BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    Premier X5 Sectional Matrix System

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·00348783004700·Premier X5 Sample Pack

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496061199·BURLESQUE 70, SIZE ML, BRONZE, GRADUATED COMPRE...

    PROVIEW EYE PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRIMECHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·April 16, 2013

    ORTHOLOCK EX-PIN 3X110

    FDA Adverse Event
    Injury ·STRYKER NAVIGATION·Product code HAW·April 5, 2011

    HIRES 90K

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·June 16, 2008

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LGD·September 17, 2014

    TENSION FREE VAGINAL TAPE - EXACT UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·April 21, 2025

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    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