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

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    DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040010044·Zirlux 16+ B2 100X14

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033298497·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297865·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297896·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297919·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297872·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297902·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033297889·

    AURENORM 75 KF

    FDA 510(k)
    FDA Class 2 ·Dental

    ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

    FDA Adverse Event
    Death ·BECTON DICKINSON·Product code FOZ·April 1, 2016

    PLUM A+ - ANIMAL HEA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 21, 2015

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 14, 2007

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 19, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 7, 2011

    SUMMIT DUOFIX TAP SZ5 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015

    UNSPECIFIED 10ML FILL IN 10ML BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FOZ·March 4, 2016

    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 16, 2018

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025