BEUDAMED
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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000453·The OX-500A Finger Pulse Oximeter will display ...

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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000415·The OX-400A Finger Pulse Oximeter will display ...

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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000408·The OX-610A Wrist Pulse Oximeter is fully autom...

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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000446·The OX-550AP Pediatric Finger Pulse Oximeter wi...

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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000422·The OX-300A Finger Pulse Oximeter will display ...

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    FDA UDI
    MEDICAL TEST SUPPLY·00869667000439·The OX-200A Finger Pulse Oximeter will display ...

    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,

    FDA Enforcement
    Class II ·Ongoing·Wondfo USA Co Ltd·June 19, 2024

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    FDA Enforcement
    Class II ·Terminated·Sky Medical Supplies and Equipments LLC·February 24, 2021

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·May 14, 2024

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·April 3, 2024

    Streptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A Test Kit, Guangzhou Wondfo Biotech Co., Ltd, Wondfo One Step Strep A Swab Test, Dealmed Medical Supplies LLC, Strep A Rapid Test Kit, Jant Pharmacal Corporation, Accustrip VALUPAK Strep A Test Strip, SMC Direct, LLC, RefuAH Strep A Rapid,

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    HAMILTON-C1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·January 31, 2024

    PKG, MEDICAL POWER SUPPLY

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code FWB·August 14, 2015

    AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC.

    FDA Recall
    Terminated ·Sky Medical Supplies and Equipments LLC·Product code QKO·January 19, 2021

    REMSTAR M SERIES POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code BZD·April 16, 2009

    HAMILTON-C3

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 9, 2025

    HAMILTON-T1

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·April 25, 2025

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·February 28, 2019

    MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·November 7, 2012

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·April 6, 2020