ClearanceBrief
Product code NKE ยท Class 3

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

0510(k)s in 12 months (0 all time)
1recalls in 12 months (28 all time)
0recalls that name a 510(k)
Get daily alerts for NKESample briefCSV

Top companies in NKE

DateFirm and productCodeLinked 510(k)
Apr 24, 2026Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225;
Open, Classified
NKENone listed
Oct 10, 2025Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Open, Classified
NKENone listed
Oct 10, 2025Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Open, Classified
NKENone listed
Oct 10, 2025Boston Scientific Corporation
Model Number U225 VISIONIST CRT-P EL
Open, Classified
NKENone listed
Oct 10, 2025Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Open, Classified
NKENone listed
Oct 10, 2025Boston Scientific Corporation
Model Number U125, VALITUDE CRT-P EL
Open, Classified
NKENone listed
Jan 10, 2025Boston Scientific Corporation
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Open, Classified
NKENone listed
Jan 10, 2025Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Open, Classified
NKENone listed
Jul 13, 2021Boston Scientific Corporation
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Open, Classified
NKENone listed
Jul 13, 2021Boston Scientific Corporation
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Open, Classified
NKENone listed
Jul 13, 2021Boston Scientific Corporation
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
Open, Classified
NKENone listed
Jul 2, 2021Boston Scientific Corporation
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Open, Classified
NKENone listed
Jul 2, 2021Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Open, Classified
NKENone listed
Apr 6, 2021Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05, W4TR02, W4TR05 c. Solara CRT-P MRI: W1TR03, W1TR06, W4TR03, W4TR06. implantabl
Open, Classified
NKENone listed
Jul 10, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pa
Terminated
NKENone listed
Jul 10, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient
Terminated
NKENone listed
Jul 10, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pa
Terminated
NKENone listed
Jul 10, 2018Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient
Terminated
NKENone listed
Dec 7, 2017Boston Scientific Corporation
VISIONIST X4 CRT-P Pacemaker
Open, Classified
NKENone listed
Dec 7, 2017Boston Scientific Corporation
VISIONIST CRT-P Pacemaker
Open, Classified
NKENone listed
Dec 7, 2017Boston Scientific Corporation
VALITUDE X4 CRT-P Pacemaker
Open, Classified
NKENone listed
Dec 7, 2017Boston Scientific Corporation
VALITUDE CRT-P Pacemaker
Open, Classified
NKENone listed
Aug 28, 2017St Jude Medical Inc.
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply
Terminated
NKENone listed
Aug 28, 2017St Jude Medical Inc.
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that
Terminated
NKENone listed
Aug 28, 2017St Jude Medical Inc.
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CR
Terminated
NKENone listed
Nov 27, 2015Medtronic Inc.
Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.
Terminated
NKENone listed
Jun 27, 2013Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefi
Terminated
NKENone listed
Sep 28, 2006Boston Scientific CRM Corp
CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. Quantities Distributed by model are as follows: CONTAK RENE
Terminated
NKENone listed

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