BEUDAMED
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    BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221045201·Unitek(TM) Molar Band General Purpose Wide Regu...

    NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYMMETRIC TOTAL KNEE AGUMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Widex

    FDA UDI
    Widex A/S·05706069701630·Widex UNIQUE U-CIC TR (Dark brown ) 30, Right, ...

    Widex

    FDA UDI
    Widex A/S·05706069701623·Widex UNIQUE U-CIC TR (Clay brown ) 30, Right, ...

    Widex

    FDA UDI
    Widex A/S·05706069701616·Widex UNIQUE U-CIC TR (Light beige ) 30, Right,...

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·March 20, 2018

    CARELINK

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code DXY·June 10, 2013

    ACCESS

    FDA Adverse Event
    Malfunction ·UNKNOWN MANUFACTURING FACILITY·Product code FPA·July 13, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 16, 2008

    CELL-DYN EMERALD 22 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code GKZ·June 9, 2022

    UNKNOWN CHLORAPREP

    FDA Adverse Event
    Injury ·CAREFUSION, INC·Product code KXF·February 22, 2021

    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959

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

    Artis zeego, Model Number 10280959

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

    Artis zeego, Model Number 10280959

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

    Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 26, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021