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

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    Accuject Refra Injector AR2900

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111139956·SKLARLITE OP SCISS SB ST 5 1/2

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

    IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX

    FDA 510(k)
    FDA Class 2 ·Dental

    DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG WIRELESS, DIGITAL RADIOGRAPHY CXDI-801C WIRELESS,

    FDA 510(k)
    FDA Class 2 ·Radiology

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·February 3, 2025

    STINGRAY? LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    DIGITAL RADIOGRAPHY CXDI

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·December 22, 2019

    MICROMAX SYSTEM MOTORS

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT·Product code HBB·November 11, 2008

    INTERSTIM

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 26, 2011

    PLUM A+ DRIVER EDITI

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·July 12, 2013

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·November 6, 2024

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 30, 2025

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·April 23, 2025

    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    CARESCAPE Canvas Smart Display, Model Numbers: a) 5700023, b) 5700023-02, c) 5939590-102; monitor, physiological, patient

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare Finland Oy·July 3, 2024