BEUDAMED
    23 results · 27ms · Sources: EU EUDAMED, US FDA

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    COATEST SP FVIII

    FDA 510(k)
    FDA Class 2 ·Hematology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040100349·Maxima Tapered GPPTS CC.04

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810425761·Maxima Tapered GPPTS CC.04

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040141240·Maxima Tapered GPPTS CC.04

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809870381·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND OPEN T...

    BIOPSY BREAST COIL, MODEL BBC

    FDA 510(k)
    FDA Class 2 ·Radiology

    CIC-C1Q EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    RED DCI-DC3 SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 15, 2015

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 19, 2021

    RD SET GE - 12

    FDA Adverse Event
    Malfunction ·Product code DQA·August 13, 2021

    RD SET DCI

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 2, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 6, 2011

    KIT, RADICAL-7 HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

    KIT, RADICAL-7 HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

    KIT, RADICAL-7 HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

    SMARTPHONE ANDROID APP: PUMP CONNECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PKU·January 26, 2024

    RD SET NEO CS-3

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016