BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    GME LinScan Lite 808 Laser System

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

    RESTORIS

    FDA UDI
    MAKO SURGICAL CORP.·00848486000677·MCK Femoral Component

    Responsive Orthopedics Total Knee Arthroplasty System

    FDA UDI
    RESPONSIVE ORTHOPEDICS, LLC·00841973107118·TRIAL 90-SRK-180518 POLY PS 5X18MM

    INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHAFT FOR 90 SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·September 24, 2020

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 24, 2024

    M2A-MAGNUM PF CUP 60ODX54ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 17, 2014

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code MMH·June 20, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 27, 2011

    SHAFT FOR 90 SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code DZI·December 9, 2021

    SHAFT

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code DZI·November 18, 2019

    DRIVESHAFT FOR SCREWDRIVER 90°

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·June 20, 2019

    TROPONIN T STAT (SHORT TURN AROUND TIME)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·June 15, 2015

    STABLE BASE

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code DRX·July 31, 2019

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025