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

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    Voyant Maryland Fusion Device

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

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003555·Fixed Curve Diagnostic EP Catheter Josephson, 5F

    PTR Robots

    FDA UDI
    Blue Ocean Robotics ApS·05744000015989·Belt connector for PTR Robot

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750007400·HTR SHELL/CABLE/CONN ASSY 3830

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180108691·5 MM DIA., 45 CM BIPOLAR DUAL NEEDLE MYOMA COAG...

    DUVAL COLLIN FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084902·DEBAKEY COLLIN FORCEPS DEBAKEY TIP

    N/A

    FDA UDI
    STRYKER SUSTAINABILITY SOLUTIONS, INC.·00885825003562·Fixed Curve Diagnostic EP Catheter Josephson, 5F

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code QFG·March 28, 2023

    5F GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PENRITH ELETTRA ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 24, 2014

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·July 1, 2013

    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

    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

    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