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 |
|---|---|---|---|
| Sep 12, 1979 | K791379 | MODEL 228-02 THINLITH II PACEMAKER, BIPO Intermedics, Inc. | DXY |
| Sep 7, 1979 | K791678 | LITHICRON II 0403 IMPLANTABLE PACEMAKER Medcor, Inc. | DXY |
| Sep 4, 1979 | K791417 | IMPLANTABLE PULSE GENERATOR PACEMAKER Intermedics, Inc. | DXY |
| Aug 10, 1979 | K791225 | BJORK-SHILEY AORTIC GRAFT VALVE PROSTH Shiley, Inc. | DXY |
| Aug 10, 1979 | K791095 | LITHICRON MODEL 0401, PACEMAKER Medcor, Inc. | DXY |
| Aug 10, 1979 | K790428 | MDL-201A & T DL-201A PULSE GENERATOR Pacesetter Systems | DXY |
| Aug 10, 1979 | K790141 | PULSE GENERATOR, R WAVE DEMAND Pacesetter Systems | DXY |
| Aug 3, 1979 | K791147 | ARCO PROGAMMABLE PACEMAKER SYSTEM Arco Medical Products Co. | DXY |
| Jul 30, 1979 | K791219 | UNILITH PULSE GENERATOR Ela Medical, Inc. | DXY |
| Jul 30, 1979 | K790446 | OVALITH-300 Coratomic, Inc. | DXY |
| Jul 24, 1979 | K782162 | BATTERY CHARGER, 171 PACEMAKER Telectronics, Inc. | DXY |
| Jul 24, 1979 | K782161 | PULSE GENERATOR, MODEL 171 Telectronics, Inc. | DXY |
| Jul 10, 1979 | K791165 | ARCOLITH 4000 Arco Medical Products Co. | DXY |
| Jun 27, 1979 | K790670 | PULSE GENERATOR MODEL 629 Elema-Schonander, Inc. | DXY |
| Jun 20, 1979 | K791093 | MODELS 2411/2418 VENTRICULAR-INHIBITED Medtronic Vascular | DXY |
| Jun 1, 1979 | K790666 | VITALITH S 3000 SERIES Vitatron Medical BV | DXY |
| May 31, 1979 | K790867 | CARDIAC PULSE GENERATOR, 16 SERIES Telectronics, Inc. | DXY |
| May 25, 1979 | K790868 | GENERATOR, 16 SERIES, MODIFIED TOP CAP Telectronics, Inc. | DXY |
| May 16, 1979 | K790690 | OMNI-STANICOR-(THETA) MODEL 217 Cordis Corp. | DXY |
| May 8, 1979 | K790562 | PULSE GENERATOR MODEL 61 AND 128 Ela Medical, Inc. | DXY |
| May 8, 1979 | K790452 | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS Edwards Pacemaker Systems | DXY |
| Apr 26, 1979 | K790764 | PACEMAKERS WITHOUT SILASTIC COATING Telectronics, Inc. | DXY |
| Mar 21, 1979 | K781973 | CARDIOPHONE North American Motronic | DXY |
| Mar 20, 1979 | K790432 | MICROLITH MODELS 505;605;507;607;703;803 Cardiac Pacemakers, Inc. | DXY |
| Mar 19, 1979 | K790566 | PACEMAKER, OVALITH-D CARDIAC Caratomic | DXY |
| Feb 26, 1979 | K790276 | MINILITH AND MICROLITH Cardiac Pacemakers, Inc. | DXY |
| Feb 8, 1979 | K790014 | BIPOLAR, STANICOR LAMBDA MODEL 236,235 Cordis Corp. | DXY |
| Feb 8, 1979 | K782149 | PULSE GENERATOR, IMPLANTABLE CARDIAC Telectronics, Inc. | DXY |
| Jan 24, 1979 | K790101 | ISOLATION SLEEVE, MODEL 346-01 Intermedics, Inc. | DXY |
| Jan 24, 1979 | K790100 | ISOLATION SLEEVE, MODEL 348-01 Intermedics, Inc. | DXY |
| Jan 24, 1979 | K790099 | ISOLATION SLEEVE, MODEL 347-01 Intermedics, Inc. | DXY |
| Jan 24, 1979 | K790098 | ISOLATION SLEEVE, MODEL 349-01 Intermedics, Inc. | DXY |
| Dec 27, 1978 | K782146 | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT Arco Medical Products Co. | DXY |
| Dec 22, 1978 | K782023 | MICROLITH A MODEL 803 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1978 | K782022 | MICROLITH A MODEL 703 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1978 | K780430 | LITHICRON F PROGRAMMABLE PULSE GEN Medcor, Inc. | DXY |
| Dec 21, 1978 | K781835 | PULSTRON MODEL 100 Micro-Rel | DXY |
| Dec 7, 1978 | K781738 | PACEMAKER, MODEL 229-01 Intermedics, Inc. | DXY |
| Dec 6, 1978 | K780897 | GENERATOR, PULSE, SORIN MODEL DL-1 Bentley Laboratories, Inc. | DXY |
| Dec 4, 1978 | K781377 | OVALITH 10BP Coratomic, Inc. | DXY |
| Oct 3, 1978 | K781252 | GENERATOR, PULSE, MODEL 5997 Medtronic Vascular | DXY |
| Oct 3, 1978 | K781208 | GENERATORS, PULSE, MODELS 5988/5989 Medtronic Vascular | DXY |
| Oct 3, 1978 | K780776 | ARCOBIOLITH PACEMAKER MODEL Arco Medical Products Co. | DXY |
| Sep 27, 1978 | K781424 | GENERATORS: UDL-201B, BDL-201B, MDL-201B Pacesetter Systems | DXY |
| Sep 27, 1978 | K780940 | GENERATOR, PULSE, MODEL 160B Telectronics, Inc. | DXY |
| Sep 27, 1978 | K772226 | PACEMAKER, MODEL 225 & 227 Intermedics, Inc. | DXY |
| Sep 7, 1978 | K781426 | CARDIAL PULSE GENERATORS Telectronics, Inc. | DXY |
| Sep 7, 1978 | K781178 | PULSE GENERATOR MODEL 208 Elema-Schonander, Inc. | DXY |
| Sep 7, 1978 | K781090 | GENERATOR, CARDIAC PULSE, 250B Telectronics, Inc. | DXY |
| Aug 31, 1978 | K781168 | GENERATOR, PULSE, PACEMAKER Vitatron Medical BV | DXY |
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