| Freestyle Libre Flash Glucose Monitoring System (P160030/S008) | Abbott Diabetes Care, Inc. | 2017-12-29 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S017) | Abbott Diabetes Care, Inc. | 2017-12-29 |
| Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II (P160019/S004) | Roche Diagnostics, Inc. | 2017-12-29 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S047) | W. L. Gore & Associates, Inc. | 2017-12-28 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S006) | Abbott Diabetes Care, Inc. | 2017-12-28 |
| SUPERION INDIRECT DECOMPRESSION SYSTEM (P140004/S006) | Boston Scientific Neuromodulation | 2017-12-28 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Comfilcon A Soft (Hydrophilic) Extended Wear Contace Lenses (P080011/S065) | CooperVision, Inc. | 2017-12-28 |
| EUFLEXXA (1% Sodium Hyaluronate) (P010029/S025) | Ferring Pharmaceuticals, Inc. | 2017-12-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S108) | W. L. Gore & Associates, Inc. | 2017-12-28 |
| VNS Therapy System (P970003/S214) | LivaNova USA, Inc. | 2017-12-27 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022) | ZOLL Medical Corporation | 2017-12-27 |
| Amplatzer Septal Occluder (P000039/S061) | ABBOTT MEDICAL | 2017-12-26 |
| Biocor Heart Valve (P040021/S033) | ABBOTT MEDICAL | 2017-12-26 |
| Cobas 4800 Wash and Lysis Reagents (P100020/S028) | Roche Molecular Systems, Inc. | 2017-12-26 |
| Therapy (Flexability) Ablation Catheters (P110016/S052) | ABBOTT MEDICAL | 2017-12-26 |
| Trifecta Heart Valve (P100029/S028) | ABBOTT MEDICAL | 2017-12-26 |
| Spectra WaveWriter Spinal Cord Stimulator System (P030017/S302) | Boston Scientific Corp | 2017-12-22 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S005) | Abbott Diabetes Care, Inc. | 2017-12-22 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S015) | Abbott Diabetes Care, Inc. | 2017-12-22 |
| Implantable System for Remodulin (P140032) | Medtronic, Inc. | 2017-12-22 |
| CVX-300 Excimer Laser System (P910001/S102) | Spectranetics Corp. | 2017-12-22 |
| LCS Total Knee System Trumatch Personalized Solutions Surgical Technique with Attune Knee System Intuition Solo Instrume (P830055/S192) | Depuy, Inc. | 2017-12-22 |
| WaveLight EX500 Laser System (P020050/S027) | Alcon Laboratories, Inc. | 2017-12-21 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S107) | Alcon Laboratories, Inc. | 2017-12-21 |
| MiniMed 670G System (P160017/S026) | Medtronic Minimed, Inc. | 2017-12-21 |
| PreveLeak Surgical Sealant (P100030/S008) | Baxter Healthcare Corporation | 2017-12-21 |
| AcrySof IQ ReSTOR Posterior Chambers Intraocular Lenses (P040020/S075) | Alcon Research, Ltd. | 2017-12-21 |
| Evera MRI DF-1 ICD / Evera S DR /VR ICD / Evera XT VR ICD / Protecta ICD / Protecta XT ICD /Visia AF MRI DF 1 ICD / Visi (P980016/S654) | Medtronic Cardiac Rhythm Disease Management | 2017-12-21 |
| MiniMed Paradigm Real-Time Revel System (P150019/S033) | Medtronic Minimed | 2017-12-21 |
| Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S014) | Boston Scientific Corp | 2017-12-21 |
| SynchroMed Infusion System (P860004/S275) | Medtronic, Inc. | 2017-12-21 |
| Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110022/S022) | Roche Diagnostics Corp. | 2017-12-21 |
| FreeStyle Libre Flash Glucose Monitoring System (P160030/S004) | Abbott Diabetes Care, Inc. | 2017-12-21 |
| remede® System (P160039/S001) | Respicardia | 2017-12-21 |
| WaveLight EX500 Laser System (P030008/S023) | Alcon Laboratories, Inc. | 2017-12-21 |
| t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (P140015/S021) | Tandem Diabetes Care, Inc. | 2017-12-21 |
| Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test (P890064/S035) | Qiagen Gaithersburg, Inc. | 2017-12-21 |
| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S013) | Medtronic Minimed | 2017-12-21 |
| MiniMed 630G System (P150001/S030) | Medtronic Minimed | 2017-12-21 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S297) | Boston Scientific Corp | 2017-12-21 |
| Amplia MRI CRT-D / Brava CRT-D / Claria & Compia MRI CRT-D / Protecta CR-d / Protecta XT CRT-D / Viva S CRT-D (P010031/S614) | Medtronic Cardiac Rhythm Disease Management | 2017-12-21 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S014) | Abbott Diabetes Care, Inc. | 2017-12-21 |
| LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger (P160012) | Physio-Control, Inc. | 2017-12-21 |
| MiniMed 530G System (P120010/S107) | Medtronic, Inc. | 2017-12-21 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S003) | Abbott Diabetes Care, Inc. | 2017-12-20 |
| Endurant/Endurant II/Endurant IIs Stent Graft Systems, Talent Occluder with Occluder Delivery System (P100021/S068) | Medtronic Vascular | 2017-12-20 |
| Elecsys HBeAg (P130015/S014) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Cobas TaqMan HBV Test v2.0 (P050028/S060) | Roche Molecular Systems, Inc. | 2017-12-20 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S013) | Abbott Diabetes Care, Inc. | 2017-12-20 |
| Birmingham Hip Resurfacing System (P040033/S032) | Smith & Nephew, Inc. | 2017-12-20 |
| Resolute Integrity Coronary Stent Systems (P110013/S085) | Medtronic Vascular | 2017-12-20 |
| Elecsys total PSA (P990056/S029) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys HBsAg II (P160019/S006) | Roche Diagnostics, Inc. | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090009/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Cobas TaqMan HCV Test, v2.0 (P060030/S061) | Roche Molecular Systems, Inc. | 2017-12-20 |
| MiniMed 630G Insulin Pump (P150001/S028) | Medtronic Minimed | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090008/S019) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBs (P010054/S032) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys HBsAg Immunoassay (P990012/S029) | Roche Diagnostics Corp. | 2017-12-20 |
| REFLECTION Ceramic Acetabular Hip System (P030022/S045) | Smith & Nephew, Inc. | 2017-12-20 |
| Elecsys Anti-HBc II (P100032/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys free PSA (P000027/S028) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110022/S024) | Roche Diagnostics Corp. | 2017-12-20 |
| TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip (P150016/S007) | Neomend, Inc. | 2017-12-20 |
| R3 DELTA Ceramic Hip System (P150030/S004) | Smith & Nephew, Inc. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110025/S021) | Roche Diagnostics Corp. | 2017-12-20 |
| Integrity Coronary Stent System (P030009/S093) | Medtronic, Ireland | 2017-12-20 |
| Elecsys Anti-HCV Immunoassay (P090007/S017) | Roche Diagnostics Corp. | 2017-12-20 |
| Elecsys Anti-HBc II (P100031/S021) | Roche Diagnostics Corp. | 2017-12-20 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S033) | Roche Molecular Systems, Inc. | 2017-12-20 |
| Elecsys Anti-HBc IgM (P110031/S020) | Roche Diagnostics Corp. | 2017-12-20 |
| LifePulse High Frequency Ventilator (P850064/S035) | Bunnell, Inc. | 2017-12-20 |
| Valiant Thoracic Stent Graft System (P100040/S033) | Medtronic Vascular | 2017-12-20 |
| Elecsys Anti-HCV II (P140021/S012) | Roche Diagnostics Operations, Inc. | 2017-12-20 |
| Linox Smart, Protego, and Plexa (P980023/S083) | Biotronik, Inc. | 2017-12-19 |
| Siello, Solia, Setrox, and Safio (P950037/S184) | Biotronik, Inc. | 2017-12-19 |
| Emblem, Emblem MRI S-ICDs (P110042/S098) | Boston Scientific Corporation | 2017-12-19 |
| Intua, Invive, Valitude, Visionist, CRT-Ps (P030005/S170) | Guidant Corp. | 2017-12-19 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S091) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-12-19 |
| Clarisert Preloaded IOL System (P080004/S020) | Hoya Surgical Optics, Inc. | 2017-12-19 |
| Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI (P150012/S050) | Boston Scientific | 2017-12-19 |
| Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs (P960040/S412) | Boston Scientific | 2017-12-19 |
| Autogen, Cognis, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Punctua, Resonate, Vigiliant, CRT-Ds (P010012/S472) | Boston Scientific Corp | 2017-12-19 |
| Accolade, Advantio, Altrua, Altrua 2, Essentio, Formio, Ingenio, Insignia, Proponent, Vitalio Pacemakers (N970003/S222) | Boston Scientific Corp | 2017-12-19 |
| Implantable Cardioverter Defibrillator (ICD) (P910023/S388) | ABBOTT MEDICAL | 2017-12-19 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S026) | Medinol, Ltd. | 2017-12-19 |
| Prometra Programmable Implantable Pump / Prometra II Programmable Implantable Pump (P080012/S047) | Infusyn Therapeutics, LLC | 2017-12-19 |
| High Voltage Active Fixation Lead, (P030054/S332) | ABBOTT MEDICAL | 2017-12-19 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P950022/S109) | ABBOTT MEDICAL | 2017-12-19 |
| ocufilcon D Sift (Hydrophilie) Contact Lenses (P890023/S028) | The Cooper Companies | 2017-12-19 |
| Low Voltage Active Fixation Lead (P140033/S010) | ABBOTT MEDICAL | 2017-12-19 |
| Oncomine Dx Target Test (P160045/S003) | Life Technologies Corporation | 2017-12-18 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S108) | Alcon Laboratories, Inc. | 2017-12-18 |
| Cologuard (P130017/S021) | Exact Sciences Corporation | 2017-12-18 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S140) | Boston Scientific Corp | 2017-12-18 |
| CyPass Ultra System (P150037/S008) | Alcon Research, Ltd. | 2017-12-18 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S076) | Alcon Research, Ltd. | 2017-12-18 |
| SynchroMed Infusion System (P860004/S293) | Medtronic, Inc. | 2017-12-17 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S035) | Siemens Healthcare Diagnostics | 2017-12-15 |