| SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S099) | Edwards Lifesciences, LLC | 2021-01-27 |
| myChoice CDx (P190014/S004) | Myriad Genetic Laboratories, Inc. | 2021-01-27 |
| Preveleak Surgical Sealant (P100030/S013) | Baxter Healthcare Corporation | 2021-01-26 |
| GORE Cardioform Septal Occluder and GORE Cardioform ASD Occluder (P050006/S089) | W. L. Gore & Associates, Inc. | 2021-01-26 |
| TECNIS Simplicity Delivery System (P980040/S129) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-26 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S082) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S141) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| ThermoCool SmartTouch Catheters (P030031/S111) | Biosense Webster, Inc. | 2021-01-22 |
| GORE® EXCLUDER® AAA Endoprosthesis and GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S177) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S054) | Boston Scientific Corporation | 2021-01-22 |
| Intellis Spinal Cord Stimulation Systems (P840001/S465) | Medtronic Neuromodulation | 2021-01-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S080) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| Medstream Programmable Infusion Pump System (P890055/S075) | Intera Oncology | 2021-01-22 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S027) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| ThermoCool SmartTouch SF Catheters (P040036/S076) | Biosense Webster, Inc. | 2021-01-22 |
| GORE® CARDIOFORM Septa! Occluder and GORE® CARDIOFORM ASD Occluder (P050006/S088) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| GORE® TAG® Thoracic Endoprosthesis and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S121) | W. L. Gore & Associates, Inc. | 2021-01-22 |
| Micra AV TPS, Micra TPS (P150033/S090) | Medtronic, Inc. | 2021-01-21 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S034) | Boston Scientific Corp | 2021-01-21 |
| Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable (P890003/S437) | Medtronic, Inc. | 2021-01-21 |
| Axium Neurostimulator System (P150004/S040) | ABBOTT MEDICAL | 2021-01-21 |
| Patient Cable and Surgical Cable (P820003/S138) | Medtronic Cardiac Rhythm Disease Management | 2021-01-21 |
| TMR Holmium Laser System (P970029/S038) | Cryolife, Inc. | 2021-01-21 |
| VenaSeal Closure System (P140018/S021) | Medtronic Vascular, Inc. | 2021-01-21 |
| Abbott RealTime IDH1 (P170041/S003) | Abbott Molecular, Inc. | 2021-01-19 |
| INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S092) | Integra Lifesciences Corp. | 2021-01-19 |
| Helistat Absorbable Collagen Hemostatic Agent and Helitene Absorbable Collagen hemostatic Agent - Fibrillar Form (P850010/S092) | Integra LifeSciences Corporation | 2021-01-19 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collasta Absorbable Collagen hemostatic Agent - Microfibrillar Form (P810006/S092) | Integra LifeSciences Corporation | 2021-01-19 |
| Proclaim SCS Neurostimulator System (P150004/S041) | ABBOTT MEDICAL | 2021-01-19 |
| Abbott RealTime IDH2 (P170005/S002) | Abbott Molecular, Inc. | 2021-01-19 |
| Alinity m HCV (P190025/S003) | Abbott Molecular, Inc. | 2021-01-19 |
| Alinity m HBV (P200013/S001) | Abbott Molecular, Inc. | 2021-01-19 |
| Proclaim SCS Neurostimulation System (P140009/S062) | ABBOTT MEDICAL | 2021-01-19 |
| Proclaim SCS Neurostimulation System (P010032/S166) | ABBOTT MEDICAL | 2021-01-19 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery (P840062/S078) | Integra Lifesciences Corp. | 2021-01-19 |
| GEM 21S Growth Factor Enhanced Matrix (P040013/S025) | Lynch Biologics, LLC | 2021-01-15 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S361) | Medtronic, Inc. | 2021-01-15 |
| Implantable System for Remodulin (ISR) (P140032/S058) | Medtronic, Inc. | 2021-01-15 |
| Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S122) | CooperVision, Inc. | 2021-01-15 |
| Percept Deep Brain Stimulation Therapy System (P960009/S393) | Medtronic, Inc. | 2021-01-15 |
| Percept Deep Brain Stimulation Therapy Systems (P960009/S394) | Medtronic, Inc. | 2021-01-15 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S082) | Medtronic, Inc. | 2021-01-15 |
| Guardian Connect System (P160007/S035) | Medtronic Minimed | 2021-01-14 |
| Bulkamid Urethral Bulking System (P170023/S008) | Boston Scientific Corporation | 2021-01-14 |
| AEGEA Vapor System (P160047/S019) | CooperSurgical, Inc. | 2021-01-14 |
| MiniMed 630G System with Smart Guard (P150001/S084) | Medtronic Minimed | 2021-01-14 |
| miniMed 670G System (P160017/S083) | Medtronic Minimed, Inc. | 2021-01-14 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S032) | Cardiovascular Systems, Inc. | 2021-01-14 |
| Scandinavian Total Ankle Replacment (STAR Ankle) (P050050/S016) | Djo Global | 2021-01-13 |
| OcuCoat OVD (P860047/S034) | Bausch & Lomb, Inc. | 2021-01-13 |
| FINELINE II Sterox, Endocardial Pacing Lead, Passive Fixation (P960004/S092) | Boston Scientific | 2021-01-13 |
| EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti (P010012/S531) | Boston Scientific Corp | 2021-01-13 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S019) | Berlin Heart, Inc. | 2021-01-13 |
| INGEVITY non-MRI Lead Passive Fixation, Preformed Atrial J, INGEVITY non-MRI Lead Passive Fixation, Ventricular, INGEV (P150012/S106) | Boston Scientific | 2021-01-13 |
| HEMOBLAST Bellows (P170012/S024) | Dilon Technologies, Inc. | 2021-01-13 |
| ACUITY Steerable Heart Failure Lead (P050046/S030) | Guidant Corp. | 2021-01-13 |
| EMBLEM S-ICD Subcutaneous Electrode (P110042/S152) | Boston Scientific Corporation | 2021-01-13 |
| iSert Preloaded IOL System (P080004/S039) | Hoya Surgical Optics, Inc. | 2021-01-13 |
| Endotak Lead System (P910073/S159) | Boston Scientific | 2021-01-13 |
| FLEXTEND® Bipolar, Steroid Eluting, Extendable/Retractable Pacing Lead (P960006/S050) | Boston Scientific | 2021-01-13 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S039) | Bausch & Lomb, Inc. | 2021-01-13 |
| Biofinity XR Toric (Comfilcon A) soft (Hydrophilic) contact lenses for extended wear (P080011/S121) | CooperVision, Inc. | 2021-01-12 |
| Philips HeartStart FR3 Defibrillator (P160028/S002) | Philips Medical Systems, Inc. | 2021-01-11 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (WEB 017) (P170032/S004) | MicroVention, Inc. | 2021-01-11 |
| Imagio Breast Imaging System (P200003) | Seno Medical Instruments, Inc. | 2021-01-11 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S066) | St Jude Medical | 2021-01-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S063) | St Jude Medical | 2021-01-10 |
| TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB (P980040/S128) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-08 |
| Implantable System for Remodulin (P140032/S065) | Medtronic, Inc. | 2021-01-08 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S367) | Medtronic, Inc. | 2021-01-08 |
| TECNIS Multifocal Foldable Posterior Chamber IOL (P080010/S020) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-08 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems, Pisces, Specify, and Vectris Spinal Cord Stimulati (P840001/S481) | Medtronic Neuromodulation | 2021-01-08 |
| TECNIS CL Foldable Silicone Posterior Chamber IOL (P880081/S046) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-08 |
| iSert Preloaded IOL System (P080004/S038) | Hoya Surgical Optics, Inc. | 2021-01-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S392) | Medtronic, Inc. | 2021-01-08 |
| TECNIS Foldable Acrylic IOL (P990080/S055) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-08 |
| Titan Inflatable Penile Prosthesis (P000006/S059) | Coloplast Corp. | 2021-01-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S327) | Medtronic Neuromodulation | 2021-01-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S222) | Medtronic Neuromodulation | 2021-01-08 |
| SENSAR 3-Piece Monofocal IOLs with OptiEdge Design, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IO (P980040/S127) | Johnson & Johnson Surgical Vision, Inc. | 2021-01-08 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |
| Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S038) | Lenstec, Inc. | 2021-01-07 |
| Natural Eyes HydraWear XW Multifocal (P080011/S112) | CooperVision, Inc. | 2021-01-07 |
| Hydrus Microstent (P170034/S006) | Alcon Research, LLC | 2021-01-07 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S033) | ABBOTT MEDICAL | 2021-01-07 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S005) | Boston Scientific Corporation | 2021-01-07 |
| Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst (P130021/S084) | Medtronic, Inc. | 2021-01-06 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S072) | ABBOTT MEDICAL | 2021-01-06 |
| KARL STORZ Photodynamic Diagnostic (PDD) D-Light System (P050027/S026) | KARL STORZ Endoscopy-America, Inc. | 2021-01-06 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S025) | ZOLL Medical Corporation | 2021-01-05 |
| AEGEA Vapor System (P160047/S017) | CooperSurgical, Inc. | 2021-01-05 |
| R Series Device (P160022/S024) | ZOLL Medical Corporation | 2021-01-05 |
| Freestyle Bioprosthesis (P970031/S068) | Medtronic, Inc. | 2021-01-05 |
| Hancock Valved Conduit (P870078/S048) | Medtronic, Inc. | 2021-01-05 |
| LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly (P080011/S110) | CooperVision, Inc. | 2021-01-05 |
| Hancock II Bioprosthesis (P980043/S074) | Medtronic, Inc. | 2021-01-05 |
| Infuse Bone Graft (P050053/S052) | Medtronic, Inc. | 2021-01-05 |
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S046) | Abbott Diabetes Care, Inc. | 2021-01-05 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S052) | Abbott Diabetes Care, Inc. | 2021-01-05 |
| Mosaic Bioprosthesis (P990064/S083) | Medtronic, Inc. | 2021-01-05 |