BEUDAMED
    2,685 results · 30ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    8015 ALARIS SYSTEM PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 24, 2020

    INRATIO

    FDA Adverse Event
    ALERE SAN DIEGO, INC.·Product code GJS·February 10, 2011

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 22, 2011

    ROCHE CARDIAC TROP T

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·May 28, 2019

    ALARIS SYSTEM PUMP MODULE

    FDA Adverse Event
    Injury ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·July 12, 2007

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·August 1, 2012

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 30, 2012

    SPYSCOPE DS II ACCESS & DELIVERY CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FBN·October 25, 2022

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 23, 2016

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·June 12, 2015

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 28, 2015

    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 2, 2015

    INRATIO PT/INR TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 20, 2014

    ALERE BIOSITE TRIAGE METER/CARDIAC MARKER CARTRIDGE

    FDA Adverse Event
    Injury ·ALERE BIOSITE·Product code MMI·May 3, 2012

    ENDO CATCH GOLD 10MM SPECIMEN POUCH INTL

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GCI·July 29, 2015

    INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR

    FDA Adverse Event
    Malfunction ·INOGEN·Product code CAW·July 12, 2024

    INOGEN G5 PORTABLE OXYGEN CONCENTRATOR

    FDA Adverse Event
    Malfunction ·INOGEN, INC.·Product code CAW·August 21, 2024

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 3, 2013

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·January 18, 2011

    MILEX

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code FMF·October 3, 2005