170 results
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26ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics Inc·May 7, 2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·January 1, 2025
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
FDA Enforcement
Class III
·Ongoing·Cardiac Assist, Inc·December 8, 2021
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17
FDA Enforcement
Class II
·Ongoing·Cardiac Assist, Inc·September 6, 2023
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators
FDA Enforcement
Class I
·Ongoing·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·June 28, 2023