BEUDAMED
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    Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

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

    ZIMMER PERIARTICULAR LOCKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AMBU DISPOSABLE ECG ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PML·February 26, 2026

    ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, B.V.·Product code MGB·November 10, 2014

    DUROM US ACETABULAR COMPONENT 54/48 N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWB·November 24, 2008

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 9, 2011

    Cardinal Health Brand 120mL/53mm sterile, individual peel pouch specimen container with orange cap (100/pk) Catalog number: CHB13905

    FDA Enforcement
    Class II ·Terminated·Thermo Fisher Scientific (Monterrey)·November 13, 2019

    M.U.S.T. PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code PML·November 13, 2025

    Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA. The device is intended to facilitate placement of interventional devices into the neurovascular system.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·October 6, 2009

    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 24, 2009

    Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 24, 2009

    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