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)
Get daily alerts for LWSSample briefCSV

Top companies in LWS

DateFirm and productCodeLinked 510(k)
Nov 28, 2025Medtronic, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Open, Classified
LWSNone listed
Oct 10, 2025Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Open, Classified
LWSNone listed
Aug 20, 2025Boston Scientific Corporation
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175,
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD C
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 26, 2024Medtronic Inc.
EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jan 22, 2024Medtronic Inc.
Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Open, Classified
LWSNone listed
Jan 5, 2024Boston Scientific Corporation
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40,
Open, Classified
LWSNone listed
Sep 19, 2023Abbott Medical
Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT
Open, Classified
LWSNone listed
Aug 22, 2023Boston Scientific Corporation
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Aug 22, 2023Boston Scientific Corporation
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed
Jun 16, 2023Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators
Open, Classified
LWSNone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.