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

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    AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEPILASE TWIN YAG LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·December 4, 2017

    SJM SGUIN SEMI-RIGID ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC.·Product code KRH·April 27, 2020

    TAILOR FLEXIBLE RING AND BAND

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC.·Product code KRH·April 27, 2020

    32MM MOD HEAD COCR STD NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·October 24, 2014

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 1, 2013

    G7 PPS LTD ACET SHELL 54F

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·November 7, 2025

    AUTOPULSE NXT RESUSCITATION SYSTEM

    FDA Adverse Event
    Injury ·ZOLL CIRCULATION, INC.·Product code DRM·April 8, 2025

    115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired patient temperature through conductive heat transfer. Part number 86165.

    FDA Enforcement
    Class II ·Terminated·Cincinnati Sub-Zero Products Inc·June 11, 2014

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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