| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S433) | Medtronic, Inc. | 2020-04-14 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D (P980035/S623) | Medtronic, Inc. | 2020-04-14 |
| Edwards INTUITY Elite Tube Extrusion (P150036/S051) | Edwards Lifesciences, LLC | 2020-04-14 |
| Inspire Upper Airway Stimulation (P130008/S039) | Inspire Medical Systems | 2020-04-14 |
| ExAblate 4000 System (Exablate Neuro or the system) (P150038/S012) | Insightec | 2020-04-14 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q (P010031/S697) | Medtronic Cardiac Rhythm Disease Management | 2020-04-14 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S057) | Boston Scientific Corporation | 2020-04-13 |
| Epic Vascular Self-Expanding Stent System (P110035/S058) | Boston Scientific Corp | 2020-04-13 |
| SofLens Toric (alphafilcon A) Contact Lenses (P960022/S012) | Bausch & Lomb, Inc. | 2020-04-13 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S048) | Abbott Diabetes Care, Inc. | 2020-04-13 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S080) | Boston Scientific Corp | 2020-04-13 |
| Livewire TC Ablation Catheter (P960016/S082) | St Jude Medical | 2020-04-13 |
| FreeStyle Libre 14-day Flash Glucose Monitoring System (P160030/S041) | Abbott Diabetes Care, Inc. | 2020-04-13 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S004) | Boston Scientific Corporation | 2020-04-13 |
| SURGICEL SNoW Absorbable Hemostat (N12159/S070) | ETHICON, Inc. | 2020-04-13 |
| SofLens (polymacon) Contact Lenses (N16895/S103) | Bausch & Lomb, Inc. | 2020-04-13 |
| Cologuard (P130017/S039) | Exact Sciences Corporation | 2020-04-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S037) | Boston Scientific Corp | 2020-04-11 |
| prodisc L Total Disc Replacement (P050010/S020) | Centinel Spine, LLC | 2020-04-10 |
| GORE EXCLUDER AAA Endoprosthesis product family (P020004/S174) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| Axonics Sacral Neuromodulation System (P190006/S010) | Boston Scientific Corporation | 2020-04-10 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve (P150048/S043) | Edwards Lifesciences, LLC | 2020-04-10 |
| GORE TAG Thoracic Endoprosthesis product family (P040043/S114) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| BioMimics 3D Vascular Stent System (P180003/S002) | Veryan Medical, Ltd. | 2020-04-10 |
| GORE CARDIOFORM Occluder product family (P050006/S082) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S001) | Medtronic Vascular, Inc. | 2020-04-10 |
| ARCHITECT Total PSA Reagent/Calibrator/Control Kit (P910007/S052) | Abbott Laboratories | 2020-04-10 |
| VenaSeal Closure System (P140018/S019) | Medtronic Vascular, Inc. | 2020-04-10 |
| Vercise PC and Vercise Gevia DBS Systems (P150031/S026) | Boston Scientific Corp | 2020-04-10 |
| EDWARDS INTUITY Elite Valve (P150036/S048) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S105) | Edwards Lifesciences, LLC | 2020-04-10 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2020-04-10 |
| Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther (P860057/S196) | Edwards Lifesciences, LLC | 2020-04-10 |
| Axonics Sacral Neuromodulation System (P180046/S010) | Boston Scientific Corporation | 2020-04-10 |
| Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve (P140031/S102) | Edwards Lifesciences, LLC | 2020-04-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S060) | Boston Scientific Corporation | 2020-04-09 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S026) | C.R. Bard, Inc. | 2020-04-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S071) | Abiomed, Inc. | 2020-04-09 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S025) | Medinol, Ltd. | 2020-04-09 |
| Impella RP (P170011/S023) | Abiomed, Inc. | 2020-04-09 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S033) | Davol Inc., Sub. C. R. Bard, Inc. | 2020-04-09 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S026) | ABBOTT MEDICAL | 2020-04-09 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S031) | Medtronic Vascular | 2020-04-09 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S035) | Medinol, Ltd. | 2020-04-09 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S176) | Boston Scientific Corp | 2020-04-09 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S077) | ABBOTT MEDICAL | 2020-04-09 |
| CyPass Micro-Stent (P150037/S014) | Alcon Research, Ltd. | 2020-04-09 |
| LIAISON XL MUREX HCV Ab (P190011/S001) | DiaSorin, Inc. | 2020-04-08 |
| HeartWare Ventricular Assist System (P100047/S157) | Medtronic | 2020-04-08 |
| DuraSeal Exact System (P080013/S018) | Integra LifeSciences Corporation | 2020-04-08 |
| LIAISON XL MUREX anti-HBc (P180038/S001) | DiaSorin, Inc. | 2020-04-08 |
| LIAISON QuantiFERON - TB Gold Plus (P180047/S002) | DiaSorin, Inc. | 2020-04-08 |
| DuraSeal Dural Sealant System (P040034/S030) | Integra LifeSciences Corporation | 2020-04-08 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S026) | W. L. Gore & Associates, Inc. | 2020-04-08 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S451) | Boston Scientific | 2020-04-07 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S354) | Medtronic, Inc. | 2020-04-07 |
| Axonics Sacral Neuromodulation System (P190006/S009) | Boston Scientific Corporation | 2020-04-07 |
| Activa Deep Brain Stimulation Therapy System (P960009/S371) | Medtronic, Inc. | 2020-04-07 |
| Restore,Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimula (P840001/S458) | Medtronic Neuromodulation | 2020-04-07 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S519) | Boston Scientific Corp | 2020-04-07 |
| coflex Interlaminar Stabilization Device (P110008/S011) | Companion Spine France | 2020-04-07 |
| Axonics Sacral Neuromodulation System (P180046/S009) | Boston Scientific Corporation | 2020-04-07 |
| S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S136) | Boston Scientific Corporation | 2020-04-07 |
| Implantable System for Remodulin (P140032/S051) | Medtronic, Inc. | 2020-04-07 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S733) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| CapSure Sense Lead (P830061/S180) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| 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/S694) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| NeuroPace RNS System (P100026/S080) | NeuroPace, Inc. | 2020-04-06 |
| 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/S695) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S621) | Medtronic, Inc. | 2020-04-06 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S431) | Medtronic, Inc. | 2020-04-06 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S734) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| Micra TPS (P150033/S068) | Medtronic, Inc. | 2020-04-06 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S056) | St Jude Medical | 2020-04-06 |
| XIENCE Sierra Everolimus Eluting Coronary System (P110019/S109) | Abbott Vascular | 2020-04-06 |
| T SPOT .TB Test (P070006/S013) | Oxford Immunotec, Ltd. | 2020-04-03 |
| Solo Smart Heart Valve (P130011/S009) | Corcym Canada Corp | 2020-04-03 |
| therascreen FGFR RGQ PCR Kit (P180043/S002) | QIAGEN GmbH | 2020-04-03 |
| Atellica IM Alpha Fetoprotien (AFP) Assay (P930036/S014) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S018) | Bimini Health Tech | 2020-04-03 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S019) | Corcym S.r.l. | 2020-04-03 |
| Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S017) | Siemens Healthcare Diagnostics | 2020-04-03 |
| therascreen EGFR RGQ PCR Kit (P120022/S021) | QIAGEN GmbH | 2020-04-03 |
| Atellica IM Hepatitis B surface Antigen II (HBs11) and Atellica IM Hepatitis B surface Antigen 11 confirmatory (HBs11 Co (P110041/S009) | Siemens Corp. | 2020-04-03 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2)Assay (P100039/S009) | Siemens Healthcare Diagnostics, Inc. | 2020-04-03 |
| therascreen KRAS RGQ PCR Kit (P110027/S011) | QIAGEN GmbH | 2020-04-03 |
| Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S017) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S021) | Siemens Healthcare Diagnostics | 2020-04-03 |
| cobas HPV for use on the cobas 6800/8800 Systems (P190028) | Roche Molecular Systems, Inc. | 2020-04-03 |
| therascreen PIK3CA RGQ PCR Kit (P190001/S001) | QIAGEN GmbH | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P190006/S008) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P180046/S007) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P180046/S008) | Boston Scientific Corporation | 2020-04-03 |
| Axonics Sacral Neuromodulation System (P190006/S007) | Boston Scientific Corporation | 2020-04-03 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S021) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S008) | Siemens Healthcare Diagnostics | 2020-04-03 |
| Promus PREMIER and Promus ELITE (P110010/S177) | Boston Scientific Corp | 2020-04-03 |
| HiResolution Bionic Ear System (P960058/S145) | Advanced Bionics | 2020-04-03 |
| Atellica IM Hepatitis C (aHCV) Assay (P030056/S016) | Siemens Healthcare Diagnostics | 2020-04-03 |
| WOLVERINE Coronary Cutting Balloon (P950020/S107) | Boston Scientific Corp | 2020-04-02 |