BEUDAMED
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    VITAMIN B12 (57CO) RADIOIMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synergy

    FDA UDI
    Rmo, Inc.·00885797100894·BRACHY SY 185 W/O HK 5-5 20EA

    VITROS

    FDA UDI
    ORTHO CLINICAL DIAGNOSTICS·10758750002320·VITROS Immunodiagnostic Products Total B HCG II...

    NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SOMATOM FLASH DS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCOM 28MM RINGLOC LINER HWALL 24

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 24, 2018

    28MM DIA COBALT CHROME MODULAR HEAD +3MM NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 24, 2018

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·MICROPORT ORTHOPEDICS INC.·Product code JDL·May 9, 2014

    COULTER® ACT DIFF 2¿ ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·October 23, 2012

    SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code MND·August 17, 2010

    1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 1, 2016

    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021