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ABBOTT MEDICAL

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

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RecordFirmDate
Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033)ABBOTT MEDICAL2017-01-31
LWS, OSR (P910023/S378)ABBOTT MEDICAL2017-01-31
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS (P030035/S151)ABBOTT MEDICAL2017-01-31
Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA (P030054/S316)ABBOTT MEDICAL2017-01-31
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S276)ABBOTT MEDICAL2017-01-31
QuickFlex u and Quartet leads (P030054/S311)ABBOTT MEDICAL2017-01-13
IsoFlex Optim leads (P960030/S047)ABBOTT MEDICAL2017-01-13
Durata and Optisure leads (P950022/S095)ABBOTT MEDICAL2017-01-13
Tendril SDX, Tendril ST, Tendril STS and Optisense leads (P960013/S085)ABBOTT MEDICAL2017-01-13
Prodigy Leads and Extension Insertion Tool (P010032/S124)ABBOTT MEDICAL2017-01-09
Infinity Lead and Extension Insertion Tool (P140009/S020)ABBOTT MEDICAL2017-01-09
DURATA AND OPTISURE LEADS (HV ACTIVE AND PASSIVE) (P950022/S098)ABBOTT MEDICAL2017-01-08
QUICKFLEX U AND QUARTET LEADS (CRT) (P030054/S315)ABBOTT MEDICAL2017-01-08
ISOFLEX OPTIM LEADS (LV PASSIVE) (P960030/S049)ABBOTT MEDICAL2017-01-08
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (LV ACTIVE) (P960013/S087)ABBOTT MEDICAL2017-01-08
ST JUDE MEDICAL TRIFECTA VALVE (P100029/S023)ABBOTT MEDICAL2016-12-30
CARDIOMEMS HF SYSTEM (P100045/S016)ABBOTT MEDICAL2016-12-22
ELLIPSE (P910023/S377)ABBOTT MEDICAL2016-12-19
MECHANICAL HEART VALVES (P810002/S099)ABBOTT MEDICAL2016-12-15
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S062)ABBOTT MEDICAL2016-12-14
SJM Master Series Mechanical Heart Valve with Silzone Coating, Expanded Polyester Cuff with Silzone Coating, HP Cuff wit (P810002/S098)ABBOTT MEDICAL2016-12-01
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S063)ABBOTT MEDICAL2016-12-01
EON MINI, PRODIGY AND BRIO CHARGING SYSTEMS (P010032/S126)ABBOTT MEDICAL2016-12-01
BRIO NEUROSTIMULATION SYSTEM (P140009/S021)ABBOTT MEDICAL2016-12-01
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S013)ABBOTT MEDICAL2016-11-30
DEEP BRAIN STIMULATION (DBS) EXTERNAL PROGRAMMER APPS (P140009/S015)ABBOTT MEDICAL2016-11-28
SPINAL CORD STIMULATION (SCS) EXTERNAL PROGRAMMER APPS (P010032/S118)ABBOTT MEDICAL2016-11-28
PROCLAIM DORSAL ROOT GANGLION (DRG) NEUROSTIMULATION SYSTEM (P150004/S002)ABBOTT MEDICAL2016-11-28
Durata Family Of High Voltage Leads (P950022/S097)ABBOTT MEDICAL2016-11-20
ALLURE QUADRA, RF, MP (P030035/S150)ABBOTT MEDICAL2016-11-17
CURRENT AND FORTIFY FAMILY OF ICD DEVICES (P910023/S376)ABBOTT MEDICAL2016-11-17
PROMOTE, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA. (P030054/S313)ABBOTT MEDICAL2016-11-17
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S061)ABBOTT MEDICAL2016-11-17
CARDIOMEMS HF SYSTEM (P100045/S012)ABBOTT MEDICAL2016-11-16
IsoFlex Optim Leads (P960030/S048)ABBOTT MEDICAL2016-11-06
QuickFlex and Quartet Leads (P030054/S312)ABBOTT MEDICAL2016-11-06
Durata and Optisure Leads (P950022/S096)ABBOTT MEDICAL2016-11-06
TENDRIL SDX, TENDRIL ST, TENDRIL STS AND OPTISENSE LEADS (P960013/S086)ABBOTT MEDICAL2016-11-06
AMPLATZER PFO OCCLUDER (P120021)ABBOTT MEDICAL2016-10-28
QuickFlex U (P030054/S310)ABBOTT MEDICAL2016-10-26
CARDIOMEMS HF SYSTEM (P100045/S011)ABBOTT MEDICAL2016-10-19
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S115)ABBOTT MEDICAL2016-10-18
SJM BIOCOR AND EPIC VALVES (P040021/S027)ABBOTT MEDICAL2016-10-14
FlexAbility Ablation Catheter (Bi-Directional) (P110016/S036)ABBOTT MEDICAL2016-10-07
THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S058)ABBOTT MEDICAL2016-10-05
EON MINI LE CHARGING SYSTEM AND PRODIGY CHARGER SYSTEM (P010032/S122)ABBOTT MEDICAL2016-10-04
BRIO LE CHARGING SYSTEM (P140009/S019)ABBOTT MEDICAL2016-10-04
INFINITY FAMILY OF DBS IPGS AND DBS EPG (P140009/S010)ABBOTT MEDICAL2016-10-03
PROTEGE,PRODIGY,PROCLAIM ELITE FAMILY OF SCS IPGS AND SCS EPG (P010032/S109)ABBOTT MEDICAL2016-10-03
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S060)ABBOTT MEDICAL2016-09-29
Allure, Allure Quadra, Quadra Allure MP (P030035/S149)ABBOTT MEDICAL2016-09-27
Assurity, Assurity+, Endurity, Endurity Core (P880086/S275)ABBOTT MEDICAL2016-09-27
TENDRIL ST, STS AND OPTISENSE LV LEADS (P960013/S083)ABBOTT MEDICAL2016-09-26
INFINITY NEUROSTIMULATION SYSTEM (P010032/S097)ABBOTT MEDICAL2016-09-19
INFINITY NEUROSTIMULATION SYSTEM (P140009/S001)ABBOTT MEDICAL2016-09-19
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S120)ABBOTT MEDICAL2016-09-15
BRIO NEUROSTIMULATION SYSTEM (P140009/S017)ABBOTT MEDICAL2016-09-15
ELLIPSE FAMILY OF ICDS (P910023/S373)ABBOTT MEDICAL2016-09-08
Therapy Cool Path Duo/Safire Blu Duo Ablation Catheters (P110016/S035)ABBOTT MEDICAL2016-09-08
FORTIFY ASSURA VR, FORTIFY ASSURA DR (P910023/S375)ABBOTT MEDICAL2016-09-06
UNIFY ASSURA, QUADRA ASSURA (P030054/S307)ABBOTT MEDICAL2016-09-06
CARDIOMEMS HF SYSTEM (P100045/S010)ABBOTT MEDICAL2016-08-30
Allure, Allure RF, Allure Quadra, Allure Quadra RF - PM3120, PM3222, PM3140, PM3242 (P030035/S148)ABBOTT MEDICAL2016-08-19
Assurity - PM1240, PM2240, Assurity+ - PM1260, PM2260, Endurity - PM1160, PM2160, Endurity Core - PM1152, PM2152 (P880086/S274)ABBOTT MEDICAL2016-08-19
AXIUM SHEATHS (P150004/S004)ABBOTT MEDICAL2016-08-18
MITRACLIP CLIP DELIVERY SYSTEM (P100009/S018)ABBOTT MEDICAL2016-08-09
AMPLATZER MUSCULAR VSD OCCLUDER (P040040/S029)ABBOTT MEDICAL2016-08-04
AMPLATZER Duct Occluder and AMPLATZER Duct Occluder II (P020024/S046)ABBOTT MEDICAL2016-08-04
AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S056)ABBOTT MEDICAL2016-08-04
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE (P040021/S028)ABBOTT MEDICAL2016-08-01
QUARTET CRT LEADS (P030054/S308)ABBOTT MEDICAL2016-08-01
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT) (P100029/S022)ABBOTT MEDICAL2016-07-26
BIOCOR VALVE, SUPRA VALVE; EPIC VALVE, SUPRA VALVE; TRIFECTA VALVE, TRIFECTA VALVE WITH GLIDE TECHONOLOGY (TRIFECTA GT) (P040021/S029)ABBOTT MEDICAL2016-07-26
CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICD'S (P910023/S372)ABBOTT MEDICAL2016-07-25
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S (P030035/S147)ABBOTT MEDICAL2016-07-25
CARDIOMEMS HF SYSTEM (P100045/S009)ABBOTT MEDICAL2016-07-25
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S273)ABBOTT MEDICAL2016-07-25
PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+ (P030054/S304)ABBOTT MEDICAL2016-07-25
TENDRIL SDX, TENDRIL ST, TENDRIL STS, OPTISENSE (P960013/S082)ABBOTT MEDICAL2016-07-19
DURATA, OPTISURE (P950022/S093)ABBOTT MEDICAL2016-07-19
ISOFLEX OPTIM (P960030/S045)ABBOTT MEDICAL2016-07-19
QUICKFLEX u, QUARTET (P030054/S305)ABBOTT MEDICAL2016-07-19
Current+ ICDS (P910023/S374)ABBOTT MEDICAL2016-07-19
Promote + ICDS (P030054/S306)ABBOTT MEDICAL2016-07-19
MITRACLIP AND MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S020)ABBOTT MEDICAL2016-07-05
MICRONY PACEMAKERS (P970013/S069)ABBOTT MEDICAL2016-06-28
ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERS (P880086/S272)ABBOTT MEDICAL2016-06-28
Quadra Assura/Unify Assura Family of CRt-Ds (P030054/S302)ABBOTT MEDICAL2016-06-28
Ellipse/Fortify Assura Family of ICDs (P910023/S371)ABBOTT MEDICAL2016-06-28
SPINAL CORD STIMULATION SYSTEM (GENESIS, ECO-C)IPG'S ; GENESIS, ECO, PROTEGE, PRODIGY) PATIENT PROGRAMMERS (P010032/S119)ABBOTT MEDICAL2016-06-28
ANTHEM AND FRONTIER II CRT-P'S (P030035/S146)ABBOTT MEDICAL2016-06-28
DEEP BRAIN STIMULATION SYSTEM (LIBRA, LIBRA XP)IPG'S; (LIBRA, BRIO) CLINICIAN PROGRAMMERS (P140009/S016)ABBOTT MEDICAL2016-06-28
COOL PATH DUO ABLATION CATHETER MEDIGUIDE ENABLED, AND SAFIRE DUO ABLATION CATHETER MEDIGUIDE ENABLED, THERAPY COOL PATH (P110016/S033)ABBOTT MEDICAL2016-06-24
MITRACLIP NT CLIP DELIVERY SYSTEM (P100009/S019)ABBOTT MEDICAL2016-06-24
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S052)ABBOTT MEDICAL2016-06-17
FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL), (UNI-DIRECTIONAL) (P110016/S032)ABBOTT MEDICAL2016-06-14
Tripole, Tripole 16C, Tripole 16, Exclaim, Lamitrode 4, Lamitrode 44, Lamitrode S-4, Lamitrode S-8, Lamitrode 88, Lamitr (P010032/S117)ABBOTT MEDICAL2016-05-27
DBS Extensions (P140009/S014)ABBOTT MEDICAL2016-05-27
Axium Neurostimulator System (P150004/S001)ABBOTT MEDICAL2016-05-26
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S056)ABBOTT MEDICAL2016-05-24
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