BEUDAMED
    19 results · 26ms · Sources: EU EUDAMED, US FDA

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    Dario Blood Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HHM

    FDA UDI
    Oticon A/S·05707131280817·H160V2, BTE 13 WL 100 CNB HHM

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158211957·FORCEPS TENACULUM STAUDE-MOORE 6.75"

    BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    T-TEK

    FDA 510(k)
    FDA Class 2 ·Hematology

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·June 6, 2013

    UNKNOWN DEPUY 32MM ACETABULAR LINER

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 8, 2014

    CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CAPTURED HIP SCREW LAG SCREW

    FDA Adverse Event
    Malfunction ·BIOMET TRAUMA·Product code KTT·May 3, 2017

    CATHETER MOUNT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·April 28, 2016

    NAVLOCK TRACKER UNIVERSAL ORANGE

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (LOUISVILLE)·Product code OLO·November 25, 2015

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    AIRVO2 HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2016

    NON-VENTED HOSPITAL FULL FACE MASK

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code MNT·August 4, 2016

    CATHETER MOUNT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·March 23, 2016

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018