BEUDAMED
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    Persona Revision Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 2023

    IVD-GE02

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCREW INSERTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HSB·May 12, 2021

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 21, 2013

    CAPSURE SP NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 28, 2011

    AFFINITY 3

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code HDD·September 26, 2008

    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

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021