BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    Single-use Sterile High-pressure Angiographic Syringes and Accessories

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SpheRx

    FDA UDI
    Nuvasive, Inc.·00887517443120·SpheRx® II Hook, 10mm Lamina Wide

    APERIO EPATHOLOGY EIHC IVD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ZIMMER ANATOMIC II HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    BD CONVENTIONAL NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·May 13, 2025

    TRILOGY AB ACETABULAR SYSTEM ALTERNATE BEARING SHELL INSERT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWB·November 21, 2008

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·July 22, 2013

    TRUE METRIX AIR

    FDA Adverse Event
    Injury ·TRIVIDIA HEALTH INC·Product code NBW·March 17, 2023

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    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