21 results
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48ms
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Sources: EU EUDAMED, US FDA
GT Metabolic Solutions, Inc.
Manufacturer
🇺🇸 United States
GT METABOLIC SOLUTIONS, INC.
FDA registration
GT METABOLIC SOLUTIONS, INC.·4 products·🇺🇸 United States
GT Metabolic DI Magnet - 50mm
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216113·
GT Metabolic Laparoscopic Positioning Device
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216014·
GT Metabolic Delivery System
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216052·
GT Metabolic Laparoscopic Positioning Device
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216045·
GT Metabolic DI Magnet - 40mm
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216069·
GT Metabolic Laparoscopic Positioning Device
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216021·
GT Metabolic Laparoscopic Positioning Device
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216038·
GT Metabolic Instrument Set
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216144·
GT Metabolic Laparoscopic Positioning Device
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216007·
GT Metabolic Magnetic Retrieval Device (MRD)
FDA UDI
Gt Metabolic Solutions, Inc.·00850054216106·
SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 10, 2017
SAFIL QUI+ UNDY 3/0 (2) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 10, 2017
SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 10, 2017
SAFIL QUI+ UNDY 2/0 (3) 90CM HRT37(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 10, 2017
SAFIL VIOLET 2/0 (3) 70CM HR22 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·April 26, 2019
SAFIL VIOLET 2/0 (3) 70CM HR22 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·April 26, 2019
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: 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. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code JAK·May 29, 2018
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: 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. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·June 27, 2018