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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 1983 | K833199 | SILICONE RUBBER ISOLATION SLEEVE 350-01 Intermedics, Inc. | DXY |
| Oct 27, 1983 | K833198 | SILICONE RUBBER ISOLATION SLEEVE 351-01 Intermedics, Inc. | DXY |
| Oct 27, 1983 | K831860 | GENERATOR, PULSE, PACEMAKER #532 Vitatron Medical BV | DXY |
| Oct 27, 1983 | K831859 | PACEMAKER PROGRAMMER #2032 Vitatron Medical BV | DXY |
| Oct 12, 1983 | K831633 | QUANTUM BIPOLAR CARDIAC PULSE GENERATOR Intermedics, Inc. | DXY |
| Oct 4, 1983 | K832893 | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| Aug 16, 1983 | K831771 | IMPLANTABLE PROGRAM. CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Aug 8, 1983 | K832052 | MODEL 327T UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. | DXY |
| Jul 12, 1983 | K831216 | COMMAND ULTRA II Cardiac Pacemakers, Inc. | DXY |
| Jun 15, 1983 | K831161 | COMMAND ULTRA I Cardiac Pacemakers, Inc. | DXY |
| May 27, 1983 | K830344 | SIEMENS-ELMA PULSE GENERATOR #718 Burditt & Calkins-Siemens-Elema | DXY |
| May 25, 1983 | K830862 | NEDS-01 & EPR-500 Biotronik Sales, Inc. | DXY |
| Mar 24, 1983 | K830390 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Mar 24, 1983 | K823878 | IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 Pacesetter Systems | DXY |
| Mar 17, 1983 | K830401 | UNILITH PULSE GENERATOR VVI #7542 Ela Medical, Inc. | DXY |
| Mar 17, 1983 | K830382 | COMMAND ULTRA II Cardiac Pacemakers, Inc. | DXY |
| Mar 16, 1983 | K823831 | MEDTRONIC MODELS 59401 5941 Medtronic Vascular | DXY |
| Mar 10, 1983 | K823863 | CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC Intermedics, Inc. | DXY |
| Feb 18, 1983 | K823559 | AFP PULSE GENERATOR Pacesetter Systems | DXY |
| Feb 18, 1983 | K822639 | AFP SYSTEM PULSE GENERATOR MODEL 261/262 Pacesetter Systems | DXY |
| Dec 22, 1982 | K823678 | TELEMETRY DECODER #540-02 Intermedics, Inc. | DXY |
| Dec 22, 1982 | K823371 | DURAPULSE Cpm International, Inc. | DXY |
| Dec 15, 1982 | K822791 | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. Coratomic, Inc. | DXY |
| Nov 1, 1982 | K822907 | KALOS-03 BIPOLAR Biotronik Sales, Inc. | DXY |
| Oct 15, 1982 | K822904 | MODEL 325D UNIPOLAR CARDIAC PULSE GEN Cook Pacemaker Corp. | DXY |
| Oct 4, 1982 | K822652 | JAIN INSULATING BOOT MODEL 225B Cook Pacemaker Corp. | DXY |
| Oct 4, 1982 | K822309 | COMMAND NP Cardiac Pacemakers, Inc. | DXY |
| Oct 4, 1982 | K822297 | ENERTRAX MODEL 7100E Medtronic Vascular | DXY |
| Aug 6, 1982 | K822147 | MEDTRONIC ENERTRAX MODEL 7100 Medtronic Vascular | DXY |
| Jun 22, 1982 | K820939 | C-101-P Coratomic, Inc. | DXY |
| May 28, 1982 | K821033 | CORATOMIC MODEL OVALITH-920 Coratomic, Inc. | DXY |
| May 28, 1982 | K821014 | CORATOMIC MODEL OVALITH 920BP Coratomic, Inc. | DXY |
| May 7, 1982 | K821147 | COOK #326T PROGRAM/TELEMETRY BIPOLAR Cook Pacemaker Corp. | DXY |
| May 7, 1982 | K821073 | PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| May 7, 1982 | K821003 | PROGRAMMALITH II, #225 & 226 Pacesetter Systems | DXY |
| Apr 15, 1982 | K820657 | PULSE GENERATOR 678 B Siemens Elema AB | DXY |
| Apr 9, 1982 | K820853 | QUANTUM MODELS 253-09, 254-09 254-10 Intermedics, Inc. | DXY |
| Apr 9, 1982 | K820774 | IMPLANTABLE, MULTIPROGRAMMABLE Biotronik Sales, Inc. | DXY |
| Mar 18, 1982 | K820356 | MULTICOR (GAMMA) 402 CARDIAC PACER Cordis Corp. | DXY |
| Mar 15, 1982 | K820231 | COMMAND ULTRA I Cardiac Pacemakers, Inc. | DXY |
| Feb 12, 1982 | K813246 | MEDICAL MULTILITH PULSE GENERA-1140 Ela Medical, Inc. | DXY |
| Jan 22, 1982 | K813576 | SIEMENS-ELEMA PULSE GENERATOR 659 Siemens Elema AB | DXY |
| Jan 22, 1982 | K813534 | COMMAND P5 Cardiac Pacemakers, Inc. | DXY |
| Dec 10, 1981 | K813079 | BIPOLAR OPTIMA MP #255 Telectronics, Inc. | DXY |
| Dec 10, 1981 | K812610 | SIEMENS-ELEMA PULSE GENERATOR 668 B Siemens Corp. | DXY |
| Dec 2, 1981 | K813150 | DIRECTIONAL BOOT Pacesetter Systems | DXY |
| Nov 27, 1981 | K813101 | CARDIOBEEPER MEMORY MONITOR Survival Technology, Inc. | DXY |
| Nov 16, 1981 | K812464 | SYNTHEMED PULSE GENERATOR VVI MODEL 1000 Synthemed Corp. | DXY |
| Nov 5, 1981 | K812832 | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. Cook Pacemaker Corp. | DXY |
| Oct 29, 1981 | K812790 | IMPLANTABLE VENTRICULAR-INHIBITED CARDI Telectronics, Inc. | DXY |
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