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

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    WOLF LONG BONE PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704261622·

    XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AP409 -PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·December 18, 2025

    AP205 - INFUSION SET WITH NON-VENTED SPIKE, 1.2UM FILTER AND NEEDLE Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 5, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 6, 2024

    AP210 - MICROBORE WITH NON-VENTED SPIKE AND 1.2UM FILTER

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·June 17, 2024

    AP403 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 31, 2026

    AP407 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER AND NEEDLELESS Y-SITE

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FPA·March 4, 2026

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·October 1, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - BUFFALO GROVE·Product code FRN·June 16, 2011

    ELECSYS HCG + BETA TEST SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DHA·June 23, 2017

    Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·October 18, 2017

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018