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Boston Scientific Corp

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

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RecordFirmDate
Epic Vascular Self-Expanding Stent System (P110035/S050)Boston Scientific Corp2019-06-18
PROMUS Element Plus Everolimus-Eluting Plaatinum Chromium Coronary Stent System (Monorail and Over-the-Wire), PROMUS PRE (P110010/S165)Boston Scientific Corp2019-06-18
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Cardiac Ablation Percutaneous Catheter (P150005/S045)Boston Scientific Corp2019-06-17
Blazer II XP, Blazer Prime HTD, Blazer Prime XP Cardiac Ablation Percutaneous Catheter (P920047/S116)Boston Scientific Corp2019-06-17
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S166)Boston Scientific Corp2019-06-14
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivey System (P130013/S029)Boston Scientific Corp2019-06-13
CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, (P010012/S501)Boston Scientific Corp2019-06-10
Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA II supported (N970003/S238)Boston Scientific Corp2019-06-10
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S020)Boston Scientific Corp2019-06-05
WATCHMAN Left Atrial Appendage Closure Device and Delivery System and WATCHMAN Access System (P130013/S030)Boston Scientific Corp2019-06-04
Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S016)Boston Scientific Corp2019-06-03
AngioJet Ultra Thrombectomy System (P980037/S073)Boston Scientific Corp2019-06-03
Implantable Pulse Generator (IPG) Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision (P030017/S324)Boston Scientific Corp2019-06-03
Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S064)Boston Scientific Corp2019-05-30
Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S178)Boston Scientific Corp2019-05-30
Maestro™ Ablation Connection Box, IntellaNav™ XP and IntellaNav™ MiFi XP (P150005/S043)Boston Scientific Corp2019-05-29
Open Irigation (OI) Ablation Catheter families: Blazer OI, IntellaTip MiFi OI, IntellaNav OI, and IntellaNav MiFi OI Abl (P150005/S046)Boston Scientific Corp2019-05-23
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S234)Boston Scientific Corp2019-05-22
Precision Spinal Cord Stimulator (SCS) Systems -Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S323)Boston Scientific Corp2019-05-14
Acuity X4 Liners (P010012/S503)Boston Scientific Corp2019-05-13
Eluvia Drug-Eluting Vascular Stent System (P180011/S007)Boston Scientific Corp2019-05-09
Epic Vascular Self-Expanding Stent System (P110035/S049)Boston Scientific Corp2019-05-09
AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S157)Boston Scientific Corp2019-05-06
AMS 700 Inflatable Penile Prosthesis, AMS Ambicor Penile Prosthesis (N970012/S158)Boston Scientific Corp2019-05-06
AMS 800 Artifical Urinary Sphinchter (P000053/S101)Boston Scientific Corp2019-05-06
AMS 800 Artificial Urinary Sphincter (P000053/S100)Boston Scientific Corp2019-05-06
Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaTip MiFi Open-Irrigated Abl (P150005/S044)Boston Scientific Corp2019-05-03
Chilli II (P980003/S089)Boston Scientific Corp2019-05-03
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S019)Boston Scientific Corp2019-05-03
Blazer II, Blazer II HTD, Blazer Prime HTD, IntellaNav ST (P920047/S115)Boston Scientific Corp2019-05-03
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S018)Boston Scientific Corp2019-05-02
ELUVIA Drug-Eluting Vascular Stent System (P180011/S004)Boston Scientific Corp2019-05-02
ROTAPRO Rotational Atherectomy System Console (P900056/S176)Boston Scientific Corp2019-05-02
AMS 700 Series Product Line/ Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S162)Boston Scientific Corp2019-04-18
IntellaNav OI and IntellaNav MiFi OI Ablation Catheters (P150005/S042)Boston Scientific Corp2019-04-18
Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S177)Boston Scientific Corp2019-04-17
Wallstent TIPS Endoprosthesis with UNISTEP Plus (P930031/S063)Boston Scientific Corp2019-04-17
IntellaTip MiFi Xp Ablation Catheters, IntellaNsv MiFi XP Ablation Catheters and IntellaNav ST Ablation Catheters (P920047/S114)Boston Scientific Corp2019-04-16
ACUITY X4 Straight 86CM ,95CM, ACUITY X4 Spiral S 86CM, 95CM, ACUITY X4 Spiral L 86CM, L95CM, Accessory Suture Sleeves S (P010012/S500)Boston Scientific Corp2019-04-08
Accessory Wrench Socket Cap Brady/Tachy (N970003/S237)Boston Scientific Corp2019-04-08
Vercise Vercise PC, and Vercise Gevia, Deep Brain Stimulation (DBS) Systems (P150031/S017)Boston Scientific Corp2019-04-05
Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spexctra WaveWriter Spinal Co (P030017/S325)Boston Scientific Corp2019-04-05
AMS Ambicor Inflatable Penile Prosthesis (N970012/S160)Boston Scientific Corp2019-04-03
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S020)Boston Scientific Corp2019-04-02
WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S028)Boston Scientific Corp2019-04-01
AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S150)Boston Scientific Corp2019-04-01
AMS 800 Artificial Urinary Sphincter with and without Inhibizone Treatment (P000053/S102)Boston Scientific Corp2019-03-29
AMS Ambicor Inflatable Penile Prosthesis (N970012/S161)Boston Scientific Corp2019-03-28
AMS 800 Artificial Urinary Sphincter (with and without InhibiZone); AMS 700 Inflatable Penile Prosthesis (with and witho (P000053/S103)Boston Scientific Corp2019-03-28
AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S159)Boston Scientific Corp2019-03-27
Wolverine Coronary Cutting Balloon (P950020/S096)Boston Scientific Corp2019-03-19
Vercise, Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S015)Boston Scientific Corp2019-03-19
Eluvia Drug-Eluting Vascular Stent System (P180011/S005)Boston Scientific Corp2019-03-18
Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S014)Boston Scientific Corp2019-03-14
Cardiac Resynchronization Therapy Defibrillator (P010012/S499)Boston Scientific Corp2019-03-13
Vercise PC Deep and Vercise Geviarn Deep Brain Stimulation (DBS) Systems (P150031/S013)Boston Scientific Corp2019-03-13
WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S027)Boston Scientific Corp2019-03-12
Precision Spectra Spinal Cord Stimulatory (SCS) Sytem; Spectra WaveWriter Spinal Cord Stimulator (SCS) System; Precision (P030017/S322)Boston Scientific Corp2019-03-11
Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S012)Boston Scientific Corp2019-03-07
Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S025)Boston Scientific Corp2019-03-01
Acuity X4 Leads, Acuity Spiral Leads (P010012/S494)Boston Scientific Corp2019-02-28
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult (N970003/S233)Boston Scientific Corp2019-02-22
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM and VIGILIANT (CRT-D Resynchroni (P010012/S492)Boston Scientific Corp2019-02-22
WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S026)Boston Scientific Corp2019-02-20
WOLVERINE Coronary Cutting Balloon (P950020/S093)Boston Scientific Corp2019-02-19
Accolade Pacemakers (N970003/S235)Boston Scientific Corp2019-02-19
MAS 700 Inflatable Penile PRosthesis (IP) with and without InhibiZone (N970012/S155)Boston Scientific Corp2019-02-15
AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S156)Boston Scientific Corp2019-02-15
PROMUS Element Plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-THe-Wire (OTW); Pr (P110010/S162)Boston Scientific Corp2019-02-14
WOLVERINE Coronary Cutting Balloon (P950020/S094)Boston Scientific Corp2019-02-14
REBEL Stent System Monorail (MR) and Over-The-Wire (OTW) (P130030/S059)Boston Scientific Corp2019-02-14
NG4 Devices (P010012/S497)Boston Scientific Corp2019-02-13
Wolverine Coronary Cutting Balloon (P950020/S095)Boston Scientific Corp2019-02-12
ACUITY X4 E24 Molding NOR Optimization (P010012/S496)Boston Scientific Corp2019-02-04
Maestro 4000 Controller (P980003/S087)Boston Scientific Corp2019-01-28
Maestro 4000 Controller (P920047/S110)Boston Scientific Corp2019-01-28
MetriQ Pump (P150005/S039)Boston Scientific Corp2019-01-28
Cardiac Resynchronization Therapy Defibrillators (CRT-D) Origen, Inogen, Dynagen, Autogen and Momentum CRT-D (P010012/S495)Boston Scientific Corp2019-01-23
Vercise PC/Gevia DBS System (P150031/S002)Boston Scientific Corp2019-01-18
Rebel Platinum Chromium Coronary Stent System (P130030/S058)Boston Scientific Corp2019-01-17
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S161)Boston Scientific Corp2019-01-17
AMS Ambicor Inflatable Penile Prosthesis (IPP) (N970012/S151)Boston Scientific Corp2019-01-15
EasyTrak II Lead Family (P010012/S493)Boston Scientific Corp2019-01-10
Rotapro Rotational Atherectomy System (P900056/S174)Boston Scientific Corp2019-01-10
Vercise PC DBS System / Vercise Gevia DBS System (P150031/S001)Boston Scientific Corp2019-01-10
AngioJet Rheolytic Thrombectomy System (P980037/S072)Boston Scientific Corp2019-01-10
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI (P150005/S041)Boston Scientific Corp2019-01-09
IntellaNav ST (P920047/S112)Boston Scientific Corp2019-01-09
Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S061)Boston Scientific Corp2018-12-21
Wolverine Coronary Cutting Balloon (P950020/S092)Boston Scientific Corp2018-12-20
REBEL Platinum Chromium Coronary Stent System (P130030/S057)Boston Scientific Corp2018-12-20
AMS 800 Artificial Urinary Sphincter (P000053/S096)Boston Scientific Corp2018-12-20
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S095)Boston Scientific Corp2018-12-19
Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S062)Boston Scientific Corp2018-12-17
Eluvia Drug-Eluting Vascular Stent System (P180011/S002)Boston Scientific Corp2018-12-14
WATCHMAN Left Atrial Appendage Closure (LAAC) Device and Delivery System (P130013/S023)Boston Scientific Corp2018-12-14
Eluvia Drug-Eluting Vascular Stent System (P180011/S003)Boston Scientific Corp2018-12-11
AMS 800 Urinary Control System (P000053/S098)Boston Scientific Corp2018-12-11
AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses (N970012/S153)Boston Scientific Corp2018-12-11
Watchman Left Atrial Appendage (LLAC) Closure Technology (P130013/S024)Boston Scientific Corp2018-12-11
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Every clearance here is in the API, with alerts when new ones post.