Product code DXY— Cardiovascular
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- Advisory panel
- Cardiovascular
- Total cleared
- 461
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DXY
1–100 of 461- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
- K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
- K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
- K940039 — PELLETHANE 75D
- K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
- K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
- K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
- K941937 — PIKOS E 01-B
- K932884 — MINIX/MINIX ST PULSE GENERATORS
- K923026 — PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
- K923868 — CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
- K930770 — MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
- K920601 — ASTRA T2, ASTRA T4, ASTRA T6
- K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
- K920157 — SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
- K914109 — PIKOS 01 & PIKOS E 01
- K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
- K913134 — MODEL 4220
- K912545 — MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
- K905824 — MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
- K911122 — 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
- K905087 — TRIOS 02
- K903186 — OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
- K904602 — MEDTRONIC MODEL 5301B TEST CABLE
- K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
- K904892 — VACUUM BAKE CYCLE
- K903919 — IMPLANTABLE PULSE DEVICES
- K903081 — NEOS (TM) 02 B PULSE GENERATOR
- K901535 — MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
- K902134 — MINIX, MINIX ST, NEW IC: L74
- K900622 — MODIFIED MODEL 5401B TEST CABLE
- K897116 — OPTIMA MPT MODEL 5281E AND MODEL 5282E
- K900461 — OPUS MODEL 4021, VVI, 5MM UNIPOLAR
- K896809 — MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
- K896184 — KALOS 05 PULSE GENERATOR
- K894239 — NANOS
- K894240 — NEOS 02
- K894494 — LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
- K894065 — OPUS MODEL 4001
- K895495 — ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
- K894267 — OPUS MODELS 4033 AND 4034
- K891231 — OPTIMA MPT AND SPT PACEMAKERS
- K884420 — HOME BLOOD PRESSURE KIT, ANEROID
- K894055 — MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
- K894185 — OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
- K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR
- K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
- K884733 — AFP MODEL 262T PULSE GENERATOR
- K884411 — OPTIMA MPT AND SPT PACEMAKERS
- K883037 — UNILITH 3 MODELS 7580/7583/7680/7683
- K883750 — VENTRALITH I
- K883755 — MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
- K884215 — MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
- K882391 — OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
- K884023 — MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
- K882427 — CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
- K883087 — PROLOG MP 658M PULSE GENERATOR
- K882474 — OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
- K882476 — OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
- K881904 — CHANGE TO CATHODE POWDER SPECIFICATION
- K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
- K881711 — VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
- K880898 — MULTICOR AND PACEMAKERS
- K880326 — MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
- K880422 — MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
- K880432 — VICOR PACER, MODEL 410A
- K873158 — MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
- K874158 — CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
- K874394 — QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
- K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K872779 — PROLOG MP PULSE GENERATORS 658K AND 658T
- K873202 — VICOR, MODEL 410A
- K873528 — MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
- K871992 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K871866 — MEDTRONIC CLASSIX MODELS 8436/8437/8438
- K871861 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K870142 — PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
- K865013 — ASTRA T2, T4 AND T6
- K863898 — MULTILITH 3 MODELS 1350, 3350, 1370, 3370
- K862226 — DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
- K860036 — EDP-20 PACEMAKER
- K862459 — MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
- K863878 — TRIOS-M VS-1 PULSE GENERATOR
- K863879 — NEOS-M VS-1 PULSE GENERATOR
- K863365 — MODIFICATION OF STERILITY CYCLE PARAMETERS
- K863417 — CORDIS MULTICOR II MODEL 402D PACER
- K863582 — MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
- K863418 — MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
- K862974 — ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
- K854790 — CERYX PACEMAKER MODELS 114, 314 & 614
- K860921 — NEOS VS-1, PULSE GENERATOR
- K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR
- K860585 — ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
- K853771 — PINNACLE MULTI-PROGRAMMABLE PACING SYS
- K861719 — MODIFIED MODELS 8320/8322/8329/8316/8317/8318
Data sourced from openFDA. This site is unofficial and independent of the FDA.