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

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    MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C

    FDA 510(k)
    FDA Class 2 ·Hematology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040059958·Standard Needles 27Ga Short

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015685·The ENDO CARRY-ON Procedure Kit contains all of...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040066836·Instrument Tray Plastic #16

    PREMIUM PLUS CEEA

    FDA Adverse Event
    Malfunction ·US SURGICAL PUERTO RICO·Product code GDW·April 19, 2018

    STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·September 20, 2024

    PROMUS ELEMENT ?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 13, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·February 25, 2011

    SUNQUEST BLOOD BANK AND BLOOD DONOR

    FDA Adverse Event
    Malfunction ·SUNQUEST INFORMATION SYSTEMS·Product code MMH·December 17, 2007

    BD SAFETYGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 23, 2019

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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