Panels › Cardiovascular › Product code DXY · Class 3
Implantable Pacemaker Pulse-Generator
Regulation 870.3610
0510(k)s in 12 months (461 all time)
0recalls in 12 months (75 all time)
1recalls that name a 510(k)
Top companies in DXY
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Vascular | 59 | 0 |
| Intermedics, Inc. | 52 | 0 |
| Telectronics, Inc. | 47 | 0 |
| Cardiac Pacemakers, Inc. | 37 | 0 |
| Guidant Corp-Cpi Division | 0 | 32 |
| Pacesetter Systems | 28 | 0 |
| Cook Pacemaker Corp. | 24 | 0 |
| Ela Medical, Inc. | 22 | 2 |
| Biotronik Sales, Inc. | 22 | 0 |
| Cordis Corp. | 21 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin.net model MN5000 Software Open, Classified |
DXY | None listed |
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin 2 PCS MER37000 programmer Model MER3400 software Open, Classified |
DXY | None listed |
| Jun 17, 2022 | St. Jude Medical, Cardiac Rhythm Management Division Merlin PCS 3650 programmer Model 3330 software Open, Classified |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM 1260 ASSURITY +
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that pr Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI
These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power s Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Assurity MRI Model Numbers: PM1272, PM2272
Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: S Terminated |
DXY | None listed |
| Aug 28, 2017 | St Jude Medical Inc. Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224
Implantation of a single Terminated |
DXY | None listed |
| Jan 11, 2012 | St Jude Medical CRMD Anthem CRT-P models PM3110 and PM3210
St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Terminated |
DXY | None listed |
| Jan 11, 2012 | St Jude Medical CRMD Implantable Pacemaker Accent DR models PM2110 and PM2210
St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy. Terminated |
DXY | None listed |
| Apr 26, 2010 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial ta Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker, model SVVI103, for ventricular use only. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, model SVDD303. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Rate Responsive Pacemaker, models DR353, SDR203, SDR303, and SDR306. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Dual Chamber Pacemaker, models SD203 and SD303. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Rate Responsive Pacemaker; models SR353, SSR203, SSR303, and SSR306. Terminated |
DXY | None listed |
| Jun 11, 2009 | Medtronic Inc. Cardiac Rhythm Disease Managment Medtronic SIGMA 100/200/300 Series IPGs, Single Chamber Pacemaker; models SS103, SS106, SS203, and SS303. Terminated |
DXY | None listed |
| Dec 19, 2006 | St Jude Medical CRMD St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers) Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only. Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Rate Responsive Pacemaker, models SSR203, SSR303, SSR306 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker, models SS103, SS106, SS203, SS303 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303. Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) Dual Chamber Rate Responsive Pacemaker, models SDR203, SDR303, SDR306 Terminated |
DXY | None listed |
| Feb 18, 2006 | Medtronic Inc. Cardiac Rhythm Managment Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303 Terminated |
DXY | None listed |
| Dec 2, 2005 | ela Medical Llc ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, Terminated |
DXY | None listed |
| Dec 2, 2005 | ela Medical Llc Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. S Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 1394) a Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) Terminated |
DXY | None listed |
| Nov 23, 2005 | Guidant Corporation Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics N Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemake Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: SR (model 13 Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model Terminated |
DXY | None listed |
| Sep 24, 2005 | Guidant Corporation Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedi Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled nano blades, 6-1/2'', 16.5 cm. Catalog no. 7007-598. Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, 90-degree angled nano blades, 6-12'', 16.5 cm. Catalog no. 7007-596. Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc SCANLAN Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled nano blades, 6-1/8'', 15.5 cm. Catalog no. 7007-548. Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc SCANLAN Premier Jacobson Micro Scissors, spring style, round handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog no. 7007-499-8 Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc SCANLAN Premier Jacobson Micro Scissors, Spring Style, round handle, V-neck, 125-degree angled micro fine blades, 6-1/2'', 16.5 cm. Catalog no. 7007-499. Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 8'', 20 cm. Catalog Number 7007-449-8. Terminated |
DXY | None listed |
| Sep 13, 2005 | Scanlan International Inc Scanlan Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled micro fine blades, 6-1/4'', 16 cm. Catalog Number 7007-449. Terminated |
DXY | None listed |
| Oct 24, 2003 | St Jude Medical Pulse Generator Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Pulsar Max II Multiprogrammable Pacemaker, Model 1280 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 1286 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 1284 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 1283 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 1184 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 0981 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Discovery II Multiprogrammable Pacemaker, Model 0481 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Pulsar Max II Multiprogrammable Pacemaker, Model 1181 Terminated |
DXY | None listed |
| Jul 15, 2003 | Guidant Corp-Cpi Division Pulsar Max II Multiprogrammable Pacemaker, Model 1180 Terminated |
DXY | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.