BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    SAFE-T-PINS RETENTIVE PIN SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110577·COAXIAL IRRIGATING/ASPIRATING TIP CURVED

    Ortho Specialties

    FDA UDI
    Young Innovations, Inc.·00843471187036·Anatomical Molar Bands, Lower Left 2nd Molars, ...

    40 L HIGH FLOW INSUFFLATOR F113

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OnSight 3D Extremity System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAESTRO SMALL FIXED DURAGUARD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBB·April 21, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·September 20, 2012

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·July 15, 2010

    GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·April 17, 2013

    GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 31, 2013

    Model Number U228, VISIONIST CRT-P EL MRI

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·January 22, 2025