BEUDAMED
    14 results · 37ms · Sources: EU EUDAMED, US FDA

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    1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    1.5MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036059149·

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122758·K-WIRE - SINGLE TROCAR THREADED 1.5mm DIA x 100mm

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707052355·.022 SAA L7L MINI HK BRKT

    ANAM Test System: Military Battery

    FDA 510(k)
    FDA Class 2 ·Neurology

    POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FRESENIUS 2008K

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 27, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

    SOMARAD DIGITAL RADIOGRAPHY SYSTEM

    FDA Adverse Event
    Malfunction ·IMIX AMERICAS, INC.·Product code KPR·December 9, 2010

    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HWC·November 25, 2020

    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 23, 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