BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    Protean Fragment Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247577·No-Profile Interbody, 43mm x 30mm x 18mm, 15 Deg

    LNCS OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dornier MAGELLAN Ureteral Access Sheath

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 20, 2024

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 10, 2014

    PRECISE PRO RX CAROTID STENT SYSTEM

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIM·September 9, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 22, 2013

    M-LNCS Y-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·August 12, 2017

    PKG, ALLIS FORCEPS, P/N 0250080240. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020