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

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    PERSYST SPIKE DETECTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111603·Modular Stem 11mm x 75mm

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094300·4.5mm Tap

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707052263·.022 EDGE UR MINI TUBE DIST EXT HK

    Medtronic Patient Asistant

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    MINIARC SLING SYSTEM

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

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 8, 2010

    BIOLOX DELTA CERAMIC HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.1818910·Product code LZO·July 22, 2014

    1820334-2020-01805

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

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025

    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