BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Femoral Elevator

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215058104·

    RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 12, 2024

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 23, 2014

    MD4 VASCULAR SYSTEM

    FDA Adverse Event
    Malfunction ·PHILLIPE MEDICAL SYSTEMS OF NORTH AMERICA·Product code JAA·May 2, 2006

    EYE SURGERY STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 29, 2011

    CARDIOSAVE HYBRID

    FDA Adverse Event
    Injury ·DATASCOPE CORP. - MAHWAH·Product code DSP·June 11, 2020

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·April 24, 2024

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code PSZ·January 22, 2024

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 1, 2022

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 19, 2021

    KIT FLU VERITOR SYSTEM 30 TEST JAPAN

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·March 25, 2021

    COULTER LH 750 ANALYZER

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code GKZ·October 8, 2008

    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular, LLC·January 16, 2013

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025