DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
217–240 of 461
Cleared Mar 15, 1982
COMMAND ULTRA I
K820231
Cardiac Pacemakers, Inc.
Cardiovascular · 46d
Cleared Feb 12, 1982
MEDICAL MULTILITH PULSE GENERA-1140
K813246
Ela Medical, Inc.
Cardiovascular · 86d
Cleared Jan 22, 1982
COMMAND P5
K813534
Cardiac Pacemakers, Inc.
Cardiovascular · 36d
Cleared Jan 22, 1982
SIEMENS-ELEMA PULSE GENERATOR 659
K813576
Siemens Elema AB
Cardiovascular · 30d
Cleared Dec 10, 1981
SIEMENS-ELEMA PULSE GENERATOR 668 B
K812610
Siemens Corp.
Cardiovascular · 86d
Cleared Dec 10, 1981
BIPOLAR OPTIMA MP #255
K813079
Telectronics, Inc.
Cardiovascular · 38d
Cleared Dec 02, 1981
DIRECTIONAL BOOT
K813150
Pacesetter Systems
Cardiovascular · 26d
Cleared Nov 05, 1981
MODEL 325C UNIPOLAR CARDIAC PULSE GEN.
K812832
Cook Pacemaker Corp.
Cardiovascular · 27d
Cleared Oct 29, 1981
MODEL 325T PROGRAMMABLE PULSE GENERATOR
K812358
Cook Pacemaker Corp.
Cardiovascular · 70d
Cleared Oct 29, 1981
IMPLANTABLE VENTRICULAR-INHIBITED CARDI
K812790
Telectronics, Inc.
Cardiovascular · 24d
Cleared Oct 13, 1981
KALOS-03
K812218
Biotronik Sales, Inc.
Cardiovascular · 68d
Cleared Sep 23, 1981
CYBERLITH IX IMPLANTABLE PULSE GENERATOR
K801337
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
TELEMETRY DECODER
K801339
Intermedics, Inc.
Cardiovascular · 476d
Cleared Sep 23, 1981
MEDTRONIC MODEL 2409
K812580
Medtronic Vascular
Cardiovascular · 13d
Cleared Sep 16, 1981
MEDTRONIC ENERTRAX MODEL 7100
K812096
Medtronic Vascular
Cardiovascular · 54d
Cleared Aug 31, 1981
MEDTRONIC SPECTRAX
K812153
Medtronic Vascular
Cardiovascular · 33d
Cleared Jul 27, 1981
COMMAND P5(BIPOLAR PULSE GENERATOR)
K811402
Cardiac Pacemakers, Inc.
Cardiovascular · 70d
Cleared Jul 20, 1981
ELA MEDICAL UNILITH 7540 PULSE GENERATOR
K810887
Ela Medical, Inc.
Cardiovascular · 110d
Cleared Jul 20, 1981
CORDIS OMNI-ARTICOR CARDIAC PACER #308
K811691
Cordis Corp.
Cardiovascular · 35d
Cleared Jul 01, 1981
UNIPOLAR SPECTRAX IMPL. PULSE GENERAT.
K811350
Medtronic Vascular
Cardiovascular · 49d
Cleared Jun 16, 1981
#325 PROGRAMMABLE CARD. PULSE GENERATOR
K810884
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared Jun 16, 1981
#326 PROGRAMMABLE CARD. PULSE GENERATOR
K810885
Cook Pacemaker Corp.
Cardiovascular · 76d
Cleared May 29, 1981
ELA MEDICAL UNILITH PULSE GENERATOR
K810142
Ela Medical, Inc.
Cardiovascular · 128d
Cleared May 29, 1981
MULTILITH PULSE GENERATOR #1140
K810489
Ela Medical, Inc.
Cardiovascular · 95d