD·07290012207334·Dental Amalgam Capsules

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 30, 2023

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    MARQUETTE HUBER TRAP SAFETY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AXLE INTERSPINOUS FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PERSONA TRABECULAR METAL 2 PEG TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code MBH·August 29, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    NAVISTAR® THERMOCOOL®

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·September 26, 2014

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·May 6, 2011

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of 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 with the AXIOM Artis zee and Q/ Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 22, 2019

    Artis Q biplane, Model Number 10848282

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

    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022