BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    Invictus™ CT Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM

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

    10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·January 5, 2016

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 7, 2019

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    CORE OSC SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·July 1, 2011

    ALLURA XPER FD10

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·May 30, 2013

    UNKNOWN_EXETER STEM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code LPH·March 30, 2023

    MOTIVA IMPLANTS

    FDA Adverse Event
    Injury ·ESTABLISHMENT LABS S.A·Product code FTR·December 12, 2024

    MOTIVA IMPLANTS

    FDA Adverse Event
    Injury ·ESTABLISHMENT LABS S.A.·Product code FTR·March 24, 2025

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016