BEUDAMED
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    M/L-10 CLIP APPLIER STERILIZATION TRAY (Catalog#3706)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RADIFOCUS GLIDEWIRE M

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·January 22, 2018

    ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·October 8, 2014

    TERUMO CDI 100 MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DTY·June 24, 2011

    HARMONIC ACE 36 MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·September 10, 2008

    UNKNOWN VANGUARD CR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 13, 2017

    UNKNOWN KNEE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 27, 2015

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023