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

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    PAPAYA 3D Premium & PAPAYA 3D Premium Plus

    FDA 510(k)
    FDA Class 2 ·Radiology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113516·MINIATURE BLADE #69 (BX/5)

    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    CAL-CHEX CD PLUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    RANDOX COMPLEMENT C3

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUADRA-P LAT STEM SIZE 1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 24, 2024

    ALARIS SECONDARY SET

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 13, 2016

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·October 24, 2014

    COLLEAGUE PRE-P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    STRATA II VALVE, REGULAR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·July 1, 2013

    ENVEO PRO DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·September 28, 2023

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021