BEUDAMED
    2,057 results · 61ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    MEDICAL FLOW SELECTOR

    FDA Adverse Event
    Injury ·MEDICAL FITTINGS, INC.·Product code CAX·June 21, 1996

    FLOW SELECTOR

    FDA Adverse Event
    MEDICAL FITTINGS, INC.·Product code CAX·January 6, 1997

    OHMEDA 1251 CONTINUOUS/INTERMITTENT VACUUM REGULATOR

    FDA Adverse Event
    Malfunction ·MEDICAL FITTINGS, INC.·Product code BYX·September 24, 2019

    FORM FIT HYDROGEL CANALICULAR PLUGS

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·October 20, 2008

    FORM FIT HYDROGEL CANALICULAR PLUGS

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·December 5, 2008

    FORM FIT HYDROGEL CANALICULAR PLUGS

    FDA Adverse Event
    Other ·OASIS MEDICAL, INC.·Product code LZU·October 20, 2008

    (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

    FDA Enforcement
    Class II ·Terminated·Argon Medical Devices, Inc·November 13, 2019

    Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion tables, which allow the user to secure his or her ankles to the table and invert. The products were intended to be fitness equipment; i.e. consumer products.

    FDA Enforcement
    Class II ·Terminated·Dick's Sporting Goods·January 28, 2015

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 19, 2012

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·September 10, 2011

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 27, 2012

    O2 HOSES

    FDA Adverse Event
    Malfunction ·PRECISION MEDICAL INC·Product code BYX·March 19, 2020

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·February 21, 2011

    SYNCHRON LX®I 725 SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 17, 2011

    COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code GKZ·May 16, 2011

    LH 750 SLIDEMAKER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·April 7, 2011

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 29, 2012

    COULTER LH 750 SLIDEMAKER ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code LOQ·March 4, 2011

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·February 9, 2012

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·March 26, 2012