BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    TO BE ASSIGNED

    FDA UDI
    FGX INTERNATIONAL INC.·00193033540107·

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD4882007130·5 inch Chondro Pick, 20° Angled Tip, Curved

    RONGEUR LFI POST. WALL BSSO MED.

    FDA UDI
    W.H. Holden, Inc.·D9282007130·

    World Knee System

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215037918·

    BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 23, 2023

    LINK TrabecuLink Tibial Cones

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MS-30 LATERAL FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD¿ COLUMBIA AGAR WITH 5% SHEEP BLOOD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON GMBH·Product code KZI·December 3, 2021

    LASSO? 2515 VARIABLE CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·October 24, 2014

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Death ·PHYSIO-CONTROL, INC.·Product code MKJ·August 4, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 1, 2013

    TFNA HELICAL BLADE L80 TAN

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·July 18, 2017

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021