BEUDAMED
    20 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Primary Relief

    FDA 510(k)
    FDA Class 2 ·Neurology

    Meridian

    FDA UDI
    Seaspine Orthopedics Corporation·10889981247201·No-Profile Interbody, 39mm x 27mm x 14mm, 25 Deg

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094022147·Packing Gauze X-Ray Detectable

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197051781·Dietrich DeBakey Bulldog Clamp angled...

    Disposable Intraoperative Probe (DIOP8)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1823260-2017-01932

    FDA Adverse Event
    Malfunction ·September 11, 2017

    AUTOSUTURE ENDO STITCH

    FDA Adverse Event
    Malfunction ·COVIDIEN UNITED STATES SURGICAL CORPORATION·Product code MFJ·October 31, 2008

    ENERGY CAPITAL GENERATOR 11

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·August 24, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 11, 2013

    1823260-2017-01504

    FDA Adverse Event
    Malfunction ·July 20, 2017

    COBAS 8000 C 702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·March 8, 2018

    1823260-2017-02190

    FDA Adverse Event
    Malfunction ·October 3, 2017

    COBAS 8000 C (701) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·May 8, 2018

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    COBAS 8000 C 702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 10, 2017

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    COBAS 8000 C (701) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·August 16, 2017

    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