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

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    GammaPod - Model A

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CKMB UDR ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZOLL IVTM ICY CATHETER

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·June 30, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 5, 2025

    ELECSYS INSULIN

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 16, 2014

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·June 17, 2013

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 22, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE LLC·Product code HHS·September 18, 2008

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023