| WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CELSIUS Catheter (P950005/S067) | Biosense Webster, Inc. | 2017-10-10 |
| CELSIUS DS Catheter, NAVISTAR DS Catheter (P010068/S055) | Biosense Webster, Inc. | 2017-10-10 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S059) | W. L. Gore & Associates, Inc. | 2017-10-10 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S104) | W. L. Gore & Associates, Inc. | 2017-10-10 |
| PROGEL Pleural Air Leak Sealant (PALS), PROGEL Spare Tips accessory, PROGEL 6 and 11 Extended Tips accessory (P010047/S049) | Neomend, Inc. | 2017-10-10 |
| ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM (P150023/S003) | Abbott Vascular, Inc. | 2017-10-10 |
| NaviStar Catheter (P990025/S054) | Biosense Webster, Inc. | 2017-10-10 |
| CELSIUS THERMOCOOL Catheter (P030031/S083) | Biosense Webster, Inc. | 2017-10-10 |
| Therakos Cellex Procedural Kit (P860003/S096) | Therakos Development Limited | 2017-10-06 |
| InterStim Therapy System, Verify Evaluation System (P970004/S257) | Medtronic Neuromodulation | 2017-10-06 |
| Nevro Corp Senza Spinal Cord Stimulation System (P130022/S016) | Nevro Corporation | 2017-10-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S296) | Medtronic, Inc. | 2017-10-06 |
| Master Restore, Itrel, Synergy and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cor (P840001/S379) | Medtronic Neuromodulation | 2017-10-06 |
| AMS 700 Series Product Line / Implantable Penile Prosthesis with and without InhibiZone Treatment (N970012/S138) | Boston Scientific Corp | 2017-10-06 |
| remede® System (P160039) | Respicardia | 2017-10-06 |
| Chilli II Cooled Ablation System (P980003/S081) | Boston Scientific Corp | 2017-10-06 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Ablation Catheter (P150005/S029) | Boston Scientific Corp | 2017-10-06 |
| InterStim THerapy System, Verify Evaluation System (P080025/S152) | Medtronic Neuromodulation | 2017-10-06 |
| SyncroMed Infusion System, Ascenda Intrathecal Catheter Product Code:LKK (P860004/S271) | Medtronic, Inc. | 2017-10-06 |
| Oxford Partial Knee System (P010014/S066) | Biomet Manufacturing Corp | 2017-10-06 |
| Open Pivot Heart Valve (P990046/S051) | Medtronic Ats Medical, Inc. | 2017-10-06 |
| Amploa MRI CRT-D, Quad CRT-D, Brava CRT-D, Quad CRT-D, Claria MRI CRT-D, Quad CRT-D, Compia MRI CRT-D Quad CRT-D, Viva Q (P010031/S602) | Medtronic Cardiac Rhythm Disease Management | 2017-10-05 |
| Oxford Partial Knee System - tibial tray and femoral components (P010014/S067) | Biomet Manufacturing Corp | 2017-10-05 |
| INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI (P150012/S038) | Boston Scientific | 2017-10-05 |
| HiResolution Bionic Ear System (P960058/S123) | Advanced Bionics | 2017-10-05 |
| Azure XT DR/SR Mri SureScan IPG; Azure S DR/SR MRI Sure Scan IPG (P980035/S520) | Medtronic, Inc. | 2017-10-05 |
| Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S051) | Zimmer, Inc. | 2017-10-05 |
| Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD (P980016/S641) | Medtronic Cardiac Rhythm Disease Management | 2017-10-05 |
| Fluency Plus Endovascular Stent Graft (P130029/S007) | Bard Peripheral Vascular, Inc. | 2017-10-05 |
| GORE TIGRIS VASCULAR STENT (P160004/S006) | W. L. Gore & Associates, Inc. | 2017-10-04 |
| St. Jude Medical Infinity DBS System 4CH Lead & 8CH Directional Lead (P140009/S029) | ABBOTT MEDICAL | 2017-10-04 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S080) | Medtronic Vascular | 2017-10-04 |
| AcrySof IQ ReStor Posterior Chamber Intraocular Lenses (P040020/S072) | Alcon Research, Ltd. | 2017-10-04 |
| Integrity Coronary Stent Systems (P030009/S092) | Medtronic, Ireland | 2017-10-04 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S053) | Edwards Lifesciences, LLC | 2017-10-04 |
| Edwards Expandable Introducer Sheath Set (P130009/S082) | Edwards Lifesciences, LLC | 2017-10-04 |
| AcrySf Posterior Chamber Single Piece Intraocular Lenses (P930014/S105) | Alcon Laboratories, Inc. | 2017-10-04 |
| Hancock Valved Conduit (P870078/S038) | Medtronic, Inc. | 2017-10-03 |
| Hancock II and Hancock Ultra II Bioprosthesis (P980043/S063) | Medtronic, Inc. | 2017-10-03 |
| Melody Transcatheter Pulmonary Valve (TPV) (P140017/S008) | Medtronic, Inc. | 2017-10-03 |
| Edwards Commander Delivery System (P140031/S054) | Edwards Lifesciences, LLC | 2017-10-03 |
| VNS Therapy Model 3000 Programmer (P970003/S211) | LivaNova USA, Inc. | 2017-10-03 |
| Hancock Modified Orific Valved Conduit. (P790007/S053) | Medtronic Heart Valves | 2017-10-03 |
| Freestyle Bioprosthesis (P970031/S059) | Medtronic, Inc. | 2017-10-03 |
| VNS THERAPY SYSTEM (P970003/S210) | LivaNova USA, Inc. | 2017-10-03 |
| Arctic Front Cryoablation System (CryoConsole) (P100010/S065) | Medtronic Cryocath, LP | 2017-10-03 |
| Avalus Bioprosthesis Valve (P170006/S001) | Medtronic, Inc. Heart Valve Division | 2017-10-03 |
| Mosaic Bioprosthesis & Mosaic Ultra Bioprosthesis (P990064/S071) | Medtronic, Inc. | 2017-10-03 |
| Freezor CryoAblation System (CryoConsole) (P020045/S083) | Medtronic Cryocath, LP | 2017-10-03 |
| Evolut R Transcatheter Aortic Valve (TAV) (P130021/S042) | Medtronic, Inc. | 2017-10-03 |
| TactiSys Quartz Mounting Bracket, TactiSys Quartz Equipment (P130026/S026) | St Jude Medical | 2017-10-02 |
| Lap-Band Adjustable Gastric Banding System (P000008/S039) | Medtimo, Inc. | 2017-10-02 |
| Revanesse Ultra (Revanesse Versa) (P160042/S001) | Prollenium Medical Technologies, Inc. | 2017-10-02 |
| Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005) | Siemens Medical Solutions USA, Inc. | 2017-09-29 |
| Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S050) | Zimmer, Inc. | 2017-09-29 |
| Misago RX Self-expanding Peripheral Stent (P140002/S008) | Terumo Medical Corporation | 2017-09-29 |
| Model 3501 EMBLEM S-ICD subcutaneous Electrode (P110042/S077) | Boston Scientific Corporation | 2017-09-29 |
| Axium Neurostimulator System (P150004/S008) | ABBOTT MEDICAL | 2017-09-29 |
| Endurant II/IIs Stent Graft System (P100021/S063) | Medtronic Vascular | 2017-09-29 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S056) | Syncardia Systems, LLC | 2017-09-29 |
| FlexAbility Ablation Catheters (Bi & Uni Directional) (P110016/S034) | ABBOTT MEDICAL | 2017-09-29 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD) (P960040/S402) | Boston Scientific | 2017-09-28 |
| MynxGrip Vascular Closure Device (P040044/S077) | Cordis US Corporation | 2017-09-28 |
| Bellafill Dermal Filler (P020012/S015) | Tiger Aesthetics Medical, LLC | 2017-09-28 |
| LCS TOTAL KNEE SYSTEM (P830055/S179) | Depuy, Inc. | 2017-09-28 |
| AngioJet Ultra Thrombectomy System (P980037/S067) | Boston Scientific Corp | 2017-09-28 |
| Sapien 3 Transcatheter Heart Valve (P140031/S052) | Edwards Lifesciences, LLC | 2017-09-28 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE; Implantable Cardiac Resynchronization Therapy Defibrilla (P010012/S461) | Boston Scientific Corp | 2017-09-28 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S015) | Boston Scientific Corp | 2017-09-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S042) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S058) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| GORE TAG Thoracic Endoprosthesis (P040043/S095) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| Mometasone Furoate Container Closure System (P100044/S030) | Intersect Ent. | 2017-09-27 |
| GORE VIABAHN Endoprosthesis (P040037/S103) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| HeartWare HVAD System (P100047/S090) | Medtronic | 2017-09-27 |
| InterStim Therapy System (Bowl Screening) (P080025/S150) | Medtronic Neuromodulation | 2017-09-27 |
| InterStim Therapy System (Urinary Screening) (P970004/S255) | Medtronic Neuromodulation | 2017-09-27 |
| ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS (P110029/S026) | Abbott Laboratories | 2017-09-27 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S147) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| HeartWare Ventricular Assist System (P100047/S109) | Medtronic | 2017-09-27 |
| GORE CADIOFORM Septal Occluder (P050006/S061) | W. L. Gore & Associates, Inc. | 2017-09-27 |
| Freestyle Libre Flash Glucose Monitoring System (P160030) | Abbott Diabetes Care, Inc. | 2017-09-27 |
| OraQuick HCV Rapid Antibody Test (P080027/S030) | OraSure Technologies, Inc. | 2017-09-27 |
| AMS 800 Artificial Urinary Sphincter (P000053/S080) | Boston Scientific Corp | 2017-09-26 |
| AMS 700 and Ambicor Inflatable Penile Prosthesis (N970012/S136) | Boston Scientific Corp | 2017-09-26 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S367) | Medtronic Neuromodulation | 2017-09-26 |
| Fortify, Fortify Assura (P910023/S390) | ABBOTT MEDICAL | 2017-09-26 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S334) | ABBOTT MEDICAL | 2017-09-26 |
| Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP, IntellaNav XP, IntellaNav MiFi XP (P020025/S106) | Boston Scientific | 2017-09-26 |
| Blazer II HTD, Blazer Prime HTD (P920047/S102) | Boston Scientific Corp | 2017-09-26 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S027) | Boston Scientific Corp | 2017-09-26 |
| InterStim Therapy System (P080025/S144) | Medtronic Neuromodulation | 2017-09-26 |
| TECNIS Symfony and Symfony Toric Intraocular Lenses (P980040/S083) | Johnson & Johnson Surgical Vision, Inc. | 2017-09-26 |
| Chill II (P980003/S079) | Boston Scientific Corp | 2017-09-26 |
| InterStim Therapy System (Urinary) (P970004/S249) | Medtronic Neuromodulation | 2017-09-26 |
| SynchroMed Infusion System (P860004/S284) | Medtronic, Inc. | 2017-09-26 |
| Activa Deep Brain Stimulation Therapy System (P960009/S286) | Medtronic, Inc. | 2017-09-26 |
| ICDs: Origen, Inogen, Dynagen, Momentum EL ICD, Autogen, Vigiliant EL ICD, Perciva ICD, Resonate EL ICD, Perciva HF ICD, (P960040/S403) | Boston Scientific | 2017-09-25 |
| CRT-Ds: Origen, Momentum, Inogen, Dynagen, Autogen, Vigilant, Resonate, Punctua, Energen and Incepta (P010012/S462) | Boston Scientific Corp | 2017-09-25 |
| Pacemakers: Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent, Accolade, and Altrua 2 (N970003/S212) | Boston Scientific Corp | 2017-09-25 |