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

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    Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525

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

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142006170·CC-000

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540256911·SCREWDRIVER BLADE, 1.7MM CROSS-FIT

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120061700000·French Rod Bender

    NSI HEXED AND NON-HEXED IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARTICULEZE M HEAD 36MM +12

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 2, 2013

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·May 2, 2013

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·October 24, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·July 1, 2013

    CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·April 20, 2018

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 19, 2021

    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022

    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·March 5, 2014