BEUDAMED
    14 results · 19ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2016

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 8, 2016

    LACTOSORB PUSH SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    MUCOGRAFT

    FDA 510(k)
    FDA Class 2 ·Dental

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 3, 2016

    EXCELSIOR SL-10 PRE-SHAPED S 150CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR CORK·Product code DQY·April 29, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·May 9, 2011

    PATELLA DRILL TEMPLATE-CEM TD 9+11

    FDA Adverse Event
    Malfunction ·STRYKER ORTOPAEDICS MAHWAH·Product code LXH·July 21, 2008

    Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)

    FDA Enforcement
    Class II ·Ongoing·Becton Dickinson & Company·July 27, 2022

    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

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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