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

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    LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    Kwire tip protector Dia 1.2/1.6 mm sterile

    FDA UDI
    IN2BONES·03760225714782·Kwire tip protector Dia 1.2/1.6 mm sterile

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450159989·

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131101·IN-OVATION® C Base Rx 018 U3-3 CS HK

    MYSTIQUE® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K110151101·MYSTIQUE® MB RT RX 018 U 5-5 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131611·IN-OVATION® C Roncone 018 U3-3 CS HK

    PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

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

    FIDUCIAL MARKERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZMR AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL, INC.·Product code GFD·December 3, 2019

    OSIGRAFT (EPTOTERMIN ALFA)

    FDA Adverse Event
    Other ·OLYMPUS BIOTECH·Product code MQV·June 28, 2011

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·May 21, 2021

    CARDIOSAVE HYBRID INT TYPE G PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·April 2, 2021

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·October 5, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 13, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 23, 2014

    COULTER® ACT 5DIFF CAP PIERCE HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·June 1, 2011

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·February 15, 2021

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·March 26, 2021

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·February 25, 2021

    Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code LNH·August 3, 2011