BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    LEICA FL800

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2024

    MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    FISIO CHAMBER SPACE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 11, 2003

    Widex

    FDA UDI
    Widex A/S·05706069812640·Widex EVOKE E-PA (Deep Blue ) 440, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069886665·WIDEX MOMENT MRB0 (Deep Blue ) 440, RIC 10

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 26, 2020

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·June 14, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 3, 2014

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·June 3, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 22, 2011

    VIDAS TSH

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JLW·November 25, 2020

    5.5 EXP VERSE UNITIZED SET SCR

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    5.5 EXP VERSE SCR 6.0X45

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·December 19, 2019

    VIDAS HCG

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code JHI·August 19, 2021

    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015