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)
Top companies in LWS
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2025 | Medtronic, Inc. Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4 Open, Classified |
LWS | None listed |
| Oct 10, 2025 | Boston Scientific Corporation Model Number L101, ESSENTIO DR SL Pacemaker Open, Classified |
LWS | None listed |
| Aug 20, 2025 | Boston 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 |
LWS | None listed |
| Jun 26, 2024 | Medtronic 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 |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 26, 2024 | Medtronic Inc. EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jan 22, 2024 | Medtronic Inc. Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1 Open, Classified |
LWS | None listed |
| Jan 5, 2024 | Boston 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 |
LWS | None listed |
| Sep 19, 2023 | Abbott 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 |
LWS | None listed |
| Aug 22, 2023 | Boston Scientific Corporation EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Aug 22, 2023 | Boston Scientific Corporation EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic 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 |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
| Jun 16, 2023 | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators Open, Classified |
LWS | None listed |
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