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

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    Saline Wound Wash, SteriCleanse(TM)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304272026·

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304466227·

    CRITICOOL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOMET CC CRUCIATE TRAY 71MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·June 22, 2013

    COLLEAGUE VOLUMETRIC INFUSION PUMP

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

    FLEXCATH STEERABLE SHEATH

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code DRA·July 29, 2011

    BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 19, 2018

    BIOMET MODULAR TIBIAL LOCKING BAR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 19, 2018

    E1 VNGD PS TIB BRG 79/83X12 OR

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·March 6, 2015

    BIOMET CC I-BEAM TRAY 79MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 19, 2021

    BIOMET CRUCIATE TIBIAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 28, 2017

    VANGUARD INTERLOK FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 28, 2017

    ARCOM SERIES-A STANDARD PATELLA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 28, 2017

    VAN PS OPEN INTL FEM-RT 67.5

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·April 19, 2021

    BIOMET CC CRUCIATE TRAY 79MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 26, 2018

    VNGD PS OPEN INTL FEM RT 70 70

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 26, 2018

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020