BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    AI Platform 2.0 (AIP002)

    FDA 510(k)
    FDA Class 2 ·Radiology

    AESKULISA ANA HEP-2

    FDA 510(k)
    FDA Class 2 ·Immunology

    GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER

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

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 9, 2011

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH LTD / HUNTINGTON·Product code HQL·November 5, 2014

    WIRELESS BATTERY MODULE G

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 17, 2013

    BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152, USA , 800-638-8663, BENEX Limited, Shannon, County Clare, Ireland.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code LHJ·August 17, 2006

    PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 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