| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S059) | Edwards Lifesciences, LLC | 2018-02-03 |
| Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue) (P150048/S013) | Edwards Lifesciences, LLC | 2018-02-03 |
| EDWARDS INTUITY ELITE Valve System (P150036/S024) | Edwards Lifesciences, LLC | 2018-02-03 |
| NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva) (P960040/S414) | Boston Scientific | 2018-02-02 |
| NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Origen) / NG4 Family of CRT-Ds (Resonate, Vigilant) (P010012/S473) | Boston Scientific Corp | 2018-02-02 |
| ThermoCool SmartTouch Uni-Directional Navigation Catheter (P040036/S060) | Biosense Webster, Inc. | 2018-02-02 |
| Accent MRI Pacemaker (P140033/S018) | ABBOTT MEDICAL | 2018-02-02 |
| Ventak PRx and Ventak Mini AICDs (P910077/S164) | Boston Scientific | 2018-02-02 |
| Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade) (N970003/S223) | Boston Scientific Corp | 2018-02-02 |
| ThermoCool SmartTouch Bi-Directional Navigation Catheter (P030031/S082) | Biosense Webster, Inc. | 2018-02-02 |
| Essentio MRI, Proponent MRI, Accolade MRI Pacemakers (P150012/S051) | Boston Scientific | 2018-02-02 |
| Ingenio CRT-P Devices (Invive, Intua), Ingenio 2 CRT-P Devices (Valitude, Valitude X4, Visiionist, Visionist X4) (P030005/S171) | Guidant Corp. | 2018-02-02 |
| AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S086) | Boston Scientific Corp | 2018-02-01 |
| Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra (P030054/S347) | ABBOTT MEDICAL | 2018-02-01 |
| Nucleus 24 Cochlear Implant System (P970051/S174) | Cochlear Americas | 2018-02-01 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S088) | Boston Scientific Corp | 2018-02-01 |
| Nucleus Auditory Brainstem Implant System (P000015/S029) | Cochlear Americas | 2018-02-01 |
| Current+, Ellipse, Fortify, Fortify Assura, and Quadra Assura MP (P910023/S402) | ABBOTT MEDICAL | 2018-02-01 |
| Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL (P880086/S294) | ABBOTT MEDICAL | 2018-02-01 |
| Nucleus Hybrid Implant System (P130016/S033) | Cochlear Americas | 2018-02-01 |
| Allure, Allure Quadra, Quadra Allure MP, Anthem, and Frontier II (P030035/S165) | ABBOTT MEDICAL | 2018-02-01 |
| Nucleus Auditory Brainstem Implant System (P000015/S028) | Cochlear Americas | 2018-02-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S034) | Medtronic Vascular | 2018-02-01 |
| Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- (P160032) | Defibtech, LLC | 2018-02-01 |
| Necleus 24 Cochlear Implant System (P970051/S175) | Cochlear Americas | 2018-02-01 |
| Assurity MRI and Endurity MRI (P140033/S024) | ABBOTT MEDICAL | 2018-02-01 |
| Endurant, Endurant II, Endurant LLs talent Occluder (P100021/S069) | Medtronic Vascular | 2018-02-01 |
| OraQuick HCV Rapid Antibody Test (P080027/S032) | OraSure Technologies, Inc. | 2018-02-01 |
| PROGEL Pleural Air Leak Sealant (PALS) (P010047/S053) | Neomend, Inc. | 2018-02-01 |
| Hoya iSert and Clarisert Intraocular Lens (P080004/S021) | Hoya Surgical Optics, Inc. | 2018-02-01 |
| Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD (P980016/S649) | Medtronic Cardiac Rhythm Disease Management | 2018-01-31 |
| Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S306) | Boston Scientific Corp | 2018-01-31 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, and Viva XT CRT-D (P010031/S610) | Medtronic Cardiac Rhythm Disease Management | 2018-01-31 |
| Closer Vascular Sealing System (VSS) (P150022/S003) | Rex Medical, L.P. | 2018-01-31 |
| MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM (P860004/S262) | Medtronic, Inc. | 2018-01-31 |
| EXCOR Blood Pump (P160035/S003) | Berlin Heart, Inc. | 2018-01-31 |
| Restylane Refyne, Restylane Defyne (P140029/S004) | Q-Med AB | 2018-01-31 |
| BRYAN (TM) CERVICAL DISC (P060023/S006) | Companion Spine France Sas | 2018-01-31 |
| PRESTIGE: LP(TM) CERVICAL DISC (P090029/S008) | Medtronic Sofamor Danek USA, Inc. | 2018-01-31 |
| Trifecta Heart Valves (P100029/S029) | ABBOTT MEDICAL | 2018-01-30 |
| EDWARDS INTUITY Elite Valve System (P150036/S019) | Edwards Lifesciences, LLC | 2018-01-30 |
| AMS 700 Implantable/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S143) | Boston Scientific Corp | 2018-01-30 |
| OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) (P940010/S014) | Pinnacle Biologics, Inc. | 2018-01-30 |
| Biocor and Epic Heart Valves (P040021/S034) | ABBOTT MEDICAL | 2018-01-30 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX (P860057/S169) | Edwards Lifesciences, LLC | 2018-01-30 |
| Sientra Silicone Gel Breast Implants (P070004/S009) | Tiger Aesthetics Medical, LLC | 2018-01-30 |
| VenaSeal Closure System (P140018/S008) | Medtronic Vascular, Inc. | 2018-01-30 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S006) | Edwards Lifesciences, LLC | 2018-01-30 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S045) | Mentor Corp. | 2018-01-30 |
| Linx Reflux Management System (P100049/S020) | Torax Medical | 2018-01-29 |
| REPLY & ESPRIT SR & DR Pacemakers (P950029/S117) | MicroPort CRM USA, Inc. | 2018-01-29 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S119) | MicroPort CRM USA, Inc. | 2018-01-29 |
| Therakos Cellex Photopheresis System (P860003/S093) | Therakos Development Limited | 2018-01-28 |
| Therakos Cellex Photopheresis System (P860003/S097) | Therakos Development Limited | 2018-01-26 |
| Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack (P810031/S063) | Johnson & Johnson Surgical Vision, Inc. | 2018-01-26 |
| Obalon Balloon System (P160001/S009) | Medtimo, Inc. | 2018-01-26 |
| Artegraft Collagen Vascular Graft (N16837/S024) | LeMaitre Vascular, Inc. | 2018-01-26 |
| MULTI-LINK 8 Coronary Stent System / SV / LL Coronary Stent System (P020047/S066) | Abbott Vascular | 2018-01-25 |
| XACT Carotid Stent System (P040038/S032) | Abbott Vascular, Inc. | 2018-01-25 |
| Supera Peripheral Stent System (P120020/S017) | Abbott Vascular (Idef Technologies Inc) | 2018-01-25 |
| Exablate 2100/2100 VI System (P110039/S008) | Insightec | 2018-01-25 |
| Cardiac Resynchronization Therapy Defibrillator CRT-Ds (P060027/S092) | MicroPort CRM USA, Inc. | 2018-01-25 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System / SV / LL ; XIENCE Xpedition Everolimus Eluting Coronary Stent Sys (P110019/S095) | Abbott Vascular | 2018-01-25 |
| XIENCE V Everolimus Eluting Coronary Stent System / XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S138) | Abbott Vascular, Inc. | 2018-01-25 |
| Implantable Cardioverter Defibrillator ICDs (P980049/S127) | MicroPort CRM USA, Inc. | 2018-01-25 |
| VNS Therapy System (P970003/S216) | LivaNova USA, Inc. | 2018-01-24 |
| ReVision Optics Raindrop Near Vision Inlay (P150034/S002) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2018-01-24 |
| DuraSeal Exact Spine Sealant System 3mL & 5mL (P080013/S014) | Integra LifeSciences Corporation | 2018-01-24 |
| Maestro Rechargeable System (P130019/S015) | Reshape Lifesciences, Inc. | 2018-01-24 |
| Aptima HBV Quant Assay (P170025) | Hologic, Inc. | 2018-01-23 |
| AcrySof® Single Piece Intraocular Lenses (P930014/S104) | Alcon Laboratories, Inc. | 2018-01-23 |
| AcrySof® IQ ReSTOR® Intraocular Lenses (P040020/S071) | Alcon Research, Ltd. | 2018-01-23 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S042) | Medtimo, Inc. | 2018-01-23 |
| EGFR pharmDx (P030044/S004) | Agilent Technologies, Inc. | 2018-01-22 |
| Maestro Rechargeable System (P130019/S016) | Reshape Lifesciences, Inc. | 2018-01-22 |
| PD L1 IHC 22C3 pharmDx (P150013/S008) | Agilent Technologies, Inc. | 2018-01-22 |
| PD-L1 IHC 28-8 pharmDx (P150025/S008) | Agilent Technologies, Inc. | 2018-01-22 |
| Medtronic MiniMed 670G System (P160017/S029) | Medtronic Minimed, Inc. | 2018-01-19 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S001) | Invivoscribe Technologies, Inc. | 2018-01-19 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Punctua, Energen, Incepta CRT-D (P010012/S475) | Boston Scientific Corp | 2018-01-19 |
| EDWARDS INTUITY Elite Valve System, Aortic Valve and Delivery System (P150036/S023) | Edwards Lifesciences, LLC | 2018-01-19 |
| Medtronic MiniMed Paradigm Real-Time Revel System (P150019/S035) | Medtronic Minimed | 2018-01-19 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S310) | Boston Scientific Corp | 2018-01-19 |
| Medtronic MiniMed 530G System (P120010/S109) | Medtronic, Inc. | 2018-01-19 |
| Medtronic MiniMed 630G System (P150001/S032) | Medtronic Minimed | 2018-01-19 |
| Sientra OPUS Silicone Gel Breast Implants (P070004/S014) | Tiger Aesthetics Medical, LLC | 2018-01-19 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Perciva,Punctua, Energen, Incepta ICD (P960040/S416) | Boston Scientific | 2018-01-19 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S300) | Boston Scientific Corp | 2018-01-19 |
| Medtronic MiniMed iPro2 CGM System with Enlite Sensor (P150029/S014) | Medtronic Minimed | 2018-01-19 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S003) | Roche Diagnostics, Inc. | 2018-01-18 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S041) | Medtimo, Inc. | 2018-01-18 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S013) | Gen-Probe Incorporated | 2018-01-18 |
| Artegraft Collagen Vascular Graft (N16837/S023) | LeMaitre Vascular, Inc. | 2018-01-18 |
| HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM (P100047/S057) | Medtronic | 2018-01-18 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S049) | Medtronic, Inc. | 2018-01-18 |
| Aptima HPV Assay (P100042/S015) | Gen-Probe Incorporated | 2018-01-18 |
| Precision WaveWriter Spinal Cord Stimulator (SCS) System / WaveWriter IPG Test Equipment System (P030017/S309) | Boston Scientific Corp | 2018-01-17 |
| HeartLight Endoscopic Ablation System (P150026/S003) | Cardiofocus, Inc. | 2018-01-17 |
| PHOTOFRIN 630 PDT Laser (P990021/S004) | Pinnacle Biologics, Inc. | 2018-01-17 |
| OPTIGUIDE Fiber Optic Diffuser (DCYL Cylindrical Diffuser Series) (P940010/S012) | Pinnacle Biologics, Inc. | 2018-01-17 |