BEUDAMED
    6,898 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    INSULIN PUMP CONTROL DEVICE (PDM)

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code QRX·December 22, 2022

    The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.

    FDA Recall
    Open, Classified ·Product code QRX·September 11, 2025

    Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

    FDA Recall
    Open, Classified ·Product code QRX·May 23, 2025

    Continuous Glucose Monitor Informed Insulin Dose Calculator

    FDA classification
    FDA Class 2 ·Continuous Glucose Monitor Informed Insulin Dose Calculator

    TRx Orthopaedics Limited

    Manufacturer

    QRS MEDICAL Ltd.

    Manufacturer
    🇮🇱 Israel

    QX World Ltd.

    Manufacturer
    🇭🇺 Hungary

    ARX SCIENCES

    FDA registration
    ARX SCIENCES·7 products·🇺🇸 United States

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013103452·COLUMBIA 4L-4R (3/8) RED

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013115639·MT VALUE CURETTE COLUMBIA 4L-4R (3/8)

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013103414·COLUMBIA 2L-2R (3/8) ORANGE

    Control RX-LP Mechanical Thrombectomy System, 136cm

    FDA UDI
    ZIEN MEDICAL TECHNOLOGIES, INC.·B090ARXLP60·The Control RX-LP Mechanical Thrombectomy Cathe...

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013119965·GRACEY ACCESS 1-2 RIGID (3/8)

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013105913·GRACEY 1-2 RIGID (3/8) PURPLE

    American Eagle Instruments

    FDA UDI
    AMERICAN EAGLE INSTRUMENTS, INC.·00841013119941·Gracey Access 00-0 Rigid

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·September 4, 2015

    ADVANIX BILIARY STENT

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·September 4, 2015

    RX CYTOLOGY BRUSH

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code FDX·September 4, 2015

    NAVIFLEX RX DELIVERY SYSTEM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code FGE·September 4, 2015

    RX CYTOLOGY BRUSH

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC - SPENCER·Product code FDX·September 4, 2015