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

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    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021470·SPIRA®-A Integrated,Trial, 32x38mm, 8° Lordotic...

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021470·Trial, 16mm x 20mm Lordotic 7°, 5mm

    FOCUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE

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

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 10, 2002

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 21, 2015

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 28, 2022

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    *

    FDA Adverse Event
    Malfunction ·APTUS ENDOSYSTEMS, INC.·Product code OTD·May 1, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·July 12, 2024

    ONCONTROL COAXIAL TRAY(11/13GA X 102/147

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code KNW·April 30, 2019

    ONCONTROL COAXIAL TRAY(11/13GA X 102/147

    FDA Adverse Event
    Injury ·TELEFLEX MEDICAL·Product code KNW·September 24, 2019

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·LABSTYLE INNOVATIONS LTD.·Product code NBW·May 2, 2018

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021