| Comet II Pressure Guidewire (K193279) | Boston Scientific Corporation | 2019-12-23 |
| EXALT Model D Single-Use Duodenoscope, EXALT Controller (K193202) | Boston Scientific Corporation | 2019-12-13 |
| Rhythmia HDxTM Mapping System (K192438) | Boston Scientific Corporation | 2019-11-27 |
| IntellaMap Orion High Resolution Mapping Catheter (K192360) | Boston Scientific Corporation | 2019-10-25 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K192043) | Boston Scientific Corporation | 2019-08-26 |
| Tria Soft Ureteral Stent (K191609) | Boston Scientific Corporation | 2019-08-16 |
| 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) | Boston Scientific Corporation | 2019-08-07 |
| Stonetome Stone Removal Device (K191789) | Boston Scientific Corporation | 2019-07-25 |
| iLab Polaris Multi-Modality Guidance System (K191008) | Boston Scientific Corporation | 2019-07-02 |
| Tria Firm Ureteral Stent (K190603) | Boston Scientific Corporation | 2019-05-24 |
| MAKO 7 (K182975) | Boston Scientific Corporation | 2019-05-21 |
| Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device (K183619) | Boston Scientific Corporation | 2019-04-16 |
| AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System (K181905) | Boston Scientific Corporation | 2019-03-25 |
| MAMBA and MAMBA Flex Microcatheters (K190401) | Boston Scientific Corporation | 2019-03-15 |
| CoreDx™ Pulmonary Mini-Forceps (K183085) | Boston Scientific Corporation | 2019-03-08 |
| Nitinol Thermocouple (TCN) Electrode (K183177) | Boston Scientific Corporation | 2019-03-08 |
| SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller (K183636) | Boston Scientific Corporation | 2019-01-22 |
| AdVance XP Male Sling (K182169) | Boston Scientific Corporation | 2018-11-27 |
| Magic Torque DLVR Guidewire (K182315) | Boston Scientific Corporation | 2018-09-26 |
| Agile Esophageal Stent System (K180144) | Boston Scientific Corporation | 2018-09-21 |
| Seal Single Use Biopsy Valve (K182275) | Boston Scientific Corporation | 2018-09-13 |
| SpyGlass DS and DS II Direct Visualization System (K181439) | Boston Scientific Corporation | 2018-08-23 |
| RHYTHMIA HDx Mapping System (with software Version 2.0) (K173837) | Boston Scientific Corporation | 2018-07-25 |
| iSLEEVE Introducer Set (K180785) | Boston Scientific Corporation | 2018-06-22 |
| Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042) | Boston Scientific Corporation | 2018-05-17 |
| Imager II Urology Torque Catheter (K180530) | Boston Scientific Corporation | 2018-04-10 |
| OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173820) | Boston Scientific Corporation | 2018-01-17 |
| Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath (K172929) | Boston Scientific Corporation | 2018-01-10 |
| Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device (K172565) | Boston Scientific Corporation | 2017-12-20 |
| LumiCoil Platinum Fiducial Marker (K173251) | Boston Scientific Corporation | 2017-12-19 |
| Polyform Synthetic Mesh (K171271) | Boston Scientific Corporation | 2017-12-15 |
| OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) (K173284) | Boston Scientific Corporation | 2017-11-16 |
| WATCHDOG Hemostasis Valve Kit (K172453) | Boston Scientific Corporation | 2017-11-09 |
| Fixed Patient Leads ECG Cable (Model 3153) (K172591) | Boston Scientific Corporation | 2017-11-03 |
| Capio SLIM Suture Capturing Device (K172060) | Boston Scientific Corporation | 2017-11-03 |
| CRE RX Biliary Balloon Dilatation Catheter (K172520) | Boston Scientific Corporation | 2017-10-04 |
| MAMBA and MAMBA FLEX Microcatheters (K171452) | Boston Scientific Corporation | 2017-08-21 |
| Epic Biliary Endoscopic Stent System (K171809) | Boston Scientific Corporation | 2017-08-09 |
| Rubicon 14, 18 and 35 Support Catheters (K171913) | Boston Scientific Corporation | 2017-07-25 |
| Interject Injection Therapy Needle Catheter (K171454) | Boston Scientific Corporation | 2017-07-07 |
| PSA Cable (K170815) | Boston Scientific Corporation | 2017-07-06 |
| ACUITY Pro Lead Delivery System (K171612) | Boston Scientific Corporation | 2017-06-30 |
| CRE Pulmonary Balloon Dilatation Catheter (K170759) | Boston Scientific Corporation | 2017-06-23 |
| Tria Firm Ureteral Stent (K163399) | Boston Scientific Corporation | 2017-06-22 |
| Direxion and Direxion HI-FLO Torqueable Microcatheters (K163701) | Boston Scientific Corporation | 2017-05-16 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248) | Boston Scientific Corporation | 2017-03-27 |
| FFR Link, FFR Signal Processing Module (K170204) | Boston Scientific Corporation | 2017-03-24 |
| Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter (K163314) | Boston Scientific Corporation | 2017-03-23 |
| Fathom-16 Steerable Guidewires (K170636) | Boston Scientific Corporation | 2017-03-22 |
| RHYTHMIA HDx Mapping System (K162793) | Boston Scientific Corporation | 2017-03-10 |
| AXIOS Stent and Electrocautery Enhanced Delivery System (K163272) | Boston Scientific Corporation | 2017-02-18 |
| Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete (K163200) | Boston Scientific Corporation | 2016-12-14 |
| Emerge PTCA Dilatation Catheter (K163174) | Boston Scientific Corporation | 2016-12-14 |
| Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 (K162350) | Boston Scientific Corporation | 2016-11-04 |
| Express SD Biliary Monorail Premounted Stent System (K162404) | Boston Scientific Corporation | 2016-10-12 |
| NC Quantum Apex PTCA Dilatation Catheter (K160823) | Boston Scientific Corporation | 2016-06-23 |
| OptiCross 18, 30 MHz Peripheral Imaging Catheter (K160514) | Boston Scientific Corporation | 2016-06-22 |
| EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector (K161003) | Boston Scientific Corporation | 2016-06-17 |
| WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL (K152842) | Boston Scientific Corporation | 2016-05-19 |
| OptiCross X, 40 MHz Coronary Imaging Catheter (K161125) | Boston Scientific Corporation | 2016-05-19 |
| Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845) | Boston Scientific Corporation | 2016-05-03 |
| Rotatable Snares (K160637) | Boston Scientific Corporation | 2016-03-30 |
| Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) (K160173) | Boston Scientific Corporation | 2016-02-26 |
| OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) (K153617) | Boston Scientific Corporation | 2016-02-25 |
| Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire (K152231) | Boston Scientific Corporation | 2016-02-12 |
| Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire (K151840) | Boston Scientific Corporation | 2015-12-16 |
| AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System (K153088) | Boston Scientific Corporation | 2015-12-11 |
| Stingray LP Catheter (K152401) | Boston Scientific Corporation | 2015-12-04 |
| LithoVue System (K153049) | Boston Scientific Corporation | 2015-11-13 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151315) | Boston Scientific Corporation | 2015-11-10 |
| Impulse Angiographic Catheter, Expo Angiographic Catheter (K152605) | Boston Scientific Corporation | 2015-10-29 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151895) | Boston Scientific Corporation | 2015-10-22 |
| CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (K152693) | Boston Scientific Corporation | 2015-10-21 |
| AXIOS Stent and Delivery System (K152572) | Boston Scientific Corporation | 2015-10-06 |
| Comet Pressure Guidewire (K151610) | Boston Scientific Corporation | 2015-10-06 |
| iLab Polaris Multi-Modality Guidance System (K151613) | Boston Scientific Corporation | 2015-10-06 |
| ZelanteDVT Thrombectomy Set (K151313) | Boston Scientific Corporation | 2015-09-21 |
| Resolution Clip (K151802) | Boston Scientific Corporation | 2015-08-06 |
| CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels (K150235) | Boston Scientific Corporation | 2015-04-22 |
| SpyGlass DS Direct Visualization System (K142922) | Boston Scientific Corporation | 2015-01-16 |
| ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire (K143587) | Boston Scientific Corporation | 2015-01-15 |
| Resolution Clip (K142973) | Boston Scientific Corporation | 2014-12-01 |
| ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM (K141584) | Boston Scientific Corporation | 2014-10-16 |
| IDC INTERLOCKING DETACHABLE COIL (K141378) | Boston Scientific Corporation | 2014-10-08 |
| MUSTANG BALLOON DIALATION CATHETER (K141597) | Boston Scientific Corporation | 2014-08-22 |
| MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER (K141521) | Boston Scientific Corporation | 2014-08-21 |
| NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) (K141236) | Boston Scientific Corporation | 2014-08-07 |
| THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER (K134031) | Boston Scientific Corporation | 2014-07-21 |
| VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA (K140641) | Boston Scientific Corporation | 2014-07-03 |
| EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM (K133110) | Boston Scientific Corporation | 2014-07-02 |
| ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS (K133700) | Boston Scientific Corporation | 2014-05-14 |
| CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER (K140733) | Boston Scientific Corporation | 2014-04-28 |
| INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER (K133933) | Boston Scientific Corporation | 2014-04-02 |
| CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES (K133987) | Boston Scientific Corporation | 2014-01-24 |
| OCCLUDER OCCLUSION BALLOON CATHETER (K133750) | Boston Scientific Corporation | 2014-01-08 |
| EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE (K133312) | Boston Scientific Corporation | 2014-01-03 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K130004) | Boston Scientific Corporation | 2013-12-06 |
| HEARTSTRING III PROXIMAL SEAL SYSTEM (K130382) | Boston Scientific Corporation | 2013-06-05 |
| UROMAX ULTRA BALLOON DILATATION CATHETER (K130804) | Boston Scientific Corporation | 2013-05-22 |
| SHORT PORT BLUNT TIP TROCAR (K130121) | Boston Scientific Corporation | 2013-04-11 |