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 |
|---|---|---|---|
| Jun 26, 1986 | K861422 | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY Pacesetter Systems | DXY |
| Jun 17, 1986 | K862071 | MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN Medtronic Vascular | DXY |
| Jun 17, 1986 | K862038 | MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER Medtronic Vascular | DXY |
| Jun 17, 1986 | K862037 | MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN Medtronic Vascular | DXY |
| May 28, 1986 | K860573 | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR Telectronics, Inc. | DXY |
| May 9, 1986 | K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS Cook Pacemaker Corp. | DXY |
| May 2, 1986 | K861140 | PROGRAMALITH III PULSE GENERATOR Pacesetter Systems | DXY |
| Apr 23, 1986 | K861009 | BIPOLAR CARDIAC PACEMAKER, MODEL 110 Cardiac Control Systems, Inc. | DXY |
| Mar 31, 1986 | K852973 | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 Ela Medical, Inc. | DXY |
| Mar 17, 1986 | K855147 | MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS Medtronic Vascular | DXY |
| Mar 7, 1986 | K855081 | PHOENIX MODELS 250/251 PULSE GENERATORS Pacesetter Systems | DXY |
| Feb 28, 1986 | K854482 | ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS Medtronic Vascular | DXY |
| Feb 24, 1986 | K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. Cook Pacemaker Corp. | DXY |
| Feb 24, 1986 | K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. Cook Pacemaker Corp. | DXY |
| Feb 24, 1986 | K853471 | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA Cardiac Control Systems, Inc. | DXY |
| Feb 24, 1986 | K853400 | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK Cardiac Control Systems, Inc. | DXY |
| Jan 22, 1986 | K855171 | TELEMETRY WAND MODEL Cardiac Pacemakers, Inc. | DXY |
| Jan 16, 1986 | K854560 | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR Telectronics, Inc. | DXY |
| Jan 14, 1986 | K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER Sorin Biomedica, Fiat, USA, Inc. | DXY |
| Jan 14, 1986 | K851968 | CORDIS MULTICOR ST, MODEL 350A Cordis Corp. | DXY |
| Jan 7, 1986 | K854195 | PROGRAMALITH III MODELS 238 & 239 Pacesetter Systems | DXY |
| Dec 19, 1985 | K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY Cook Pacemaker Corp. | DXY |
| Dec 3, 1985 | K854214 | MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE Cordis Corp. | DXY |
| Dec 3, 1985 | K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS Cook Pacemaker Corp. | DXY |
| Dec 3, 1985 | K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM Sorin Biomedica, Fiat, USA, Inc. | DXY |
| Nov 8, 1985 | K852340 | SUPRIMA MODEL 254-24 Intermedics, Inc. | DXY |
| Nov 8, 1985 | K852339 | SUPRIMA MODEL 254-22 Intermedics, Inc. | DXY |
| Nov 1, 1985 | K854143 | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS Telectronics, Inc. | DXY |
| Nov 1, 1985 | K852748 | CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK Cordis Corp. | DXY |
| Nov 1, 1985 | K852688 | MEDTRONICS MODELS 8320/8322/8329 Medtronic Vascular | DXY |
| Oct 23, 1985 | K853651 | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER Cook Pacemaker Corp. | DXY |
| Oct 23, 1985 | K853590 | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI Cook Pacemaker Corp. | DXY |
| Sep 13, 1985 | K853058 | NEOS - M ABP Biotronik Sales, Inc. | DXY |
| Sep 12, 1985 | K853206 | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW Telectronics, Inc. | DXY |
| Sep 12, 1985 | K853057 | TRIOS - M Biotronik Sales, Inc. | DXY |
| Aug 19, 1985 | K853425 | CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR Cardio-Pace Medical, Inc. | DXY |
| Aug 6, 1985 | K852435 | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA Cardiac Control Systems, Inc. | DXY |
| Jul 25, 1985 | K853034 | #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ Intermedics, Inc. | DXY |
| Jul 25, 1985 | K853017 | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 Ela Medical, Inc. | DXY |
| Jul 19, 1985 | K852431 | SUPRIMA II MODEL 254-26 Intermedics, Inc. | DXY |
| Jul 17, 1985 | K852432 | SUPRIMA II MODEL 254-28 Intermedics, Inc. | DXY |
| Jul 17, 1985 | K852430 | SUPRIMA II MODEL 253-23 Intermedics, Inc. | DXY |
| Jun 21, 1985 | K851420 | MULTICOR S, MODELS 330A/331A Cordis Corp. | DXY |
| Jun 18, 1985 | K844360 | CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS Cordis Corp. | DXY |
| Jun 11, 1985 | K851419 | MULTICOR GAMMA 402 SERIES PACER Cordis Corp. | DXY |
| Jun 11, 1985 | K851418 | OMNI-ATRICOR MODEL 308A Cordis Corp. | DXY |
| Jun 11, 1985 | K851417 | MULTICOR GAMMA MODELS 336/337 Cordis Corp. | DXY |
| Jun 11, 1985 | K851416 | STANICOR GAMMA 333B/334A Cordis Corp. | DXY |
| May 16, 1985 | K851861 | PROGRAMALITH III MODEL 249 PULSE GENERATOR Pacesetter Systems | DXY |
| May 16, 1985 | K851699 | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE Cook Pacemaker Corp. | DXY |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.