BEUDAMED
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    LUOFUCON® Silver Collagen Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    HUMERIS 135

    FDA UDI
    FX SOLUTIONS·03701037301685·HUMERAL CUP SYMMETRIC STANDARD PE/TA6V Ø40+9 / ...

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA UDI
    FX SOLUTIONS·03701037306925·TRIAL HUMERAL CUP ECCENTRIC SYMMETRIC STANDARD ...

    CRYMED CRYO-ABLATOR

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

    CLIQ DV-300 ASPIRATOR

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

    SKINTACT

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·January 13, 2026

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

    SAMSUNG GALAXY WATCH 5 PRO (Z9NL)

    FDA Adverse Event
    Malfunction ·SAMSUNG ELECTRONICS AMERICA, INC.·Product code QDA·May 26, 2026

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 10, 2014

    NAVISTAR THERMOCOOL EP

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER·Product code OAD·August 28, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 20, 2015

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·September 21, 2016

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025