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 |
|---|---|---|---|
| May 15, 1985 | K850464 | PROGRAMALITH III 240 PULSE GENERATOR Pacesetter Systems | DXY |
| Apr 18, 1985 | K844842 | NEOS-LP PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844841 | KALOS-04 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844812 | NEOS - PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844795 | NEOS-M PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844794 | LEPTOS PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 4, 1985 | K851081 | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II Telectronics, Inc. | DXY |
| Apr 4, 1985 | K850252 | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR Telectronics, Inc. | DXY |
| Apr 1, 1985 | K850651 | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR Pacesetter Systems | DXY |
| Mar 21, 1985 | K850384 | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER Cardiac Control Systems, Inc. | DXY |
| Mar 1, 1985 | K850656 | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM Cook Pacemaker Corp. | DXY |
| Mar 1, 1985 | K842051 | EKG TRANSMITTER MODEL 5134 Instromedix, Inc. | DXY |
| Feb 8, 1985 | K844958 | MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE Medtronic Vascular | DXY |
| Feb 8, 1985 | K844957 | MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR Medtronic Vascular | DXY |
| Feb 8, 1985 | K844793 | SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR Intermedics, Inc. | DXY |
| Jan 10, 1985 | K844334 | VIVALITH II 301 PULSE GENERATOR Pacesetter Systems | DXY |
| Jan 10, 1985 | K842193 | MULTILITH PULSE GENERATORS, 1141 & 2141 Ela Medical, Inc. | DXY |
| Dec 3, 1984 | K841232 | PULSE GENERATOR 696, 696B & 696L Siemens Elema AB | DXY |
| Dec 3, 1984 | K841230 | PULSE GENERATOR 686, 686B 686L Siemens Elema AB | DXY |
| Dec 3, 1984 | K841225 | PULSE GENERATOR 689, 689B & 689L Siemens Elema AB | DXY |
| Nov 29, 1984 | K842220 | MULTILITH 2 PULSE GENERATOR 1141 & 2141 Ela Medical, Inc. | DXY |
| Oct 26, 1984 | K842473 | IMPLANTABLE PROGRAMMABLE PULSE GENERAT Telectronics, Inc. | DXY |
| Oct 17, 1984 | K843837 | MEDTRONIC 5984-5984LP-5985 Medtronic Vascular | DXY |
| Oct 17, 1984 | K842394 | ASTRA 2, ASTRA 3, 4 & 6 Cardiac Pacemakers, Inc. | DXY |
| Aug 29, 1984 | K843089 | MEDTRONIC 8437/8438 Medtronic Vascular | DXY |
| Aug 6, 1984 | K841633 | NEOS LP Biotronik Sales, Inc. | DXY |
| Aug 3, 1984 | K841635 | LEPTOS Biotronik Sales, Inc. | DXY |
| Aug 3, 1984 | K840748 | LITHIUM PACEMAKER 811-811L & 811XL Omikron Scientific, Ltd. | DXY |
| Jul 11, 1984 | K841983 | COOK PACEMAKER 216 BIPOLAR CARDIAC - Cook Pacemaker Corp. | DXY |
| Jul 11, 1984 | K841928 | COOK PACEMAKER 215 UNIPOLAR CARDIAC- Cook Pacemaker Corp. | DXY |
| Jul 6, 1984 | K842081 | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| Jul 6, 1984 | K841233 | PULSE GENERATOR 678L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841231 | PULSE GENERATOR 688B & 688L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841228 | PULSE GENERATOR 718B & 718L Siemens Elema AB | DXY |
| Jun 26, 1984 | K841226 | PULSE GENERATOR 728, 728B & 728L Siemens Elema AB | DXY |
| Jun 25, 1984 | K841950 | PULSE GENERATOR KALOS-04 Biotronik Sales, Inc. | DXY |
| Jun 25, 1984 | K841636 | NEOS M Biotronik Sales, Inc. | DXY |
| Jun 25, 1984 | K841229 | PULSE GENERATOR 698, 698B & 698L Siemens Elema AB | DXY |
| May 30, 1984 | K841404 | PRIMA 236-02 NONPROGRAMMABLE CARDIAC Intermedics, Inc. | DXY |
| May 16, 1984 | K841075 | CARCIAC PULSE GENERATOR 254-20 Intermedics, Inc. | DXY |
| May 16, 1984 | K841074 | CARDIAC PULSE GENERATOR 254-18 Intermedics, Inc. | DXY |
| May 16, 1984 | K841073 | QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE Intermedics, Inc. | DXY |
| May 16, 1984 | K840737 | IMPLANTABLE PROGRAMMABLE PULSE GENER Telectronics, Inc. | DXY |
| May 2, 1984 | K840701 | PACEMAKER 147 VVI-THE OPTINIA Telectronics, Inc. | DXY |
| Feb 10, 1984 | K833428 | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Feb 10, 1984 | K833427 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN Telectronics, Inc. | DXY |
| Jan 30, 1984 | K833519 | PULSE GENERATOR MODEL 688 Burditt & Calkins-Siemens-Elema | DXY |
| Dec 16, 1983 | K834096 | IMPLANTABLE PULSE GENERATOR Intermedics, Inc. | DXY |
| Dec 1, 1983 | K833798 | OPTIMA MDT PULSE GENERATOR W/TELEMETRY Telectronics, Inc. | DXY |
| Nov 14, 1983 | K832914 | PRIMA-UNIPOLAR CARDIAC PULSE GENERAT Intermedics, Inc. | DXY |
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