| Algovita Spinal Cord Stimulation System (P130028/S025) | Nuvectra Corporation | 2019-12-31 |
| AcrySof Intraocular Lenses (P930014/S120) | Alcon Laboratories, Inc. | 2019-12-30 |
| iSert Preloaded IOL Models, iSymm, Clarisert IOL Models (P080004/S029) | Hoya Surgical Optics, Inc. | 2019-12-30 |
| HeartMate 3 Left Ventricular Assist System (P160054/S024) | ABBOTT MEDICAL | 2019-12-30 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S105) | Boston Scientific Corp | 2019-12-30 |
| AMS 700 Implantable numbera Penile Prosthesis with and without Inhibizone Treatment (N970012/S164) | Boston Scientific Corp | 2019-12-30 |
| BRACAnalysis CDx (P140020/S019) | Myriad Genetic Laboratories | 2019-12-27 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S447) | Medtronic Neuromodulation | 2019-12-26 |
| Radiesse Injecable Implant, Radiesse (+) Lidocaine Dermal Filler (P050052/S118) | Merz North America, Inc. | 2019-12-26 |
| Radiesse Injectable Implant (P050037/S101) | Merz North America, Inc. | 2019-12-26 |
| Cobra PzF NanoCoated Coronary Stent System (P160014/S009) | Celonova Biosciences, Inc. | 2019-12-24 |
| Assurity, Assurity+, Endurity, Accent family of Pacemaker (P880086/S307) | ABBOTT MEDICAL | 2019-12-23 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S177) | ABBOTT MEDICAL | 2019-12-23 |
| Microny family of Pacemakers (P970013/S081) | ABBOTT MEDICAL | 2019-12-23 |
| LCS(R) Total Knee System (P830055/S239) | Depuy, Inc. | 2019-12-23 |
| HiResolution Bionic Ear System (P960058/S144) | Advanced Bionics | 2019-12-23 |
| remede® System (P160039/S005) | Respicardia | 2019-12-23 |
| LCS Total Knee System (P830055/S236) | Depuy, Inc. | 2019-12-23 |
| CERAMAX Ceramic Total Hip System (P070026/S068) | DePuy Orthopaedics, Inc. | 2019-12-23 |
| Assurity MRI and Endurity MRI family of Pacemakers (P140033/S049) | ABBOTT MEDICAL | 2019-12-23 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S373) | ABBOTT MEDICAL | 2019-12-23 |
| Zephyr Endobronchial Valve System (P180002/S011) | Pulmonx Corporation | 2019-12-23 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S422) | ABBOTT MEDICAL | 2019-12-23 |
| VenaSeal Closure System (P140018/S017) | Medtronic Vascular, Inc. | 2019-12-20 |
| Organ Care System (OCS) Lung System (P160013/S005) | TransMedics, Inc. | 2019-12-20 |
| Organ Care System (OCS) Lung System (P160013/S006) | TransMedics, Inc. | 2019-12-20 |
| Quadripolar Pacing (P030054/S372) | ABBOTT MEDICAL | 2019-12-20 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S010) | Berlin Heart, Inc. | 2019-12-20 |
| Floseal Hemostatic Matrix (P990009/S059) | Baxter Healthcare Corp | 2019-12-20 |
| Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis (P020004/S172) | W. L. Gore & Associates, Inc. | 2019-12-20 |
| BioGlue Surgical Adhesive (P010003/S037) | Cryolife, Inc. | 2019-12-20 |
| Siello/Solia S Leads Tip (P950037/S208) | Biotronik, Inc. | 2019-12-20 |
| Karl Storz Photodynamic D-light C (PDD) System (P050027/S018) | KARL STORZ Endoscopy-America, Inc. | 2019-12-20 |
| Exogen Ultrasound Bone Healing System (P900009/S044) | Bioventus, LLC | 2019-12-20 |
| MiniMed 530G System (P120010/S137) | Medtronic, Inc. | 2019-12-19 |
| MiniMed 630G System with SmartGuard (P150001/S078) | Medtronic Minimed | 2019-12-19 |
| Interstim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S304) | Medtronic Neuromodulation | 2019-12-19 |
| Solesta Injectable Gel (P100014/S023) | Palette Life Sciences | 2019-12-19 |
| iPro2 CGM System with Enlite Sensor (P150029/S034) | Medtronic Minimed | 2019-12-19 |
| IMMULITE 2000 Anti HBc IgM (P010053/S011) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S449) | Medtronic Neuromodulation | 2019-12-19 |
| CP Stent, Covered CP Stent, Mounted CP Stent, Covered and Mounted CP Stent, Mounted CP Stent, NuDEL (P150028/S004) | NuMED, Inc. | 2019-12-19 |
| MiniMed 630G System With SmartGuard (P150001/S079) | Medtronic Minimed | 2019-12-19 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S051) | Boston Scientific Corporation | 2019-12-19 |
| Guardian Connect System (P160007/S033) | Medtronic Minimed | 2019-12-19 |
| MyCareLink Smart Patient Reader, CareLink Encore Programmer (P890003/S424) | Medtronic, Inc. | 2019-12-19 |
| IMMULITE 2000 Anti-HBc (P010051/S012) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| IMMULITE 2000 PSA (P930027/S022) | Siemens Healthcare Diagnostics, Inc. | 2019-12-19 |
| Guardian Connect System (P160007/S031) | Medtronic Minimed | 2019-12-19 |
| LifeVest Wearable Defibrillator (P010030/S130) | Zoll Manufacturing Corporation | 2019-12-19 |
| Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S131) | Boston Scientific Corporation | 2019-12-19 |
| MiniMed 670G System (P160017/S078) | Medtronic Minimed, Inc. | 2019-12-19 |
| MiniMed 670G System (P160017/S077) | Medtronic Minimed, Inc. | 2019-12-19 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S348) | Medtronic, Inc. | 2019-12-19 |
| Active Deep Brain Stimulation Therapy System (P960009/S364) | Medtronic, Inc. | 2019-12-19 |
| Medtronic MiniMed 670G System (P160017/S079) | Medtronic Minimed, Inc. | 2019-12-19 |
| Onyx Liquid Embolic System and Apollo Onyx Delivery Micro Catheter (P030004/S022) | Ev3 Neurovascular | 2019-12-19 |
| Paradigm Real-Time Revel System (P150019/S061) | Medtronic Minimed | 2019-12-19 |
| IMMULITE 2000 Anti-HBs (P010052/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| DEFLUX Injectable Gel (P000029/S086) | Palette Life Sciences | 2019-12-19 |
| Epic Vascular Self-Expanding Stent System (P110035/S054) | Boston Scientific Corp | 2019-12-19 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System (P140015/S029) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im (P050023/S140) | Biotronik, Inc. | 2019-12-19 |
| IMMULITE 2000 HBsAg & HBs Ag Confirmatory (P010050/S017) | Siemens Healthcare Diagnostics Products, Ltd. | 2019-12-19 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S007) | Tandem Diabetes Care, Inc. | 2019-12-19 |
| MiniMed 630G System (P150001/S080) | Medtronic Minimed | 2019-12-19 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S199) | Medtronic Neuromodulation | 2019-12-19 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S077) | Boston Scientific Corp | 2019-12-19 |
| Implantable System for Remodulin (P140032/S044) | Medtronic, Inc. | 2019-12-19 |
| IMMULITE 2000 AFP (P010007/S011) | Siemens Healthcare Diagnostics, Inc. | 2019-12-19 |
| Guardian Connect system (P160007/S030) | Medtronic Minimed | 2019-12-19 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB) (P130024/S030) | Lutonix | 2019-12-19 |
| IMMULITE 2000 Free PSA (P060005/S010) | Siemens Medical Solutions Diagnostics Limited | 2019-12-19 |
| Senza spinal Cord Stimulation (SCS) System (P130022/S024) | Nevro Corporation | 2019-12-18 |
| COBAS HBV TEST (P150014/S034) | Roche Molecular Systems, Inc. | 2019-12-18 |
| Lutonix 018 Drug Coated Balloon PTA Catheters (P130024/S032) | Lutonix | 2019-12-18 |
| Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses (P890023/S040) | The Cooper Companies | 2019-12-18 |
| Innova Vascular Self-Expanding Stent System (P140028/S050) | Boston Scientific Corporation | 2019-12-18 |
| COBAS CMV TEST (P160041/S027) | Roche Molecular Systems, Inc. | 2019-12-18 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S097) | Medtronic Vascular | 2019-12-18 |
| Bellafill Dermal Filler (P020012/S032) | Tiger Aesthetics Medical, LLC | 2019-12-18 |
| Astra S DR/SR MRI IPG, Astra XT DR/DR MRI IPG and Azure S SR MRI IPG XT DR/SR MRI IPG (P980035/S610) | Medtronic, Inc. | 2019-12-18 |
| Rebel Platinum Chromium Coronary Stent System (Monrail and Over-The-Wire) (P130030/S064) | Boston Scientific Corp | 2019-12-18 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S112) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-12-18 |
| Silicone Gel Breast Implants (P070004/S019) | Tiger Aesthetics Medical, LLC | 2019-12-18 |
| CareLink SmartSync Device Manager Programmer (P890003/S423) | Medtronic, Inc. | 2019-12-18 |
| Durolane, Hyaluronic Acid, Stabilized Single Injection (P170007/S005) | Bioventus, LLC | 2019-12-18 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S076) | W. L. Gore & Associates, Inc. | 2019-12-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S020) | Boston Scientific Corp | 2019-12-18 |
| COBAS HCV TEST (P150015/S036) | Roche Molecular Systems, Inc. | 2019-12-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P and Solara Bipolar/Qu (P010015/S423) | Medtronic, Inc. | 2019-12-18 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S015) | Lutonix | 2019-12-18 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S007) | Bausch and Lomb, Inc., | 2019-12-18 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems of the Evolut R, PRO, PRO+ Systems (P130021/S070) | Medtronic, Inc. | 2019-12-17 |
| Total Temporomandibular Joint Replacement System (P020016/S011) | Biomet Microfixation, Inc. | 2019-12-17 |
| Tendril ST and Tendril STS Low Voltage Leads (P960013/S110) | ABBOTT MEDICAL | 2019-12-17 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S029) | Medtronic Vascular | 2019-12-17 |
| CardioMessenger Smart 4G LTE (P050023/S138) | Biotronik, Inc. | 2019-12-17 |
| NeuroPace RNS System (P100026/S075) | NeuroPace, Inc. | 2019-12-17 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S048) | Medtronic, Inc. | 2019-12-17 |