BEUDAMED
    28 results · 21ms · Sources: EU EUDAMED, US FDA

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    MIRADA XD

    FDA 510(k)
    FDA Class 2 ·Radiology

    Preat

    FDA UDI
    Preat Corporation·00842092108154·Preci-Clix Bur #2 Cavity

    Bur PM2-70 80K diam Ø6.0 St

    FDA UDI
    Bien-Air Surgery SA·17630055516005·

    omniTRAX Patient Tracker

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102640·Reusable non-sterile multi-modality fiducial ma...

    EXTERNAL FIXATION ANCHOR PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSAPULSE MODEL P20 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD DISCARDIT¿ II - 2-PIECE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 3, 2022

    DERMAGRAFT-TC

    FDA Adverse Event
    Injury ·ADVANCED TISSUE SCIENCES, INC.·Product code MGR·April 3, 1998

    VIVA QUAD XT

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DXY·December 9, 2015

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·September 19, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2011

    THORATEC® HEARTMATE®, SYSTEM MONITOR

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·June 6, 2024

    GALAXY G3 MINI 2MM X 4CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 5MM X 15CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 3MM X 8CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    GALAXY G3 MINI 2MM X 3CM

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code KRD·June 16, 2021

    Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025