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

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    Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271814·

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145643·.17/.06/25mm ZenFlex CM NiTi FILE REFILL PACK

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304476714·

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JPI·December 17, 2024

    Immucor GTI Diagnostics, Inc.

    FDA registration
    Immucor GTI Diagnostics, Inc.·5 products·🇺🇸 United States

    ERBE HYBRID KNIFE

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

    I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·May 25, 2023

    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·April 17, 2020

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 22, 2013

    PF4 ENHANCED ASSAY

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS, INC.·Product code LCO·January 26, 2016

    DONORSCREEN-HLA CLASS I AND CLASS II

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS, INC.·Product code MZI·August 29, 2016

    MATCH IT! DNA SOFTWARE

    FDA Adverse Event
    Malfunction ·IMMUCOR GTI DIAGNOSTICS, INC.·Product code MZI·February 10, 2021

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017