BEUDAMED
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    AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SEMIAL 5°

    FDA UDI
    SIGNUS Medizintechnik GmbH·04047844000717·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508435·

    GAS3 module: Auto ID Multi-Gas/BIS modul

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904006543·

    VPAP III

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO JMS APHERESIS NEEDLE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEEDLE CNV 22X1

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code FMI·August 29, 2019

    UNKNOWN COPELAND SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·April 14, 2017

    COPELAND SH HUM SZ4 STND PLUS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·June 8, 2016

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·October 21, 2016

    UNKNOWN COPELAND RESURFACING SHOULDER

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·May 16, 2017

    UNKNOWN COPELAND SHOULDER GLENOID COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code HSD·July 5, 2017

    PROLIFT +M PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·April 10, 2013

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011

    TVL-ADX ACTIVE FIXATION LEAD

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code DQO·April 15, 2008

    BD¿ SYRINGE S2

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·December 12, 2018

    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