BEUDAMED
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    ASTRA-OCT Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EP BLUE™

    FDA UDI
    INNOVATIVE HEALTHCARE CORPORATION·10813172021714·Gloves, Exam, Latex, Chemo, Non-Sterile, Powder...

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515025653·Caspar Retr, 67x17mm, 8"

    RADSCAN EQUIPMENT SLICKER

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

    MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM

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

    ECHELON LINEAR CUTTER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 17, 2014

    M2A MAGNUM MODULAR HD COCR 44MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code KWA·June 21, 2013

    VIBRANT SOUNDBRIDGE

    FDA Adverse Event
    Malfunction ·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·July 8, 2011

    Quanta System Sterile Optical Laser Fiber, reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021

    CR PROLONG 40MM BRNG +3 RET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·June 23, 2023

    CR 40MM GLENOSPHERE +3MM COCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·June 23, 2023

    MINI TRAY +5MM COCR +6 OFFSET

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·June 23, 2023

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014