6 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
FDA Enforcement
Class II
·Ongoing·TAS Medical Inc·March 12, 2025
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·April 1, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020
Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment.
FDA Enforcement
Class II
·Terminated·MEDTRONIC ATS MEDICAL, INC.·December 2, 2020