| Chilli II Cooled Ablation Catheter and Cable (P980003/S083) | Boston Scientific Corp | 2017-12-01 |
| Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs) (P960040/S409) | Boston Scientific | 2017-12-01 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S106) | Boston Scientific Corp | 2017-12-01 |
| RADIESSE (+) Lidocaine Dermal Filler (P050052/S099) | Merz North America, Inc. | 2017-11-30 |
| KARL STORZ Photodynamic D-Light C (PDD) System (P050027/S010) | KARL STORZ Endoscopy-America, Inc. | 2017-11-30 |
| R3 Delta Ceramic Acetabular System (P150030/S003) | Smith & Nephew, Inc. | 2017-11-30 |
| FoundationOne CDx (P170019) | Foundation Medicine, Inc. | 2017-11-30 |
| COAPTITE Injectable Implant (P040047/S047) | Merz North America, Inc. | 2017-11-30 |
| RESILIA Aortic Valve (P150048/S008) | Edwards Lifesciences, LLC | 2017-11-30 |
| Sientra Silicone Gel Breast Implants (P070004/S011) | Tiger Aesthetics Medical, LLC | 2017-11-30 |
| KARL STORZ PHOTODYNAMIC DIAGNOSTIC D-LIGHT C (PDD) SYSTEM (P050027/S009) | KARL STORZ Endoscopy-America, Inc. | 2017-11-30 |
| AcrySof IQ ReSTOR Intraocular Lenses (P040020/S074) | Alcon Research, Ltd. | 2017-11-30 |
| RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMs (P110013/S065) | Medtronic Vascular | 2017-11-30 |
| AcrySof Single Piece Intraocular Lenses (P930014/S106) | Alcon Laboratories, Inc. | 2017-11-30 |
| Adapta, Versa, Sensia IPG, Attesta IPG, Sphera IPG (P980035/S524) | Medtronic, Inc. | 2017-11-30 |
| RADIESSE Injectable Implant (P050037/S083) | Merz North America, Inc. | 2017-11-30 |
| PROGEL Pleural Air Leak Sealant (P010047/S050) | Neomend, Inc. | 2017-11-29 |
| FlexAbility Ablation Catheter/ FlexAbility Ablation Catheter, Sensor Enabled (P110016/S051) | ABBOTT MEDICAL | 2017-11-29 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S139) | Boston Scientific Corp | 2017-11-29 |
| Advisa DR IPG, Advisa DR MRI IPG (P980035/S518) | Medtronic, Inc. | 2017-11-29 |
| TRIDYNE Vascular Sealant (P150016/S006) | Neomend, Inc. | 2017-11-29 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S038) | Bard Peripheral Vascular | 2017-11-28 |
| Proclaim DRG Implantable Pulse Generator (P150004/S018) | ABBOTT MEDICAL | 2017-11-28 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S002) | Abbott Diabetes Care, Inc. | 2017-11-28 |
| Active Fixation INGEVITY Leads (P150012/S047) | Boston Scientific | 2017-11-28 |
| Lutonix Drug Coated Balloon (P130024/S020) | Lutonix | 2017-11-28 |
| FLUENCY PLUS ENDOVASCULAR STENT GRAFT (P130029/S006) | Bard Peripheral Vascular, Inc. | 2017-11-28 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template andIntegra Omnigraft Dermal Regenerati (P900033/S066) | Integra Lifesciences Corp. | 2017-11-28 |
| Proclaim Family of Implantable Pulse Generators (P010032/S138) | ABBOTT MEDICAL | 2017-11-28 |
| iPro2 Continuous Glucose Monitoring (CGM) System with Enlite Sensor (P150029/S012) | Medtronic Minimed | 2017-11-28 |
| Infinity Family of Implantable Pulse Generators (P140009/S032) | ABBOTT MEDICAL | 2017-11-28 |
| Paradigm Real-Time Revel System (P150001/S027) | Medtronic Minimed | 2017-11-28 |
| MiniMed 530G System (P120010/S106) | Medtronic, Inc. | 2017-11-28 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008) | Medinol, Ltd. | 2017-11-28 |
| MiniMed 630G System with Enlite Sensor (P150019/S032) | Medtronic Minimed | 2017-11-28 |
| EverFlex Self-Expanding Peripheral Stent System; EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System; (P110023/S024) | Medtronic Vascular, Inc. | 2017-11-27 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S055) | Edwards Lifesciences, LLC | 2017-11-27 |
| Automated Impella Controller (P140003/S025) | Abiomed, Inc. | 2017-11-27 |
| Arctic Front Cardiac CryoAblation System (P100010/S068) | Medtronic Cryocath, LP | 2017-11-27 |
| IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac) (P030045/S004) | Medtronic Vascular, Inc. | 2017-11-27 |
| Protege GPS and Protege RX Carotid Stent System; Protege GPS Self-expanding Peripheral Stent System (Iliac) (P060001/S026) | Medtronic Vascular, Inc. | 2017-11-27 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S007) | Edwards Lifesciences, LLC | 2017-11-27 |
| SAPIEN XT Transcatheter Heart Valve (P130009/S083) | Edwards Lifesciences, LLC | 2017-11-27 |
| EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) (P110042/S095) | Boston Scientific Corporation | 2017-11-27 |
| TactiCath Quartz Set (P130026/S027) | St Jude Medical | 2017-11-27 |
| EDWARDS INTUITY ELITE Valve System (P150036/S020) | Edwards Lifesciences, LLC | 2017-11-27 |
| Freezor Cardiac CryoAblation System (P020045/S084) | Medtronic Cryocath, LP | 2017-11-27 |
| LCS Total Knee System (P830055/S193) | Depuy, Inc. | 2017-11-27 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with the ThermaFix (P860057/S170) | Edwards Lifesciences, LLC | 2017-11-27 |
| Ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S029) | The Cooper Companies | 2017-11-22 |
| HeartWare Ventricular Assist System (P100047/S116) | Medtronic | 2017-11-22 |
| LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055) | Rxsight, Inc. | 2017-11-22 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato (P030017/S295) | Boston Scientific Corp | 2017-11-22 |
| Frequency Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf (P850079/S076) | CooperVision, Inc. | 2017-11-22 |
| Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S063) | CooperVision, Inc. | 2017-11-22 |
| Polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S058) | CooperVision, Inc. | 2017-11-22 |
| Precision Spinal Cord/ Spectra/Novi Spinal Cord Stimulatior (SCS) System, Precision Montage MRI and Precision Montage Sp (P030017/S296) | Boston Scientific Corp | 2017-11-22 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S027) | ABBOTT MEDICAL | 2017-11-21 |
| Radiesse (+) Lidocaine Dermal Filler (P050052/S100) | Merz North America, Inc. | 2017-11-21 |
| QuantiFERON - TB Gold Test and TB Gold Plus Test (P010033/S035) | Qiagen | 2017-11-21 |
| Genesis IPG/Eon IPG/Eon C IPG/Eon Mini IPG/Protege IPG/Protege MRI IPG/Prodigy/Prodigy MRI IPG/Proclaim IPG/Port Plug Ac (P010032/S136) | ABBOTT MEDICAL | 2017-11-21 |
| Blazer Open-Irrigated Ablation Catheter System (P150005/S031) | Boston Scientific Corp | 2017-11-21 |
| Brio IPG/Infinity IPG (P140009/S031) | ABBOTT MEDICAL | 2017-11-21 |
| Radiesse Injectable Implant (P050037/S084) | Merz North America, Inc. | 2017-11-21 |
| PRISMAFLEX TPE 2000 Set (P830063/S010) | Vantive US Healthcare, LLC | 2017-11-21 |
| HiResolution Bionic Ear System (P960058/S126) | Advanced Bionics | 2017-11-21 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S046) | Medtronic, Inc. | 2017-11-21 |
| Avalus Bioprosthesis (P170006/S004) | Medtronic, Inc. | 2017-11-21 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S048) | Edwards Lifesciences, LLC | 2017-11-20 |
| PD-L1 IHC 22C3 pharmDx (P150013/S007) | Agilent Technologies, Inc. | 2017-11-20 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S047) | Edwards Lifesciences, LLC | 2017-11-20 |
| Water for Injection Sterile, USP (P100030/S009) | Baxter Healthcare Corporation | 2017-11-20 |
| MyCareLink Patient Monitor Telemetry Head Printed Circuit Board (P890003/S380) | Medtronic, Inc. | 2017-11-20 |
| HeartWare Ventricular Assist System (P100047/S113) | Medtronic | 2017-11-19 |
| Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement (P990046/S052) | Medtronic Ats Medical, Inc. | 2017-11-18 |
| LifeVest Wearable Defibrillator (P010030/S101) | Zoll Manufacturing Corporation | 2017-11-17 |
| InterStim Therapy System (P080025/S149) | Medtronic Neuromodulation | 2017-11-17 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S289) | Medtronic, Inc. | 2017-11-17 |
| Nucleus N22 Cochlear Implant Systems (P840024/S090) | Cochlear Americas | 2017-11-17 |
| Nucleus Hybrid L24 Implant System (P130016/S028) | Cochlear Americas | 2017-11-17 |
| InterStim Therapy System (P970004/S254) | Medtronic Neuromodulation | 2017-11-17 |
| Nucleus® Cochlear Implant System (P970051/S164) | Cochlear Americas | 2017-11-17 |
| Activa Deep Brain Stimulation Therapy System (P960009/S292) | Medtronic, Inc. | 2017-11-17 |
| Ideal Implant Saline-filled Breast Implant (P120011/S010) | Bimini Health Tech | 2017-11-17 |
| Restore, Itrel and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S374) | Medtronic Neuromodulation | 2017-11-17 |
| SMART-MSP (P010012/S464) | Boston Scientific Corp | 2017-11-17 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) Micro Crown Orbital Atherectomy Device (OAD) (P130005/S020) | Cardiovascular Systems, Inc. | 2017-11-17 |
| SMART-MSP (P960040/S405) | Boston Scientific | 2017-11-17 |
| Restylane / Perlane / Restylane-L / Restylane-Lyft(formerly Perlane-L) Restylane Silk. (P040024/S100) | Q-Med AB | 2017-11-17 |
| Nucleus N22 Cochlear Implant Systems (P890027/S059) | Cochlear Americas | 2017-11-17 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S148) | Boston Scientific Corp | 2017-11-17 |
| SJM Masters Series mechanical heart valve, SJM Regent Valve, SJM Masters Series Aortic Valved Graft with Hemashield Tech (P810002/S105) | ABBOTT MEDICAL | 2017-11-16 |
| InterStim Therapy System, Verify Evalution System (SNS Bowel) (P080025/S155) | Medtronic Neuromodulation | 2017-11-16 |
| GORE VIABAHN Endoprosthesis (P040037/S106) | W. L. Gore & Associates, Inc. | 2017-11-16 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces. Specify and Vectris Spinal Cord Stimula (P840001/S381) | Medtronic Neuromodulation | 2017-11-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S260) | Medtronic Neuromodulation | 2017-11-16 |
| Wolverine Coronary Cutting Balloon (P950020/S087) | Boston Scientific Corp | 2017-11-16 |
| Juvederm Ultra, Juvederm Ultra XC, Juvederm Ultra Plus, Juvederm Ultra XC, Juvederm 30 (Juvederm Forma) (P050047/S061) | Allergan | 2017-11-16 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S008) | Abbott Diabetes Care, Inc. | 2017-11-16 |
| Activa Deep Brain Stimulation Therapy System (P960009/S300) | Medtronic, Inc. | 2017-11-16 |