BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    Allcem, Allcem Core

    FDA 510(k)
    FDA Class 2 ·Dental

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2016

    DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYNAPSE 3D CARDIAC TOOLS

    FDA 510(k)
    FDA Class 2 ·Radiology

    INRATIO2 PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 1, 2016

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·December 11, 2019

    INRATIO PT/INR STRIPS

    FDA Adverse Event
    Injury ·DRES. FREILINGER & PARTNER·Product code GJS·May 10, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 18, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013

    ADULT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 28, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·November 23, 2021

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·January 30, 2023

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·December 14, 2019

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023