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Boston Scientific Corporation

944 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
S-ICD Battery Anode Laser Edge Weld Process (P110042/S109)Boston Scientific Corporation2018-05-08
Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S106)Boston Scientific Corporation2018-04-25
Emblem S-ICD Electrode Delivery System (model 4712) (P110042/S102)Boston Scientific Corporation2018-04-19
Enroute Transcarotid Stent System (P140026/S009)Boston Scientific Corporation2018-04-18
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S038)Boston Scientific Corporation2018-03-28
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM MRI S-ICD and S-ICD Pulse Generator (P110042/S105)Boston Scientific Corporation2018-03-28
SYNERGY Everolimus-Eluting Platinum Chronium Coronary Stent System (P150003/S032)Boston Scientific Corporation2018-03-23
Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MRI (P110042/S104)Boston Scientific Corporation2018-03-12
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S037)Boston Scientific Corporation2018-02-23
ENROUTE Transcarotid Stent System (P140026/S008)Boston Scientific Corporation2018-02-14
EMBLEM S-ICD; EMBLEM MRI S-ICD (P110042/S103)Boston Scientific Corporation2018-02-08
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S099)Boston Scientific Corporation2018-01-16
Orbera Intragastric Balloon System (P140008/S011)Boston Scientific Corporation2018-01-12
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S100)Boston Scientific Corporation2018-01-12
EMBLEM MRI S-ICD; EMBLEM S-ICD (P110042/S101)Boston Scientific Corporation2018-01-10
Emblem, Emblem MRI S-ICDs (P110042/S098)Boston Scientific Corporation2017-12-19
Innova Self-Expanding Stent System (P140028/S030)Boston Scientific Corporation2017-12-14
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S035)Boston Scientific Corporation2017-12-14
Emblem (P110042/S092)Boston Scientific Corporation2017-12-13
EMBLEM SICD GEN 2, SICD EMBLEM MRI , Subcutaneous Implantable Cardioverter Defibrillator (SICD) (P110042/S097)Boston Scientific Corporation2017-12-06
Emblem S-ICD System Model A209 / Emblem MRI S-ICD System Model A219 (P110042/S096)Boston Scientific Corporation2017-12-01
EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S095)Boston Scientific Corporation2017-11-27
Innova Self-Expanding Stent System (P140028/S029)Boston Scientific Corporation2017-11-09
EMBLEM S-ICD (P110042/S094)Boston Scientific Corporation2017-10-27
ReShape Integrated Dual Balloon System (P140012/S011)Boston Scientific Corporation2017-10-26
EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S093)Boston Scientific Corporation2017-10-16
Model 3501 EMBLEM S-ICD subcutaneous Electrode (P110042/S077)Boston Scientific Corporation2017-09-29
Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire (P150003/S034)Boston Scientific Corporation2017-09-22
Express LD LLiac Premounted Stent System (P090003/S043)Boston Scientific Corporation2017-09-13
Synerg Everolimus Eluting Conronary Stent System (P150003/S033)Boston Scientific Corporation2017-09-13
Torque Wrench (P110042/S088)Boston Scientific Corporation2017-09-11
S-ICD (Subcutaneous-ICD) Telemetry Wand (P110042/S083)Boston Scientific Corporation2017-09-11
ICD; S-ICD, EMBLEM S-ICD MRI (P110042/S091)Boston Scientific Corporation2017-08-30
Innova Self-Expanding Stent System (P140028/S028)Boston Scientific Corporation2017-08-29
Orbera Intragastric Balloon (P140008/S007)Boston Scientific Corporation2017-08-21
Voltage Ceramic Capacitors (P110042/S090)Boston Scientific Corporation2017-08-18
SQ-RX, Emblem, Emblem MRI S-ICD (P110042/S089)Boston Scientific Corporation2017-08-16
Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator (P110042/S087)Boston Scientific Corporation2017-08-08
Subcutaneous ICD Devices EMBLEM (P110042/S086)Boston Scientific Corporation2017-08-07
ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S005)Boston Scientific Corporation2017-07-18
Model 2889 EMBLEM S-ICD Automated Screening Tool, v1.01 (P110042/S067)Boston Scientific Corporation2017-07-06
Wallstent (Venous) Endoprosthesis with unistep plus delivery system (P980033/S049)Boston Scientific Corporation2017-07-03
Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S048)Boston Scientific Corporation2017-06-28
ReShape Integrated Dual Ballon System (P140012/S010)Boston Scientific Corporation2017-06-27
Innova Vascular Self-Expanding Stent System (P140028/S027)Boston Scientific Corporation2017-06-16
SYNERGY Everolimus Eluting Coronary Stent System (P150003/S031)Boston Scientific Corporation2017-06-14
Innova Vascular Self-Expanding Stent System (P140028/S026)Boston Scientific Corporation2017-06-14
Orbera Intragastric Balloon System (P140008/S006)Boston Scientific Corporation2017-06-06
Subcutaneous Implantable Defibrillator (S-ICD) EMBLEM MRI, S-ICD Gen 2. (P110042/S085)Boston Scientific Corporation2017-06-06
Innova Self-Expanding Stent System (P140028/S025)Boston Scientific Corporation2017-05-26
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S030)Boston Scientific Corporation2017-05-26
EMBLEM S-ICD Pulse Generator (PG) & MRI S-ICD Pulse Generator (PG) (S-ICD's) (P110042/S084)Boston Scientific Corporation2017-05-23
Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App (P110042/S080)Boston Scientific Corporation2017-05-19
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S029)Boston Scientific Corporation2017-05-10
ORBERA Intragastric Balloon System (P140008/S005)Boston Scientific Corporation2017-05-01
All Flex 4-Socket Hi-POT/Pulse Test System (P110042/S082)Boston Scientific Corporation2017-04-23
Reshape Integrated Dual Balloon System (P140012/S009)Boston Scientific Corporation2017-04-20
EMBLEM SUBCUTANEOUS ICD's (P110042/S068)Boston Scientific Corporation2017-04-17
EMBLEM™ S-ICD Model A209; EMBLEM™ MRI S-ICD Model A219 (P110042/S081)Boston Scientific Corporation2017-04-13
Enroute Transcarotid Stent System (P140026/S006)Boston Scientific Corporation2017-04-13
Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and Over-the-Wire. (P150003/S028)Boston Scientific Corporation2017-04-11
INNOVA(TM)VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S021)Boston Scientific Corporation2017-04-07
Emblem S-ICD Programmer - Plexus SMT Mfg. Line (P110042/S079)Boston Scientific Corporation2017-03-21
Subcutaneous Implantable Defibrillator (S-ICD) System. (P110042/S078)Boston Scientific Corporation2017-03-06
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S076)Boston Scientific Corporation2017-03-01
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S008)Boston Scientific Corporation2017-02-21
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM EMBLEM (P110042/S070)Boston Scientific Corporation2017-02-16
EMBLEM SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S075)Boston Scientific Corporation2017-02-14
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S024)Boston Scientific Corporation2017-02-13
ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S004)Boston Scientific Corporation2017-01-26
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S074)Boston Scientific Corporation2017-01-19
Emblem and Emblem MRI S-ICDs (P110042/S073)Boston Scientific Corporation2017-01-11
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S006)Boston Scientific Corporation2017-01-06
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S007)Boston Scientific Corporation2017-01-06
BUZZER COMPONENT (P110042/S072)Boston Scientific Corporation2017-01-06
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S071)Boston Scientific Corporation2016-12-19
INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S022)Boston Scientific Corporation2016-12-19
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S027)Boston Scientific Corporation2016-12-16
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S026)Boston Scientific Corporation2016-12-12
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW (P150003/S015)Boston Scientific Corporation2016-12-07
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S025)Boston Scientific Corporation2016-12-07
Innova Vascular Self-Expanding Stent With Delivery System (P140028/S020)Boston Scientific Corporation2016-12-01
EMBLEM™ MRI S-CD Pulse Generator (PG) Model A219, EMBLEM™ S-CD Pulse Generator (PG) Model A209 (P110042/S069)Boston Scientific Corporation2016-11-29
INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S023)Boston Scientific Corporation2016-11-29
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S023)Boston Scientific Corporation2016-11-18
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S024)Boston Scientific Corporation2016-11-18
WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S047)Boston Scientific Corporation2016-11-01
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) (P110042/S066)Boston Scientific Corporation2016-11-01
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S019)Boston Scientific Corporation2016-11-01
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S022)Boston Scientific Corporation2016-10-26
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S005)Boston Scientific Corporation2016-10-25
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (MR) (P150003/S021)Boston Scientific Corporation2016-10-14
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR DEVICE (S-ICD) SYSTEM EMBLEM (P110042/S065)Boston Scientific Corporation2016-10-13
WALLSTENT ENDOPROSTHESIS VENOUS (P980033/S046)Boston Scientific Corporation2016-10-12
EMBLEM AND EMBLEM MRI S-ICD SYSTEM (P110042/S064)Boston Scientific Corporation2016-10-12
EMBLEM; EMBLEM MRI (S-ICD) (P110042/S063)Boston Scientific Corporation2016-09-29
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S020)Boston Scientific Corporation2016-09-29
INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S018)Boston Scientific Corporation2016-09-16
EMBLEM S-ICD SYSTEM & EMBLEM MRI S-ICD SYSTEM (P110042/S062)Boston Scientific Corporation2016-09-13
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S017)Boston Scientific Corporation2016-09-12
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Every clearance here is in the API, with alerts when new ones post.