4 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
×
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.
FDA Enforcement
Class II
·Ongoing·Merge Healthcare, Inc.·September 10, 2025
Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
FDA Enforcement
Class II
·Terminated·Merge Healthcare, Inc.·May 10, 2017
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
FDA Enforcement
Class II
·Ongoing·Schiller, Ag·October 8, 2025
CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number: 3.920570
FDA Enforcement
Class II
·Ongoing·Schiller, Ag·September 4, 2024