BEUDAMED
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    Cortera Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Luna

    FDA UDI
    ULTRADENT PRODUCTS, INC.·00883205004444·Luna Opal R Mini .022 Kit 5x5 U & L Hooks 3

    CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M-H HA/PC 11X160MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    M-H SOLID SHELL HA/PC DIA54MM LN24

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·March 1, 2016

    MALLORY-HEAD SHORT FEMORAL STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·July 28, 2017

    MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code MEH·August 11, 2016

    UNKNOWN_INSTRUMENTS_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·November 3, 2014

    MAVERICK 2 (TM)

    FDA Adverse Event
    Malfunction ·Product code LOX·August 24, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 11, 2013

    MLRY-HD XR LAT POR FMRL 8MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HXX·August 1, 2024

    M-H HA/PC 12X165MM T1

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·December 16, 2015

    Syngo.via, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 5, 2017

    Syngo.x, Picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. Syngo.via supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S. The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission. It supports the physician in diagnosis and treatment planning. Syngo.via also supports storage of Structured DICOM Reports. In a comprehensive imaging suite syngo.via integrates Radiology Information Systems (RIS) to enable customer specific workflows. Syngo.via allows to use a variety of advanced applications (clinical applications) designed for syngo.via just as the predicate device syngo.x,(K092519,cleared on August 27, 2009). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo.via medical device. Syngo.via has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and post processing algorithms compared to the above mentioned predicate devices. Syngo.via is based on Windows. Due to special customer requirements and the clinical focus syngo.via can be configured in the same way as the predicate device with different combinations of syngo- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages. Syngo.via Data Management ...ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 5, 2017

    Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;

    FDA Enforcement
    Class III ·Terminated·Cook Medical Incorporated·April 13, 2022