68 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·November 6, 2024
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes in pulmonary artery (PA) pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 3, 2025
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial Electronics System (PES) REF CM3000 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·October 5, 2024
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)). Model Number MN6000
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·October 5, 2024
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·October 4, 2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use to initiate or modify heart failure treatment.
FDA Recall
Open, Classified
·St. Jude Medical·Product code MOM·February 7, 2023
Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code MWS·October 16, 2024
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.
FDA Recall
Open, Classified
·Maquet Cardiovascular, LLC·Product code DWS·June 28, 2023
MIM software; System, Image Processing, Radiological
FDA Recall
Open, Classified
·MIM Software Inc·Product code LLZ·February 19, 2025
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HSB·October 13, 2025
HammerTube Implant, 2.75mm, 10 Cannulated (Sterile)
FDA Recall
Open, Classified
·Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062·Product code HTY·May 26, 2022