BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

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    2010 PLUS HOLTER FOR WINDOWS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085021973·NPC-67 Neutralizing Buffer 50x50ml

    MICOR ANESTHESIA CONDUCTION KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HUMAN SERUM ALBUMIN (HSA)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 3, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 5, 2026

    BD ANGIOCATH¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·July 26, 2019

    PDS LL PLUS ANTIBACTERIAL SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code NEW·March 14, 2013

    PLASMABALDE

    FDA Adverse Event
    PEAK SURGICAL INC·Product code GEI·February 11, 2011

    DST, EEA, XL

    FDA Adverse Event
    Malfunction ·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code GAG·February 1, 2008

    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

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020