BEUDAMED
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    HARMONY VLED SURGICAL LIGHTNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Bur PM2-70 80K Carb Ø1.4 St

    FDA UDI
    Bien-Air Surgery SA·17630055503593·

    ARGESOL YSF STRIP

    FDA UDI
    ARGEN CORPORATION, THE·D818100395·Gold based noble metal

    Tongue-Away Sheild

    FDA UDI
    TP ORTHODONTICS INC·00192029049433·Small

    VACUETTE TUBE 9 ML CAT SERUM SEPARATOR CLOT ACTIVATOR 16X100

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·January 8, 2021

    E-POWER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EINSTEIN PROCESSING AND REVIEW WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    REAMER SHAFT, MOD. TRINKLE BIXCUT 8.0 X 284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·December 18, 2012

    PORTEX® CUSTOM EPIDURAL SET

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code OGE·July 14, 2017

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·May 8, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 18, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Other ·INVACARE·Product code ITI·May 16, 2011

    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

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025