ClearanceBrief
Product code LWS ยท Class 3

Implantable Cardioverter Defibrillator (Non-Crt)

0510(k)s in 12 months (0 all time)
1recalls in 12 months (219 all time)
0recalls that name a 510(k)
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Top companies in LWS

DateFirm and productCodeLinked 510(k)
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Mar 3, 2023Boston Scientific Corporation
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Open, Classified
LWSNone listed
Aug 9, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
Open, Classified
LWSNone listed
Jul 7, 2022Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functi
Open, Classified
LWSNone listed
Jul 7, 2022Boston Scientific Corporation
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use con
Open, Classified
LWSNone listed
Apr 12, 2022Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3D4; b) Crome DR: DDPC3D1, DDPC3D4; c) Crome HF: DTPC2D4, DTPC2D1; d) Crome HF Q
Open, Classified
LWSNone listed
Mar 10, 2022St. Jude Medical, Cardiac Rhythm Management Division
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Open, Classified
LWSNone listed
Mar 10, 2022St. Jude Medical, Cardiac Rhythm Management Division
Gallant VR Implantable Cardioverter Defibrillator REF # CDVRA500Q
Open, Classified
LWSNone listed
Mar 10, 2022St. Jude Medical, Cardiac Rhythm Management Division
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
Open, Classified
LWSNone listed
Mar 27, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF
Open, Classified
LWSNone listed
Mar 8, 2021BIOTRONIK Inc
BIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRI, REF 429553, UDI: 04035479156831 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment
Terminated
LWSNone listed
Mar 8, 2021BIOTRONIK Inc
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of l
Terminated
LWSNone listed
Mar 8, 2021BIOTRONIK Inc
BIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRI, REF 429559, UDI: 04035479156855 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment o
Terminated
LWSNone listed
Mar 8, 2021BIOTRONIK Inc
BIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRI, REF 429531, UDI: 04035479156763 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of l
Terminated
LWSNone listed
Feb 5, 2021Boston Scientific Corporation
EMBLEM MRI S-ICD Model A219
Terminated
LWSNone listed
Feb 5, 2021Boston Scientific Corporation
EMBLEM S-ICD Model A209
Terminated
LWSNone listed

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