Atlas FDA

DXY

461 FDA 510(k) clearances · Product code

56 daysmedian time to decision
175 days90th percentile
461clearances measured

FDA profile

Official device name
Implantable Pacemaker Pulse-Generator
Device class
Class III (high risk)
Regulation
21 CFR 870.3610
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 561 · 2022: 784 · 2023: 922 · 2024: 773 · 2025: 817 · 2026: 593
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072)Ela Medical, Inc.1997-08-29
PIKOS LP 01, PIKOS LP E01 (K945627)Biotronik, Inc.1996-03-04
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866)Medtronic Vascular1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092)Medtronic Vascular1995-12-15
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328)Biotronik, Inc.1995-09-29
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03
PIKOS E 01-B (K941937)Biotronik, Inc.1994-08-30
MINIX/MINIX ST PULSE GENERATORS (K932884)Medtronic Vascular1994-05-02
PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER (K923026)Biotronik, GmbH & Co.1993-08-19
CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER (K923868)Cardiac Control Systems, Inc.1993-05-14
MEDTRONIC MINIX & MINIX ST PULSE GENERATORS (K930770)Medtronic Vascular1993-05-14
ASTRA T2, ASTRA T4, ASTRA T6 (K920601)Cardiac Pacemakers, Inc.1992-10-28
INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG (K920530)Intermedics, Inc.1992-03-17
SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER (K920157)Schneider Intl., Ltd.1992-03-16
PIKOS 01 & PIKOS E 01 (K914109)Biotronik, GmbH & Co.1992-02-26
MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (K905403)Cook Pacemaker Corp.1991-10-16
MODEL 4220 (K913134)Pace Medical1991-08-22
MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE (K912545)Pace Medical1991-07-26
8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS (K911122)Intermedics, Inc.1991-05-16
MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (K905824)Cardiac Control Systems, Inc.1991-05-16
TRIOS 02 (K905087)Biotronik, GmbH & Co.1991-05-07
OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (K903186)Telectronics Pacing Systems, Inc.1991-01-18
MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE (K904941)Cardiac Control Systems, Inc.1991-01-03
MEDTRONIC MODEL 5301B TEST CABLE (K904602)Medtronic Vascular1991-01-03
VACUUM BAKE CYCLE (K904892)Medtronic Vascular1990-12-20
IMPLANTABLE PULSE DEVICES (K903919)Medtronic Vascular1990-10-23
NEOS (TM) 02 B PULSE GENERATOR (K903081)Biotronik, GmbH & Co.1990-09-14
MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. (K901535)Medtronic Vascular1990-07-03
MINIX, MINIX ST, NEW IC: L74 (K902134)Medtronic Vascular1990-07-03
MODIFIED MODEL 5401B TEST CABLE (K900622)Medtronic Vascular1990-04-26
OPUS MODEL 4021, VVI, 5MM UNIPOLAR (K900461)Ela Medical, Inc.1990-03-14
OPTIMA MPT MODEL 5281E AND MODEL 5282E (K897116)Telectronics Pacing Systems, Inc.1990-03-14
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR (K896809)Medtronic Vascular1990-01-26
KALOS 05 PULSE GENERATOR (K896184)Biotronik Cardiac Pacemakers1990-01-18
NANOS (K894239)Biotronik Cardiac Pacemakers1989-11-01
NEOS 02 (K894240)Biotronik Cardiac Pacemakers1989-10-26
LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD (K894494)Biotronik, GmbH & Co.1989-10-17
OPUS MODEL 4001 (K894065)Ela Medical, Inc.1989-09-26
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS (K895495)Medtronic Vascular1989-09-26
OPUS MODELS 4033 AND 4034 (K894267)Ela Medical, Inc.1989-09-20
OPTIMA MPT AND SPT PACEMAKERS (K891231)Telectronics, Inc.1989-09-12
MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS (K894055)Medtronic Vascular1989-08-25
HOME BLOOD PRESSURE KIT, ANEROID (K884420)Yamasu Co. , Ltd.1989-08-25
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR (K894185)Telectronics Pacing Systems, Inc.1989-08-17
VS-1 MODEL NUMBER 251K PULSE GENERATOR (K885267)Pacesetter Systems1989-03-28
ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE (K890785)Cardiac Pacemakers, Inc.1989-03-10
AFP MODEL 262T PULSE GENERATOR (K884733)Pacesetter Systems1989-02-10
OPTIMA MPT AND SPT PACEMAKERS (K884411)Telectronics, Inc.1989-01-26
UNILITH 3 MODELS 7580/7583/7680/7683 (K883037)Ela Medical, Inc.1989-01-25
VENTRALITH I (K883750)Bio Pace Technology, Inc.1989-01-13
MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS (K883755)Medtronic Vascular1988-11-17
MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 (K884215)Medtronic Vascular1988-11-17
OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024 (K882391)Ela Medical, Inc.1988-11-14
MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (K884023)Cardiac Control Systems, Inc.1988-10-17
CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066 (K882427)Ela Medical, Inc.1988-09-23
PROLOG MP 658M PULSE GENERATOR (K883087)Pacesetter Systems1988-09-14
OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004 (K882476)Ela Medical, Inc.1988-09-12
OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004 (K882474)Ela Medical, Inc.1988-09-12
CHANGE TO CATHODE POWDER SPECIFICATION (K881904)Telectronics and Cordis Pacing Systems1988-07-22
OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (K881837)Telectronics, Inc.1988-07-18
VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA. (K881711)Telectronics and Cordis Pacing Systems1988-05-26
MULTICOR AND PACEMAKERS (K880898)Tpl-Cordis, Inc.1988-05-06
MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS (K880326)Cardiac Control Systems, Inc.1988-04-11
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER (K880422)Cardiac Control Systems, Inc.1988-03-31
VICOR PACER, MODEL 410A (K880432)Tpl-Cordis, Inc.1988-02-22
MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS (K873158)Tpl-Cordis, Inc.1988-01-07
CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. (K874158)Cardiac Control Systems, Inc.1987-12-29
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. (K874394)Intermedics, Inc.1987-11-23
PROLOG MP PULSE GENERATORS 658K AND 658T (K872779)Pacesetter Systems1987-11-04
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K872766)Telectronics, Inc.1987-11-04
VICOR, MODEL 410A (K873202)Tpl-Cordis, Inc.1987-10-15
MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS (K873528)Intermedics, Inc.1987-10-09
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K871992)Telectronics, Inc.1987-08-12
MEDTRONIC CLASSIX MODELS 8436/8437/8438 (K871866)Medtronic Vascular1987-08-10
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K871861)Telectronics, Inc.1987-06-05
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR (K870142)Cardio-Pace Medical, Inc.1987-04-22
ASTRA T2, T4 AND T6 (K865013)Cardiac Pacemakers, Inc.1987-02-19
MULTILITH 3 MODELS 1350, 3350, 1370, 3370 (K863898)Ela Medical, Inc.1987-02-10
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS (K862226)Pacesetter Systems1987-02-03
EDP-20 PACEMAKER (K860036)Biotronik Sales, Inc.1987-01-12
MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE (K862459)Medtronic Vascular1987-01-02
NEOS-M VS-1 PULSE GENERATOR (K863879)Biotronik Sales, Inc.1986-12-10
TRIOS-M VS-1 PULSE GENERATOR (K863878)Biotronik Sales, Inc.1986-12-10
CORDIS MULTICOR II MODEL 402D PACER (K863417)Cordis Corp.1986-10-08
MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (K863582)Cook Pacemaker Corp.1986-10-08
MODIFICATION OF STERILITY CYCLE PARAMETERS (K863365)Coratomic, Inc.1986-10-08
MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE (K863418)Intermedics, Inc.1986-09-24
ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. (K862974)Medtronic Vascular1986-09-04
CERYX PACEMAKER MODELS 114, 314 & 614 (K854790)Vitatron Medical BV1986-08-28
NEOS VS-1, PULSE GENERATOR (K860921)Biotronik Sales, Inc.1986-08-08
MIKROS, MIKROS VS-1, PULSE GENERATOR (K860922)Biotronik Sales, Inc.1986-08-04
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR (K860585)Cardiac Pacemakers, Inc.1986-07-16
PINNACLE MULTI-PROGRAMMABLE PACING SYS (K853771)Cardio-Pace Medical, Inc.1986-07-15
MODIFIED MODELS 8320/8322/8329/8316/8317/8318 (K861719)Medtronic Vascular1986-07-01
Next →

Track DXY automatically

Every clearance here is in the API, with alerts when new ones post.