| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S020) | Medtronic Minimed | 2018-07-16 |
| HEMOBLAST Bellows (P170012/S006) | Dilon Technologies, Inc. | 2018-07-16 |
| MiniMed 530G System (P120010/S118) | Medtronic, Inc. | 2018-07-16 |
| Guardian Connect system (P160007/S007) | Medtronic Minimed | 2018-07-16 |
| LifeVest Wearable Defibrillator (P010030/S106) | Zoll Manufacturing Corporation | 2018-07-16 |
| MiniMed 630G System (P150001/S047) | Medtronic Minimed | 2018-07-16 |
| MiniMed 670G System (P160017/S045) | Medtronic Minimed, Inc. | 2018-07-16 |
| MiniMed Paradigm Real-Time Revel System (P150019/S044) | Medtronic Minimed | 2018-07-16 |
| Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21 (P140031/S069) | Edwards Lifesciences, LLC | 2018-07-15 |
| Nevisense (P150046/S001) | Scibase AB | 2018-07-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- (P010031/S638) | Medtronic Cardiac Rhythm Disease Management | 2018-07-13 |
| Surpass Streamline Flow Diverter (P170024) | Stryker Neurovascular | 2018-07-13 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/ S VR ICD, Evera XT DR/ XT VR ICD, Primo MRI DR/VR ICD, Visia AF MRI DF1 I (P980016/S679) | Medtronic Cardiac Rhythm Disease Management | 2018-07-13 |
| Elecsys Ani-HBs, PreciControl Anti-HBs and Anti-HBs CalCheck (P010054/S037) | Roche Diagnostics Corp. | 2018-07-13 |
| Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation Device; Freezor MAX Cardiac Cryoablati (P020045/S088) | Medtronic Cryocath, LP | 2018-07-12 |
| Transvene CS/SVC Lead (P980050/S119) | Medtronic, Inc. | 2018-07-12 |
| Attain Bipolar OTW Lead; Attain OTW LV Lead (P010015/S375) | Medtronic, Inc. | 2018-07-12 |
| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S004) | Siemens Healthcare Diagnostics | 2018-07-12 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S002) | Celonova Biosciences, Inc. | 2018-07-12 |
| Attain StarFix Lead (P060039/S089) | Medtronic, Inc. | 2018-07-12 |
| Sprint Quattro Lead; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S216) | Medtronic, Inc. | 2018-07-12 |
| 13 C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT) (P110015/S004) | Advanced Breath Diagnostics | 2018-07-12 |
| CapSureFix Lead; CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S190) | Medtronic, Inc. | 2018-07-12 |
| CapSure VDD 2 Lead; Vitatron Brilliant S+ VDD Lead (P890003/S393) | Medtronic, Inc. | 2018-07-12 |
| CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead (P830061/S161) | Medtronic Cardiac Rhythm Disease Management | 2018-07-12 |
| Freezor MAX Cardiac Cryoablation Catheter (P100010/S079) | Medtronic Cryocath, LP | 2018-07-12 |
| Attain Ability Lead; Attain Performa Lead (P080006/S125) | Medtronic, Inc. | 2018-07-12 |
| CapSure SP Novus Lead; CapSure SP Z Lead; CapSure SP Z Novus; CapSure SP Z Lead; CapSure Z Novus Lead; Vitatron Impulse (P850089/S135) | Medtronic Cardiac Rhythm Disease Management | 2018-07-12 |
| CapSureFix MRI Lead (P090013/S287) | Medtronic, Inc. | 2018-07-12 |
| Artegraft Collagen Vascular Graft (N16837/S025) | LeMaitre Vascular, Inc. | 2018-07-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S068) | Edwards Lifesciences, LLC | 2018-07-11 |
| Vysis ALK Break Apart FISH Probe Kit (P110012/S016) | Abbott Molecular, Inc. | 2018-07-11 |
| Nucleus C1532 Cochlear Implant (P970051/S180) | Cochlear Americas | 2018-07-11 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S112) | Boston Scientific | 2018-07-11 |
| Obalon Balloon Kit (P160001/S019) | Medtimo, Inc. | 2018-07-11 |
| Animas Vibe System (P130007/S036) | Animas Corp. | 2018-07-11 |
| Her Option Office Cryoablation Therapy System (P000032/S043) | CooperSurgical, Inc. | 2018-07-11 |
| Vysis CLL FISH Probe Kit (P150041/S003) | Abbott Molecular, Inc. | 2018-07-11 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S091) | Edwards Lifesciences, LLC | 2018-07-11 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S086) | Boston Scientific Corp | 2018-07-11 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent S (P110010/S158) | Boston Scientific Corp | 2018-07-11 |
| Express SD Monorail Premounted Stent System (P060006/S092) | Boston Scientific Corp | 2018-07-11 |
| Path Vysion HER-2 DNA Probe Kit (P980024/S018) | Abbott Molecular, Inc. | 2018-07-11 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S052) | Boston Scientific Corp | 2018-07-11 |
| Heartware Ventricular Assist System (P100047/S125) | Medtronic | 2018-07-11 |
| UroVysion Bladder Cancer Kit (P030052/S023) | Abbott Molecular | 2018-07-11 |
| Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft (P990046/S054) | Medtronic Ats Medical, Inc. | 2018-07-11 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S038) | Boston Scientific Corp | 2018-07-11 |
| Rotablator Rotational Atherectomy System (P900056/S172) | Boston Scientific Corp | 2018-07-11 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S109) | Boston Scientific Corp | 2018-07-11 |
| DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI (P960040/S427) | Boston Scientific | 2018-07-11 |
| HEMOBLAST Bellows (P170012/S005) | Dilon Technologies, Inc. | 2018-07-11 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S032) | Corcym Canada Corp | 2018-07-11 |
| Carbomedics Prosthetic Heart Valve (P900060/S058) | Corcym S.r.l. | 2018-07-11 |
| TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION INTRAOCULAR LENSES (IOLS), MODELS ZXT150, ZXT225,ZXT300, AND ZT375 (P980040/S072) | Johnson & Johnson Surgical Vision, Inc. | 2018-07-10 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S099) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2018-07-10 |
| HeartWare HVAD System (P100047/S112) | Medtronic | 2018-07-10 |
| Enhanced enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S030) | Bausch & Lomb, Inc. | 2018-07-10 |
| MULTI-LINK Ultra Coronary Stent System (P970020/S083) | Abbott Vascular, Inc. | 2018-07-10 |
| CardioMEMS HF System (P100045/S029) | ABBOTT MEDICAL | 2018-07-10 |
| Impella CP/LD, Impella 2.5/5.0 (P140003/S033) | Abiomed, Inc. | 2018-07-10 |
| TMR Holmium Laser System (P970029/S037) | Cryolife, Inc. | 2018-07-10 |
| MULTI-LINK Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System (P020047/S069) | Abbott Vascular | 2018-07-10 |
| Closer Vascular Sealing System (VSS) (P150022/S005) | Rex Medical, L.P. | 2018-07-10 |
| MynxGrip Vascular Closure Device (P040044/S081) | Cordis US Corporation | 2018-07-10 |
| Elecsys total PSA and total PSA CalSet II (P990056/S028) | Roche Diagnostics Corp. | 2018-07-09 |
| Straumann Emdogain (P930021/S020) | The Straumann Company | 2018-07-09 |
| Codman 3000 Series Constant Flow Implantable infusion Pump (P890055/S069) | Intera Oncology | 2018-07-06 |
| Radiesse (P050037/S093) | Merz North America, Inc. | 2018-07-06 |
| Radiesse (+) Lidocaine Dermal Filter (P050052/S106) | Merz North America, Inc. | 2018-07-06 |
| Atellica IM Anti-Hepatitis B core Total (HBcT), Atellica IM Anti-Hepatitis B core Total Quality Control (HBcT QC) (P040004/S013) | Siemens Healthcare Diagnostics | 2018-07-06 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S030) | Abbott Diabetes Care, Inc. | 2018-07-06 |
| Radiesse (+) (P050052/S109) | Merz North America, Inc. | 2018-07-06 |
| Radiesse Injectable Implant (P050037/S090) | Merz North America, Inc. | 2018-07-06 |
| FreeStyle Libre Flash Glucose Monitoring System (P160030/S022) | Abbott Diabetes Care, Inc. | 2018-07-06 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S155) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads (P150012/S063) | Boston Scientific | 2018-07-05 |
| Dimension Vista TPSA Flex reagent cartridge (K6451) (P000021/S038) | Siemens Healthcare Diagnostics | 2018-07-05 |
| Radiesse Injectable Implant (P050037/S092) | Merz North America, Inc. | 2018-07-05 |
| GORE TAG Thoracic Endoprosthesis (P040043/S102) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| cobas EGFR Mutation Test, V2.0 (P120019/S022) | Roche | 2018-07-05 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S007) | ABBOTT MEDICAL | 2018-07-05 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S066) | Roche Molecular Systems, Inc. | 2018-07-05 |
| LifeVest Wearable Defibrillator (Model 4000) (P010030/S100) | Zoll Manufacturing Corporation | 2018-07-05 |
| cobas HPV Test (P100020/S035) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas BRAF V600 Mutation Test (P110020/S026) | Roche Molecular Systems, Inc. | 2018-07-05 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S117) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| cobas KRAS Mutation Test (P140023/S015) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas CMV (P160041/S010) | Roche Molecular Systems, Inc. | 2018-07-05 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S056) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE TIGRIS Vascular Stent (P160004/S014) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| Dimension Vista FPSA Flex reagent cartridge (K6452) (P020027/S033) | Siemens Healthcare Diagnostics | 2018-07-05 |
| Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S012) | Rayner Intraocular Lenses , Ltd. | 2018-07-05 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S010) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S064) | W. L. Gore & Associates, Inc. | 2018-07-05 |
| COBAS TaqMan HBV Test for Use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S067) | Roche Molecular Systems, Inc. | 2018-07-05 |
| Radiesse Hands, Radiesse (+) Lidocaine Dermal Filler (P050052/S108) | Merz North America, Inc. | 2018-07-05 |
| cobas HCV (P150015/S016) | Roche Molecular Systems, Inc. | 2018-07-05 |
| cobas HBV (P150014/S017) | Roche Molecular Systems, Inc. | 2018-07-05 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S038) | Roche Molecular Systems, Inc. | 2018-07-05 |