| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S012) | Medtronic Vascular | 2018-12-14 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S088) | Medtronic Vascular | 2018-12-14 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S118) | Alcon Laboratories, Inc. | 2018-12-14 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S086) | Alcon Research, Ltd. | 2018-12-14 |
| Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S044) | Boston Scientific Corporation | 2018-12-14 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S002) | Boston Scientific Corp | 2018-12-14 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device and Delivery System (P130013/S023) | Boston Scientific Corp | 2018-12-14 |
| GORE TIGIRIS Vascular Stent (P160004/S023) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| cobas BRAF V600 Mutation Test (P110020/S031) | Roche Molecular Systems, Inc. | 2018-12-13 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S415) | Medtronic Neuromodulation | 2018-12-13 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System (P060030/S071) | Roche Molecular Systems, Inc. | 2018-12-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S331) | Medtronic, Inc. | 2018-12-13 |
| Tendril STS 2088TC Lead (P140033/S033) | ABBOTT MEDICAL | 2018-12-13 |
| Tendril STS 2088TC Lead (P910023/S410) | ABBOTT MEDICAL | 2018-12-13 |
| GORE Carotid Stent (P180010/S001) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| SENSAR 1-Piece IOL; TECNIS 1-Piece IOL; TECNIS 1-Piece OptiBlue IOL; Preloaded TECNIS 1-Piece IOL (P980040/S094) | Johnson & Johnson Surgical Vision, Inc. | 2018-12-13 |
| Tendril STS 2088TC Lead (P960013/S098) | ABBOTT MEDICAL | 2018-12-13 |
| cobas CMV (P160041/S015) | Roche Molecular Systems, Inc. | 2018-12-13 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S063) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D) (P050023/S127) | Biotronik, Inc. | 2018-12-13 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S124) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| ARCHITECT AFP assay (P120008/S012) | Abbott Laboratories | 2018-12-13 |
| Tendril STS 2088TC Lead (P030054/S355) | ABBOTT MEDICAL | 2018-12-13 |
| cobas KRAS Mutation Test (P140023/S019) | Roche Molecular Systems, Inc. | 2018-12-13 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S072) | Roche Molecular Systems, Inc. | 2018-12-13 |
| GORE VIABAHN Balloon Expandable Endoprosthesis (P160021/S015) | W. L. Gore & Associates, Inc. | 2018-12-13 |
| cobas HCV (P150015/S022) | Roche Molecular Systems, Inc. | 2018-12-13 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S043) | Roche Molecular Systems, Inc. | 2018-12-13 |
| cobas HBV (P150014/S022) | Roche Molecular Systems, Inc. | 2018-12-13 |
| Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI (P140033/S042) | ABBOTT MEDICAL | 2018-12-13 |
| Implantable Cardioverter Defibrillatory (Non-CRT) and Defibrillatort, Implantable, Dual-Chamber (P980023/S088) | Biotronik, Inc. | 2018-12-13 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex u, Quartet, and Quartet CRT Leads (P030054/S365) | ABBOTT MEDICAL | 2018-12-12 |
| RF Enhancr II Catheter (P930029/S064) | Medtronic, Inc. | 2018-12-12 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S160) | W. L. Gore & Associates, Inc. | 2018-12-12 |
| Allure, Allure Quadra and Quadra Allure MP (P030035/S176) | ABBOTT MEDICAL | 2018-12-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S003) | Boston Scientific Corp | 2018-12-11 |
| Microny Pacemaker (P970013/S080) | ABBOTT MEDICAL | 2018-12-11 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S (P880086/S305) | ABBOTT MEDICAL | 2018-12-11 |
| AMS 800 Urinary Control System (P000053/S098) | Boston Scientific Corp | 2018-12-11 |
| Tendril SDX Lead, Tendril ST Lead, OptiSense and Tendril STS Lead (P960013/S104) | ABBOTT MEDICAL | 2018-12-11 |
| AMS 700 Series Product Line and the Ynaflex Inflatable Penile Prostheses (N970012/S153) | Boston Scientific Corp | 2018-12-11 |
| cobas HPV Test (P100020/S041) | Roche Molecular Systems, Inc. | 2018-12-11 |
| Innova Vascular Self-Expanding Stent System (P140028/S035) | Boston Scientific Corporation | 2018-12-11 |
| Nevisense (P150046/S003) | Scibase AB | 2018-12-11 |
| Watchman Left Atrial Appendage (LLAC) Closure Technology (P130013/S024) | Boston Scientific Corp | 2018-12-11 |
| Durata and Optisure (P950022/S124) | ABBOTT MEDICAL | 2018-12-11 |
| IsoFlex Optim (P960030/S063) | ABBOTT MEDICAL | 2018-12-11 |
| Cortify, Fortify Assura, and Ellipse (P910023/S415) | ABBOTT MEDICAL | 2018-12-11 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S026) | Roche | 2018-12-11 |
| Express SD Renal Monorail Premounted Stent System (P060006/S095) | Boston Scientific Corp | 2018-12-10 |
| Astra S DR, S SR MRI IPG, Astra XT DR,SR MRI IPG; Azure S DR,S SR MRI IPG, Azure XT DR,SR MRI IPG. (P980035/S573) | Medtronic, Inc. | 2018-12-10 |
| cobas HBV (P150014/S021) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas HPV Test (P100020/S040) | Roche Molecular Systems, Inc. | 2018-12-07 |
| MiniMed 530G System (P120010/S126) | Medtronic, Inc. | 2018-12-07 |
| MiniMed 630G System (P150001/S056) | Medtronic Minimed | 2018-12-07 |
| Ventana ALK (D5f3) CDx Assay (P140025/S010) | Ventana Medical Systems, Inc. | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System (P050028/S071) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas HCV (P150015/S021) | Roche Molecular Systems, Inc. | 2018-12-07 |
| R3 delta Ceramic Acetabular System (P150030/S005) | Smith & Nephew, Inc. | 2018-12-07 |
| cobas BRAF V600 Mutation Test (P110020/S030) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas KRAS Mutation Test (P140023/S018) | Roche Molecular Systems, Inc. | 2018-12-07 |
| cobas CMV (P160041/S014) | Roche Molecular Systems, Inc. | 2018-12-07 |
| Powerheart® G5 AED, Powerheart® AED G3 Plus, and Powerheart® AED G3 (P160033) | ZOLL Medical Corporation | 2018-12-07 |
| Eversense Continuous Glucose Monitoring System (P160048/S005) | Senseonics, Incorporated | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S042) | Roche Molecular Systems, Inc. | 2018-12-07 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S117) | Alcon Laboratories, Inc. | 2018-12-07 |
| MiniMed iPro2 CGM System with Enlite Sensor (P150029/S025) | Medtronic Minimed | 2018-12-07 |
| SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505) (P810002/S107) | ABBOTT MEDICAL | 2018-12-07 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S003) | Invivoscribe Technologies, Inc. | 2018-12-07 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System (P060030/S070) | Roche Molecular Systems, Inc. | 2018-12-07 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA)Liquid Embolic System (P990040/S028) | Cerenovus, Inc. | 2018-12-07 |
| Paradigm Real-Time Revel System (P150019/S052) | Medtronic Minimed | 2018-12-07 |
| Gore CardioForm Septal Occluder (P050006/S067) | W. L. Gore & Associates, Inc. | 2018-12-07 |
| SURGICEL Absorbable Hemostats (N12159/S051) | ETHICON, Inc. | 2018-12-07 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S025) | Roche | 2018-12-07 |
| Venaseal Closure System (P140018/S014) | Medtronic Vascular, Inc. | 2018-12-07 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S085) | Alcon Research, Ltd. | 2018-12-07 |
| Paradigm REAL-Time Revel Insulin Pump (P150019/S050) | Medtronic Minimed | 2018-12-07 |
| Paradigm REAL-Time Insulin Pump (P980022/S207) | Medtronic Minimed | 2018-12-07 |
| Minimed 530G Insulin Pump (P120010/S124) | Medtronic, Inc. | 2018-12-07 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve (TAV) (P130021/S057) | Medtronic, Inc. | 2018-12-06 |
| EMBLEM S-ICD Pulse Generator; EMBLEM MRI S-ICD Pulse Generator (P110042/S117) | Boston Scientific Corporation | 2018-12-06 |
| AEGEA Vapor System, AEGEA Vapor Probe Procedure Kit, AEGEA Vapor Generator, AEGEA Vapor Generator Accessory Kit (P160047/S001) | CooperSurgical, Inc. | 2018-12-06 |
| Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis (P170006/S008) | Medtronic, Inc. | 2018-12-06 |
| CRT-Ds (Cardiac Resynchronization Therapy Defibrillator) Platinium (P060027/S097) | MicroPort CRM USA, Inc. | 2018-12-06 |
| ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR (P980049/S132) | MicroPort CRM USA, Inc. | 2018-12-06 |
| Supartz FX and Visco-3 (P980044/S050) | Seikagaku Corp. | 2018-12-06 |
| Eversense Continuous Glucose Monitoring System (P160048/S004) | Senseonics, Incorporated | 2018-12-06 |
| Proclaim SCS IPG (P010032/S145) | ABBOTT MEDICAL | 2018-12-06 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S001) | Defibtech, LLC | 2018-12-06 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S001) | Boston Scientific Corp | 2018-12-06 |
| Proclaim DRG IPG (P150004/S028) | ABBOTT MEDICAL | 2018-12-06 |
| Powerheart® AED G3 Pro (P160034) | ZOLL Medical Corporation | 2018-12-06 |
| LIFEPAK 15 monitor/defibrillator (P160026/S003) | Physio-Control, Inc. | 2018-12-06 |
| Gel-One (P080020/S031) | Seikagaku Corp. | 2018-12-06 |
| Integra Dermal Regeneration Template - Terminally Sterilized (P900033/S074) | Integra Lifesciences Corp. | 2018-12-06 |
| OraQuick HCV Rapid Antibody Test (P080027/S034) | OraSure Technologies, Inc. | 2018-12-06 |
| Infinity DBS IPG (P140009/S043) | ABBOTT MEDICAL | 2018-12-06 |
| Durata, Optisure High Voltage Active and Passive Leads (P950022/S125) | ABBOTT MEDICAL | 2018-12-05 |
| Tendril MRI Low Voltage Leads (P140033/S043) | ABBOTT MEDICAL | 2018-12-05 |