| Adapta Versa Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, En (P980035/S628) | Medtronic, Inc. | 2020-07-24 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S742) | Medtronic Cardiac Rhythm Disease Management | 2020-07-24 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S703) | Medtronic Cardiac Rhythm Disease Management | 2020-07-24 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S041) | Ferrosan Meidcal Devices A/S | 2020-07-24 |
| Micra AV TPS, Micra TPS (P150033/S075) | Medtronic, Inc. | 2020-07-24 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S438) | Medtronic, Inc. | 2020-07-24 |
| PERFLUORON (P950018/S019) | Alcon Laboratories | 2020-07-24 |
| AFX Endovascular AAA System (P040002/S065) | Endologix, LLC | 2020-07-23 |
| Endurant, Endurant II, and Endurant IIs Stent Graft System (P100021/S081) | Medtronic Vascular | 2020-07-23 |
| LIAISON QuantiFERON TB Gold Plus (P180047/S003) | DiaSorin, Inc. | 2020-07-23 |
| Valiant Thoracic Stent Graft with Captiva Delivery System (P100040/S040) | Medtronic Vascular | 2020-07-23 |
| RF Conductr, RF Contactr, RF Marinr, RF Enhancr II (P930029/S066) | Medtronic, Inc. | 2020-07-23 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S631) | Medtronic, Inc. | 2020-07-22 |
| HiResolution Bionic Ear System (P960058/S150) | Advanced Bionics | 2020-07-22 |
| Myocardial Pacing Lead (P120017/S022) | Medtronic, Inc. | 2020-07-22 |
| Sapien 3 and Sapien 3 Ultra Transcatheter Heart Valves (P140031/S107) | Edwards Lifesciences, LLC | 2020-07-22 |
| CapSureFix MRI Lead (P090013/S306) | Medtronic, Inc. | 2020-07-22 |
| Micra AV TPS, Micra TPS (P150033/S076) | Medtronic, Inc. | 2020-07-22 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S149) | Medtronic, Inc. | 2020-07-22 |
| Attain StarFix Lead (P060039/S100) | Medtronic, Inc. | 2020-07-22 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD (P110042/S139) | Boston Scientific Corporation | 2020-07-22 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S707) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S441) | Medtronic, Inc. | 2020-07-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S747) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S212) | Medtronic, Inc. | 2020-07-22 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adapter kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S244) | Medtronic, Inc. | 2020-07-22 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S432) | Medtronic, Inc. | 2020-07-22 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S058) | Boston Scientific Corporation | 2020-07-22 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S182) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S068) | Boston Scientific Corp | 2020-07-22 |
| CapSure Epicardial Pacing Lead (P950024/S093) | Medtronic, Inc. | 2020-07-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S117) | Edwards Lifesciences, LLC | 2020-07-22 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S046) | Edwards Lifesciences, LLC | 2020-07-22 |
| Transvene CS/SVC Lead (P980050/S127) | Medtronic, Inc. | 2020-07-22 |
| EPIC Self Expanding Stent System (P110035/S061) | Boston Scientific Corp | 2020-07-22 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S004) | Cerapedics, LLC | 2020-07-22 |
| DuraSeal Exact Spine Sealant System (P080013/S020) | Integra LifeSciences Corporation | 2020-07-22 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S148) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Superion Indirect Decompression System (IDS) (P140004/S017) | Boston Scientific Neuromodulation | 2020-07-22 |
| Wallstent Iliac Endoprosthesis With Unistep Plus Delivery System (P940019/S059) | Boston Scientific Scimed, Inc. | 2020-07-22 |
| ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S159) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S110) | Edwards Lifesciences, LLC | 2020-07-22 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S121) | Medtronic Cardiac Rhythm Disease Management | 2020-07-22 |
| Axonics Sacral Neuromodulation System (P190006/S014) | Boston Scientific Corporation | 2020-07-21 |
| Aptima HBV Quant Assay (P170025/S016) | Hologic, Inc. | 2020-07-21 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S746) | Medtronic Cardiac Rhythm Disease Management | 2020-07-21 |
| Aptima HPV Assay (P100042/S031) | Gen-Probe Incorporated | 2020-07-21 |
| Aptima HCV Quant Dx Assay (P160023/S019) | Hologic, Inc. | 2020-07-21 |
| Aptima HCV RNA Qualitative Assay (P020011/S016) | Gen-Probe | 2020-07-21 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S706) | Medtronic Cardiac Rhythm Disease Management | 2020-07-21 |
| Axonics Sacral Neuromodulation System (P180046/S013) | Boston Scientific Corporation | 2020-07-21 |
| Mara Water Vapor Ablation System (P160047/S012) | CooperSurgical, Inc. | 2020-07-21 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device (P130013/S035) | Boston Scientific Corp | 2020-07-21 |
| CERAMAX Ceramic Total Hip System (P070026/S070) | DePuy Orthopaedics, Inc. | 2020-07-21 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S028) | Gen-Probe Incorporated | 2020-07-21 |
| Progensa PCA3 Assay (P100033/S012) | Gen-Probe Incorporated | 2020-07-21 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S035) | Boston Scientific Corp | 2020-07-20 |
| HeartWare Ventricular Assist System (P100047/S168) | Medtronic | 2020-07-20 |
| Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi (P190018/S003) | Alcon Laboratories, LLC | 2020-07-20 |
| Inspire Respiratory Sensing Lead (P130008/S054) | Inspire Medical Systems | 2020-07-20 |
| Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre (P190018/S002) | Alcon Laboratories, LLC | 2020-07-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S062) | Boston Scientific Corporation | 2020-07-20 |
| HeartSine samaritan Public Access Automated External Defibrillators and Accessories (P160008/S012) | Heartsine Technologies, Ltd. | 2020-07-17 |
| MemoryGel Breast Implant (P030053/S050) | Mentor Corp. | 2020-07-17 |
| Juvéderm Ultra, Ultra XC, Ultra Plus, and Ultra Plus XC (P050047/S077) | Allergan | 2020-07-17 |
| LCS Total Knee System (P830055/S253) | Depuy, Inc. | 2020-07-17 |
| Juvéderm Vollure XC and Volbella XC (P110033/S055) | Allergan | 2020-07-17 |
| Gel-One (P080020/S038) | Seikagaku Corp. | 2020-07-17 |
| Cormet Hip Resurfacing System (P050016/S012) | Corin USA | 2020-07-17 |
| Flow Re-Direction Endoluminal Device (FRED) System (P180027/S001) | MicroVention, Inc. | 2020-07-17 |
| Synvisc, Synvisc-One (P940015/S046) | Sanofi Genzyme Corp. | 2020-07-17 |
| SUPARTZ FX and VISCO-3 (P980044/S053) | Seikagaku Corp. | 2020-07-17 |
| nGEN Pump (P990071/S044) | Biosense Webster, Inc. | 2020-07-17 |
| ReSure Sealant (P130004/S009) | Ocular Therapeutix, Inc. | 2020-07-16 |
| HeartStart FRx Defibrillator (861304) (P180028/S001) | Philips Medical Systems | 2020-07-16 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S186) | Boston Scientific Corp | 2020-07-16 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S705) | Medtronic Cardiac Rhythm Disease Management | 2020-07-16 |
| VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS (P980016/S745) | Medtronic Cardiac Rhythm Disease Management | 2020-07-16 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S004) | Philips Medical Systems, Inc. | 2020-07-16 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, Automatic (P050023/S147) | Biotronik, Inc. | 2020-07-16 |
| Coseal Surgical Sealant (P030039/S025) | Baxter Bio Science | 2020-07-16 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S147) | Medtronic, Inc. | 2020-07-15 |
| SURGICEL Family of Absorbable Hemostats (N12159/S072) | ETHICON, Inc. | 2020-07-15 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S079) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| CERAMAX Ceramic Total Hip System (P070026/S075) | DePuy Orthopaedics, Inc. | 2020-07-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S078) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| HeartWare Ventricular Assist System (P100047/S167) | Medtronic | 2020-07-15 |
| Clareon and Clareon Toric Intraocular Lenses (IOLs) (P190018/S001) | Alcon Laboratories, LLC | 2020-07-15 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S139) | W. L. Gore & Associates, Inc. | 2020-07-15 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S030) | Cardiovascular Systems, Inc. | 2020-07-15 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S037) | ETHICON, Inc. | 2020-07-15 |
| NeuroPace RNS System (P100026/S083) | NeuroPace, Inc. | 2020-07-14 |
| Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S008) | Bausch and Lomb, Inc., | 2020-07-14 |
| LCS Total Knee System (P830055/S249) | Depuy, Inc. | 2020-07-14 |
| NeuroPace RNS System (P100026/S081) | NeuroPace, Inc. | 2020-07-14 |
| Cologuard (P130017/S037) | Exact Sciences Corporation | 2020-07-14 |
| LCS Total Knee System (P830055/S251) | Depuy, Inc. | 2020-07-13 |
| LIFEPAK CR2 Defibrillator (P170018/S005) | Physio-Control, Inc. | 2020-07-13 |
| NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee System (P060037/S065) | Zimmer, Inc. | 2020-07-13 |
| Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System, Evolut R TAV of the Evolut R System (P130021/S079) | Medtronic, Inc. | 2020-07-13 |