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

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    ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIOHELP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIOHELP SYSTEM

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTQ·February 23, 2015

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 29, 2013

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 17, 2011

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 21, 2008

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·January 9, 2024

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·March 25, 2016

    EQUINOXE PRESERVE STEM 12MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 29, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    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

    EQUINOXE REVERSE 46MM GLENOSPHERE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 2, 2024

    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