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

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    ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970492·

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970485·

    LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    D2RF DIGITAL DYNAMIC REMOTE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLEXOR INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·May 16, 2013

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·September 22, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    ARTIS Q ZEEGO

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHINEERS AG·Product code OWB·December 10, 2024

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 30, 2019

    INSTINCT JAVA ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 8, 2021

    INSTINCT JAVA SCREW, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER SPINE·Product code MNH·October 31, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024