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

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    EVIS EXERA II 180 SYSTEM

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

    INVERNESS MEDICAL EARLY PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO RAICHEM CALCIUM REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LGW·April 16, 2013

    HYDROTHERMABLATOR CONSOLE UNIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MNB·June 13, 2008

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

    36MM I.D. SIZE E NEUTRAL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 25, 2024

    BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 25, 2024

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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