BEUDAMED
    38 results · 20ms · 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.
    Filters FDA Recall ×

    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code MUE·August 4, 2017

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, Model Number 11965175. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995115. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    GIBCO CTS AIM V Serum-Free Media (SFM), Model Number 0870112BK. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    StemPro MSC SFM CTS"

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code NDS·June 11, 2019

    Gibco Dulbecco's Modified Eagle Medium (DMEM), high glucose, pyruvate, Model Number 11995123. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    Gibco CTS OpTmizer T Cell Expansion Serum Free Medium, bag format, Model Numbers A1048503 and A1022103. Tissue and cell culture medium.

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code NDS·May 10, 2018

    CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. Provides ventricular tachyarrhythmia and cardiac resynchronization therapies.

    FDA Recall
    Terminated ·Guidant Corporation·Product code NIK·June 16, 2005

    ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.

    FDA Recall
    Terminated ·Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China·Product code DPS·September 10, 2010

    Theratron Elite 80 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron Phoenix Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 780E Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 780C Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron Elite 100 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 1000E Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Theratron 1000 Cobalt Radiotherapy

    FDA Recall
    Terminated ·MDS Canada Inc. DBA MDS Nordion·Product code IWB·July 8, 2004

    Temporary Titanium Abutments

    FDA Recall
    Open, Classified ·DDS Lab·Product code NHA·December 6, 2024

    Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.

    FDA Recall
    Terminated ·Sysmex America, Inc.·Product code GGK·April 11, 2011

    NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

    FDA Recall
    Open, Classified ·NxStage MDS Corporation·Product code KDI·January 29, 2024