BEUDAMED
    30 results · 27ms · Sources: EU EUDAMED, US FDA

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    Customized Contour Implant

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

    2008T BlueStar Hemodialysis Machine

    FDA UDI
    Fresenius Medical Care Holdings, Inc.·00840861102112·

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365104978·

    BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·November 21, 2001

    DREAMSTATION BIPAP PRO

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·November 6, 2024

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·July 29, 2011

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 14, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 26, 2008

    NEEDLE 26X1/2 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·October 9, 2020

    BAB TOUGH STRIPS

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON CONSUMER INC.·Product code KGX·April 22, 2021

    EXEL HYPO NDL 27GX1-1/4"

    FDA Adverse Event
    Injury ·EXELINT INTERNATIONAL, CO.·Product code FMF·March 25, 2024

    BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    BD Microtainer SST- Amber Part/Catalog Number: 365978

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·April 17, 2024

    BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019

    2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·May 29, 2024

    BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·October 16, 2019