BEUDAMED
    22 results · 21ms · Sources: EU EUDAMED, US FDA

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    ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800

    FDA 510(k)
    FDA Class 2 ·Immunology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210514350·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496051435·ROSSELLA 70 SHEER, SIZE S, NERO, GRADUATED COMP...

    VIKING OPTIMA GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 10, 2013

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    INJECTION GOLD PROBE BIPOLAR CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·May 21, 2008

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 26, 2011

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·October 30, 2013

    C/HESIVE NAT WFR FLEX 25/45MM (1X5)GB/NL

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·October 19, 2020

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·April 14, 2015

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    FDA Adverse Event
    Injury ·CORMATRIX CARDIOVASCULAR, INC.·Product code DXZ·May 7, 2010

    C/HESIVE NAT WFR FLEX 25/45MM (1X5)GB/NL

    FDA Adverse Event
    Malfunction ·CONVATEC DOMINICAN REPUBLIC INC·Product code EXE·October 19, 2020

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022