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DXY

461 FDA 510(k) clearances · Product code

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RecordFirmDate
SILICONE RUBBER ISOLATION SLEEVE 350-01 (K833199)Intermedics, Inc.1983-10-28
GENERATOR, PULSE, PACEMAKER #532 (K831860)Vitatron Medical BV1983-10-27
SILICONE RUBBER ISOLATION SLEEVE 351-01 (K833198)Intermedics, Inc.1983-10-27
PACEMAKER PROGRAMMER #2032 (K831859)Vitatron Medical BV1983-10-27
QUANTUM BIPOLAR CARDIAC PULSE GENERATOR (K831633)Intermedics, Inc.1983-10-12
MODEL 329T PROGRAMMABLE, BIPOLAR CARDI (K832893)Cook Pacemaker Corp.1983-10-04
IMPLANTABLE PROGRAM. CARDIAC PULSE GEN (K831771)Telectronics, Inc.1983-08-16
MODEL 327T UNIPOLAR CARDIAC PULSE GEN (K832052)Cook Pacemaker Corp.1983-08-08
COMMAND ULTRA II (K831216)Cardiac Pacemakers, Inc.1983-07-12
COMMAND ULTRA I (K831161)Cardiac Pacemakers, Inc.1983-06-15
SIEMENS-ELMA PULSE GENERATOR #718 (K830344)Burditt & Calkins-Siemens-Elema1983-05-27
NEDS-01 & EPR-500 (K830862)Biotronik Sales, Inc.1983-05-25
IMPLANTABLE PACEMAKER PULSE GEN, MODELS 241 & 242 (K823878)Pacesetter Systems1983-03-24
IMPLANTABLE BIPOLAR CARDIAC PULSE GEN (K830390)Telectronics, Inc.1983-03-24
UNILITH PULSE GENERATOR VVI #7542 (K830401)Ela Medical, Inc.1983-03-17
COMMAND ULTRA II (K830382)Cardiac Pacemakers, Inc.1983-03-17
MEDTRONIC MODELS 59401 5941 (K823831)Medtronic Vascular1983-03-16
CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC (K823863)Intermedics, Inc.1983-03-10
AFP SYSTEM PULSE GENERATOR MODEL 261/262 (K822639)Pacesetter Systems1983-02-18
AFP PULSE GENERATOR (K823559)Pacesetter Systems1983-02-18
DURAPULSE (K823371)Cpm International, Inc.1982-12-22
TELEMETRY DECODER #540-02 (K823678)Intermedics, Inc.1982-12-22
CORATOMIC #VX5-105 & VX5-205 PULSE GEN. (K822791)Coratomic, Inc.1982-12-15
KALOS-03 BIPOLAR (K822907)Biotronik Sales, Inc.1982-11-01
MODEL 325D UNIPOLAR CARDIAC PULSE GEN (K822904)Cook Pacemaker Corp.1982-10-15
ENERTRAX MODEL 7100E (K822297)Medtronic Vascular1982-10-04
COMMAND NP (K822309)Cardiac Pacemakers, Inc.1982-10-04
JAIN INSULATING BOOT MODEL 225B (K822652)Cook Pacemaker Corp.1982-10-04
MEDTRONIC ENERTRAX MODEL 7100 (K822147)Medtronic Vascular1982-08-06
C-101-P (K820939)Coratomic, Inc.1982-06-22
CORATOMIC MODEL OVALITH-920 (K821033)Coratomic, Inc.1982-05-28
CORATOMIC MODEL OVALITH 920BP (K821014)Coratomic, Inc.1982-05-28
PULSE GENERATOR (K821073)Biotronik Sales, Inc.1982-05-07
COOK #326T PROGRAM/TELEMETRY BIPOLAR (K821147)Cook Pacemaker Corp.1982-05-07
PROGRAMMALITH II, #225 & 226 (K821003)Pacesetter Systems1982-05-07
PULSE GENERATOR 678 B (K820657)Siemens Elema AB1982-04-15
QUANTUM MODELS 253-09, 254-09 254-10 (K820853)Intermedics, Inc.1982-04-09
IMPLANTABLE, MULTIPROGRAMMABLE (K820774)Biotronik Sales, Inc.1982-04-09
MULTICOR (GAMMA) 402 CARDIAC PACER (K820356)Cordis Corp.1982-03-18
COMMAND ULTRA I (K820231)Cardiac Pacemakers, Inc.1982-03-15
MEDICAL MULTILITH PULSE GENERA-1140 (K813246)Ela Medical, Inc.1982-02-12
COMMAND P5 (K813534)Cardiac Pacemakers, Inc.1982-01-22
SIEMENS-ELEMA PULSE GENERATOR 659 (K813576)Siemens Elema AB1982-01-22
BIPOLAR OPTIMA MP #255 (K813079)Telectronics, Inc.1981-12-10
SIEMENS-ELEMA PULSE GENERATOR 668 B (K812610)Siemens Corp.1981-12-10
DIRECTIONAL BOOT (K813150)Pacesetter Systems1981-12-02
CARDIOBEEPER MEMORY MONITOR (K813101)Survival Technology, Inc.1981-11-27
SYNTHEMED PULSE GENERATOR VVI MODEL 1000 (K812464)Synthemed Corp.1981-11-16
MODEL 325C UNIPOLAR CARDIAC PULSE GEN. (K812832)Cook Pacemaker Corp.1981-11-05
MODEL 325T PROGRAMMABLE PULSE GENERATOR (K812358)Cook Pacemaker Corp.1981-10-29
IMPLANTABLE VENTRICULAR-INHIBITED CARDI (K812790)Telectronics, Inc.1981-10-29
KALOS-03 (K812218)Biotronik Sales, Inc.1981-10-13
TELEMETRY DECODER (K801339)Intermedics, Inc.1981-09-23
CYBERLITH IX IMPLANTABLE PULSE GENERATOR (K801337)Intermedics, Inc.1981-09-23
MEDTRONIC MODEL 2409 (K812580)Medtronic Vascular1981-09-23
MEDTRONIC ENERTRAX MODEL 7100 (K812096)Medtronic Vascular1981-09-16
MEDTRONIC SPECTRAX (K812153)Medtronic Vascular1981-08-31
COMMAND P5(BIPOLAR PULSE GENERATOR) (K811402)Cardiac Pacemakers, Inc.1981-07-27
CORDIS OMNI-ARTICOR CARDIAC PACER #308 (K811691)Cordis Corp.1981-07-20
ELA MEDICAL UNILITH 7540 PULSE GENERATOR (K810887)Ela Medical, Inc.1981-07-20
CORATOMIC MODEL OVALITH-920BP (K811768)Corptomic1981-07-20
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. (K811350)Medtronic Vascular1981-07-01
#326 PROGRAMMABLE CARD. PULSE GENERATOR (K810885)Cook Pacemaker Corp.1981-06-16
#325 PROGRAMMABLE CARD. PULSE GENERATOR (K810884)Cook Pacemaker Corp.1981-06-16
MULTILITH PULSE GENERATOR #1140 (K810489)Ela Medical, Inc.1981-05-29
ELA MEDICAL UNILITH PULSE GENERATOR (K810142)Ela Medical, Inc.1981-05-29
MODELS 5976/5977 PACEMAKER PULSE GENER (K810677)Medtronic, Inc.1981-05-27
INTERMEDICS CYBERLITH BIPOLAR CARDIAC (K811221)Intermedics, Inc.1981-05-27
MEDTRONIC PULSE GENERATOR (K811123)Medtronic Vascular1981-05-27
CORATOMIC MODEL OVALITH-920 (K810808)Coratomic, Inc.1981-05-15
MODELS 8420 THRU 8423 PACEMAKER GENER (K810734)Medtronic Vascular1981-05-15
MODEL 230-06 CYBERLITH TM I BIPOLAR IN (K811066)Intermedics, Inc.1981-05-01
THINLITH III UNIPOLAR CARDIAC PULSE GEN. (K810752)Intermedics, Inc.1981-05-01
MODEL 230-05 CYBERLITH I BIPOL. PULSE G. (K810800)Intermedics, Inc.1981-05-01
INSULATIVE COATING FOR CARD. PULSE GEN (K810901)Intermedics, Inc.1981-04-14
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE (K810603)Telectronics, Inc.1981-04-14
INTERMEDICS CYBERLITH I BIOPOLAR CARDI (K810383)Intermedics, Inc.1981-04-01
CYBERLITH I PULSE GENERATOR MODEL 253-04 (K810385)Intermedics, Inc.1981-04-01
THINLITH II PULSE GNEERATOR MODEL 227-05 (K810386)Intermedics, Inc.1981-03-13
STERILE PACKAGING (K810410)Telectronics, Inc.1981-03-05
UNIFOCAL 3 (K810121)American Pacemaker Corp.1981-02-23
MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. (K801584)Medtronic Vascular1981-02-12
SIEMENS-ELEMA PULSE GENERATOR 678 (K802864)Siemens Elema AB1981-02-05
SIEMENS-ELEMA MYOCARDIAL LEAD (K810036)Siemens Elema AB1981-01-29
IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274 (K803197)Telectronics, Inc.1981-01-22
CYBERLITH PROGRAMMER (K801338)Intermedics, Inc.1981-01-07
MICRO THIN-PII, #0523 (K802353)Cardiac Pacemakers, Inc.1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0623 (K803034)Cardiac Pacemakers, Inc.1980-12-22
MICROTHIN-PII BIPOLAR PULSE GEN. #0621 (K803035)Cardiac Pacemakers, Inc.1980-12-22
MICRO THIN-DII, #0521 (K802352)Cardiac Pacemakers, Inc.1980-12-22
UNIFOCAL VP, MODELS 7501 AND 7502 (K800746)American Pacemaker Corp.1980-12-16
SIEMENS-ELEMA PULSE GENERATOR 668 (K801324)Siemens Elema AB1980-12-01
MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (K802588)Arco Medical Products Co.1980-11-19
LITHICRON 0520 P-SYNCHRONEOUS PULSE GEN. (K792609)Medcor, Inc.1980-11-19
MICROTHIN-DI BIPOLAR PULSE GENERATOR (K802409)Cardiac Pacemakers, Inc.1980-10-31
MICROTHIN-PI BIPOLAR PULSE GENERATOR (K802410)Cardiac Pacemakers, Inc.1980-10-31
SORIN PULSE GENERATOR, MODEL #LIT-214 (K801640)Bentley Laboratories, Inc.1980-10-03
PROGRAMALITH #'S 221, 222, 221A & 222A (K801978)Pacesetter Systems1980-09-26
IMPLANTABLE VENTRICULAR-INHIB. C.P. GEN (K802028)Telectronics, Inc.1980-09-26
BIFOCAL 2 8200 SERIES (A,B C,D) (K800379)American Pacemaker Corp.1980-09-26
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