| cobas CMV (P160041/S032) | Roche Molecular Systems, Inc. | 2020-12-10 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S113) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-12-10 |
| cobas HCV (P150015/S042) | Roche Molecular Systems, Inc. | 2020-12-10 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S668) | Medtronic, Inc. | 2020-12-10 |
| cobas HPV (P190028/S004) | Roche Molecular Systems, Inc. | 2020-12-10 |
| Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S046) | The Cooper Companies | 2020-12-10 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S036) | Pfizer, Inc. | 2020-12-10 |
| Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves (P040021/S045) | ABBOTT MEDICAL | 2020-12-10 |
| Sprint Quattro Lead (P920015/S251) | Medtronic, Inc. | 2020-12-10 |
| CapSure Sense Lead (P830061/S190) | Medtronic Cardiac Rhythm Disease Management | 2020-12-10 |
| CapSureFix Novus Lead (P930039/S221) | Medtronic, Inc. | 2020-12-10 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S031) | Cardiovascular Systems, Inc. | 2020-12-10 |
| cobas HBV (P150014/S040) | Roche Molecular Systems, Inc. | 2020-12-10 |
| Edwards Commander Delivery System (P200015/S006) | Edwards Lifesciences, LLC | 2020-12-10 |
| Intellis Spinal Cord Stimulation Systems (P840001/S476) | Medtronic Neuromodulation | 2020-12-10 |
| Angio Seal Vascular Closure Device (P930038/S098) | Terumo Medical Corporation | 2020-12-09 |
| ActaStim-S Spine Fusion Stimulator (P190030) | Theragen, Inc. | 2020-12-09 |
| Attain StarFix Lead (P060039/S105) | Medtronic, Inc. | 2020-12-08 |
| DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS (P920015/S250) | Medtronic, Inc. | 2020-12-08 |
| CapSure Epicardial Pacing Lead (P950024/S097) | Medtronic, Inc. | 2020-12-08 |
| Nucleus Hybrid L24 Cochlear Implant System (P130016/S045) | Cochlear Americas | 2020-12-08 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S155) | Medtronic, Inc. | 2020-12-08 |
| Transvene CS/SVC Lead (P980050/S131) | Medtronic, Inc. | 2020-12-08 |
| Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead (P830061/S188) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S462) | Medtronic, Inc. | 2020-12-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S030) | Medinol, Ltd. | 2020-12-08 |
| Innova Vascular Self-Expanding Stent System (P140028/S065) | Boston Scientific Corporation | 2020-12-08 |
| Orthovisc (P030019/S025) | Anika Therapeutics, Inc. | 2020-12-08 |
| End Cap, Epicardial Patch Lead, and Upsizing Sleeve (P900061/S163) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S186) | Boston Scientific Corp | 2020-12-08 |
| Attain Ability Lead (P080006/S154) | Medtronic, Inc. | 2020-12-08 |
| Myocardial Pacing Lead (P120017/S026) | Medtronic, Inc. | 2020-12-08 |
| CapSureFix MRI Lead (P090013/S312) | Medtronic, Inc. | 2020-12-08 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead (P930039/S219) | Medtronic, Inc. | 2020-12-08 |
| Evolut R, Pro and Pro+ Systems (P130021/S083) | Medtronic, Inc. | 2020-12-08 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S039) | Boston Scientific Corp | 2020-12-08 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S069) | Boston Scientific Corporation | 2020-12-08 |
| Nucleus Auditory Brainstem Implant System (P000015/S045) | Cochlear Americas | 2020-12-08 |
| Abbott RealTime HCV Assay (P100017/S023) | Abbott Molecular, Inc. | 2020-12-08 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le (P850089/S152) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S128) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Nucleus 24 Cochlear Implant System (P970051/S201) | Cochlear Americas | 2020-12-08 |
| Floseal Hemostatic Matrix (P990009/S064) | Baxter Healthcare Corp | 2020-12-08 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S441) | Medtronic, Inc. | 2020-12-08 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S071) | Boston Scientific Corp | 2020-12-08 |
| Inspire II Upper Airway Stimulator (P130008/S061) | Inspire Medical Systems | 2020-12-07 |
| Oxford Partial Knee System (P010014/S100) | Biomet Manufacturing Corp | 2020-12-07 |
| Titan Inflatable Penile Prosthesis (P000006/S058) | Coloplast Corp. | 2020-12-07 |
| X Series, R Series, and AED Pro (P160022/S023) | ZOLL Medical Corporation | 2020-12-07 |
| Avalus Bioprosthesis (P170006/S019) | Medtronic, Inc. | 2020-12-06 |
| Abbott RealTime HBV Assay (P080026/S023) | Abbott Molecular, Inc. | 2020-12-04 |
| GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S081) | W. L. Gore & Associates, Inc. | 2020-12-04 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse Injectable Gels (P140029/S031) | Q-Med AB | 2020-12-04 |
| Praxis Extended RAS Panel (P160038/S018) | Illumina, Inc. | 2020-12-04 |
| StarClose SE Vascular Closure System (P050007/S040) | Abbott Vascular Devices | 2020-12-04 |
| Prostar XL Percutaneous Vascular Surgical System, Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Su (P960043/S110) | Abbott Vascular, Inc. | 2020-12-04 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S456) | Boston Scientific | 2020-12-04 |
| GORE CARDIOFORM Septal Occluder (P050006/S087) | W. L. Gore & Associates, Inc. | 2020-12-04 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S525) | Boston Scientific Corp | 2020-12-04 |
| ENDOTAK LEAD SYSTEM (P910073/S158) | Boston Scientific | 2020-12-04 |
| GEM21S Growth Factor Enhanced Matrix (P040013/S024) | Lynch Biologics, LLC | 2020-12-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S050) | Medtronic, Inc. | 2020-12-04 |
| Organ Care System (OCS) Lung System (P160013/S007) | TransMedics, Inc. | 2020-12-03 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S248) | Medtronic, Inc. | 2020-12-03 |
| VISTAKON (senofilcon A) Multifocal and Multifocal Toric Contact Lenses (P040045/S118) | Vistakon, Division of Johnson & Johnson Vision Car | 2020-12-03 |
| SelectSecure Lead (P030036/S126) | Medtronic Cardiac Rhythm Disease Management | 2020-12-03 |
| TREO® Abdominal Stent-Graft System (P190015/S004) | Bolton Medical, Inc. | 2020-12-03 |
| Preveleak Surgical Sealant - 1O-Pack Delivery Tips (P100030/S014) | Baxter Healthcare Corporation | 2020-12-02 |
| ORBERA Intragastric Balloon System (P140008/S019) | Boston Scientific Corporation | 2020-12-02 |
| LCS Total Knee System (P830055/S260) | Depuy, Inc. | 2020-12-02 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S001) | Boston Scientific Corporation | 2020-12-02 |
| Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate) (P110007/S013) | Johnson & Johnson Surgical Vision, Inc. | 2020-12-02 |
| Bulkamid Urethral Bulking System (P170023/S005) | Boston Scientific Corporation | 2020-12-02 |
| HiResolution Bionic Ear System (P960058/S149) | Advanced Bionics | 2020-12-02 |
| Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack (P810031/S068) | Johnson & Johnson Surgical Vision, Inc. | 2020-12-02 |
| Paradigm Real-Time REVEL System (P150019/S062) | Medtronic Minimed | 2020-12-01 |
| PRESTIGE LP Cervical Disc (P090029/S015) | Medtronic Sofamor Danek USA, Inc. | 2020-12-01 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 5 (P980023/S103) | Biotronik, Inc. | 2020-12-01 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T (P000009/S088) | Biotronik, Inc. | 2020-12-01 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S152) | Biotronik, Inc. | 2020-12-01 |
| Dromos DR/SR Rate Adaptive Pacing Systems (P950037/S217) | Biotronik, Inc. | 2020-12-01 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T (P070008/S120) | Biotronik, Inc. | 2020-12-01 |
| Guardian Connect system (P160007/S039) | Medtronic Minimed | 2020-12-01 |
| Saline-Filled and Spectrum Breast Implants (P990075/S049) | Mentor Worldwide, LLC | 2020-12-01 |
| WaveWriter Alpha Spinal Cord Stimulator (SCS) System (P030017/S338) | Boston Scientific Corp | 2020-12-01 |
| MiniMed 630G System (P150001/S089) | Medtronic Minimed | 2020-12-01 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S009) | Stryker Leibinger GmbH & Co KG | 2020-12-01 |
| Oncomine Dx Target Test (P160045/S024) | Life Technologies Corporation | 2020-12-01 |
| MiniMed 530G System (P120010/S138) | Medtronic, Inc. | 2020-12-01 |
| iPro2 CGM System with Enlite Sensor (P150029/S035) | Medtronic Minimed | 2020-12-01 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S015) | Djo Global | 2020-12-01 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S148) | Boston Scientific Corporation | 2020-12-01 |
| MiniMed 670G System and MiniMed 770G System (P160017/S088) | Medtronic Minimed, Inc. | 2020-12-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S038) | Boston Scientific Corp | 2020-11-30 |
| Epic Self Expanding Stent System (P110035/S063) | Boston Scientific Corp | 2020-11-30 |
| Implantable System for Remodulin (P140032/S063) | Medtronic, Inc. | 2020-11-30 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S183) | Boston Scientific Corp | 2020-11-30 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S321) | Medtronic Neuromodulation | 2020-11-30 |
| SynchroMed Infusion System (P860004/S365) | Medtronic, Inc. | 2020-11-30 |
| CERAMAX Ceramic Total Hip System (P070026/S078) | DePuy Orthopaedics, Inc. | 2020-11-30 |