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ABBOTT MEDICAL

3,576 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S026)ABBOTT MEDICAL2013-06-03
BIOCOR/EPIC VALVE (P040021/S023)ABBOTT MEDICAL2013-06-03
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S027)ABBOTT MEDICAL2013-06-03
REGENT MECHANICAL HEART VALVE, STANDARD MECHANICAL HEART VALVE, MASTER MECHANICAL HEART VALVE (P810002/S085)ABBOTT MEDICAL2013-05-30
IDENTITY, VERITY, INTEGRITY, VOCTORY, XEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S233)ABBOTT MEDICAL2013-05-30
FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S111)ABBOTT MEDICAL2013-05-30
TENDRILL STS MODEL 2088TC LEAD (P960013/S075)ABBOTT MEDICAL2013-05-29
DURATA FAMILY OF HIGH VOLTAGE LEADS (P950022/S086)ABBOTT MEDICAL2013-05-29
EON MINI 2.0 SYSTEM (P010032/S068)ABBOTT MEDICAL2013-05-17
MICRONY (P970013/S056)ABBOTT MEDICAL2013-05-14
ADDVENT, AFFINITY, IDENTITY, VERITY, INTEGRITY, VICTORY, ZEPHYR, ACCENT, TRIOLOGY, SYNCHRONY AND PARAGON (P880086/S232)ABBOTT MEDICAL2013-05-14
FRONTIER, FRONTIER II AND ANTHEM (P030035/S110)ABBOTT MEDICAL2013-05-14
CADENCE, CADET, CONTOUR, CONTOUR 11/MD, ADGSTROM II/MD, PROFILEII/MD, PHOTON, PHOTON MICRO (P910023/S314)ABBOTT MEDICAL2013-05-14
EPIC HF, EPIC + HR, EPIC II HF, EPIC II+ HF, ATLAS HF, ATLAS+HF, ATLAS II +HF, ATLAS, PROMOTE, PROMOTE + (P030054/S245)ABBOTT MEDICAL2013-05-14
GENESIS, GENESISRC AND GENESIS XP NEUROSTIMULATION SYSTEMS (P010032/S061)ABBOTT MEDICAL2013-05-08
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (P060040/S023)ABBOTT MEDICAL2013-05-07
ATLAS/ATLAS+, ATLAS II/ATLAS II+, CURRENT, CURRENT ACCEL, CURRENT+, EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY (P910023/S312)ABBOTT MEDICAL2013-04-23
IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF PACEMAKER DEVICES (P880086/S231)ABBOTT MEDICAL2013-04-23
FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-P DEVICES (P030035/S109)ABBOTT MEDICAL2013-04-23
ATLAS+ HF/ATLAS II HF, ATLAS II+ HF, EPIC+, EPIC II HF, EPIC II+HF, PROMOTE, PROMOTE+, PROMOTE, RF, PROMOTE ACCEL, UNIFY (P030054/S242)ABBOTT MEDICAL2013-04-23
BI-DIRECTIONAL THERAPY COOL PATH DUO IRRIGATED ABLATION CATHETERS (P110016/S006)ABBOTT MEDICAL2013-04-18
EON NEUROSTIMULATION SYSTEM, EON MINI NEUROSTIMULATION SYSTEM, 3788 AND EON NEUROSTIMULATION SYSTEM, 3688 (P010032/S063)ABBOTT MEDICAL2013-04-11
PROMOTE, PROMOTE+. PROMOTE RF, PROMOTE ACCEL, UNIFY, QUICKSITE, QUICKFLEX, (P030054/S244)ABBOTT MEDICAL2013-04-11
GENESIS NEUROSTIMULATION SYSTEMS (P010032/S070)ABBOTT MEDICAL2013-04-10
THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS) (P060040/S025)ABBOTT MEDICAL2013-04-01
EON MINI IMPLANTABLE PULSE GENERATOR (P010032/S066)ABBOTT MEDICAL2013-03-15
CURRENT+,EPIC II/EPIC II+, FORTIFY, FORTIFY ASSURA, ELLIPSE FAMILY OF ICD DEVICES (P910023/S313)ABBOTT MEDICAL2013-02-25
PROMOTE+, UNIFY, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S243)ABBOTT MEDICAL2013-02-25
SJM MASTERS HP VALVED GRAFT (P810002/S080)ABBOTT MEDICAL2013-02-19
QUADRIPOLAR PACING PAS (QUAD PAS) (P030054/S236)ABBOTT MEDICAL2013-02-15
EON MINI LE CHARGER, EON MINI LE CHARGING SYSTEM (P010032/S065)ABBOTT MEDICAL2013-01-16
EON NEUROSTIMULATION SYSTEM (P010032/S059)ABBOTT MEDICAL2013-01-09
MERLIN NET 6.1M (P030054/S237)ABBOTT MEDICAL2012-12-19
AMPLATZER SEPTAL OCCLUDER (P000039/S047)ABBOTT MEDICAL2012-12-19
MERLIN HOME 6.1M (P910023/S307)ABBOTT MEDICAL2012-12-19
CURRENT FAMILY OF ICDS (P910023/S310)ABBOTT MEDICAL2012-12-17
PROMOTE FAMILY OF CRT-DS (P030054/S239)ABBOTT MEDICAL2012-12-17
ACCENT, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS (P880086/S202)ABBOTT MEDICAL2012-12-04
ATLAS II/+, EPIC +/II/II+, CURRENT RF/+/ACCEL, FORTIFY ICDS (P910023/S263)ABBOTT MEDICAL2012-12-04
EON 16-CHANNEL IPG NEUROSTIMULATION SYSTEM, EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S064)ABBOTT MEDICAL2012-12-04
ANTHEM, FRONTIER II CRT-PS (P030035/S082)ABBOTT MEDICAL2012-12-04
ATLAS +HF, EPIC HF/+HF, PROMOTE RF/+/ACCEL, UNIFY CRT-DS (P030054/S188)ABBOTT MEDICAL2012-12-04
SAFIRE BLU DUO ABLATION CATHETERS (P110016/S005)ABBOTT MEDICAL2012-11-29
MICRONY FAMILY OF PACEMAKERS (P970013/S051)ABBOTT MEDICAL2012-11-07
FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-P'S (P030035/S101)ABBOTT MEDICAL2012-11-07
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S223)ABBOTT MEDICAL2012-11-07
CADENCE CURRENT FAMILY OF ICD'S (P910023/S302)ABBOTT MEDICAL2012-11-07
EPIC HF/ ATLAS + HF PROMOTE FAMILY OF CRT-D'S (P030054/S230)ABBOTT MEDICAL2012-11-07
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S078)ABBOTT MEDICAL2012-11-01
EPIC VALVE (P040021/S020)ABBOTT MEDICAL2012-11-01
TRIFECA HEART VALVE (P100029/S008)ABBOTT MEDICAL2012-11-01
ATLAS+HF, ATLAS II, HF, ATLAS II+ HF, EPIC + EPIC HF, EPIC + EPIC II HF, EPIC II + HF, PROMOTE, PROMOTE + PROMOTE RF, PR (P030054/S235)ABBOTT MEDICAL2012-10-31
FRONTIER, FRONTIER II, ANTHEM FAMILY OF CRT-PS (P030035/S105)ABBOTT MEDICAL2012-10-31
ATLAS/ATLAS+, ATLAS II/ATLAS 11+ CURRENT, CURRENT ACCEL, CURRENT+ EPIC/EPIC+, EPIC II/EPIC II+, FORTIFY, FORTFY ASSURA, (P910023/S306)ABBOTT MEDICAL2012-10-31
IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DE PACERS (P880086/S227)ABBOTT MEDICAL2012-10-31
EON NEUROSTIMULATION SYSTEM (P010032/S055)ABBOTT MEDICAL2012-10-25
QUARTET IS4 LEAD MODELS 1458Q (P030054/S232)ABBOTT MEDICAL2012-10-16
DURATA DF-4 LEAD MODELS 7120Q, 7121Q, 7170Q, 7171Q, 7172Q (P950022/S083)ABBOTT MEDICAL2012-10-16
DURATA, DURATA DF4 (P950022/S084)ABBOTT MEDICAL2012-10-10
CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, EPIC/EPIC+, ATLAS/II/+ (P910023/S304)ABBOTT MEDICAL2012-10-10
IDENTITY, INTEGRITY, AFFINITY, VERITY, VICTORY, ZEPHYR, SUSTAIN, ACCENT (P880086/S226)ABBOTT MEDICAL2012-10-10
MICRONY (P970013/S052)ABBOTT MEDICAL2012-10-10
ISOFLEX P, ISOFLEX OPTIM, ISOFLEX S (P960030/S037)ABBOTT MEDICAL2012-10-10
QUICKSITE, QUICKFLEX, QUICKFLEX MICRO, QUARTET, PROMOTE, PROMOTE+, PROMOTE RF, PROMOTE ACCEL, PROMOTE Q,PROMOTE QUADRA (P030054/S233)ABBOTT MEDICAL2012-10-10
ANTHEM, FRONTIER II (P030035/S104)ABBOTT MEDICAL2012-10-10
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S074)ABBOTT MEDICAL2012-10-10
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S024)ABBOTT MEDICAL2012-10-05
ATLAS HF,ATLAS II HF,ATLAS II,HF,EPIC,EPIC HF,EPIC,EPIC II HF,EPIC II HF,PROMOTE,PROMOTE,PROMOTE RF,PROMOTE ACCEL,UNIFY (P030054/S231)ABBOTT MEDICAL2012-09-24
IDENTIFY, VERITY, VICTORY, ZEPHYR, ACCENT FAMILY OF DEVICES (P880086/S225)ABBOTT MEDICAL2012-09-24
ATLAS/ATLAS,ATLAS II/ATLAS II,CURRENT,CURRENT ACCEL,CURRENT,EPIC/EPIC,EPIC II/EPIC II,FORTIFY,FORTIFY ASSURA,ELLIPSE (P910023/S303)ABBOTT MEDICAL2012-09-24
FRONTIER, FRONTIER II, ANTHEM FAMILY OF DEVICES (P030035/S103)ABBOTT MEDICAL2012-09-24
ACCENT FAMILY OF PACEMAKERS (P880086/S222)ABBOTT MEDICAL2012-09-14
ANTHEM FAMILY OF PACEMAKERS (P030035/S100)ABBOTT MEDICAL2012-09-14
EON MINI IPG NEUROSTIMULATION SYSTEM (P010032/S058)ABBOTT MEDICAL2012-09-14
THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR (P110016/S001)ABBOTT MEDICAL2012-09-13
TENDRIL FAMILY OF LEADS (P960013/S068)ABBOTT MEDICAL2012-09-13
DURATA LEADS (P950022/S079)ABBOTT MEDICAL2012-09-13
ACCENT FAMILY OF DEVICES (P880086/S224)ABBOTT MEDICAL2012-09-12
ANTHEM FAMILY OF DEVICES (P030035/S102)ABBOTT MEDICAL2012-09-12
THERAPY COOL PATH DUO ABLATION CATHETER (P110016/S004)ABBOTT MEDICAL2012-09-07
ACCENT FAMILY OF DEVICES (P880086/S221)ABBOTT MEDICAL2012-09-06
ANTHEM FAMILY OF DEVICES (P030035/S099)ABBOTT MEDICAL2012-09-06
SJM ELLIPSE AND FORTIFY ASSURA ICDS (P910023/S298)ABBOTT MEDICAL2012-09-06
SJM QUADRA ASSURA AND UNIFY ASSURA CRTDS (P030054/S227)ABBOTT MEDICAL2012-09-06
PENTA LEAD SERIES (P010032/S062)ABBOTT MEDICAL2012-08-31
CURRENT, FORTIFY, ELLIPSE ASSURA FAMILY OF ICD DEVICES (P910023/S300)ABBOTT MEDICAL2012-08-30
EPIC, ATLAS, PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S228)ABBOTT MEDICAL2012-08-30
ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES (P040021/S022)ABBOTT MEDICAL2012-08-30
EON IMPLANTABLE PULSE GENERATOR (P010032/S057)ABBOTT MEDICAL2012-08-24
FORTIFY VR DF-4 FAMILY OF ICDS (P910023/S299)ABBOTT MEDICAL2012-08-22
EON, EONC AND EON MINI NEUROSTIMULATION SYSTEMS (P010032/S060)ABBOTT MEDICAL2012-08-10
PROMOTE AND UNIFY FAMILIES OF CRT-DS AND LEADS (P030054/S217)ABBOTT MEDICAL2012-08-09
ICD FAMILY OF DEVICES & FORTIFY FAMILY OF DEVICES (P910023/S295)ABBOTT MEDICAL2012-08-09
UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA (P030054/S223)ABBOTT MEDICAL2012-08-09
CURRENT AND FORTIFY FAMILIES OF ICDS (P910023/S290)ABBOTT MEDICAL2012-08-09
TRIFECTA VALVE (P100029/S014)ABBOTT MEDICAL2012-08-08
MERLIN PATIENT CARE SYSTEM ACCESSORIES (P030054/S225)ABBOTT MEDICAL2012-08-08
CHARGING ANTENNA AND PORTABLE CHARGER ANTENNA (P010032/S056)ABBOTT MEDICAL2012-08-01
RAPID PROGRAMMER (P010032/S053)ABBOTT MEDICAL2012-07-31
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S083)ABBOTT MEDICAL2012-07-26
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