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    Lumipulse G TP-N Immunoreaction Cartridge Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197412001·Metzenbaum-Fino Dissecting Scissors Fig. 1...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197039598·Super-Cut Metzenbaum-Fino Scissors Fig.1 curved...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197381406·CERA-CUT® Metzenbaum Fino Scissors curved...

    ECHELON OVAL MRI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    HAMMERLOC TM TIBIAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

    OUTLOOK ES

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL, INC.·Product code FRN·June 17, 2011

    POLYFLUX R CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIAYLZATOREN GMBH·Product code MSF·September 4, 2008

    Artis zee biplane, Model Number 10094141

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

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    Artis zee biplane, Model Number 10094141

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

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    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

    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