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 29, 1981 | K812358 | MODEL 325T PROGRAMMABLE PULSE GENERATOR Cook Pacemaker Corp. | DXY |
| Oct 13, 1981 | K812218 | KALOS-03 Biotronik Sales, Inc. | DXY |
| Sep 23, 1981 | K812580 | MEDTRONIC MODEL 2409 Medtronic Vascular | DXY |
| Sep 23, 1981 | K801339 | TELEMETRY DECODER Intermedics, Inc. | DXY |
| Sep 23, 1981 | K801337 | CYBERLITH IX IMPLANTABLE PULSE GENERATOR Intermedics, Inc. | DXY |
| Sep 16, 1981 | K812096 | MEDTRONIC ENERTRAX MODEL 7100 Medtronic Vascular | DXY |
| Aug 31, 1981 | K812153 | MEDTRONIC SPECTRAX Medtronic Vascular | DXY |
| Jul 27, 1981 | K811402 | COMMAND P5(BIPOLAR PULSE GENERATOR) Cardiac Pacemakers, Inc. | DXY |
| Jul 20, 1981 | K811768 | CORATOMIC MODEL OVALITH-920BP Corptomic | DXY |
| Jul 20, 1981 | K811691 | CORDIS OMNI-ARTICOR CARDIAC PACER #308 Cordis Corp. | DXY |
| Jul 20, 1981 | K810887 | ELA MEDICAL UNILITH 7540 PULSE GENERATOR Ela Medical, Inc. | DXY |
| Jul 1, 1981 | K811350 | UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. Medtronic Vascular | DXY |
| Jun 16, 1981 | K810885 | #326 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. | DXY |
| Jun 16, 1981 | K810884 | #325 PROGRAMMABLE CARD. PULSE GENERATOR Cook Pacemaker Corp. | DXY |
| May 29, 1981 | K810489 | MULTILITH PULSE GENERATOR #1140 Ela Medical, Inc. | DXY |
| May 29, 1981 | K810142 | ELA MEDICAL UNILITH PULSE GENERATOR Ela Medical, Inc. | DXY |
| May 27, 1981 | K811221 | INTERMEDICS CYBERLITH BIPOLAR CARDIAC Intermedics, Inc. | DXY |
| May 27, 1981 | K811123 | MEDTRONIC PULSE GENERATOR Medtronic Vascular | DXY |
| May 27, 1981 | K810677 | MODELS 5976/5977 PACEMAKER PULSE GENER Medtronic, Inc. | DXY |
| May 15, 1981 | K810808 | CORATOMIC MODEL OVALITH-920 Coratomic, Inc. | DXY |
| May 15, 1981 | K810734 | MODELS 8420 THRU 8423 PACEMAKER GENER Medtronic Vascular | DXY |
| May 1, 1981 | K811066 | MODEL 230-06 CYBERLITH TM I BIPOLAR IN Intermedics, Inc. | DXY |
| May 1, 1981 | K810800 | MODEL 230-05 CYBERLITH I BIPOL. PULSE G. Intermedics, Inc. | DXY |
| May 1, 1981 | K810752 | THINLITH III UNIPOLAR CARDIAC PULSE GEN. Intermedics, Inc. | DXY |
| Apr 14, 1981 | K810901 | INSULATIVE COATING FOR CARD. PULSE GEN Intermedics, Inc. | DXY |
| Apr 14, 1981 | K810603 | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE Telectronics, Inc. | DXY |
| Apr 1, 1981 | K810385 | CYBERLITH I PULSE GENERATOR MODEL 253-04 Intermedics, Inc. | DXY |
| Apr 1, 1981 | K810383 | INTERMEDICS CYBERLITH I BIOPOLAR CARDI Intermedics, Inc. | DXY |
| Mar 13, 1981 | K810386 | THINLITH II PULSE GNEERATOR MODEL 227-05 Intermedics, Inc. | DXY |
| Mar 5, 1981 | K810410 | STERILE PACKAGING Telectronics, Inc. | DXY |
| Feb 23, 1981 | K810121 | UNIFOCAL 3 American Pacemaker Corp. | DXY |
| Feb 12, 1981 | K801584 | MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. Medtronic Vascular | DXY |
| Feb 5, 1981 | K802864 | SIEMENS-ELEMA PULSE GENERATOR 678 Siemens Elema AB | DXY |
| Jan 29, 1981 | K810036 | SIEMENS-ELEMA MYOCARDIAL LEAD Siemens Elema AB | DXY |
| Jan 22, 1981 | K803197 | IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 Telectronics, Inc. | DXY |
| Jan 7, 1981 | K801338 | CYBERLITH PROGRAMMER Intermedics, Inc. | DXY |
| Dec 22, 1980 | K803035 | MICROTHIN-PII BIPOLAR PULSE GEN. #0621 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K803034 | MICROTHIN-PII BIPOLAR PULSE GEN. #0623 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K802353 | MICRO THIN-PII, #0523 Cardiac Pacemakers, Inc. | DXY |
| Dec 22, 1980 | K802352 | MICRO THIN-DII, #0521 Cardiac Pacemakers, Inc. | DXY |
| Dec 16, 1980 | K800746 | UNIFOCAL VP, MODELS 7501 AND 7502 American Pacemaker Corp. | DXY |
| Dec 1, 1980 | K801324 | SIEMENS-ELEMA PULSE GENERATOR 668 Siemens Elema AB | DXY |
| Nov 19, 1980 | K802588 | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. Arco Medical Products Co. | DXY |
| Nov 19, 1980 | K792609 | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. Medcor, Inc. | DXY |
| Oct 31, 1980 | K802410 | MICROTHIN-PI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Oct 31, 1980 | K802409 | MICROTHIN-DI BIPOLAR PULSE GENERATOR Cardiac Pacemakers, Inc. | DXY |
| Oct 3, 1980 | K801640 | SORIN PULSE GENERATOR, MODEL #LIT-214 Bentley Laboratories, Inc. | DXY |
| Sep 26, 1980 | K802028 | IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN Telectronics, Inc. | DXY |
| Sep 26, 1980 | K801978 | PROGRAMALITH #'S 221, 222, 221A & 222A Pacesetter Systems | DXY |
| Sep 26, 1980 | K800379 | BIFOCAL 2 8200 SERIES (A,B C,D) American Pacemaker Corp. | DXY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.