BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    Flexitouch System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111049569·SKLHN METZ SCISS SMO CVD 8"

    Zavation

    FDA UDI
    Zavation LLC·00842166177420·Z-Link Lumbar Sizer 15 deg, 33mm x 11

    Zavation

    FDA UDI
    Zavation LLC·00842166112407·Z-Link Lumbar Spacer 15deg 33mmx11

    U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    STRYKER SCOPE WARMER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 22, 2020

    CAPSUREFIX NOVUS

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

    MEMBRAGEL

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

    WALLSTENT RX BILIARY ENDOPROSTHESIS

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

    GMK-HINGE FEMORAL COMPONENT SIZE 2 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·June 28, 2019

    GMK-HINGE FIXED TIBIAL INSERT SIZE 1/26MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code KRO·July 12, 2019

    EDI BZO Uncut Sheet - Cup*, Item No. 160170

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Artis zee biplane, Model Number 10094141

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

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; 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