BEUDAMED
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    Dentis s-Clean SQ-SL Fixture

    FDA 510(k)
    FDA Class 2 ·Dental

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690191384·Patella Resection Cover Size 29

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946012434·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946012915·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946062279·X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTER...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946006303·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946060473·X SERIES, MONITOR/DEFIBRILLATOR, 3/5 LEAD, ECG,...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946018887·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946005733·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    X SERIES

    FDA UDI
    Zoll Medical Corporation·00847946019334·Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFI...

    ROSA ONE Brain application

    FDA 510(k)
    FDA Class 2 ·Neurology

    SCD EXPRESS PORTABLE COMPRESSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    TENDRIL SDX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 15, 2013

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 8, 2025

    TERUMO RADIFOCUS GUIDE WIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 8, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

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