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

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    i-STAT CG8+ cartridge with the i-STAT 1 System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    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

    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

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517570239·CoRoent Ant TLIF Ti, 13x10x30mm 0°

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776350284·RUSKIN LISTON BONE CUTTING RONGEUR

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780382812·Integra® Jarit® Liston Bone Cutting Forceps, 5-...

    HiRes™ Auria™ Processor

    FDA UDI
    Advanced Bionics, LLC·07630016805622·Beige

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869621366·MOSS VRS Ti Rod, Ø5.5x300mm, straight, hex on b...

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869604314·MOSS Ti Rod, Ø5.5x300mm straight

    GOMCO

    FDA UDI
    Allied Medical, LLC·00026072001912·ASPIRATOR, PORTABLE 220V/50HZ

    Vasomedical-Biox™ Model 2303 3 CH/ABP COMB Recorder

    FDA UDI
    VASOMEDICAL, INC.·00817980020511·Model 2303 3 CH/ABP COMB Recorder

    OPAQUE HERRICK LACRIMAL PLUG

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEATER-COOLER UNIT HCU 40

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·October 20, 2023

    ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE

    FDA Adverse Event
    Malfunction ·EUROSETS S.R.L.·Product code DTZ·October 20, 2023

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·February 12, 2024

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·March 15, 2024

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    BIVONA CUSTOM TTS FLEXTEND TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, INC.·Product code JOH·October 21, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013