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

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    Icare ic100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 29, 2015

    TISSUE SAMPLING NEEDLE

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

    SAM JUNCTIONAL TOURNIQUET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PEDICLE SCREW REDUCTION PEDICLE SCREW 6X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·May 29, 2019

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 27, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 30, 2012

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis zee biplane, Model Number 10094141

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

    Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016