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Boston Scientific Corporation

944 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S083)Boston Scientific Corporation2024-05-02
EMBLEM S-ICD (P110042/S193)Boston Scientific Corporation2024-04-30
Axonics Sacral Neuromodulation System (P180046/S081)Boston Scientific Corporation2024-04-12
Axonics Sacral Neuromodulation System (P190006/S081)Boston Scientific Corporation2024-04-12
AGENT Paclitaxel-Coated Balloon Catheter (P230035/S001)Boston Scientific Corporation2024-04-11
Axonics Sacral Neuromodulation System (P190006/S082)Boston Scientific Corporation2024-04-10
Axonics Sacral Neuromodulation System (P180046/S082)Boston Scientific Corporation2024-04-10
TheraSphere (P200029/S009)Boston Scientific Corporation2024-04-05
A209 SICD Gen 2, A219 SICD MRI (P110042/S194)Boston Scientific Corporation2024-04-05
Axonics Sacral Neuromodulation System (P180046/S077)Boston Scientific Corporation2024-04-01
Axonics Sacral Neuromodulation System (P190006/S077)Boston Scientific Corporation2024-04-01
ENROUTE Transcarotid Stent System (P140026/S029)Boston Scientific Corporation2024-03-26
Ranger Paclitaxel-Coated Balloon Catheter (P190019/S029)Boston Scientific Corporation2024-03-22
Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S028)Boston Scientific Corporation2024-03-19
Cryo Cable (P220032/S003)Boston Scientific Corporation2024-03-18
Wallstent Venous Endoprosthesis with Unistep Plus™ Delivery System (P980033/S065)Boston Scientific Corporation2024-03-13
Express LD Iliac Premounted Stent System (P090003/S056)Boston Scientific Corporation2024-03-13
Innova Vascular Self-Expanding Stent with Delivery System (P140028/S079)Boston Scientific Corporation2024-03-13
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S027)Boston Scientific Corporation2024-03-07
AGENT Paclitaxel-Coated Balloon Catheter (P230035)Boston Scientific Corporation2024-02-29
Wallstent™ Venous Endoprosthesis with Unistep Plus™ Delivery System (P980033/S064)Boston Scientific Corporation2024-02-20
Axonics Sacral Neuromodulation System (P190006/S076)Boston Scientific Corporation2024-02-08
Axonics Sacral Neuromodulation System (P180046/S076)Boston Scientific Corporation2024-02-08
TheraSphereTM Y-90 Glass Microspheres System (P200029/S008)Boston Scientific Corporation2024-02-07
TheraSphere (P200029/S006)Boston Scientific Corporation2024-02-06
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ XD Everolimus-Eluting Platinum Chromium Co (P150003/S096)Boston Scientific Corporation2024-01-19
Bulkamid Urethral Bulking System (P170023/S016)Boston Scientific Corporation2023-12-18
TheraSphere (P200029/S007)Boston Scientific Corporation2023-12-18
ORBERA Intragastric Balloon (IGB) System, Endoline Punc (P140008/S025)Boston Scientific Corporation2023-12-14
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S189)Boston Scientific Corporation2023-12-13
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S002)Boston Scientific Corporation2023-12-12
Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S025)Boston Scientific Corporation2023-12-12
EMBLEM S-ICD VI Electrode (Lead) (P110042/S192)Boston Scientific Corporation2023-12-08
Axonics Sacral Neuromodulation System (P180046/S075)Boston Scientific Corporation2023-11-28
Axonics Sacral Neuromodulation System (P190006/S075)Boston Scientific Corporation2023-11-28
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S026)Boston Scientific Corporation2023-11-24
SICD Gen 2, SICD MRI (P110042/S191)Boston Scientific Corporation2023-11-21
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S001)Boston Scientific Corporation2023-11-17
Innova™ Vascular Self-Expanding Stent System (P140028/S078)Boston Scientific Corporation2023-11-15
Axonics Sacral Neuromodulation System (P190006/S071)Boston Scientific Corporation2023-10-23
Axonics Sacral Neuromodulation System (P180046/S071)Boston Scientific Corporation2023-10-23
SICD Gen 2, SICD MRI (P110042/S190)Boston Scientific Corporation2023-10-18
SYNERGY™ SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom (P150003/S098)Boston Scientific Corporation2023-10-17
ENROUTE® Transcarotid Stent System (P140026/S028)Boston Scientific Corporation2023-10-16
Axonics Sacral Neuromodulation System (P180046/S074)Boston Scientific Corporation2023-10-11
Axonics Sacral Neuromodulation System (P190006/S074)Boston Scientific Corporation2023-10-11
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S023)Boston Scientific Corporation2023-10-05
Axonics Sacral Neuromodulation System (P190006/S073)Boston Scientific Corporation2023-09-26
Axonics Sacral Neuromodulation System (P180046/S073)Boston Scientific Corporation2023-09-26
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S024)Boston Scientific Corporation2023-09-22
Axonics Sacral Neuromodulation System (P190006/S072)Boston Scientific Corporation2023-08-25
Axonics Sacral Neuromodulation System (P180046/S072)Boston Scientific Corporation2023-08-25
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S097)Boston Scientific Corporation2023-08-17
POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032)Boston Scientific Corporation2023-08-08
VENOUS WALLSTENT™ Self-Expanding Stent (P980033/S063)Boston Scientific Corporation2023-08-04
Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S022)Boston Scientific Corporation2023-07-27
TheraSphere (P200029/S005)Boston Scientific Corporation2023-07-26
EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD (P110042/S188)Boston Scientific Corporation2023-07-21
ENROUTE Transcarotid Stent System (P140026/S027)Boston Scientific Corporation2023-07-20
S-ICD GEN 2 A209, S-ICD EMBLEM MRI A219 (P110042/S187)Boston Scientific Corporation2023-07-20
Bulkamid Urethral Bulking System (P170023/S015)Boston Scientific Corporation2023-07-12
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S186)Boston Scientific Corporation2023-07-07
EMBLEM™ S-ICD, (P110042/S185)Boston Scientific Corporation2023-07-06
Axonics Sacral Neuromodulation System (P180046/S069)Boston Scientific Corporation2023-06-21
Axonics Sacral Neuromodulation System (P190006/S069)Boston Scientific Corporation2023-06-21
ENROUTE® Transcarotid Stent System (P140026/S024)Boston Scientific Corporation2023-06-16
EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator (P110042/S181)Boston Scientific Corporation2023-06-15
WALLSTENT™ Venous Endoprosthesis with Unistep Plus™ Delivery System (P980033/S062)Boston Scientific Corporation2023-06-14
Axonics Sacral Neuromodulation System (P180046/S063)Boston Scientific Corporation2023-06-13
Axonics Sacral Neuromodulation System (P190006/S063)Boston Scientific Corporation2023-06-13
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY™ SHIELD Everolimus-Eluting Plat (P150003/S093)Boston Scientific Corporation2023-06-12
eCoin implanted tibial stimulator (P200036/S006)Boston Scientific Corporation2023-06-12
Axonics Sacral Neuromodulation System (P190006/S066)Boston Scientific Corporation2023-06-02
Axonics Sacral Neuromodulation System (P180046/S066)Boston Scientific Corporation2023-06-02
Axonics Sacral Neuromodulation System (P180046/S068)Boston Scientific Corporation2023-05-16
Axonics Sacral Neuromodulation System (P190006/S068)Boston Scientific Corporation2023-05-16
EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Anneal Parameters (P110042/S182)Boston Scientific Corporation2023-05-12
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S183)Boston Scientific Corporation2023-05-11
Express LD Iliac Premounted Stent System (P090003/S054)Boston Scientific Corporation2023-05-08
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY™ MEGATRON Everolimus-Eluting Platinum Chromi (P150003/S095)Boston Scientific Corporation2023-05-05
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P110042/S184)Boston Scientific Corporation2023-05-01
EMBLEM S-ICD (P110042/S178)Boston Scientific Corporation2023-04-21
Bulkamid Urethral Bulking System (P170023/S014)Boston Scientific Corporation2023-04-19
Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S020)Boston Scientific Corporation2023-04-18
Synergy II Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Synergy Megatron Everolimus-Eluting Platinum C (P150003/S094)Boston Scientific Corporation2023-04-10
Ranger Paclitaxel-Coated PTA Balloon Catheter OTW, Ranger Paclitaxel-Coated PTA Balloon Catheter SL (P190019/S019)Boston Scientific Corporation2023-04-10
Axonics Sacral Neuromodulation System (P190006/S067)Boston Scientific Corporation2023-04-04
Axonics Sacral Neuromodulation System (P180046/S067)Boston Scientific Corporation2023-04-04
RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S011)Boston Scientific Corporation2023-03-24
Innova Self-Expanding Stent System (P140028/S077)Boston Scientific Corporation2023-03-21
SYNERGY™ and SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S091)Boston Scientific Corporation2023-03-15
Telemetry Wand (P110042/S179)Boston Scientific Corporation2023-03-14
eCoin implanted tibial stimulator (P200036/S005)Boston Scientific Corporation2023-03-13
SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S092)Boston Scientific Corporation2023-03-10
Express LD Iliac Premounted Stent System (P090003/S055)Boston Scientific Corporation2023-03-08
Axonics Sacral Neuromodulation System (P190006/S065)Boston Scientific Corporation2023-03-02
Axonics Sacral Neuromodulation System (P180046/S065)Boston Scientific Corporation2023-03-02
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S090)Boston Scientific Corporation2023-03-02
Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019/S018)Boston Scientific Corporation2023-03-02
EMBLEM S-ICD, EMBLEM MRI S-ICD, (P110042/S180)Boston Scientific Corporation2023-02-21
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Every clearance here is in the API, with alerts when new ones post.