BEUDAMED
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    Sterile Hypodermic Syringes for Single Use

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526799424·MANUMED ACTIVE WRIST RIGHT SAND XS

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705003242·RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 11mm,...

    V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STITCHKIT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BIOMET

    FDA Adverse Event
    Other ·BIOMET·Product code JWH·June 26, 2007

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN - BENNETT CORP.·Product code CBK·October 22, 2008

    MINMARK DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·July 3, 2013

    e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·June 26, 2015

    Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·September 28, 2018

    Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·November 30, 2018

    Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·July 31, 2015

    Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·July 31, 2015

    Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging facility or in a mobile/ transportable imaging environment.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·July 31, 2015

    e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYX·August 5, 2016

    Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20)-3R, Material Number 10534159 h) mCT Flow Edge-4R, Material Number 10528955 i) mCT Flow 40-3R, Material Number 10529158 j) mCT Flow 64-3R, Material Number 10529160 k) mCT X-4R, Material Number 10248670 l) mCT X-3R, Material Number 10248673 m) mCT S(20)-4R, Material Number 10534160 n) mCT S(40)-3R, Material Number 10248668 o) mCT Flow 40-4R, Material Number 10529159 p) mCT Flow 20-3R, Material Number 10528956 q) mCT Flow Edge-3R, Material Number 10528954 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·September 28, 2018

    SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code KPS·January 16, 2023

    SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code KPS·January 16, 2023

    SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code KPS·January 16, 2023

    Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc.·Product code KPS·December 13, 2016