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Boston Scientific Corp

3,562 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
WOLVERINE Coronary Cutting Balloon (P950020/S116)Boston Scientific Corp2022-02-25
Chilli II Cooled Catheter, Sterile Cables, Tubing Kit (P980003/S093)Boston Scientific Corp2022-02-25
CRT-D Resynchronization Devices (P010012/S548)Boston Scientific Corp2022-02-24
Pacemaker Devices (N970003/S270)Boston Scientific Corp2022-02-24
IntellaNav™ ST Ablation Catheter, Blazer™ II Temperature Ablation Catheter, Blazer™ II HTD Temperature Ablation Catheter (P920047/S126)Boston Scientific Corp2022-02-22
Blazer™ Open-Irrigated Ablation Catheter, IntellaNav™ Open-Irrigated Ablation Catheter, IntellaNav MiFi™ Open-Irrigated (P150005/S069)Boston Scientific Corp2022-02-22
Alair Bronchial Thermoplasty System (P080032/S019)Boston Scientific Corp2022-02-18
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S200)Boston Scientific Corp2022-02-10
AngioJet Thrombectomy System (P980037/S087)Boston Scientific Corp2022-02-09
Rotablator/ROTAPRO Rotational Atherectomy System (P900056/S196)Boston Scientific Corp2022-01-25
Eluvia Drug-Eluting Vascular Stent System (P180011/S046)Boston Scientific Corp2021-12-23
L100 ESSENTIO™ SR, L101 ESSENTIO™ DR, L121 ESSENTIO™ EL DR, L200 PROPONENT™ SR, L201 PROPONENT™ DR, L221 PROPONENT™ EL D (N970003/S271)Boston Scientific Corp2021-12-23
ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, DYNAGEN (P010012/S549)Boston Scientific Corp2021-12-21
ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR (N970003/S272)Boston Scientific Corp2021-12-21
Eluvia™ Drug-Eluting Vascular Stent System (P180011/S048)Boston Scientific Corp2021-12-15
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S047)Boston Scientific Corp2021-12-14
Precision Spinal Cord Stimulator {SCS) Systems (P030017/S349)Boston Scientific Corp2021-12-14
IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav OI, Blazer OI (P150005/S068)Boston Scientific Corp2021-12-10
Carotid Wallstent™ Monorail Endoprosthesis (P050019/S033)Boston Scientific Corp2021-12-10
WOLVERINE™ Coronary Cutting Balloon® (P950020/S114)Boston Scientific Corp2021-12-06
WOLVERINE™ Coronary Cutting Balloon® (P950020/S115)Boston Scientific Corp2021-12-06
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S267)Boston Scientific Corp2021-11-30
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S543)Boston Scientific Corp2021-11-30
Alair Bronchial Thermoplasty System (P080032/S020)Boston Scientific Corp2021-11-26
Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System (P900056/S195)Boston Scientific Corp2021-11-26
Carotid Wallstent™ Monorail Endoprosthesis (P050019/S032)Boston Scientific Corp2021-11-15
Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems (P150031/S039)Boston Scientific Corp2021-11-15
Vercise Genus™ Deep Brain Stimulation (DBS) System (P150031/S046)Boston Scientific Corp2021-11-10
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System (P030017/S348)Boston Scientific Corp2021-11-10
Wolverine Coronary Cutting Balloon (P950020/S112)Boston Scientific Corp2021-11-02
ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; AUTOGEN CRT-D; MOMENTUM C (P010012/S547)Boston Scientific Corp2021-10-21
ESSENTIO™ SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT™ SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE™ SR; ACCOLADE DR; ACC (N970003/S269)Boston Scientific Corp2021-10-21
Vercise PC, Vercise Gevia and Vercise Genus DBS Systems (P150031/S040)Boston Scientific Corp2021-10-20
Vercise Genus™ Deep Brain Stimulation (DBS) System (P150031/S044)Boston Scientific Corp2021-10-07
Eluvia™ Drug-Eluting Vascular Stent System (P180011/S047)Boston Scientific Corp2021-10-07
Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (P010012/S528)Boston Scientific Corp2021-10-07
Wave Writer Alpha TM Spinal Cord Stimulator (SCS) System (P030017/S347)Boston Scientific Corp2021-10-07
Resonate family of CRT-D's (P010012/S540)Boston Scientific Corp2021-10-07
Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril (P010012/S546)Boston Scientific Corp2021-10-06
Rotablator™and ROTAPRO™ Rotational Atherectomy System, RotaWire™ Guidewire and wireClip™ Torquer, ROTAWIRE™ Drive Guidew (P900056/S194)Boston Scientific Corp2021-10-05
EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI (P010012/S545)Boston Scientific Corp2021-09-24
ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR (N970003/S268)Boston Scientific Corp2021-09-24
CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D, ORIGEN CRT-D, INOGEN CRT-D, DYNA (P010012/S542)Boston Scientific Corp2021-09-24
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S198)Boston Scientific Corp2021-09-22
Wolverine Coronary Cutting Balloon (P950020/S113)Boston Scientific Corp2021-09-22
ICD ORIGEN CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D (P010012/S544)Boston Scientific Corp2021-09-20
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT (N970003/S266)Boston Scientific Corp2021-09-17
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S539)Boston Scientific Corp2021-09-17
Eluvia™ Drug-Eluting Vascular Stent System (P180011/S044)Boston Scientific Corp2021-09-13
Eluvia Drug-Eluting Vascular Stent System (P180011/S045)Boston Scientific Corp2021-09-10
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S046)Boston Scientific Corp2021-09-09
AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S189)Boston Scientific Corp2021-09-08
IntellaNav Open Irrigated Ablation Catheters, IntellaNav MiFi Open-Irrigated Ablation Catheters (P150005/S067)Boston Scientific Corp2021-09-07
IntellaNav ST (P920047/S125)Boston Scientific Corp2021-09-07
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S265)Boston Scientific Corp2021-09-03
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (FLX) (P130013/S045)Boston Scientific Corp2021-08-25
PROMUS Premier and PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S197)Boston Scientific Corp2021-08-16
AngioJet Thrombectomy System (P980037/S086)Boston Scientific Corp2021-08-12
AngioJet Thrombectomy System (P980037/S085)Boston Scientific Corp2021-08-11
Blazer Open Irrigated Ablation Catheter (P150005/S066)Boston Scientific Corp2021-08-06
IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter, a (P920047/S124)Boston Scientific Corp2021-08-05
Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated Abl (P150005/S061)Boston Scientific Corp2021-08-05
Eluvia Drug-Eluting Vascular Stent System (P180011/S043)Boston Scientific Corp2021-08-04
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S541)Boston Scientific Corp2021-07-23
MetriQ Irrigation Tubing Set (P150005/S065)Boston Scientific Corp2021-07-21
IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir (P150005/S064)Boston Scientific Corp2021-07-20
Blazer Open-Irrigated Ablation Catheter (P150005/S063)Boston Scientific Corp2021-07-14
Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon (P030017/S344)Boston Scientific Corp2021-07-12
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S188)Boston Scientific Corp2021-07-08
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment (P000053/S121)Boston Scientific Corp2021-07-08
ROTAPRO Rotational Atherectomy System (P900056/S193)Boston Scientific Corp2021-07-06
Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P110010/S196)Boston Scientific Corp2021-07-02
Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus, Rotalink Burr), ROTAPRO Rotational Atherectomy Syst (P900056/S192)Boston Scientific Corp2021-06-24
Precision Spinal Cord Stimulator Systems (P030017/S346)Boston Scientific Corp2021-06-02
Vercise Deep Brain Stimulation Systems (P150031/S043)Boston Scientific Corp2021-06-02
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S187)Boston Scientific Corp2021-05-27
Promus Premier™ and Promus Elite™ Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S193)Boston Scientific Corp2021-05-27
Alair Bronchial Thermoplasty System (P080032/S018)Boston Scientific Corp2021-05-27
AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S120)Boston Scientific Corp2021-05-27
AMS 700 Inflatable Penile Prosthesis (N970012/S186)Boston Scientific Corp2021-05-26
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S042)Boston Scientific Corp2021-05-21
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S044)Boston Scientific Corp2021-05-17
Wave Writer Alpha Spinal Cord Stimulator (SCS) System (P030017/S345)Boston Scientific Corp2021-05-13
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S042)Boston Scientific Corp2021-05-13
Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S192)Boston Scientific Corp2021-05-12
Eluvia Drug-Eluting Vascular Stent System (P180011/S042)Boston Scientific Corp2021-05-12
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S538)Boston Scientific Corp2021-05-10
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S264)Boston Scientific Corp2021-05-10
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S263)Boston Scientific Corp2021-05-06
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S537)Boston Scientific Corp2021-05-06
ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D (P010012/S536)Boston Scientific Corp2021-04-30
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S262)Boston Scientific Corp2021-04-30
ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads (P010012/S534)Boston Scientific Corp2021-04-28
Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems (P150031/S041)Boston Scientific Corp2021-04-23
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S343)Boston Scientific Corp2021-04-23
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S191)Boston Scientific Corp2021-04-22
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S535)Boston Scientific Corp2021-04-09
Epic Self-Expanding Nitinol Vascular Stent with Delivery System (P110035/S066)Boston Scientific Corp2021-04-07
Pulsar, Pulsar Max, Discovery, Nexus, Intelis, Insignia, Altrua, Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent (N970003/S261)Boston Scientific Corp2021-04-02
Contak CD, Contak Renewal, Livian, Cognis, Energen CRT-D, Punctua CRT-D, Incepta CRT-D, Origen CRT-D, Inogen CRT-D, Dyna (P010012/S533)Boston Scientific Corp2021-04-02
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Every clearance here is in the API, with alerts when new ones post.