BEUDAMED
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    BIOM-SINGER LOW PRESSURE V.P.

    FDA Adverse Event
    Other ·HELIX MEDICAL, INC.·Product code EWL·January 31, 2003

    BLOM-SINGER INDWELLING VOICE PROSTHESIS

    FDA Adverse Event
    Other ·HELIX MEDICAL, INC.·Product code EWL·January 31, 2003

    BLOM-SINGER LOW PRESSURE V.P.

    FDA Adverse Event
    Other ·HELIX MEDICAL, INC.·Product code EWL·February 18, 2003

    FREEMAN FRONTAL SINUS STENT

    FDA Adverse Event
    Injury ·HELIX MEDICAL, INC.·Product code KAM·August 29, 2001

    ULTIPACE¿ LEAD, 52CM MRI

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·May 28, 2025

    Medtronic Sprint Quattro Secure S, model 6935. Steroid eluting, tripolar, screw-in, ventricular lead with RV defibrillation coil electrode. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code LWS·October 25, 2010

    Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in, ventricular lead with Right Ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.

    FDA Recall
    Terminated ·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code LWS·October 25, 2010

    TENDRIL STS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·December 1, 2021

    RIATA ACTIVE-FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·September 5, 2006

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. CRMD·Product code LWS·August 30, 2006

    RIATA ACTIVE-FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 29, 2006

    RIATA ST ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·August 15, 2006

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·February 19, 2025

    LEAD MODEL 304

    FDA Adverse Event
    Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·February 14, 2025

    ESOPHYX Z+

    FDA Adverse Event
    Injury ·ENDOGASTRIC SOLUTIONS, INC·Product code ODE·August 22, 2024

    -TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM

    FDA Adverse Event
    Malfunction ·APOLLO ENDOSURGERY, INC·Product code OCW·December 7, 2023

    ESOPHYX Z+

    FDA Adverse Event
    Malfunction ·ENDOGASTRIC SOLUTIONS INC·Product code ODE·August 30, 2024

    BLOM-SINGER

    FDA Adverse Event
    Injury ·INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.·Product code MCK·February 10, 2006

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    FDA Adverse Event
    INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.·Product code EWL·February 1, 2006

    BLOM SINGER ADVANTAGE

    FDA Adverse Event
    INHEALTH TECHNOLOGIES, A DIVISION OF HELIX MEDICAL, INC.·Product code EWL·February 1, 2006