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

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    EP Granules™ BVF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COBAS 8000 MODULAR SERIES ANALYZER

    FDA 510(k)
    FDA Class 2 ·Immunology

    DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SYRINGE 0.3ML 29GA 12.7MM 10BAG 500 WAL

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 17, 2021

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 24, 2024

    5.0MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/75MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 20, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 2, 2014

    LIFECARE PCA 3 V5.06

    FDA Adverse Event
    Death ·HOSPIRA COSTA RICA LTD.·Product code MEA·May 16, 2011

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·September 30, 2024

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 7, 2024

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·October 21, 2024

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Injury ·COOK INC·Product code FAD·April 19, 2021

    SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·June 28, 2022

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    SOF-FLEX MULTI-LENGTH URETERAL STENT SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FAD·October 21, 2024

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020

    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