BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304460843·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036177·50°/55° Fusion Recess Reamer, Quick Release

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103997·T³ Acetabular Hemispherical Shell, Cluster Hole...

    FEATHERLITE AQUA TOCODYNAMOMETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    RETRIEVE IMPLANT CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 23, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·June 17, 2011

    POLYFLUX R CAPILLARY DIALYZER

    FDA Adverse Event
    Other ·GAMBRO DIAYLSATOREN GMBH·Product code KDI·July 11, 2008

    Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315

    FDA Enforcement
    Class II ·Terminated·Philips North America Llc·September 1, 2021

    ORTHOPEDIC SALVAGE SYSTEM AXLE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM TIBIAL BEARING 12MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM BOWED IM STEM WITH SCREW 14.5MM X 150MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHINGS SET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM YOKE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KRO·April 8, 2019

    Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044. Implant is part of a system used to replace the tibial portion of the knee joint.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JDI·November 7, 2007

    ORTHOPEDIC SALVAGE SYSTEM RESURFACING FEMORAL COMPONENT 3CM LEFT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019

    ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·April 8, 2019