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DXY

461 FDA 510(k) clearances · Product code

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RecordFirmDate
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY (K861422)Pacesetter Systems1986-06-26
MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN (K862037)Medtronic Vascular1986-06-17
MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER (K862038)Medtronic Vascular1986-06-17
MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN (K862071)Medtronic Vascular1986-06-17
IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR (K860573)Telectronics, Inc.1986-05-28
SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (K861559)Cook Pacemaker Corp.1986-05-09
PROGRAMALITH III PULSE GENERATOR (K861140)Pacesetter Systems1986-05-02
BIPOLAR CARDIAC PACEMAKER, MODEL 110 (K861009)Cardiac Control Systems, Inc.1986-04-23
UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 (K852973)Ela Medical, Inc.1986-03-31
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS (K855147)Medtronic Vascular1986-03-17
PHOENIX MODELS 250/251 PULSE GENERATORS (K855081)Pacesetter Systems1986-03-07
ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS (K854482)Medtronic Vascular1986-02-28
CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA (K853471)Cardiac Control Systems, Inc.1986-02-24
CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK (K853400)Cardiac Control Systems, Inc.1986-02-24
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. (K860466)Cook Pacemaker Corp.1986-02-24
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. (K860202)Cook Pacemaker Corp.1986-02-24
TELEMETRY WAND MODEL (K855171)Cardiac Pacemakers, Inc.1986-01-22
IMPLANTABLE PROGRAMMABLE PULSE GENERATOR (K854560)Telectronics, Inc.1986-01-16
CORDIS MULTICOR ST, MODEL 350A (K851968)Cordis Corp.1986-01-14
ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER (K852641)Sorin Biomedica, Fiat, USA, Inc.1986-01-14
PROGRAMALITH III MODELS 238 & 239 (K854195)Pacesetter Systems1986-01-07
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY (K854919)Cook Pacemaker Corp.1985-12-19
SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM (K851365)Sorin Biomedica, Fiat, USA, Inc.1985-12-03
COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (K854132)Cook Pacemaker Corp.1985-12-03
MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE (K854214)Cordis Corp.1985-12-03
SUPRIMA MODEL 254-22 (K852339)Intermedics, Inc.1985-11-08
SUPRIMA MODEL 254-24 (K852340)Intermedics, Inc.1985-11-08
MEDTRONICS MODELS 8320/8322/8329 (K852688)Medtronic Vascular1985-11-01
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS (K854143)Telectronics, Inc.1985-11-01
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK (K852748)Cordis Corp.1985-11-01
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI (K853590)Cook Pacemaker Corp.1985-10-23
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER (K853651)Cook Pacemaker Corp.1985-10-23
NEOS - M ABP (K853058)Biotronik Sales, Inc.1985-09-13
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW (K853206)Telectronics, Inc.1985-09-12
TRIOS - M (K853057)Biotronik Sales, Inc.1985-09-12
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR (K853425)Cardio-Pace Medical, Inc.1985-08-19
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA (K852435)Cardiac Control Systems, Inc.1985-08-06
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 (K853017)Ela Medical, Inc.1985-07-25
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ (K853034)Intermedics, Inc.1985-07-25
SUPRIMA II MODEL 254-26 (K852431)Intermedics, Inc.1985-07-19
SUPRIMA II MODEL 253-23 (K852430)Intermedics, Inc.1985-07-17
SUPRIMA II MODEL 254-28 (K852432)Intermedics, Inc.1985-07-17
MULTICOR S, MODELS 330A/331A (K851420)Cordis Corp.1985-06-21
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS (K844360)Cordis Corp.1985-06-18
OMNI-ATRICOR MODEL 308A (K851418)Cordis Corp.1985-06-11
STANICOR GAMMA 333B/334A (K851416)Cordis Corp.1985-06-11
MULTICOR GAMMA MODELS 336/337 (K851417)Cordis Corp.1985-06-11
MULTICOR GAMMA 402 SERIES PACER (K851419)Cordis Corp.1985-06-11
PROGRAMALITH III MODEL 249 PULSE GENERATOR (K851861)Pacesetter Systems1985-05-16
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE (K851699)Cook Pacemaker Corp.1985-05-16
PROGRAMALITH III 240 PULSE GENERATOR (K850464)Pacesetter Systems1985-05-15
NEOS-LP PULSE GENERATOR (K844842)Biotronik Sales, Inc.1985-04-18
NEOS-M PULSE GENERATOR (K844795)Biotronik Sales, Inc.1985-04-18
NEOS - PULSE GENERATOR (K844812)Biotronik Sales, Inc.1985-04-18
LEPTOS PULSE GENERATOR (K844794)Biotronik Sales, Inc.1985-04-18
KALOS-04 PULSE GENERATOR (K844841)Biotronik Sales, Inc.1985-04-18
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II (K851081)Telectronics, Inc.1985-04-04
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR (K850252)Telectronics, Inc.1985-04-04
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR (K850651)Pacesetter Systems1985-04-01
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER (K850384)Cardiac Control Systems, Inc.1985-03-21
COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM (K850656)Cook Pacemaker Corp.1985-03-01
EKG TRANSMITTER MODEL 5134 (K842051)Instromedix, Inc.1985-03-01
SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR (K844793)Intermedics, Inc.1985-02-08
MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE (K844958)Medtronic Vascular1985-02-08
MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR (K844957)Medtronic Vascular1985-02-08
VIVALITH II 301 PULSE GENERATOR (K844334)Pacesetter Systems1985-01-10
MULTILITH PULSE GENERATORS, 1141 & 2141 (K842193)Ela Medical, Inc.1985-01-10
PULSE GENERATOR 689, 689B & 689L (K841225)Siemens Elema AB1984-12-03
PULSE GENERATOR 686, 686B 686L (K841230)Siemens Elema AB1984-12-03
PULSE GENERATOR 696, 696B & 696L (K841232)Siemens Elema AB1984-12-03
MULTILITH 2 PULSE GENERATOR 1141 & 2141 (K842220)Ela Medical, Inc.1984-11-29
IMPLANTABLE PROGRAMMABLE PULSE GENERAT (K842473)Telectronics, Inc.1984-10-26
ASTRA 2, ASTRA 3, 4 & 6 (K842394)Cardiac Pacemakers, Inc.1984-10-17
MEDTRONIC 5984-5984LP-5985 (K843837)Medtronic Vascular1984-10-17
MEDTRONIC 8437/8438 (K843089)Medtronic Vascular1984-08-29
NEOS LP (K841633)Biotronik Sales, Inc.1984-08-06
LITHIUM PACEMAKER 811-811L & 811XL (K840748)Omikron Scientific, Ltd.1984-08-03
LEPTOS (K841635)Biotronik Sales, Inc.1984-08-03
COOK PACEMAKER 216 BIPOLAR CARDIAC - (K841983)Cook Pacemaker Corp.1984-07-11
COOK PACEMAKER 215 UNIPOLAR CARDIAC- (K841928)Cook Pacemaker Corp.1984-07-11
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI (K842081)Cook Pacemaker Corp.1984-07-06
PULSE GENERATOR 678L (K841233)Siemens Elema AB1984-07-06
PULSE GENERATOR 688B & 688L (K841231)Siemens Elema AB1984-06-26
PULSE GENERATOR 718B & 718L (K841228)Siemens Elema AB1984-06-26
PULSE GENERATOR 728, 728B & 728L (K841226)Siemens Elema AB1984-06-26
PULSE GENERATOR 698, 698B & 698L (K841229)Siemens Elema AB1984-06-25
PULSE GENERATOR KALOS-04 (K841950)Biotronik Sales, Inc.1984-06-25
NEOS M (K841636)Biotronik Sales, Inc.1984-06-25
PRIMA 236-02 NONPROGRAMMABLE CARDIAC (K841404)Intermedics, Inc.1984-05-30
CARDIAC PULSE GENERATOR 254-18 (K841074)Intermedics, Inc.1984-05-16
IMPLANTABLE PROGRAMMABLE PULSE GENER (K840737)Telectronics, Inc.1984-05-16
QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE (K841073)Intermedics, Inc.1984-05-16
CARCIAC PULSE GENERATOR 254-20 (K841075)Intermedics, Inc.1984-05-16
PACEMAKER 147 VVI-THE OPTINIA (K840701)Telectronics, Inc.1984-05-02
IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN (K833428)Telectronics, Inc.1984-02-10
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN (K833427)Telectronics, Inc.1984-02-10
PULSE GENERATOR MODEL 688 (K833519)Burditt & Calkins-Siemens-Elema1984-01-30
IMPLANTABLE PULSE GENERATOR (K834096)Intermedics, Inc.1983-12-16
OPTIMA MDT PULSE GENERATOR W/TELEMETRY (K833798)Telectronics, Inc.1983-12-01
PRIMA-UNIPOLAR CARDIAC PULSE GENERAT (K832914)Intermedics, Inc.1983-11-14
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