BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    THERASTEAM PERSONAL STEAM INHALER

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094294·4.0mm Tap

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707052256·.022 EDGE L7L MINI HK BRKT

    UNIQSAFE ROTATABLE, RETRACTABLE SAFETY SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 6, 2013

    PLMA DVC V11.51 1 N

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·December 7, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 22, 2014

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014