| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P950037/S194) | Biotronik, Inc. | 2018-08-27 |
| INFUSE Bone Graft (P050053/S041) | Medtronic, Inc. | 2018-08-27 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S080) | CooperVision, Inc. | 2018-08-27 |
| Implantable System for Remodulin (P140032/S017) | Medtronic, Inc. | 2018-08-24 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S051) | Medtronic, Inc. | 2018-08-24 |
| QuantiFeron TB Gold and QuantiFeron TB Gold Plus (P010033/S037) | Qiagen | 2018-08-24 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S005) | ABBOTT MEDICAL | 2018-08-24 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Cologuard (P130017/S023) | Exact Sciences Corporation | 2018-08-24 |
| Superion® Indirect Decompression System (P140004/S015) | Boston Scientific Neuromodulation | 2018-08-24 |
| CERAMAX Ceramic Total Hip System (P070026/S055) | DePuy Orthopaedics, Inc. | 2018-08-24 |
| Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC) (P030040/S014) | Siemens Healthcare Diagnostics | 2018-08-24 |
| LCS Total Knee System (P830055/S205) | Depuy, Inc. | 2018-08-24 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S058) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S029) | Cook Ireland, Ltd. | 2018-08-23 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S008) | Medinol, Ltd. | 2018-08-23 |
| XIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent Systems (P110019/S099) | Abbott Vascular | 2018-08-23 |
| GORE TIGRIS Vascular Stent (P160004/S018) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| GORE VIABAHN Endoprostheis (P040037/S119) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S012) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| Vercise DBS System / Vercise PC DBS System (P150031/S005) | Boston Scientific Corp | 2018-08-23 |
| LifeVest Wearable Defibrillator (P010030/S108) | Zoll Manufacturing Corporation | 2018-08-23 |
| Astron Pulsar and Pulsar-18 Stent Systems (P160025/S005) | Biotronik AG | 2018-08-22 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S311) | Medtronic, Inc. | 2018-08-22 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S041) | Boston Scientific Corporation | 2018-08-22 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S008) | Boston Scientific Corp | 2018-08-22 |
| Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD (P140003/S037) | Abiomed, Inc. | 2018-08-22 |
| Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit (P120019/S019) | Roche | 2018-08-22 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S032) | Abbott Diabetes Care, Inc. | 2018-08-22 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S024) | Abbott Diabetes Care, Inc. | 2018-08-22 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S053) | Boston Scientific Corp | 2018-08-22 |
| Implantable System for Remodulin (P140032/S013) | Medtronic, Inc. | 2018-08-22 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S013) | Bimini Health Tech | 2018-08-22 |
| PhysioStim, SpinalStim (P850007/S039) | Orthofix, Inc. | 2018-08-22 |
| CervicalStim (P030034/S012) | Orthofix, Inc. | 2018-08-22 |
| Impella RP (P170011/S007) | Abiomed, Inc. | 2018-08-22 |
| SAPIEN 3 Transcatheter Heart Valve (23mm, 26mm, and 29mm (P140031/S073) | Edwards Lifesciences, LLC | 2018-08-22 |
| MANAGE HF Study (P960040/S426) | Boston Scientific | 2018-08-21 |
| MANAGE HF Study (P010012/S486) | Boston Scientific Corp | 2018-08-21 |
| GORE TIGRIS Vascular Stent (P160004/S019) | W. L. Gore & Associates, Inc. | 2018-08-21 |
| Longitudinal Surveillance Registry of the ACUITY Spiral Lead (P010012/S487) | Boston Scientific Corp | 2018-08-20 |
| ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL) (P030028/S004) | Ophtec BV | 2018-08-20 |
| ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS (P030028/S005) | Ophtec BV | 2018-08-20 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S068) | Roche Molecular Systems, Inc. | 2018-08-17 |
| ORBERA Intragastric Balloon (P140008/S013) | Boston Scientific Corporation | 2018-08-17 |
| DUROLOANE (P170007/S001) | Bioventus, LLC | 2018-08-17 |
| cobas HCV (P150015/S018) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas CMV (P160041/S012) | Roche Molecular Systems, Inc. | 2018-08-17 |
| Prometra Programmable Infusion Pump System (P080012/S051) | Infusyn Therapeutics, LLC | 2018-08-17 |
| cobas HBV (P150014/S019) | Roche Molecular Systems, Inc. | 2018-08-17 |
| Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S069) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas HPV Test (P100020/S037) | Roche Molecular Systems, Inc. | 2018-08-17 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S040) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas BRAF V600 Mutation Test (P110020/S028) | Roche Molecular Systems, Inc. | 2018-08-17 |
| cobas KRAS Mutation Test (P140023/S016) | Roche Molecular Systems, Inc. | 2018-08-17 |
| Guardian Sensor (3) (P160007/S004) | Medtronic Minimed | 2018-08-16 |
| Cervista HPV HR Assay (P080014/S021) | Hologic, Inc. | 2018-08-16 |
| SUPARTZ FX and VISCO-3 (P980044/S047) | Seikagaku Corp. | 2018-08-16 |
| AcrySof ReSTOR IOLs (P040020/S080) | Alcon Research, Ltd. | 2018-08-16 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S641) | Medtronic Cardiac Rhythm Disease Management | 2018-08-16 |
| Cervista HPV 16/18 Assay (P080015/S013) | Hologic, Inc. | 2018-08-16 |
| Enroute Transcarotid Stent System (P140026/S010) | Boston Scientific Corporation | 2018-08-16 |
| PD-L1 IHC 22C3 pharmDx (P150013/S011) | Agilent Technologies, Inc. | 2018-08-16 |
| Exablate 2100/2100V1 System (P110039/S010) | Insightec | 2018-08-16 |
| Exablate 2100/2100V1 System (P040003/S021) | Insightec, Ltd. | 2018-08-16 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S682) | Medtronic Cardiac Rhythm Disease Management | 2018-08-16 |
| PSW 1801.U (P000009/S076) | Biotronik, Inc. | 2018-08-15 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S023) | Roche | 2018-08-15 |
| PSW 1801.U (P070008/S092) | Biotronik, Inc. | 2018-08-15 |
| Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve (P150048/S025) | Edwards Lifesciences, LLC | 2018-08-15 |
| PSW 1801.U (P050023/S119) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P950037/S190) | Biotronik, Inc. | 2018-08-15 |
| NeuroPace RNS System (P100026/S057) | NeuroPace, Inc. | 2018-08-15 |
| Angio Seal Vascular Closure Device (P930038/S089) | Terumo Medical Corporation | 2018-08-15 |
| InterStim Therapy System SNS Bowel (P080025/S171) | Medtronic Neuromodulation | 2018-08-14 |
| Activa Deep Brain Stimulation Therapy System (P960009/S320) | Medtronic, Inc. | 2018-08-14 |
| Straumann Emdogain (P930021/S019) | The Straumann Company | 2018-08-14 |
| Anthem; Allure, Allure Quadra; Quadra Allure MP (P030035/S172) | ABBOTT MEDICAL | 2018-08-14 |
| SLS ll/GlideLight Catheters (P960042/S063) | Spectranetics (Philips) | 2018-08-14 |
| Assurity MRI; Endurity MRI; Tendril MRI (P140033/S036) | ABBOTT MEDICAL | 2018-08-14 |
| Current+; Fortify; Fortify Assura; Fortify Assura (MR Conditional); Ellipse; Ellipse (MR Conditional) (P910023/S411) | ABBOTT MEDICAL | 2018-08-14 |
| MiniMed 630G System with SmartGuard (P150001/S051) | Medtronic Minimed | 2018-08-14 |
| MiniMed 670G System (P160017/S049) | Medtronic Minimed, Inc. | 2018-08-14 |
| Restore, Itrel, Synergy and IntellisTM Spinal Cord Stimulation Systems and PiscesTM Specify, and Vectris Spinal Cord Sti (P840001/S403) | Medtronic Neuromodulation | 2018-08-14 |
| CardioMEMS HF System (P100045/S031) | ABBOTT MEDICAL | 2018-08-14 |
| Implantable System for Remodulin (P140032/S016) | Medtronic, Inc. | 2018-08-14 |
| Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump (P980022/S205) | Medtronic Minimed | 2018-08-14 |
| Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass (P030054/S358) | ABBOTT MEDICAL | 2018-08-14 |
| Microny (P970013/S078) | ABBOTT MEDICAL | 2018-08-14 |
| InterStim Therapy System SNS Urinary (P970004/S276) | Medtronic Neuromodulation | 2018-08-14 |
| Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL (P880086/S301) | ABBOTT MEDICAL | 2018-08-14 |
| Oncomine Dx Target Test (P160045/S008) | Life Technologies Corporation | 2018-08-14 |
| AngelMed Guardian System (P150009/S001) | Avertix Medical, Inc. | 2018-08-14 |
| SynchroMed Infusion System (P860004/S315) | Medtronic, Inc. | 2018-08-14 |
| Paradigm REAL-Time Revel Insulin Pump (P150019/S046) | Medtronic Minimed | 2018-08-14 |
| ELCA Coronary Atherectomy Catheters (P910001/S105) | Spectranetics Corp. | 2018-08-14 |
| MiniMed 530G Insulin Pump (P120010/S120) | Medtronic, Inc. | 2018-08-14 |
| HiResolution Bionic Ear System (P960058/S130) | Advanced Bionics | 2018-08-13 |
| HeartWare Left Ventricular Assist System (P100047/S122) | Medtronic | 2018-08-13 |
| MitraClip System (NT) (P100009/S026) | ABBOTT MEDICAL | 2018-08-13 |