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

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    INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRUST

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIFELINE PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Injury ·LIFELINE, INC.·Product code ILQ·December 22, 2017

    LIFELINE PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Injury ·LIFELINE SYSTEMS, INC.·Product code ILQ·December 22, 2017

    LIFELINE PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Death ·LIFELINE SYSTEMS, INC.·Product code ILQ·September 20, 2018

    LIFELINE PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Injury ·Product code ILQ·May 24, 2012

    LIFELINE PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Injury ·PHILIPS LIFELINE·Product code ILQ·April 13, 2018

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·September 17, 2019

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017

    UNKNOWN DEPUY SIGMA STAB RT FEMUR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 4, 2013

    TERUMO STERNAL SAW II

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·December 17, 2010

    VLOC 180 ABS 0 GR 24 GS-21

    FDA Adverse Event
    Injury ·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code GAM·July 2, 2014

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 30, 2023

    I-STAT CG4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022

    I-STAT CG4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code KHP·January 5, 2022

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025