BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564032713·REX ONSITE LP DECON GWN XLG NS

    SET, ADMINISTRATION, INTRAVASCULAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 6, 2016

    CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROSOUND F75 ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·HITACHI ALOKA MEDICAL, LTD·Product code GXX·July 16, 2014

    CLEARLINK BURETROL SOLUTION SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·June 13, 2023

    C-T II PORT CLOSURE, 10/12 (MM)

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GCJ·May 15, 2013

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014

    THERMACHOICE

    FDA Adverse Event
    Malfunction ·ETHICON·Product code MNB·June 14, 2011

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017