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ABBOTT MEDICAL

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

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RecordFirmDate
EON MINI (IMPLANTABLE PULSE GENERATOR) IPG, PROTEGE IPG, PROTEGE IPG MRI (P010032/S107)ABBOTT MEDICAL2015-12-09
VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES (P880086/S264)ABBOTT MEDICAL2015-12-07
ANTHEM,ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S142)ABBOTT MEDICAL2015-12-07
ANTHEM, ALLURE/RF, ALLURA QUADRA/RF FAMILY OF CRT-P'S (P030035/S140)ABBOTT MEDICAL2015-12-06
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S262)ABBOTT MEDICAL2015-12-06
CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS (P910023/S364)ABBOTT MEDICAL2015-12-06
PROMOTE/+RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+HF, (P030054/S294)ABBOTT MEDICAL2015-12-06
EON, EONC, EON MINI, PROTEGE, PROTEGE MRI INPLANTABLE PULSE GENERATORS (IPGS) (P010032/S106)ABBOTT MEDICAL2015-12-04
BRIO IMPLANTABLE PULSE GENERATORS (IPGS) (P140009/S008)ABBOTT MEDICAL2015-12-04
MITRACLIP CLIP DELIVERY SYSTEM AND MITRACLIP STEERABLE GUIDE CATHETER (P100009/S010)ABBOTT MEDICAL2015-11-18
EON, EONC, EON MINI PROTEGE, PROTEGE MRI IMPLANTABLE PULSE GENERATORS (IPG'S) (P010032/S105)ABBOTT MEDICAL2015-11-06
BRIO SYSTEMS (P140009/S006)ABBOTT MEDICAL2015-11-06
GENESIS/EON/EONC/EON MINI/PROTEGE SYSTEMS (P010032/S104)ABBOTT MEDICAL2015-11-06
BRIO IMPLANTABLE PULSE GENERATORS (IPG'S) (P140009/S007)ABBOTT MEDICAL2015-11-06
EXTERNAL PULSE GENERATOR, 2 PORT HEADER (P010032/S103)ABBOTT MEDICAL2015-11-05
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S045)ABBOTT MEDICAL2015-11-03
GENESIS PROGRAMMER, EON PATIENT PROGRAMMER, PROTEGE PROGRAMMER, PATIENT PROGRAMMER (MRI) (P010032/S098)ABBOTT MEDICAL2015-11-02
PROCLAIM NEUROSTIMULATION SYSTEM (P010032/S096)ABBOTT MEDICAL2015-11-02
BRIO PATIENT PROGRAMMER (P140009/S002)ABBOTT MEDICAL2015-11-02
MITRACLIP CLIP DELIVERY SYSTEM (P100009/S014)ABBOTT MEDICAL2015-10-29
FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO (P110016/S023)ABBOTT MEDICAL2015-10-21
HEARTMATE II LVAS SYSTEM (P060040/S046)ABBOTT MEDICAL2015-10-19
MITRACLIP CLIP DELIVERY SYSTEM (P100009/S013)ABBOTT MEDICAL2015-10-15
TRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE (P010032/S101)ABBOTT MEDICAL2015-10-15
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S044)ABBOTT MEDICAL2015-10-14
PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES (P030054/S293)ABBOTT MEDICAL2015-10-07
CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S363)ABBOTT MEDICAL2015-10-07
QUARTET FAMILY OF CRT LEADS (P030054/S290)ABBOTT MEDICAL2015-10-02
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S091)ABBOTT MEDICAL2015-09-25
TRIFECTA VALVE (P100029/S020)ABBOTT MEDICAL2015-09-22
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S258)ABBOTT MEDICAL2015-09-16
PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+H (P030054/S287)ABBOTT MEDICAL2015-09-16
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS (P030035/S136)ABBOTT MEDICAL2015-09-16
CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS (P910023/S358)ABBOTT MEDICAL2015-09-16
FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL) (P110016/S022)ABBOTT MEDICAL2015-09-14
SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS (P010032/S099)ABBOTT MEDICAL2015-09-10
CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES (P910023/S360)ABBOTT MEDICAL2015-09-10
SPINAL CORD STIMULATION LEADS, DEEP BRAIN STIMULATION LEADS, ADAPTORS, AND EXTENSIONS (P140009/S003)ABBOTT MEDICAL2015-09-10
PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES (P030054/S289)ABBOTT MEDICAL2015-09-10
ANTHEM, ALLURE RF, ALLURE QUADRA, ALLURE QUADRA RF FAMILY OF CRT-P DEVICES (P030035/S137)ABBOTT MEDICAL2015-09-03
ISOFLEX OPTIM FAMILY OF PACING LEADS (P960030/S039)ABBOTT MEDICAL2015-09-03
CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME (P910023/S359)ABBOTT MEDICAL2015-09-03
TENDRIL SDX, TENDRIL ST, OPTISENSE, TENDRIL STS FAMILY OF LV LEADS (P960013/S077)ABBOTT MEDICAL2015-09-03
PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES; MERLIN PROGRAMMER (P030054/S288)ABBOTT MEDICAL2015-09-03
VICTORY, ZEPHYR, ACCENT, ASSURITY, ASSURITY+, ENDURITY, IDENTITY ADX, VERITY ADX FAMILY OF PACEMAKER DEVICES (P880086/S259)ABBOTT MEDICAL2015-09-03
MICRONY PACEMAKER (P970013/S065)ABBOTT MEDICAL2015-09-03
DURATA, OPTISURE FAMILY OF HV LEADS (P950022/S088)ABBOTT MEDICAL2015-09-03
THERAPY COOL FLEX AND FLEXABILITY ABLATION CATHETERS (P110016/S020)ABBOTT MEDICAL2015-09-02
MICRONY FAMILY OF PACEMAKERS (P970013/S064)ABBOTT MEDICAL2015-08-27
AFFINITY/INTEGRITY / VICTORY /ZEPHYR ACCENT FAMILY OF PACEMAKERS (P880086/S255)ABBOTT MEDICAL2015-08-27
ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S355)ABBOTT MEDICAL2015-08-27
FRONTIER / FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S133)ABBOTT MEDICAL2015-08-27
QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S284)ABBOTT MEDICAL2015-08-27
THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S043)ABBOTT MEDICAL2015-08-20
AMPLATZER SEPTAL DEFECT OCCLUDER (P000039/S050)ABBOTT MEDICAL2015-08-14
QUICKSITE, QUICKFLEX, AND QUICKFLEX LEADS (P030054/S150)ABBOTT MEDICAL2015-08-13
TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS (P960013/S061)ABBOTT MEDICAL2015-08-13
PASSIVE PLUS, ISOFLEX S&P, AND ISOFLEX OPTIM LEADS (P960030/S031)ABBOTT MEDICAL2015-08-13
MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER (P100009/S012)ABBOTT MEDICAL2015-07-23
ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS (P910023/S357)ABBOTT MEDICAL2015-07-13
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS (P030054/S286)ABBOTT MEDICAL2015-07-13
AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S257)ABBOTT MEDICAL2015-07-13
FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS (P030035/S135)ABBOTT MEDICAL2015-07-13
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM (P100045/S002)ABBOTT MEDICAL2015-07-10
SAFIRE DUO AND COOL PATH DUO ABLATION CATHETERS (P110016/S014)ABBOTT MEDICAL2015-07-09
FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL) (P110016/S018)ABBOTT MEDICAL2015-07-09
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S092)ABBOTT MEDICAL2015-07-09
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S093)ABBOTT MEDICAL2015-07-06
FLEXABILITY ABLATION CATHETER (P110016/S016)ABBOTT MEDICAL2015-07-02
BRIO NEUROSTIMULATION SYSTEM (P140009)ABBOTT MEDICAL2015-06-12
THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM (P060040/S042)ABBOTT MEDICAL2015-06-04
THORATEC HEARTMATE II LVAS (P060040/S041)ABBOTT MEDICAL2015-06-03
CARDIOMEMS HF SYSTEM (P100045/S005)ABBOTT MEDICAL2015-05-22
THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER (P110016/S017)ABBOTT MEDICAL2015-05-20
ASSURITY, ASSURITY+ AND ENDURITY FAMILY OF PACEMAKER DEVICES (P880086/S256)ABBOTT MEDICAL2015-05-14
ALLURE AND ALLURE QUADRA FAMILY OF CRT-P DEVICES (P030035/S134)ABBOTT MEDICAL2015-05-14
MITRACLIP CLIP DELIVERY SYSTEM, MITRACLIP STEERABLE GUIDE CATHETER (P100009/S011)ABBOTT MEDICAL2015-05-07
PROTEGE MRI NEUROSTIMULATION SYSTEM (P010032/S085)ABBOTT MEDICAL2015-04-22
PROMOTE+, UNIFY, UNIFY QUADRA, UNIFY ASSURA AND QUADRA ASSURA FAMILY OF CRT-D DEVICES (P030054/S285)ABBOTT MEDICAL2015-04-17
CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES (P910023/S356)ABBOTT MEDICAL2015-04-17
REGENT,STANDARD,MASTERS MECHANICAL HEART VALVES (P810002/S096)ABBOTT MEDICAL2015-04-09
THERAPY COOL PATH DUO CATHETER (P110016/S012)ABBOTT MEDICAL2015-04-09
ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S (P030035/S132)ABBOTT MEDICAL2015-04-08
PROMOTE/+/RF/Q, ACCEL/ QUADR;UNIFY ASSURA/ QUADRA, EPIC+/HF/HF+/II HF/II+ HF,ATLAS+HF/II HH/II+ H FAMILY OF CRT-D FAMILY (P030054/S283)ABBOTT MEDICAL2015-04-08
CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+ FAMILY OF ICDS (P910023/S354)ABBOTT MEDICAL2015-04-08
ASSURITY, ASSURITY+, ENDURITY, ACCENT FAMILY OF PACEMAKERS (P880086/S254)ABBOTT MEDICAL2015-04-08
CARDIOMEMS HF SYSTEM (P100045/S004)ABBOTT MEDICAL2015-04-08
THORATEC HEARTMATE II LVAS (P060040/S040)ABBOTT MEDICAL2015-04-01
REGENT MECHANICAL HEART VALVE (P810002/S095)ABBOTT MEDICAL2015-03-26
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) (P060040/S039)ABBOTT MEDICAL2015-03-24
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S094)ABBOTT MEDICAL2015-03-24
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S090)ABBOTT MEDICAL2015-03-04
GENESIS AND EON FAMILY SPINAL CORD STIMULATION (SCS) SYSTEM (P010032/S095)ABBOTT MEDICAL2015-02-27
FLEXABILITY ABLATION CATHETER (P110016/S015)ABBOTT MEDICAL2015-02-26
QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-D'S (P030054/S281)ABBOTT MEDICAL2015-02-25
FRONTIER/FRONTIER II / ANTHEM FAMILY OF CRT-P'S (P030035/S131)ABBOTT MEDICAL2015-02-25
MICRONY FAMILY OF PACEMAKER (P970013/S063)ABBOTT MEDICAL2015-02-25
AFFINITY /INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILY OF PACEMAKERS (P880086/S253)ABBOTT MEDICAL2015-02-25
ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S (P910023/S352)ABBOTT MEDICAL2015-02-25
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S094)ABBOTT MEDICAL2015-02-19
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