| ProCol Vascular Bioprosthesis (P020049/S006) | LeMaitre Vascular, Inc. | 2018-09-28 |
| Aptima HPV Assay (P100042/S019) | Gen-Probe Incorporated | 2018-09-28 |
| Adapta Versa Sensia IPG / Attesta IPG / Sphera IPG (P980035/S563) | Medtronic, Inc. | 2018-09-28 |
| Straumann Emdogain (P930021/S018) | The Straumann Company | 2018-09-28 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S017) | Gen-Probe Incorporated | 2018-09-28 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S093) | Medtronic Vascular | 2018-09-27 |
| Endurant, Endurant II, and Endurant IIs Stent Graft Systems (P100021/S074) | Medtronic Vascular | 2018-09-27 |
| Integrity Coro0nary Stent System. (P030009/S095) | Medtronic, Ireland | 2018-09-27 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S034) | Abbott Diabetes Care, Inc. | 2018-09-27 |
| PRESTIGE LP Cervical Disc (P090029/S010) | Medtronic Sofamor Danek USA, Inc. | 2018-09-27 |
| therascreen EGFR RGQ PCR Kit (P120022/S018) | QIAGEN GmbH | 2018-09-27 |
| LCS Total Knee System (P830055/S208) | Depuy, Inc. | 2018-09-27 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S020) | Medtronic Vascular | 2018-09-27 |
| Aptima HCV Quant Dx Assay (P160023/S006) | Hologic, Inc. | 2018-09-26 |
| Sensar/Tecnis 1-Piece IOL, Tecnis Toric IOL, Tecnis Symfony Extended Range of Vision IOL, Tecnis Symfony Toric Extended (P980040/S089) | Johnson & Johnson Surgical Vision, Inc. | 2018-09-26 |
| GORE VIATORR Tips Endoprosthesis (P040027/S066) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| AUGMENT Bone Graft and AUGMENT Injectable (P100006/S006) | Biomimetic Therapeutics, LLC | 2018-09-26 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P040037/S121) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| HEMOBLAST™ Bellows (P170012/S010) | Dilon Technologies, Inc. | 2018-09-26 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit (P130027/S006) | Qiagen, Inc. | 2018-09-26 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) (P130006/S060) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S085) | Medtronic Cryocath, LP | 2018-09-25 |
| Obalon Touch Inflation System (P160001/S007) | Medtimo, Inc. | 2018-09-25 |
| Pulmonx Zephyr Endobronchial Valve (EBV) (P180002/S002) | Pulmonx Corporation | 2018-09-25 |
| AEGEA Vapor System (P160047/S002) | CooperSurgical, Inc. | 2018-09-25 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S082) | Medtronic Cryocath, LP | 2018-09-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S379) | Medtronic, Inc. | 2018-09-25 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S005) | Great Batch Medical | 2018-09-25 |
| Bellafill Dermal Filler (P020012/S018) | Tiger Aesthetics Medical, LLC | 2018-09-25 |
| Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI and Az (P980035/S562) | Medtronic, Inc. | 2018-09-25 |
| Impella RP System (P170011/S008) | Abiomed, Inc. | 2018-09-25 |
| Freestyle Libre 14 Day Flash Glucose Monitoring System (P160030/S025) | Abbott Diabetes Care, Inc. | 2018-09-25 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S040) | Abiomed, Inc. | 2018-09-25 |
| CVX-300 and CVX-300-P Excimer Laser Systems (P910001/S106) | Spectranetics Corp. | 2018-09-25 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S083) | Medtronic Cryocath, LP | 2018-09-24 |
| HV Steroid Eluting Cardiac Leads (P950022/S107) | ABBOTT MEDICAL | 2018-09-24 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant (P100044/S035) | Intersect Ent. | 2018-09-21 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord (P030017/S319) | Boston Scientific Corp | 2018-09-21 |
| LifeVest Wearable Defibrillator (P010030/S104) | Zoll Manufacturing Corporation | 2018-09-21 |
| Activa Deep Brain Stimulation Therapy System (P960009/S323) | Medtronic, Inc. | 2018-09-21 |
| MISAGO RX Self-expanding Peripheral Stent (P140002/S017) | Terumo Medical Corporation | 2018-09-20 |
| Supera Self-Expanding Stent System (P120020/S019) | Abbott Vascular (Idef Technologies Inc) | 2018-09-20 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S092) | Boston Scientific Corp | 2018-09-20 |
| CT LUCIA 202 and CT LUCIA 602 intraocular lenses (P100016/S006) | Carl Zeiss Meditec Production, LLC | 2018-09-20 |
| Misago RX Self-expanding Peripheral Stent (P140002/S013) | Terumo Medical Corporation | 2018-09-20 |
| Exablate Model 4000 System (P150038/S005) | Insightec | 2018-09-20 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S071) | ABBOTT MEDICAL | 2018-09-20 |
| ATTUNE Revision Femoral Sleeves (P830055/S206) | Depuy, Inc. | 2018-09-20 |
| Restylane Refyne, Restylane Defyne (P140029/S013) | Q-Med AB | 2018-09-20 |
| Algovita Spinal Cord Stimulation System (P130028/S022) | Nuvectra Corporation | 2018-09-20 |
| Praxis Extended RAS Panel (P160038/S006) | Illumina, Inc. | 2018-09-20 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S069) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas HPV Test (P100020/S038) | Roche Molecular Systems, Inc. | 2018-09-19 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S148) | Boston Scientific Corp | 2018-09-19 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S055) | Boston Scientific Corp | 2018-09-19 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S033) | Abbott Diabetes Care, Inc. | 2018-09-19 |
| cobas HBV (P150014/S020) | Roche Molecular Systems, Inc. | 2018-09-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S040) | Boston Scientific Corp | 2018-09-19 |
| Express SD Monorail Premounted Stent System (P060006/S093) | Boston Scientific Corp | 2018-09-19 |
| Proclaim DRG IPG (P150004/S025) | ABBOTT MEDICAL | 2018-09-19 |
| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S159) | Boston Scientific Corp | 2018-09-19 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S024) | Roche | 2018-09-19 |
| Rotablator Rotational Atherectomy System (P900056/S173) | Boston Scientific Corp | 2018-09-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-wire) (P150003/S042) | Boston Scientific Corporation | 2018-09-19 |
| 6726 Y Adaptor/Extender Kit (P920015/S217) | Medtronic, Inc. | 2018-09-19 |
| Femoral Introducer Sheath and Hemostasis(FISH) Device (P050043/S008) | Morris Innovative Research, Inc. | 2018-09-19 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S026) | Abbott Diabetes Care, Inc. | 2018-09-19 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S041) | Roche Molecular Systems, Inc. | 2018-09-19 |
| MED-EL Cochlear Implant System (P000025/S105) | Med-El Corp. | 2018-09-19 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S088) | Boston Scientific Corp | 2018-09-19 |
| ProCol Vascular Bioprosthesis (P020049/S007) | LeMaitre Vascular, Inc. | 2018-09-19 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S154) | Boston Scientific Corp | 2018-09-19 |
| cobas HCV (P150015/S020) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas CMV (P160041/S013) | Roche Molecular Systems, Inc. | 2018-09-19 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S114) | Boston Scientific | 2018-09-19 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S070) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas BRAF V600 Mutation Test (P110020/S029) | Roche Molecular Systems, Inc. | 2018-09-19 |
| cobas KRAS Mutation Test (P140023/S017) | Roche Molecular Systems, Inc. | 2018-09-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S111) | Boston Scientific Corp | 2018-09-19 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S013) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| GORE TIGRIS Vascular Stent (P160004/S020) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S059) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011) | Boston Scientific Corp | 2018-09-18 |
| HeartWare Ventricular Assist System (P100047/S127) | Medtronic | 2018-09-18 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S120) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| Eversense Continuous Glucose Monitoring System (P160048/S001) | Senseonics, Incorporated | 2018-09-18 |
| RF Contactr, RF Enhancr II, RF Marinr, RF Conductr, Cardiac Ablation Percutaneous Catheters (P930029/S061) | Medtronic, Inc. | 2018-09-17 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor (P030017/S318) | Boston Scientific Corp | 2018-09-15 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S035) | Inspire Medical Systems | 2018-09-14 |
| WOLVERINE Coronary Cutting Balloon Microsurgical Dilation Device (MR) (P950020/S090) | Boston Scientific Corp | 2018-09-14 |
| DRG Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim (P150004/S024) | ABBOTT MEDICAL | 2018-09-14 |
| Deflux Injectable Gel (P000029/S084) | Palette Life Sciences | 2018-09-14 |
| Solesta Injectable Gel (P100014/S021) | Palette Life Sciences | 2018-09-14 |
| VENTANA PD-L1 (SP263) Assay (P160046/S005) | Ventana Medical Systems, Inc. | 2018-09-13 |
| REBEL Platinum Chromium Coronary Stent System (MR) (P130030/S054) | Boston Scientific Corp | 2018-09-13 |
| VENTANA PD-L1(SP142) Assay (P160002/S007) | Ventana Medical Systems, Inc. | 2018-09-13 |
| Toray Inoue Balloon Catheter (P910054/S006) | Toray Industries (America), Inc. | 2018-09-13 |
| Aptima HPV Assay (P100042/S018) | Gen-Probe Incorporated | 2018-09-13 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S016) | Gen-Probe Incorporated | 2018-09-13 |
| Progel Pleural Air Leak Sealant (P010047/S060) | Neomend, Inc. | 2018-09-13 |