107 results
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code JAK·June 30, 2021
FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
FDA Recall
Open, Classified
·FUJIFILM Healthcare Americas Corporation·Product code KPR·September 15, 2025
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs include but are not limited to brain, heart, liver, kidney, pancreas, etc. The system may acquire data using Axial, Cine, Helical, Cardiac, and Gated CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. Further, the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
FDA Recall
Open, Classified
·GE Healthcare, LLC·Product code JAK·June 30, 2021
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.
FDA Recall
Open, Classified
·Qvella Corporation·Product code JJH·November 2, 2022
BD Pyxis Med ES Auxiliary (AUX), REF 343
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation ES (Med ES Main), REF 323
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation 4000 AUX, REF 306
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation ES AUX, REF 324
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
BD Pyxis MedStation 4000 Main, REF 303
FDA Recall
Open, Classified
·CareFusion 303, Inc.·Product code BRY·February 14, 2023
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·September 12, 2023
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code LFL·September 12, 2023
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1153
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021
HeartWare HVAD Pump Implant Kit, REF 1125
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·June 3, 2021