BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    ClearGrasp Snare

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

    HUMAN BETA-2 MICROGLOBULIN KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    ORION MICRO CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    DEPUY ASR XL FEM IMP SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·June 21, 2013

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·January 18, 2019

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2019

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·November 26, 2025

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    TRILOGY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 26, 2026

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

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

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012