BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code NTW·May 1, 2026

    UNSPECIFIED BD PAXGENE® BLOOD TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code PJE·June 13, 2025

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 23, 2026

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·March 31, 2026

    PAXGENE® BLOOD RNA TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code NTW·February 9, 2026

    Best Medical International

    FDA UDI
    BEST MEDICAL INTERNATIONAL, INC.·00841365104411·

    Clear Readers

    FDA UDI
    Diversified Products, Inc.·00842894127698·

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00037741908227·

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894114964·

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0861500·Pituitary, Up Biting, 3mm

    SONICAID FM820, SONICAID FM830

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

    PATTON ENDO-BAG

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

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 23, 2021

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 28, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·July 25, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 27, 2025

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012