26 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·April 24, 2013
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
FDA Recall
Terminated
·Transonic Systems Inc
34 Dutch Mill Rd
Warren Road Business Park
Ithaca NY 14850-9785·Product code DXG·March 28, 2013
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
FDA Recall
Terminated
·Transonic Systems Inc·Product code PEH·February 15, 2018
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
FDA Recall
Terminated
·Transonic Systems Inc·Product code DPW·July 27, 2015
Transonic Hemodialysis Monitor, Model HD03 -- Product Usage: The Hemodialysis Monitor is intended for use by trained medical personnel to measure delivered blood flow, vascular access recirculation, vascular access blood flow and cardiac output on patients receiving hemodialysis treatment.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·March 25, 2015
Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015
Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015
Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015
Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015
Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
FDA Enforcement
Class II
·Terminated·Transonic Systems Inc·September 9, 2015