BEUDAMED
    12 results · 37ms · Sources: EU EUDAMED, US FDA

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    INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001

    FDA 510(k)
    FDA Class 2 ·Radiology

    MACROPORE IB RESORBABLE PLUG

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDERED PATIENT EXAMINATION GLOVES, LATEX

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LARGE HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·April 8, 2013

    DISCOVERY II DR

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

    C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·November 14, 2016

    M-LNCS Y-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·August 12, 2017

    IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·International Biophysics Corp.·August 26, 2015

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024