FDA 510(k) Applications for Medical Device Product Code "DXY"
(Implantable Pacemaker Pulse-Generator)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K800379 | AMERICAN PACEMAKER CORP. | BIFOCAL 2 8200 SERIES (A,B C,D) | 09/26/1980 |
| K770328 | AMERICAN PACEMAKER CORP. | PACEMAKER, ANTRIO-VENTRICULAR SEQ. | 02/28/1977 |
| K791955 | AMERICAN PACEMAKER CORP. | UNIFOCAL 1 UNIPOLAR DEMAND R WAVE | 11/27/1979 |
| K792199 | AMERICAN PACEMAKER CORP. | UNIFOCAL 2-UNIPOLAR & BIPOLAR | 11/27/1979 |
| K810121 | AMERICAN PACEMAKER CORP. | UNIFOCAL 3 | 02/23/1981 |
| K792232 | AMERICAN PACEMAKER CORP. | UNIFOCAL 3-2 MODELS UNIPOLAR & BIPOLAR | 11/27/1979 |
| K800746 | AMERICAN PACEMAKER CORP. | UNIFOCAL VP, MODELS 7501 AND 7502 | 12/16/1980 |
| K791147 | ARCO MEDICAL PRODUCTS CO. | ARCO PROGAMMABLE PACEMAKER SYSTEM | 08/03/1979 |
| K780776 | ARCO MEDICAL PRODUCTS CO. | ARCOBIOLITH PACEMAKER MODEL | 10/03/1978 |
| K791715 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 2000 | 09/27/1979 |
| K792216 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 2100-CARDIAC PULSE GENERATOR | 11/29/1979 |
| K792299 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 3020-CARDIAC PULSE GENERATOR | 11/29/1979 |
| K800326 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 3021-CARDIAC PULSE GENERATOR | 03/17/1980 |
| K800838 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. | 06/04/1980 |
| K791165 | ARCO MEDICAL PRODUCTS CO. | ARCOLITH 4000 | 07/10/1979 |
| K761237 | ARCO MEDICAL PRODUCTS CO. | ELEC. CIR. PACE. MO. LI-2,LI-3,LI-4,LI-5 | 12/21/1976 |
| K801806 | ARCO MEDICAL PRODUCTS CO. | EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE | 09/09/1980 |
| K802588 | ARCO MEDICAL PRODUCTS CO. | MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. | 11/19/1980 |
| K771262 | ARCO MEDICAL PRODUCTS CO. | PACEMAKER & CARDIAC LEAD, BIPOLAR | 07/21/1977 |
| K782146 | ARCO MEDICAL PRODUCTS CO. | PACEMAKER, MODEL DDP ELECTRONIC CIRCUIT | 12/27/1978 |
| K800837 | ARCO MEDICAL PRODUCTS CO. | PROGRAMMABLE BIPOLAR CARDIAC GENERATOR | 06/30/1980 |
| K801241 | ARCO MEDICAL PRODUCTS CO. | UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. | 06/30/1980 |
| K780897 | BENTLEY LABORATORIES, INC. | GENERATOR, PULSE, SORIN MODEL DL-1 | 12/06/1978 |
| K792526 | BENTLEY LABORATORIES, INC. | PULSE GENERATOR, MODEL NO. LIT 222 | 02/05/1980 |
| K792565 | BENTLEY LABORATORIES, INC. | SORIN PULSE GENERATOR MODEL # LIT 214 H | 02/05/1980 |
| K801640 | BENTLEY LABORATORIES, INC. | SORIN PULSE GENERATOR, MODEL #LIT-214 | 10/03/1980 |
| K883750 | BIO PACE TECHNOLOGY, INC. | VENTRALITH I | 01/13/1989 |
| K896184 | BIOTRONIK CARDIAC PACEMAKERS | KALOS 05 PULSE GENERATOR | 01/18/1990 |
| K894239 | BIOTRONIK CARDIAC PACEMAKERS | NANOS | 11/01/1989 |
| K894240 | BIOTRONIK CARDIAC PACEMAKERS | NEOS 02 | 10/26/1989 |
| K860036 | BIOTRONIK SALES, INC. | EDP-20 PACEMAKER | 01/12/1987 |
| K820774 | BIOTRONIK SALES, INC. | IMPLANTABLE, MULTIPROGRAMMABLE | 04/09/1982 |
| K812218 | BIOTRONIK SALES, INC. | KALOS-03 | 10/13/1981 |
| K822907 | BIOTRONIK SALES, INC. | KALOS-03 BIPOLAR | 11/01/1982 |
| K844841 | BIOTRONIK SALES, INC. | KALOS-04 PULSE GENERATOR | 04/18/1985 |
| K841635 | BIOTRONIK SALES, INC. | LEPTOS | 08/03/1984 |
| K844794 | BIOTRONIK SALES, INC. | LEPTOS PULSE GENERATOR | 04/18/1985 |
| K860922 | BIOTRONIK SALES, INC. | MIKROS, MIKROS VS-1, PULSE GENERATOR | 08/04/1986 |
| K830862 | BIOTRONIK SALES, INC. | NEDS-01 & EPR-500 | 05/25/1983 |
| K853058 | BIOTRONIK SALES, INC. | NEOS - M ABP | 09/13/1985 |
| K844812 | BIOTRONIK SALES, INC. | NEOS - PULSE GENERATOR | 04/18/1985 |
| K841633 | BIOTRONIK SALES, INC. | NEOS LP | 08/06/1984 |
| K841636 | BIOTRONIK SALES, INC. | NEOS M | 06/25/1984 |
| K860921 | BIOTRONIK SALES, INC. | NEOS VS-1, PULSE GENERATOR | 08/08/1986 |
| K844842 | BIOTRONIK SALES, INC. | NEOS-LP PULSE GENERATOR | 04/18/1985 |
| K844795 | BIOTRONIK SALES, INC. | NEOS-M PULSE GENERATOR | 04/18/1985 |
| K863879 | BIOTRONIK SALES, INC. | NEOS-M VS-1 PULSE GENERATOR | 12/10/1986 |
| K800375 | BIOTRONIK SALES, INC. | NOMOS-01 PULSE GENERATOR | 04/16/1980 |
| K821073 | BIOTRONIK SALES, INC. | PULSE GENERATOR | 05/07/1982 |
| K841950 | BIOTRONIK SALES, INC. | PULSE GENERATOR KALOS-04 | 06/25/1984 |
| K853057 | BIOTRONIK SALES, INC. | TRIOS - M | 09/12/1985 |
| K863878 | BIOTRONIK SALES, INC. | TRIOS-M VS-1 PULSE GENERATOR | 12/10/1986 |
| K894494 | BIOTRONIK, GMBH & CO. | LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD | 10/17/1989 |
| K903081 | BIOTRONIK, GMBH & CO. | NEOS (TM) 02 B PULSE GENERATOR | 09/14/1990 |
| K914109 | BIOTRONIK, GMBH & CO. | PIKOS 01 & PIKOS E 01 | 02/26/1992 |
| K923026 | BIOTRONIK, GMBH & CO. | PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER | 08/19/1993 |
| K905087 | BIOTRONIK, GMBH & CO. | TRIOS 02 | 05/07/1991 |
| K952328 | BIOTRONIK, INC. | NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 | 09/29/1995 |
| K993434 | BIOTRONIK, INC. | PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A | 11/10/1999 |
| K941937 | BIOTRONIK, INC. | PIKOS E 01-B | 08/30/1994 |
| K945627 | BIOTRONIK, INC. | PIKOS LP 01, PIKOS LP E01 | 03/04/1996 |
| K833519 | BURDITT & CALKINS-SIEMENS-ELEMA | PULSE GENERATOR MODEL 688 | 01/30/1984 |
| K830344 | BURDITT & CALKINS-SIEMENS-ELEMA | SIEMENS-ELMA PULSE GENERATOR #718 | 05/27/1983 |
| K790566 | CARATOMIC | PACEMAKER, OVALITH-D CARDIAC | 03/19/1979 |
| K861009 | CARDIAC CONTROL SYSTEMS, INC. | BIPOLAR CARDIAC PACEMAKER, MODEL 110 | 04/23/1986 |
| K946188 | CARDIAC CONTROL SYSTEMS, INC. | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | 05/15/1995 |
| K853471 | CARDIAC CONTROL SYSTEMS, INC. | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA | 02/24/1986 |
| K852435 | CARDIAC CONTROL SYSTEMS, INC. | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA | 08/06/1985 |
| K850384 | CARDIAC CONTROL SYSTEMS, INC. | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER | 03/21/1985 |
| K853400 | CARDIAC CONTROL SYSTEMS, INC. | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK | 02/24/1986 |
| K874158 | CARDIAC CONTROL SYSTEMS, INC. | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | 12/29/1987 |
| K923868 | CARDIAC CONTROL SYSTEMS, INC. | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | 05/14/1993 |
| K950210 | CARDIAC CONTROL SYSTEMS, INC. | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | 05/03/1995 |
| K904941 | CARDIAC CONTROL SYSTEMS, INC. | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | 01/03/1991 |
| K880422 | CARDIAC CONTROL SYSTEMS, INC. | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER | 03/31/1988 |
| K880326 | CARDIAC CONTROL SYSTEMS, INC. | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS | 04/11/1988 |
| K905824 | CARDIAC CONTROL SYSTEMS, INC. | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | 05/16/1991 |
| K884023 | CARDIAC CONTROL SYSTEMS, INC. | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | 10/17/1988 |
| K842394 | CARDIAC PACEMAKERS, INC. | ASTRA 2, ASTRA 3, 4 & 6 | 10/17/1984 |
| K920601 | CARDIAC PACEMAKERS, INC. | ASTRA T2, ASTRA T4, ASTRA T6 | 10/28/1992 |
| K860585 | CARDIAC PACEMAKERS, INC. | ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR | 07/16/1986 |
| K890785 | CARDIAC PACEMAKERS, INC. | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | 03/10/1989 |
| K865013 | CARDIAC PACEMAKERS, INC. | ASTRA T2, T4 AND T6 | 02/19/1987 |
| K770198 | CARDIAC PACEMAKERS, INC. | BIPOLAR ASYNCHRONOUS PULSE GENERATOR | 02/07/1977 |
| K822309 | CARDIAC PACEMAKERS, INC. | COMMAND NP | 10/04/1982 |
| K813534 | CARDIAC PACEMAKERS, INC. | COMMAND P5 | 01/22/1982 |
| K811402 | CARDIAC PACEMAKERS, INC. | COMMAND P5(BIPOLAR PULSE GENERATOR) | 07/27/1981 |
| K831161 | CARDIAC PACEMAKERS, INC. | COMMAND ULTRA I | 06/15/1983 |
| K820231 | CARDIAC PACEMAKERS, INC. | COMMAND ULTRA I | 03/15/1982 |
| K831216 | CARDIAC PACEMAKERS, INC. | COMMAND ULTRA II | 07/12/1983 |
| K830382 | CARDIAC PACEMAKERS, INC. | COMMAND ULTRA II | 03/17/1983 |
| K770881 | CARDIAC PACEMAKERS, INC. | GENERATOR, PULSE, BIPOLAR 3608 | 06/20/1977 |
| K770715 | CARDIAC PACEMAKERS, INC. | GENERATOR, PULSE, BIPOLAR, MODEL #604 | 04/25/1977 |
| K770880 | CARDIAC PACEMAKERS, INC. | GENERATOR, PULSE, UNIPOLAR, #508 | 06/20/1977 |
| K770716 | CARDIAC PACEMAKERS, INC. | GENERATOR, PULSE, UNIPOLAR, MODEL #504 | 04/26/1977 |
| K802352 | CARDIAC PACEMAKERS, INC. | MICRO THIN-DII, #0521 | 12/22/1980 |
| K802353 | CARDIAC PACEMAKERS, INC. | MICRO THIN-PII, #0523 | 12/22/1980 |
| K782022 | CARDIAC PACEMAKERS, INC. | MICROLITH A MODEL 703 | 12/22/1978 |
| K782023 | CARDIAC PACEMAKERS, INC. | MICROLITH A MODEL 803 | 12/22/1978 |
| K790432 | CARDIAC PACEMAKERS, INC. | MICROLITH MODELS 505;605;507;607;703;803 | 03/20/1979 |
| K801122 | CARDIAC PACEMAKERS, INC. | MICROTHIN-D1 (MOD. 0620) | 06/30/1980 |
| K800026 | CARDIAC PACEMAKERS, INC. | MICROTHIN-DI | 01/31/1980 |
| K802409 | CARDIAC PACEMAKERS, INC. | MICROTHIN-DI BIPOLAR PULSE GENERATOR | 10/31/1980 |
| K801121 | CARDIAC PACEMAKERS, INC. | MICROTHIN-P1 (MOD. 0622) | 06/30/1980 |
| K800027 | CARDIAC PACEMAKERS, INC. | MICROTHIN-PI | 01/31/1980 |
| K802410 | CARDIAC PACEMAKERS, INC. | MICROTHIN-PI BIPOLAR PULSE GENERATOR | 10/31/1980 |
| K803035 | CARDIAC PACEMAKERS, INC. | MICROTHIN-PII BIPOLAR PULSE GEN. #0621 | 12/22/1980 |
| K803034 | CARDIAC PACEMAKERS, INC. | MICROTHIN-PII BIPOLAR PULSE GEN. #0623 | 12/22/1980 |
| K790276 | CARDIAC PACEMAKERS, INC. | MINILITH AND MICROLITH | 02/26/1979 |
| K772241 | CARDIAC PACEMAKERS, INC. | PULSE GENERATOR, BIPOLAR, DEMAND | 01/30/1978 |
| K772239 | CARDIAC PACEMAKERS, INC. | PULSE GENERATOR, BIPOLAR, PROGRAMMABLE | 01/30/1978 |
| K772240 | CARDIAC PACEMAKERS, INC. | PULSE GENERATOR, UNIPOLAR, DEMAND | 01/30/1978 |
| K772238 | CARDIAC PACEMAKERS, INC. | PULSE GENERATOR, UNIPOLAR, PROGRAMABLE | 01/30/1978 |
| K855171 | CARDIAC PACEMAKERS, INC. | TELEMETRY WAND MODEL | 01/22/1986 |
| K770197 | CARDIAC PACEMAKERS, INC. | UNIPOLAR, ASYNCHRONOUS PULSE GENERATOR | 02/07/1977 |
| K853425 | CARDIO-PACE MEDICAL, INC. | CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR | 08/19/1985 |
| K853771 | CARDIO-PACE MEDICAL, INC. | PINNACLE MULTI-PROGRAMMABLE PACING SYS | 07/15/1986 |
| K870142 | CARDIO-PACE MEDICAL, INC. | PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR | 04/22/1987 |
| K801647 | CAROLINA MEDICAL ELECTRONICS | SONACOLOR 6100 | 08/20/1980 |
| K810884 | COOK PACEMAKER CORP. | #325 PROGRAMMABLE CARD. PULSE GENERATOR | 06/16/1981 |
| K810885 | COOK PACEMAKER CORP. | #326 PROGRAMMABLE CARD. PULSE GENERATOR | 06/16/1981 |
| K854919 | COOK PACEMAKER CORP. | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | 12/19/1985 |
| K821147 | COOK PACEMAKER CORP. | COOK #326T PROGRAM/TELEMETRY BIPOLAR | 05/07/1982 |
| K850656 | COOK PACEMAKER CORP. | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM | 03/01/1985 |
| K841928 | COOK PACEMAKER CORP. | COOK PACEMAKER 215 UNIPOLAR CARDIAC- | 07/11/1984 |
| K841983 | COOK PACEMAKER CORP. | COOK PACEMAKER 216 BIPOLAR CARDIAC - | 07/11/1984 |
| K854132 | COOK PACEMAKER CORP. | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | 12/03/1985 |
| K853651 | COOK PACEMAKER CORP. | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER | 10/23/1985 |
| K842081 | COOK PACEMAKER CORP. | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI | 07/06/1984 |
| K853590 | COOK PACEMAKER CORP. | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI | 10/23/1985 |
| K851699 | COOK PACEMAKER CORP. | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE | 05/16/1985 |
| K822652 | COOK PACEMAKER CORP. | JAIN INSULATING BOOT MODEL 225B | 10/04/1982 |
| K953417 | COOK PACEMAKER CORP. | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | 09/29/1995 |
| K812832 | COOK PACEMAKER CORP. | MODEL 325C UNIPOLAR CARDIAC PULSE GEN. | 11/05/1981 |
| K822904 | COOK PACEMAKER CORP. | MODEL 325D UNIPOLAR CARDIAC PULSE GEN | 10/15/1982 |
| K812358 | COOK PACEMAKER CORP. | MODEL 325T PROGRAMMABLE PULSE GENERATOR | 10/29/1981 |
| K860202 | COOK PACEMAKER CORP. | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | 02/24/1986 |
| K832052 | COOK PACEMAKER CORP. | MODEL 327T UNIPOLAR CARDIAC PULSE GEN | 08/08/1983 |
| K860466 | COOK PACEMAKER CORP. | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | 02/24/1986 |
| K832893 | COOK PACEMAKER CORP. | MODEL 329T PROGRAMMABLE, BIPOLAR CARDI | 10/04/1983 |
| K905403 | COOK PACEMAKER CORP. | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | 10/16/1991 |
| K863582 | COOK PACEMAKER CORP. | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | 10/08/1986 |
| K861559 | COOK PACEMAKER CORP. | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | 05/09/1986 |
| K820939 | CORATOMIC, INC. | C-101-P | 06/22/1982 |
| K770559 | CORATOMIC, INC. | C-L0L CARDIAC PACEMAKER | 03/28/1977 |
| K822791 | CORATOMIC, INC. | CORATOMIC #VX5-105 & VX5-205 PULSE GEN. | 12/15/1982 |
| K821014 | CORATOMIC, INC. | CORATOMIC MODEL OVALITH 920BP | 05/28/1982 |
| K810808 | CORATOMIC, INC. | CORATOMIC MODEL OVALITH-920 | 05/15/1981 |
| K821033 | CORATOMIC, INC. | CORATOMIC MODEL OVALITH-920 | 05/28/1982 |
| K771992 | CORATOMIC, INC. | L-501 CARDIAC PACEMAKER | 11/02/1977 |
| K863365 | CORATOMIC, INC. | MODIFICATION OF STERILITY CYCLE PARAMETERS | 10/08/1986 |
| K781377 | CORATOMIC, INC. | OVALITH 10BP | 12/04/1978 |
| K800194 | CORATOMIC, INC. | OVALITH P-BP BIPOLAR CARDIAC PACEMAKER | 02/11/1980 |
| K790446 | CORATOMIC, INC. | OVALITH-300 | 07/30/1979 |
| K790014 | CORDIS CORP. | BIPOLAR, STANICOR LAMBDA MODEL 236,235 | 02/08/1979 |
| K780066 | CORDIS CORP. | CARDIAC PACER, MODEL 208 | 01/30/1978 |
| K770951 | CORDIS CORP. | CARDIAC PACERS W/NARROW PULSE WIDTH | 06/20/1977 |
| K791784 | CORDIS CORP. | CORDIS BIPOLAR PACER CONNECTOR SYSTEM | 09/28/1979 |
| K852748 | CORDIS CORP. | CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK | 11/01/1985 |
| K863417 | CORDIS CORP. | CORDIS MULTICOR II MODEL 402D PACER | 10/08/1986 |
| K844360 | CORDIS CORP. | CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS | 06/18/1985 |
| K851968 | CORDIS CORP. | CORDIS MULTICOR ST, MODEL 350A | 01/14/1986 |
| K811691 | CORDIS CORP. | CORDIS OMNI-ARTICOR CARDIAC PACER #308 | 07/20/1981 |
| K801910 | CORDIS CORP. | INSULATING SHEATH | 09/09/1980 |
| K820356 | CORDIS CORP. | MULTICOR (GAMMA) 402 CARDIAC PACER | 03/18/1982 |
| K801106 | CORDIS CORP. | MULTICOR (GAMMA) MODEL 336 & MODEL 337 | 07/08/1980 |
| K851419 | CORDIS CORP. | MULTICOR GAMMA 402 SERIES PACER | 06/11/1985 |
| K851417 | CORDIS CORP. | MULTICOR GAMMA MODELS 336/337 | 06/11/1985 |
| K854214 | CORDIS CORP. | MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE | 12/03/1985 |
| K851420 | CORDIS CORP. | MULTICOR S, MODELS 330A/331A | 06/21/1985 |
| K851418 | CORDIS CORP. | OMNI-ATRICOR MODEL 308A | 06/11/1985 |
| K791783 | CORDIS CORP. | OMNI-STANICOR (THETA) MOD 237A | 10/22/1979 |
| K790690 | CORDIS CORP. | OMNI-STANICOR-(THETA) MODEL 217 | 05/16/1979 |
| K851416 | CORDIS CORP. | STANICOR GAMMA 333B/334A | 06/11/1985 |
| K780453 | CORDIS CORP. | STANICOR THETA MODEL 221 CARDIAC PACER | 06/30/1978 |
| K811768 | CORPTOMIC | CORATOMIC MODEL OVALITH-920BP | 07/20/1981 |
| K823371 | CPM INTERNATIONAL, INC. | DURAPULSE | 12/22/1982 |
| K790452 | EDWARDS PACEMAKER SYSTEMS | 28 UNIPOLAR AND BIPOLAR PULSE GENERATORS | 05/08/1979 |
| K791751 | EDWARDS PACEMAKER SYSTEMS | EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR | 09/26/1979 |
| K770656 | EDWARDS PACEMAKER SYSTEMS | GENERATOR, PULSE, CARDIAC 20U | 04/26/1977 |
| K770657 | EDWARDS PACEMAKER SYSTEMS | GENERATOR, PULSE, CARDIAC 2LU | 04/26/1977 |
| K780780 | EDWARDS PACEMAKER SYSTEMS | MICROPULSE 22S PACEMAKER | 06/30/1978 |
| K780091 | EDWARDS PACEMAKER SYSTEMS | MICROPULSE 22U | 01/30/1978 |
| K771987 | EDWARDS PACEMAKER SYSTEMS | MICROPULSE 26U PULSE GENERATOR | 11/02/1977 |
| K770211 | EDWARDS PACEMAKER SYSTEMS | MICROPULSE MODEL 20S | 03/07/1977 |
| K780238 | EDWARDS PACEMAKER SYSTEMS | PACEMAKER, PROLITH 23U. PULSE GENERATOR | 03/15/1978 |
| K781042 | EDWARDS PACEMAKER SYSTEMS | PROLITH 23S PACEMAKER | 07/27/1978 |
| K770212 | EDWARDS PACEMAKER SYSTEMS | PROLITH MODEL 21S CARDIAC PULSE GEN. | 03/09/1977 |
| K882427 | ELA MEDICAL, INC. | CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 | 09/23/1988 |
| K853017 | ELA MEDICAL, INC. | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 | 07/25/1985 |
| K810887 | ELA MEDICAL, INC. | ELA MEDICAL UNILITH 7540 PULSE GENERATOR | 07/20/1981 |
| K810142 | ELA MEDICAL, INC. | ELA MEDICAL UNILITH PULSE GENERATOR | 05/29/1981 |
| K813246 | ELA MEDICAL, INC. | MEDICAL MULTILITH PULSE GENERA-1140 | 02/12/1982 |
| K842220 | ELA MEDICAL, INC. | MULTILITH 2 PULSE GENERATOR 1141 & 2141 | 11/29/1984 |
| K863898 | ELA MEDICAL, INC. | MULTILITH 3 MODELS 1350, 3350, 1370, 3370 | 02/10/1987 |
| K810489 | ELA MEDICAL, INC. | MULTILITH PULSE GENERATOR #1140 | 05/29/1981 |
| K842193 | ELA MEDICAL, INC. | MULTILITH PULSE GENERATORS, 1141 & 2141 | 01/10/1985 |
| K882391 | ELA MEDICAL, INC. | OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 | 11/14/1988 |
| K894065 | ELA MEDICAL, INC. | OPUS MODEL 4001 | 09/26/1989 |
| K900461 | ELA MEDICAL, INC. | OPUS MODEL 4021, VVI, 5MM UNIPOLAR | 03/14/1990 |
| K894267 | ELA MEDICAL, INC. | OPUS MODELS 4033 AND 4034 | 09/20/1989 |
| K952364 | ELA MEDICAL, INC. | OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) | 09/01/1995 |
| K882474 | ELA MEDICAL, INC. | OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 | 09/12/1988 |
| K882476 | ELA MEDICAL, INC. | OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 | 09/12/1988 |
| K970072 | ELA MEDICAL, INC. | OPUS S MODEL 4121 AND 4124 PACEMAKERS | 08/29/1997 |
| K790562 | ELA MEDICAL, INC. | PULSE GENERATOR MODEL 61 AND 128 | 05/08/1979 |
| K852973 | ELA MEDICAL, INC. | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 | 03/31/1986 |
| K883037 | ELA MEDICAL, INC. | UNILITH 3 MODELS 7580/7583/7680/7683 | 01/25/1989 |
| K791219 | ELA MEDICAL, INC. | UNILITH PULSE GENERATOR | 07/30/1979 |
| K830401 | ELA MEDICAL, INC. | UNILITH PULSE GENERATOR VVI #7542 | 03/17/1983 |
| K770135 | ELEMA-SCHONANDER, INC. | LEAD MODIFICATION | 02/07/1977 |
| K770005 | ELEMA-SCHONANDER, INC. | PACEMAKER 208S | 02/24/1977 |
| K781178 | ELEMA-SCHONANDER, INC. | PULSE GENERATOR MODEL 208 | 09/07/1978 |
| K790670 | ELEMA-SCHONANDER, INC. | PULSE GENERATOR MODEL 629 | 06/27/1979 |
| K790792 | ELEMA-SCHONANDER, INC. | PULSE GENERATOR MODEL 637 | 10/12/1979 |
| K842051 | INSTROMEDIX, INC. | EKG TRANSMITTER MODEL 5134 | 03/01/1985 |
| K853034 | INTERMEDICS, INC. | #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ | 07/25/1985 |
| K911122 | INTERMEDICS, INC. | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS | 05/16/1991 |
| K802040 | INTERMEDICS, INC. | BATTERY FOR #229-01 PULSE GENERATOR | 09/09/1980 |
| K772057 | INTERMEDICS, INC. | BIPOLAR PACEMAKER MODEL 224 | 11/03/1977 |
| K841075 | INTERMEDICS, INC. | CARCIAC PULSE GENERATOR 254-20 | 05/16/1984 |
| K841074 | INTERMEDICS, INC. | CARDIAC PULSE GENERATOR 254-18 | 05/16/1984 |
| K810385 | INTERMEDICS, INC. | CYBERLITH I PULSE GENERATOR MODEL 253-04 | 04/01/1981 |
| K800644 | INTERMEDICS, INC. | CYBERLITH IMPLANTABLE PULSE GEN. #253-02 | 04/16/1980 |
| K800645 | INTERMEDICS, INC. | CYBERLITH IMPLANTABLE PULSE GEN. #253-04 | 04/08/1980 |
| K801337 | INTERMEDICS, INC. | CYBERLITH IX IMPLANTABLE PULSE GENERATOR | 09/23/1981 |
| K823863 | INTERMEDICS, INC. | CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC | 03/10/1983 |
| K801338 | INTERMEDICS, INC. | CYBERLITH PROGRAMMER | 01/07/1981 |
| K834096 | INTERMEDICS, INC. | IMPLANTABLE PULSE GENERATOR | 12/16/1983 |
| K791417 | INTERMEDICS, INC. | IMPLANTABLE PULSE GENERATOR PACEMAKER | 09/04/1979 |
| K791568 | INTERMEDICS, INC. | IMPLANTABLE PULSE GENERATOR PACEMAKERS | 09/19/1979 |
| K810901 | INTERMEDICS, INC. | INSULATIVE COATING FOR CARD. PULSE GEN | 04/14/1981 |
| K811221 | INTERMEDICS, INC. | INTERMEDICS CYBERLITH BIPOLAR CARDIAC | 05/27/1981 |
| K810383 | INTERMEDICS, INC. | INTERMEDICS CYBERLITH I BIOPOLAR CARDI | 04/01/1981 |
| K920530 | INTERMEDICS, INC. | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | 03/17/1992 |
| K801450 | INTERMEDICS, INC. | INTERMEDICS THIN LITH IV SERIES UNIPOLAR | 08/14/1980 |
| K790101 | INTERMEDICS, INC. | ISOLATION SLEEVE, MODEL 346-01 | 01/24/1979 |
| K790099 | INTERMEDICS, INC. | ISOLATION SLEEVE, MODEL 347-01 | 01/24/1979 |
| K790100 | INTERMEDICS, INC. | ISOLATION SLEEVE, MODEL 348-01 | 01/24/1979 |
| K790098 | INTERMEDICS, INC. | ISOLATION SLEEVE, MODEL 349-01 | 01/24/1979 |
| K791379 | INTERMEDICS, INC. | MODEL 228-02 THINLITH II PACEMAKER, BIPO | 09/12/1979 |
| K810800 | INTERMEDICS, INC. | MODEL 230-05 CYBERLITH I BIPOL. PULSE G. | 05/01/1981 |
| K811066 | INTERMEDICS, INC. | MODEL 230-06 CYBERLITH TM I BIPOLAR IN | 05/01/1981 |
| K800895 | INTERMEDICS, INC. | MODEL 253-11 CYBERLITH PULSE GENERATOR | 04/24/1980 |
| K863418 | INTERMEDICS, INC. | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE | 09/24/1986 |
| K873528 | INTERMEDICS, INC. | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS | 10/09/1987 |
| K771626 | INTERMEDICS, INC. | PACEMAKER MODEL 251 | 09/12/1977 |
| K772226 | INTERMEDICS, INC. | PACEMAKER, MODEL 225 & 227 | 09/27/1978 |
| K781738 | INTERMEDICS, INC. | PACEMAKER, MODEL 229-01 | 12/07/1978 |
| K780437 | INTERMEDICS, INC. | PACEMAKER, MODEL 252, C-MOS | 04/05/1978 |
| K841404 | INTERMEDICS, INC. | PRIMA 236-02 NONPROGRAMMABLE CARDIAC | 05/30/1984 |
| K832914 | INTERMEDICS, INC. | PRIMA-UNIPOLAR CARDIAC PULSE GENERAT | 11/14/1983 |
| K831633 | INTERMEDICS, INC. | QUANTUM BIPOLAR CARDIAC PULSE GENERATOR | 10/12/1983 |
| K820853 | INTERMEDICS, INC. | QUANTUM MODELS 253-09, 254-09 254-10 | 04/09/1982 |
| K874394 | INTERMEDICS, INC. | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. | 11/23/1987 |
| K841073 | INTERMEDICS, INC. | QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE | 05/16/1984 |
| K833199 | INTERMEDICS, INC. | SILICONE RUBBER ISOLATION SLEEVE 350-01 | 10/28/1983 |
| K833198 | INTERMEDICS, INC. | SILICONE RUBBER ISOLATION SLEEVE 351-01 | 10/27/1983 |
| K844793 | INTERMEDICS, INC. | SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR | 02/08/1985 |
| K852430 | INTERMEDICS, INC. | SUPRIMA II MODEL 253-23 | 07/17/1985 |
| K852431 | INTERMEDICS, INC. | SUPRIMA II MODEL 254-26 | 07/19/1985 |
| K852432 | INTERMEDICS, INC. | SUPRIMA II MODEL 254-28 | 07/17/1985 |
| K852339 | INTERMEDICS, INC. | SUPRIMA MODEL 254-22 | 11/08/1985 |
| K852340 | INTERMEDICS, INC. | SUPRIMA MODEL 254-24 | 11/08/1985 |
| K801339 | INTERMEDICS, INC. | TELEMETRY DECODER | 09/23/1981 |
| K823678 | INTERMEDICS, INC. | TELEMETRY DECODER #540-02 | 12/22/1982 |
| K810386 | INTERMEDICS, INC. | THINLITH II PULSE GNEERATOR MODEL 227-05 | 03/13/1981 |
| K810752 | INTERMEDICS, INC. | THINLITH III UNIPOLAR CARDIAC PULSE GEN. | 05/01/1981 |
| K770419 | JOHNSON & JOHNSON PROFESSIONALS, INC. | CENTURION | 04/05/1977 |
| K770661 | MED TELECTRONICS LTD. | GENERATOR, PULSE, IMPLANTABLE | 04/26/1977 |
| K792609 | MEDCOR, INC. | LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. | 11/19/1980 |
| K780430 | MEDCOR, INC. | LITHICRON F PROGRAMMABLE PULSE GEN | 12/22/1978 |
| K791678 | MEDCOR, INC. | LITHICRON II 0403 IMPLANTABLE PACEMAKER | 09/07/1979 |
| K791095 | MEDCOR, INC. | LITHICRON MODEL 0401, PACEMAKER | 08/10/1979 |
| K771538 | MEDCOR, INC. | LITHICRON MODEL 3-70C-B PULSE GENERATOR | 08/22/1977 |
| K770507 | MEDCOR, INC. | PULSE GENERATOR, LITKICRON MODEL 3-70H | 04/07/1977 |
| K895495 | MEDTRONIC VASCULAR | ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS | 09/26/1989 |
| K862974 | MEDTRONIC VASCULAR | ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. | 09/04/1986 |
| K854482 | MEDTRONIC VASCULAR | ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS | 02/28/1986 |
| K954092 | MEDTRONIC VASCULAR | ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) | 12/15/1995 |
| K771786 | MEDTRONIC VASCULAR | CARDIAC PULSE GENERATORS 5982/5983 | 01/04/1978 |
| K822297 | MEDTRONIC VASCULAR | ENERTRAX MODEL 7100E | 10/04/1982 |
| K780809 | MEDTRONIC VASCULAR | GENERATOR, PULSE MODELS 5920/5921 | 07/28/1978 |
| K780741 | MEDTRONIC VASCULAR | GENERATOR, PULSE, DEMAND, MODEL 5996 | 07/28/1978 |
| K781252 | MEDTRONIC VASCULAR | GENERATOR, PULSE, MODEL 5997 | 10/03/1978 |
| K780327 | MEDTRONIC VASCULAR | GENERATORS, ATRIAL INHIBITED PULSE | 05/18/1978 |
| K781208 | MEDTRONIC VASCULAR | GENERATORS, PULSE, MODELS 5988/5989 | 10/03/1978 |
| K903919 | MEDTRONIC VASCULAR | IMPLANTABLE PULSE DEVICES | 10/23/1990 |
| K843837 | MEDTRONIC VASCULAR | MEDTRONIC 5984-5984LP-5985 | 10/17/1984 |
| K843089 | MEDTRONIC VASCULAR | MEDTRONIC 8437/8438 | 08/29/1984 |
| K871866 | MEDTRONIC VASCULAR | MEDTRONIC CLASSIX MODELS 8436/8437/8438 | 08/10/1987 |
| K822147 | MEDTRONIC VASCULAR | MEDTRONIC ENERTRAX MODEL 7100 | 08/06/1982 |
| K812096 | MEDTRONIC VASCULAR | MEDTRONIC ENERTRAX MODEL 7100 | 09/16/1981 |
| K930770 | MEDTRONIC VASCULAR | MEDTRONIC MINIX & MINIX ST PULSE GENERATORS | 05/14/1993 |
| K800226 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 2409 | 09/09/1980 |
| K812580 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 2409 | 09/23/1981 |
| K904602 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 5301B TEST CABLE | 01/03/1991 |
| K844957 | MEDTRONIC VASCULAR | MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR | 02/08/1985 |
| K823831 | MEDTRONIC VASCULAR | MEDTRONIC MODELS 59401 5941 | 03/16/1983 |
| K800069 | MEDTRONIC VASCULAR | MEDTRONIC MODELS 5966/5967, ETC. | 06/26/1980 |
| K791316 | MEDTRONIC VASCULAR | MEDTRONIC MODELS 5984/5985 | 11/15/1979 |
| K855147 | MEDTRONIC VASCULAR | MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS | 03/17/1986 |
| K844958 | MEDTRONIC VASCULAR | MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE | 02/08/1985 |
| K811123 | MEDTRONIC VASCULAR | MEDTRONIC PULSE GENERATOR | 05/27/1981 |
| K812153 | MEDTRONIC VASCULAR | MEDTRONIC SPECTRAX | 08/31/1981 |
| K896809 | MEDTRONIC VASCULAR | MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR | 01/26/1990 |
| K852688 | MEDTRONIC VASCULAR | MEDTRONICS MODELS 8320/8322/8329 | 11/01/1985 |
| K884215 | MEDTRONIC VASCULAR | MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 | 11/17/1988 |
| K894055 | MEDTRONIC VASCULAR | MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS | 08/25/1989 |
| K953866 | MEDTRONIC VASCULAR | MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) | 12/15/1995 |
| K902134 | MEDTRONIC VASCULAR | MINIX, MINIX ST, NEW IC: L74 | 07/03/1990 |
| K932884 | MEDTRONIC VASCULAR | MINIX/MINIX ST PULSE GENERATORS | 05/02/1994 |
| K800285 | MEDTRONIC VASCULAR | MODEL 5985 PACEMAKER PULSE GENERATOR | 05/20/1980 |
| K791093 | MEDTRONIC VASCULAR | MODELS 2411/2418 VENTRICULAR-INHIBITED | 06/20/1979 |
| K810677 | MEDTRONIC VASCULAR | MODELS 5976/5977 PACEMAKER PULSE GENER | 05/27/1981 |
| K810734 | MEDTRONIC VASCULAR | MODELS 8420 THRU 8423 PACEMAKER GENER | 05/15/1981 |
| K862459 | MEDTRONIC VASCULAR | MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE | 01/02/1987 |
| K862071 | MEDTRONIC VASCULAR | MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN | 06/17/1986 |
| K901535 | MEDTRONIC VASCULAR | MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. | 07/03/1990 |
| K900622 | MEDTRONIC VASCULAR | MODIFIED MODEL 5401B TEST CABLE | 04/26/1990 |
| K861719 | MEDTRONIC VASCULAR | MODIFIED MODELS 8320/8322/8329/8316/8317/8318 | 07/01/1986 |
| K883755 | MEDTRONIC VASCULAR | MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS | 11/17/1988 |
| K862037 | MEDTRONIC VASCULAR | MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN | 06/17/1986 |
| K862038 | MEDTRONIC VASCULAR | MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER | 06/17/1986 |
| K801584 | MEDTRONIC VASCULAR | MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. | 02/12/1981 |
| K940039 | MEDTRONIC VASCULAR | PELLETHANE 75D | 07/12/1995 |
| K791181 | MEDTRONIC VASCULAR | PROGRAMMER, MEDTRONIC MODEL 5984/5985 | 09/20/1979 |
| K772202 | MEDTRONIC VASCULAR | PULSE GENERATOR, A-V SEQ. | 12/20/1977 |
| K772357 | MEDTRONIC VASCULAR | PULSE GENERATORS | 01/17/1978 |
| K780061 | MEDTRONIC VASCULAR | PULSE GENERATORS, MODELS 5972/5973 | 01/24/1978 |
| K790068 | MEDTRONIC VASCULAR | PULSE GENERATORS, MODELS 5983, 5989 | 09/28/1979 |
| K950751 | MEDTRONIC VASCULAR | TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES | 05/15/1995 |
| K811350 | MEDTRONIC VASCULAR | UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. | 07/01/1981 |
| K904892 | MEDTRONIC VASCULAR | VACUUM BAKE CYCLE | 12/20/1990 |
| K780561 | MEDTRONIC VASCULAR | VENTRICULAR INHIBITED PULSE GENERATOR | 07/27/1978 |
| K771770 | MEDTRONIC VASCULAR | XYREL-RA MODELS 5994/5995 | 01/04/1978 |
| K781835 | MICRO-REL | PULSTRON MODEL 100 | 12/21/1978 |
| K781973 | NORTH AMERICAN MOTRONIC | CARDIOPHONE | 03/21/1979 |
| K840748 | OMIKRON SCIENTIFIC, LTD. | LITHIUM PACEMAKER 811-811L & 811XL | 08/03/1984 |
| K912545 | PACE MEDICAL | MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE | 07/26/1991 |
| K913134 | PACE MEDICAL | MODEL 4220 | 08/22/1991 |
| K884733 | PACESETTER SYSTEMS | AFP MODEL 262T PULSE GENERATOR | 02/10/1989 |
| K823559 | PACESETTER SYSTEMS | AFP PULSE GENERATOR | 02/18/1983 |
| K822639 | PACESETTER SYSTEMS | AFP SYSTEM PULSE GENERATOR MODEL 261/262 | 02/18/1983 |
| K862226 | PACESETTER SYSTEMS | DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS | 02/03/1987 |
| K813150 | PACESETTER SYSTEMS | DIRECTIONAL BOOT | 12/02/1981 |
| K781424 | PACESETTER SYSTEMS | GENERATORS: UDL-201B, BDL-201B, MDL-201B | 09/27/1978 |
| K823878 | PACESETTER SYSTEMS | IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 | 03/24/1983 |
| K761143 | PACESETTER SYSTEMS | LITHIUM IODIDE BATTERY PACEMAKER (#201) | 12/23/1976 |
| K772051 | PACESETTER SYSTEMS | MDL-201 | 01/30/1978 |
| K790428 | PACESETTER SYSTEMS | MDL-201A & T DL-201A PULSE GENERATOR | 08/10/1979 |
| K760757 | PACESETTER SYSTEMS | MODEL 100 CARDIAC PACEMAKER | 11/11/1976 |
| K790873 | PACESETTER SYSTEMS | MODEL 221 PROGRAMALITH PULSE GENERATOR | 09/20/1979 |
| K861422 | PACESETTER SYSTEMS | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY | 06/26/1986 |
| K855081 | PACESETTER SYSTEMS | PHOENIX MODELS 250/251 PULSE GENERATORS | 03/07/1986 |
| K801978 | PACESETTER SYSTEMS | PROGRAMALITH #'S 221, 222, 221A & 222A | 09/26/1980 |
| K850464 | PACESETTER SYSTEMS | PROGRAMALITH III 240 PULSE GENERATOR | 05/15/1985 |
| K851861 | PACESETTER SYSTEMS | PROGRAMALITH III MODEL 249 PULSE GENERATOR | 05/16/1985 |
| K854195 | PACESETTER SYSTEMS | PROGRAMALITH III MODELS 238 & 239 | 01/07/1986 |
| K861140 | PACESETTER SYSTEMS | PROGRAMALITH III PULSE GENERATOR | 05/02/1986 |
| K850651 | PACESETTER SYSTEMS | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR | 04/01/1985 |
| K821003 | PACESETTER SYSTEMS | PROGRAMMALITH II, #225 & 226 | 05/07/1982 |
| K883087 | PACESETTER SYSTEMS | PROLOG MP 658M PULSE GENERATOR | 09/14/1988 |
| K872779 | PACESETTER SYSTEMS | PROLOG MP PULSE GENERATORS 658K AND 658T | 11/04/1987 |
| K790141 | PACESETTER SYSTEMS | PULSE GENERATOR, R WAVE DEMAND | 08/10/1979 |
| K772050 | PACESETTER SYSTEMS | TDL-100 B | 01/30/1978 |
| K801763 | PACESETTER SYSTEMS | VIVALITH 5, - MDL-201A & TDL-201A | 08/27/1980 |
| K844334 | PACESETTER SYSTEMS | VIVALITH II 301 PULSE GENERATOR | 01/10/1985 |
| K885267 | PACESETTER SYSTEMS | VS-1 MODEL NUMBER 251K PULSE GENERATOR | 03/28/1989 |
| K780781 | R.E. BROWN CO., INC. | STILITH CARDIAC PACEMAKERS-M. 60 & 120 | 07/27/1978 |
| K920157 | SCHNEIDER INTL., LTD. | SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER | 03/16/1992 |
| K791225 | SHILEY, INC. | BJORK-SHILEY AORTIC GRAFT VALVE PROSTH | 08/10/1979 |
| K812610 | SIEMENS CORP. | SIEMENS-ELEMA PULSE GENERATOR 668 B | 12/10/1981 |
| K820657 | SIEMENS ELEMA AB | PULSE GENERATOR 678 B | 04/15/1982 |
| K841233 | SIEMENS ELEMA AB | PULSE GENERATOR 678L | 07/06/1984 |
| K841230 | SIEMENS ELEMA AB | PULSE GENERATOR 686, 686B 686L | 12/03/1984 |
| K841231 | SIEMENS ELEMA AB | PULSE GENERATOR 688B & 688L | 06/26/1984 |
| K841225 | SIEMENS ELEMA AB | PULSE GENERATOR 689, 689B & 689L | 12/03/1984 |
| K841232 | SIEMENS ELEMA AB | PULSE GENERATOR 696, 696B & 696L | 12/03/1984 |
| K841229 | SIEMENS ELEMA AB | PULSE GENERATOR 698, 698B & 698L | 06/25/1984 |
| K841228 | SIEMENS ELEMA AB | PULSE GENERATOR 718B & 718L | 06/26/1984 |
| K841226 | SIEMENS ELEMA AB | PULSE GENERATOR 728, 728B & 728L | 06/26/1984 |
| K800387 | SIEMENS ELEMA AB | PULSE GENERATORS MODELS 657 & 677 | 05/02/1980 |
| K810036 | SIEMENS ELEMA AB | SIEMENS-ELEMA MYOCARDIAL LEAD | 01/29/1981 |
| K801508 | SIEMENS ELEMA AB | SIEMENS-ELEMA PULSE GENERATOR 625 | 09/16/1980 |
| K813576 | SIEMENS ELEMA AB | SIEMENS-ELEMA PULSE GENERATOR 659 | 01/22/1982 |
| K801324 | SIEMENS ELEMA AB | SIEMENS-ELEMA PULSE GENERATOR 668 | 12/01/1980 |
| K802864 | SIEMENS ELEMA AB | SIEMENS-ELEMA PULSE GENERATOR 678 | 02/05/1981 |
| K852641 | SORIN BIOMEDICA, FIAT, USA, INC. | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER | 01/14/1986 |
| K851365 | SORIN BIOMEDICA, FIAT, USA, INC. | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM | 12/03/1985 |
| K813101 | SURVIVAL TECHNOLOGY, INC. | CARDIOBEEPER MEMORY MONITOR | 11/27/1981 |
| K812464 | SYNTHEMED CORP. | SYNTHEMED PULSE GENERATOR VVI MODEL 1000 | 11/16/1981 |
| K881904 | TELECTRONICS AND CORDIS PACING SYSTEMS | CHANGE TO CATHODE POWDER SPECIFICATION | 07/22/1988 |
| K881711 | TELECTRONICS AND CORDIS PACING SYSTEMS | VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. | 05/26/1988 |
| K897116 | TELECTRONICS PACING SYSTEMS, INC. | OPTIMA MPT MODEL 5281E AND MODEL 5282E | 03/14/1990 |
| K894185 | TELECTRONICS PACING SYSTEMS, INC. | OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR | 08/17/1989 |
| K903186 | TELECTRONICS PACING SYSTEMS, INC. | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | 01/18/1991 |
| K780777 | TELECTRONICS, INC. | BAGS, PLASTIC, STERILE FOR GENERATORS | 05/16/1978 |
| K782162 | TELECTRONICS, INC. | BATTERY CHARGER, 171 PACEMAKER | 07/24/1979 |
| K854143 | TELECTRONICS, INC. | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS | 11/01/1985 |
| K813079 | TELECTRONICS, INC. | BIPOLAR OPTIMA MP #255 | 12/10/1981 |
| K790867 | TELECTRONICS, INC. | CARDIAC PULSE GENERATOR, 16 SERIES | 05/31/1979 |
| K772026 | TELECTRONICS, INC. | CARDIAC PULSE GENERATOR, MODEL 150L | 11/03/1977 |
| K780113 | TELECTRONICS, INC. | CARDIAC PULSE GENERATOR, MODEL 160B | 02/13/1978 |
| K781426 | TELECTRONICS, INC. | CARDIAL PULSE GENERATORS | 09/07/1978 |
| K790868 | TELECTRONICS, INC. | GENERATOR, 16 SERIES, MODIFIED TOP CAP | 05/25/1979 |
| K781090 | TELECTRONICS, INC. | GENERATOR, CARDIAC PULSE, 250B | 09/07/1978 |
| K780420 | TELECTRONICS, INC. | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | 07/27/1978 |
| K780421 | TELECTRONICS, INC. | GENERATOR, PULSE, CARDIAC, IMPLANTABLE | 07/07/1978 |
| K780940 | TELECTRONICS, INC. | GENERATOR, PULSE, MODEL 160B | 09/27/1978 |
| K803197 | TELECTRONICS, INC. | IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 | 01/22/1981 |
| K860573 | TELECTRONICS, INC. | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR | 05/28/1986 |
| K853206 | TELECTRONICS, INC. | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW | 09/12/1985 |
| K833427 | TELECTRONICS, INC. | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | 02/10/1984 |
| K830390 | TELECTRONICS, INC. | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | 03/24/1983 |
| K800030 | TELECTRONICS, INC. | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN. | 01/11/1980 |
| K851081 | TELECTRONICS, INC. | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II | 04/04/1985 |
| K800793 | TELECTRONICS, INC. | IMPLANTABLE PROGRAM. CARDIAC PACEMAKER | 09/18/1980 |
| K831771 | TELECTRONICS, INC. | IMPLANTABLE PROGRAM. CARDIAC PULSE GEN | 08/16/1983 |
| K800573 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC | 03/25/1980 |
| K810603 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE | 04/14/1981 |
| K871861 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | 06/05/1987 |
| K871992 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | 08/12/1987 |
| K872766 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS | 11/04/1987 |
| K840737 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE PULSE GENER | 05/16/1984 |
| K842473 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE PULSE GENERAT | 10/26/1984 |
| K854560 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR | 01/16/1986 |
| K792519 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE UNIPOLAR | 12/20/1979 |
| K792052 | TELECTRONICS, INC. | IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD | 10/22/1979 |
| K833428 | TELECTRONICS, INC. | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN | 02/10/1984 |
| K802028 | TELECTRONICS, INC. | IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN | 09/26/1980 |
| K791727 | TELECTRONICS, INC. | IMPLANTABLE VENTRICULAR-INHIBITED | 09/27/1979 |
| K812790 | TELECTRONICS, INC. | IMPLANTABLE VENTRICULAR-INHIBITED CARDI | 10/29/1981 |
| K771670 | TELECTRONICS, INC. | IMPLANTED PACEMAKER PLUSE GENERATOR | 09/12/1977 |
| K833798 | TELECTRONICS, INC. | OPTIMA MDT PULSE GENERATOR W/TELEMETRY | 12/01/1983 |
| K884411 | TELECTRONICS, INC. | OPTIMA MPT AND SPT PACEMAKERS | 01/26/1989 |
| K891231 | TELECTRONICS, INC. | OPTIMA MPT AND SPT PACEMAKERS | 09/12/1989 |
| K881837 | TELECTRONICS, INC. | OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D | 07/18/1988 |
| K840701 | TELECTRONICS, INC. | PACEMAKER 147 VVI-THE OPTINIA | 05/02/1984 |
| K790764 | TELECTRONICS, INC. | PACEMAKERS WITHOUT SILASTIC COATING | 04/26/1979 |
| K782149 | TELECTRONICS, INC. | PULSE GENERATOR, IMPLANTABLE CARDIAC | 02/08/1979 |
| K782161 | TELECTRONICS, INC. | PULSE GENERATOR, MODEL 171 | 07/24/1979 |
| K850252 | TELECTRONICS, INC. | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR | 04/04/1985 |
| K810410 | TELECTRONICS, INC. | STERILE PACKAGING | 03/05/1981 |
| K873158 | TPL-CORDIS, INC. | MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS | 01/07/1988 |
| K880898 | TPL-CORDIS, INC. | MULTICOR AND PACEMAKERS | 05/06/1988 |
| K880432 | TPL-CORDIS, INC. | VICOR PACER, MODEL 410A | 02/22/1988 |
| K873202 | TPL-CORDIS, INC. | VICOR, MODEL 410A | 10/15/1987 |
| K791921 | VITATRON MEDICAL BV | CARDIAC PACEMAKER "C4000, "C1000 SER. | 10/26/1979 |
| K791920 | VITATRON MEDICAL BV | CARDIAC PACEMAKER "P4000 SER. & "P1000 | 11/29/1979 |
| K772010 | VITATRON MEDICAL BV | CARDIAC PACEMAKER C2001 | 11/28/1977 |
| K772009 | VITATRON MEDICAL BV | CARDIAC PACEMAKER S6001 | 11/28/1977 |
| K854790 | VITATRON MEDICAL BV | CERYX PACEMAKER MODELS 114, 314 & 614 | 08/28/1986 |
| K781168 | VITATRON MEDICAL BV | GENERATOR, PULSE, PACEMAKER | 08/31/1978 |
| K831860 | VITATRON MEDICAL BV | GENERATOR, PULSE, PACEMAKER #532 | 10/27/1983 |
| K831859 | VITATRON MEDICAL BV | PACEMAKER PROGRAMMER #2032 | 10/27/1983 |
| K760669 | VITATRON MEDICAL BV | PACEMAKERS, VITATRON'S | 11/12/1976 |
| K760670 | VITATRON MEDICAL BV | PACEMAKERS, VITATRONS (SERIES 2000) | 11/12/1976 |
| K760671 | VITATRON MEDICAL BV | PACEMAKERS, VITATRONS (SERIES 3000) | 11/12/1976 |
| K790666 | VITATRON MEDICAL BV | VITALITH S 3000 SERIES | 06/01/1979 |
| K884420 | YAMASU CO. LTD. | HOME BLOOD PRESSURE KIT, ANEROID | 08/25/1989 |
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