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Boston Scientific Corp

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

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RecordFirmDate
Vercise Genus™ Deep Brain Stimulation (DBS) Systems (P150031/S077)Boston Scientific Corp2024-09-04
Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S585)Boston Scientific Corp2024-08-28
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S073)Boston Scientific Corp2024-08-06
AngioJet Ultra 5000A Console (P980037/S093)Boston Scientific Corp2024-08-05
Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S075)Boston Scientific Corp2024-07-26
SYNERGY MEGATRON™ Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P950020/S143)Boston Scientific Corp2024-07-26
WaterWriter Alpha Spinal Cord Stimulator (SCS) Systems (P030017/S376)Boston Scientific Corp2024-07-26
MT PAS ACUITY X4 (P010012/S581)Boston Scientific Corp2024-07-22
Latitude™ NXT Patient Management System (ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, AL (N970003/S293)Boston Scientific Corp2024-07-18
Latitude™ NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P010012/S582)Boston Scientific Corp2024-07-18
INTELLAGEN™ Cardiac Ablation System (P920047/S133)Boston Scientific Corp2024-07-17
INTELLAGEN™ Cardiac Ablation System (P150005/S079)Boston Scientific Corp2024-07-17
IntellaNav StablePoint Catheter and Open-Irrigated Catheter (P150005/S085)Boston Scientific Corp2024-07-12
Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S076)Boston Scientific Corp2024-06-27
INTELLANAV STABLEPOINT™ Ablation Catheter (P150005/S084)Boston Scientific Corp2024-06-25
Precision Spional Cord Stimulator (SCS) Systems (P030017/S375)Boston Scientific Corp2024-06-21
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S074)Boston Scientific Corp2024-06-21
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S069)Boston Scientific Corp2024-06-14
Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S217)Boston Scientific Corp2024-06-05
ALTRUA™ 2, ESSENTIO™, PROPONENT™, ACCOLADE™ (N970003/S292)Boston Scientific Corp2024-06-04
AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S204)Boston Scientific Corp2024-05-30
G124 MOMENTUM™ CRT-D, G125 MOMENTUM™ CRT-D, G126 MOMENTUM™ CRT-D, G128 MOMENTUM, G138 MOMENTUM™ X4 CRT-D, G140 INOGEN™ C (P010012/S584)Boston Scientific Corp2024-05-29
AMS 700™ Inflatable Penile Prosthesis without InhibiZone™ (N970012/S203)Boston Scientific Corp2024-05-29
L100 ESSENTIO™ SR, L101 ESSENTIO™ DR, L121 ESSENTIO™ EL DR, L200 PROPONENT™ SR, L201 PROPONENT™ DR, L221 PROPONENT™ EL D (N970003/S294)Boston Scientific Corp2024-05-29
AMS 800™ Artificial Urinary Sphincter with and without InhibiZone™ (P000053/S135)Boston Scientific Corp2024-05-29
AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S092)Boston Scientific Corp2024-05-24
AMS 800 Artificial Urinary Sphincter (with InhibiZone) (P000053/S134)Boston Scientific Corp2024-05-23
AMS 700 Inflatable Penile Prosthesis (with InhibiZone) (N970012/S202)Boston Scientific Corp2024-05-23
ACUITY X4™ Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S583)Boston Scientific Corp2024-05-22
ELUVIA Drug-Eluting Vascular Stent System (P180011/S059)Boston Scientific Corp2024-05-20
Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S068)Boston Scientific Corp2024-05-14
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P010012/S580)Boston Scientific Corp2024-04-30
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S291)Boston Scientific Corp2024-04-30
WaveWriter Alpha SCS System (P030017/S371)Boston Scientific Corp2024-04-29
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System and WATCHMAN FLX Pro Left Atrial Appendage (P130013/S068)Boston Scientific Corp2024-04-24
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S067)Boston Scientific Corp2024-04-18
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S065)Boston Scientific Corp2024-04-16
BLAZER™ OI Catheter Cable, INTELLATIP MIFI™ OI Cable, INTELLANAV™ Ablation Catheter Cable (P150005/S077)Boston Scientific Corp2024-04-05
BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLANAV™ Ablation Cathet (P920047/S131)Boston Scientific Corp2024-04-05
mySCS™ GO Therapy Controller App (P030017/S358)Boston Scientific Corp2024-04-04
Carotid WALLSTENT Monorail Endoprosthesis (P050019/S041)Boston Scientific Corp2024-03-27
Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters (P150005/S083)Boston Scientific Corp2024-03-25
Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S216)Boston Scientific Corp2024-03-15
Epic Vascular Self-Expanding Stent System (P110035/S072)Boston Scientific Corp2024-03-13
Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus™ R32, Vercise Genus™ R16) (P150031/S071)Boston Scientific Corp2024-03-13
Rotablator Rotational Atherectomy System (P900056/S215)Boston Scientific Corp2024-03-13
Wallstent TIPS Endoprosthesis with Unistep Plus™ Delivery System (P930031/S075)Boston Scientific Corp2024-03-13
Precision Spinal Cord Stimulator (SCS) Systems (WaveWriter Alpha™, WaveWriter Alpha™ 16) (P030017/S373)Boston Scientific Corp2024-03-13
AngioJet Rheolythic Thrombectomy Catheter (P980037/S091)Boston Scientific Corp2024-03-13
Metriq Tubing Set and Metriq Footswitch (P150005/S082)Boston Scientific Corp2024-03-12
Carotid Wallstent™ Monorail™ Endoprosthesis (P050019/S040)Boston Scientific Corp2024-03-08
Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System (P150031/S064)Boston Scientific Corp2024-02-29
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S070)Boston Scientific Corp2024-02-26
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S372)Boston Scientific Corp2024-02-26
INTELLANAV STABLEPOINT™ Ablation Catheter & Force Sensing System on the RHYTHMIA HDX™ Mapping System (P150005/S074)Boston Scientific Corp2024-02-26
Wallstent™ TIPS Endoprosthesis with Unistep Plus™ Delivery System (P930031/S074)Boston Scientific Corp2024-02-20
INTELLANAV MIFI™ Open-Irrigated Ablation Catheters (P150005/S081)Boston Scientific Corp2024-02-16
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S066)Boston Scientific Corp2024-02-14
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S064)Boston Scientific Corp2024-02-05
Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S363)Boston Scientific Corp2024-02-05
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S370)Boston Scientific Corp2024-01-25
Infinion™ Pro Leads (P030017/S354)Boston Scientific Corp2024-01-24
ELUVIA™ Drug-Eluting Vascular Stent System (P180011/S055)Boston Scientific Corp2024-01-19
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S066)Boston Scientific Corp2024-01-10
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S369)Boston Scientific Corp2024-01-09
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S069)Boston Scientific Corp2024-01-09
Butylated Hydroxytoluene (BHT) (P010012/S579)Boston Scientific Corp2024-01-03
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S368)Boston Scientific Corp2023-12-29
Essentio SR, Essento DR, Proponent Dr, Proponent El Dr, Accolade Sr, Accolade Dr, Accolade El Dr, Altrua 2 Sr, Altrua 2 (N970003/S290)Boston Scientific Corp2023-12-29
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S067)Boston Scientific Corp2023-12-29
WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S060)Boston Scientific Corp2023-12-23
Blazer Open-Irrigated Ablation Catheter (P150005/S080)Boston Scientific Corp2023-12-12
Chilli Cooled Rf Ablation System (P980003/S097)Boston Scientific Corp2023-12-12
Rotablator Rotational Atherectomy System (P900056/S212)Boston Scientific Corp2023-12-12
WOLVERINE Coronary Cutting Balloon (P950020/S142)Boston Scientific Corp2023-12-12
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S212)Boston Scientific Corp2023-12-12
REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S077)Boston Scientific Corp2023-12-12
ROTAPRO™ Rotational Atherectomy System (P900056/S213)Boston Scientific Corp2023-12-12
Blazer II Cardiac Ablation System and Cable (P920047/S134)Boston Scientific Corp2023-12-12
Express® SD Renal Monorail Premounted Stent System (P060006/S109)Boston Scientific Corp2023-12-12
AMS 700™ Inflatable Penile Prosthesis (IPP (N970012/S201)Boston Scientific Corp2023-12-11
AMS 800™ Artificial Urinary Sphincter (AUS) (P000053/S133)Boston Scientific Corp2023-12-11
Rotablator™and ROTAPRO™ Rotational Atherectomy System (P900056/S214)Boston Scientific Corp2023-12-06
WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S063)Boston Scientific Corp2023-12-04
Vercise Genus DBS System (P150031/S062)Boston Scientific Corp2023-11-30
Fourier-Transform Infrared Spectroscopy (FTIR) (P010012/S578)Boston Scientific Corp2023-11-28
AMS 700 ™ Implantable Penile Prosthesis without lnhibiZone™ (N970012/S200)Boston Scientific Corp2023-11-22
AMS 800 ™ Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S132)Boston Scientific Corp2023-11-22
MOMENTUM™ CRT-D, MOMENTUM, MOMENTUM™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, VIGIL (P010012/S577)Boston Scientific Corp2023-11-21
HeartLogic™ (P010012/S571)Boston Scientific Corp2023-11-15
EPIC™ Self Expanding Stent System (P110035/S071)Boston Scientific Corp2023-11-15
Eluvia Drug-Eluting Vascular Stent System (P180011/S058)Boston Scientific Corp2023-11-15
AMS 700 Inflatable Penile Prosthesis (with and without InhibiZone) (N970012/S197)Boston Scientific Corp2023-11-14
WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S062)Boston Scientific Corp2023-11-09
WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System (P030017/S365)Boston Scientific Corp2023-11-06
WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S059)Boston Scientific Corp2023-10-31
FLEXATOME CUTTING BALLOON (P950020/S141)Boston Scientific Corp2023-10-30
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S063)Boston Scientific Corp2023-10-25
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S367)Boston Scientific Corp2023-10-25
Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) (P010012/S570)Boston Scientific Corp2023-10-19
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Every clearance here is in the API, with alerts when new ones post.