| Zenith Dissection Endovascular System (P180001) | William Cook Europe Aps | 2018-12-31 |
| Synergy Ablation System (P100046/S009) | AtriCure, Inc. | 2018-12-31 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032) | MicroVention, Inc. | 2018-12-31 |
| Synvisc One (P940015/S042) | Sanofi Genzyme Corp. | 2018-12-28 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053/S003) | Endomagnetics Ltd., | 2018-12-28 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S023) | Edwards Lifesciences, LLC | 2018-12-28 |
| Aptima HBV Quant Assay (P170025/S006) | Hologic, Inc. | 2018-12-28 |
| Aptima HCV Quant Dx Assay (P160023/S008) | Hologic, Inc. | 2018-12-28 |
| Dimension Vista FPSA Flex reagent cartridge (P020027/S034) | Siemens Healthcare Diagnostics | 2018-12-27 |
| IMMULITE/IMMULITE 1000 PSA and IMMULITE 2000 PSA AND 1000 Third Generation PSA (P930027/S020) | Siemens Healthcare Diagnostics, Inc. | 2018-12-27 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S036) | St Jude Medical | 2018-12-27 |
| IMMULITE/IMMULITE 1000 Free PSA and IMMULITE 2000 Free PSA (P060005/S009) | Siemens Medical Solutions Diagnostics Limited | 2018-12-27 |
| IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP (P010007/S010) | Siemens Healthcare Diagnostics, Inc. | 2018-12-27 |
| Lotrafilcon A and Lotrafilcon B soft contact lenses for daily and extended wear (P010019/S070) | Alcon Laboratories, Inc. | 2018-12-27 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S103) | Abbott Vascular, Inc. | 2018-12-27 |
| Dimension Vista TPSA Flex reagent cartridge (P000021/S039) | Siemens Healthcare Diagnostics | 2018-12-27 |
| Apollo Onyx Delivery Micro Catheter (P030004/S016) | Ev3 Neurovascular | 2018-12-27 |
| Pipeline Flex Embolization Device (P100018/S019) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-27 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S074) | Edwards Lifesciences, LLC | 2018-12-27 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (P800002/S024) | C.R. Bard, Inc. | 2018-12-26 |
| Proclaim DRG Neurostimulator System IPG (P150004/S027) | ABBOTT MEDICAL | 2018-12-26 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S031) | Davol Inc., Sub. C. R. Bard, Inc. | 2018-12-26 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S037) | Beckman Coulter, Inc. | 2018-12-21 |
| Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S061) | Boston Scientific Corp | 2018-12-21 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S052) | Boston Scientific Scimed, Inc. | 2018-12-21 |
| Osteonics ABC/Trident System (P000013/S016) | Howmedica Osteonics Corp. | 2018-12-21 |
| Acess AFP Reagents on the Access Immunoassay Systems (P980041/S041) | Beckman Coulter, Inc. | 2018-12-21 |
| Flash Glucose Monitoring System (P150021/S035) | Abbott Diabetes Care, Inc. | 2018-12-21 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S004) | Invivoscribe Technologies, Inc. | 2018-12-21 |
| Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System (P980033/S051) | Boston Scientific Corporation | 2018-12-21 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S022) | Beckman Coulter, Inc. | 2018-12-21 |
| Freestyle Libre Pro (P160030/S027) | Abbott Diabetes Care, Inc. | 2018-12-21 |
| LIFEPAK® CR2 Defibrillator (P170018) | Physio-Control, Inc. | 2018-12-21 |
| Organ Care System (OCS) Lung System (P160013/S003) | TransMedics, Inc. | 2018-12-21 |
| Paradigm Real-Time Revel System with Enlite Sensor (P150019/S014) | Medtronic Minimed | 2018-12-21 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S049) | Beckman Coulter, Inc. | 2018-12-21 |
| Powerheart G5 AED (P160033/S001) | ZOLL Medical Corporation | 2018-12-20 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S006) | Bard Peripheral Vascular, Inc. | 2018-12-20 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S039) | Cordis US Corporation | 2018-12-20 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S045) | Boston Scientific Corporation | 2018-12-20 |
| CervicalStim (P030034/S013) | Orthofix, Inc. | 2018-12-20 |
| Wolverine Coronary Cutting Balloon (P950020/S092) | Boston Scientific Corp | 2018-12-20 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S037) | Hologic, Inc. | 2018-12-20 |
| Obalon Balloon System with Navigation Touch (P160001/S020) | Medtimo, Inc. | 2018-12-20 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S091) | Medtronic Vascular | 2018-12-20 |
| PhysioStim/SpinalStim (P850007/S040) | Orthofix, Inc. | 2018-12-20 |
| Enroute Transcarotid Stent System (P140026/S011) | Boston Scientific Corporation | 2018-12-20 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S057) | Boston Scientific Corp | 2018-12-20 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S030) | Cook Ireland, Ltd. | 2018-12-20 |
| AMS 800 Artificial Urinary Sphincter (P000053/S096) | Boston Scientific Corp | 2018-12-20 |
| Cordis S.M.A.R.T. CONTROL/S.M.A.R.T. Vascular Stent System (P120002/S014) | Cordis US Corporation | 2018-12-20 |
| Cordis PRECISE PRO Rx Nitinol Stent System (P030047/S036) | Cordis US Corporation | 2018-12-20 |
| MiniMed 530G System (P120010/S089) | Medtronic, Inc. | 2018-12-20 |
| Restore, Itrel, and Synergy Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Leads (P840001/S416) | Medtronic Neuromodulation | 2018-12-19 |
| BRACAnalysis CDx (P140020/S018) | Myriad Genetic Laboratories | 2018-12-19 |
| Optune System (P100034/S019) | Novocure, GmbH | 2018-12-19 |
| Accessory to Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchronization (CRT-D) (P050023/S116) | Biotronik, Inc. | 2018-12-19 |
| LCS Total Knee System (P830055/S215) | Depuy, Inc. | 2018-12-19 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S095) | Boston Scientific Corp | 2018-12-19 |
| Pulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular (P070008/S090) | Biotronik, Inc. | 2018-12-19 |
| Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele (P950037/S186) | Biotronik, Inc. | 2018-12-19 |
| Glaukos Corporation iStent Trabecular Micro-Bypass Stent System (P080030/S022) | Glaukos Corporation | 2018-12-18 |
| GORE Conformable TAG Thoracic Endoprosthesis (P040043/S107) | W. L. Gore & Associates, Inc. | 2018-12-18 |
| FoundationOne CDx (P170019/S002) | Foundation Medicine, Inc. | 2018-12-18 |
| RESTYLANE INJECTABLE GEL (P040024/S105) | Q-Med AB | 2018-12-18 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S004) | Lutonix | 2018-12-18 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S025) | Lutonix | 2018-12-18 |
| Rapid fFN for the TLiIQ System (P920048/S014) | Hologic, Inc. | 2018-12-17 |
| Tendril MRI Low Voltage Active (P140033/S044) | ABBOTT MEDICAL | 2018-12-17 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S195) | Medtronic, Inc. | 2018-12-17 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S166) | Medtronic Cardiac Rhythm Disease Management | 2018-12-17 |
| SynCardia temporaty Total Artificial Heart (TAH-t) System (P030011/S065) | Syncardia Systems, LLC | 2018-12-17 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S053) | Boston Scientific Scimed, Inc. | 2018-12-17 |
| Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S062) | Boston Scientific Corp | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028) | Ortho-Clinical Diagnostics | 2018-12-17 |
| IsoFlex Low Voltage Passive (P960030/S065) | ABBOTT MEDICAL | 2018-12-17 |
| Prometra Programmable Infusion Pump System (P080012/S053) | Infusyn Therapeutics, LLC | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S031) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S034) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S003) | Heartsine Technologies, Ltd. | 2018-12-17 |
| Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System (P980033/S052) | Boston Scientific Corporation | 2018-12-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S139) | Medtronic Cardiac Rhythm Disease Management | 2018-12-17 |
| Sprint Quattro Lead (P920015/S224) | Medtronic, Inc. | 2018-12-17 |
| CapSure VDD 2 Lead and Vitatron Brilliant S+ VDD Lead (P890003/S402) | Medtronic, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S016) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| OpticSense, Tendril STS, SDX, ST Low Voltage Active (P960013/S106) | ABBOTT MEDICAL | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator (P030026/S035) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| Durata, Optisure High Voltage Passive, High Voltage Active (P950022/S126) | ABBOTT MEDICAL | 2018-12-17 |
| CapSure Epicardial Pacing Lead (P950024/S083) | Medtronic, Inc. | 2018-12-17 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015) | Ortho-Clinical Diagnostics | 2018-12-17 |
| CapSureFix MRI Lead (P090013/S295) | Medtronic, Inc. | 2018-12-17 |
| Quickflex u, Quartet Cardiac Resynchronization Therapy Passive (P030054/S367) | ABBOTT MEDICAL | 2018-12-17 |
| VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit (P000044/S039) | Ortho-Clinical Diagnostics, Inc. | 2018-12-17 |
| ExAblate (P150038/S006) | Insightec | 2018-12-16 |
| Obalon Balloon Kit (P160001/S029) | Medtimo, Inc. | 2018-12-16 |
| Innova Self-Expanding Stent System (P140028/S034) | Boston Scientific Corporation | 2018-12-14 |
| LCS Total Knee System Barcode Scanning (P830055/S219) | Depuy, Inc. | 2018-12-14 |
| AquaTech Plus Premium multifocal (P080011/S082) | CooperVision, Inc. | 2018-12-14 |
| Pipeline Flex Embolization Device (P100018/S015) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-12-14 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S161) | W. L. Gore & Associates, Inc. | 2018-12-14 |