| Alinity i HBsAg Qualitative II (P110029/S031) | Abbott Laboratories | 2020-05-23 |
| Vysis ALK Break Apart Fish Probe Kit (P110012/S020) | Abbott Molecular, Inc. | 2020-05-22 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S138) | W. L. Gore & Associates, Inc. | 2020-05-22 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S099) | Biotronik, Inc. | 2020-05-22 |
| Tendril MRI (P140033/S057) | ABBOTT MEDICAL | 2020-05-22 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S077) | W. L. Gore & Associates, Inc. | 2020-05-22 |
| CentriMag Circulatory Support System (P170038/S002) | Abbott | 2020-05-22 |
| Single/Dual Chamber ICD Systems, Bipolar CRT-D Systems and Acticor and Rivacor 1.5 T and 3.0 T ICD and CRT-D Systems (P050023/S144) | Biotronik, Inc. | 2020-05-22 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S009) | Rxsight, Inc. | 2020-05-22 |
| Quadripolar CRT-D Systems (P070008/S114) | Biotronik, Inc. | 2020-05-22 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S313) | ABBOTT MEDICAL | 2020-05-21 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S036) | ETHICON, Inc. | 2020-05-21 |
| Allure, Allure Quadra, and Quadra Allure MP (P030035/S181) | ABBOTT MEDICAL | 2020-05-21 |
| Restylane Refyne, Restylane Defyne Injectable Gels (P140029/S025) | Q-Med AB | 2020-05-21 |
| Micra AV TPS, Micra TPS (P150033/S072) | Medtronic, Inc. | 2020-05-21 |
| Freestyle Libre 14 day Flash Glucose Monitoring System (P160030/S042) | Abbott Diabetes Care, Inc. | 2020-05-21 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S031) | Boston Scientific Corp | 2020-05-21 |
| Edwards Commander Delivery System (P140031/S115) | Edwards Lifesciences, LLC | 2020-05-21 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S011) | Rxsight, Inc. | 2020-05-21 |
| Fortify, Fortify Assura, and Ellipse (P910023/S427) | ABBOTT MEDICAL | 2020-05-21 |
| Assurity MRI and Endurity MRI (P140033/S058) | ABBOTT MEDICAL | 2020-05-21 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads (P030054/S378) | ABBOTT MEDICAL | 2020-05-21 |
| Implantable System for Remodulin (P140032/S055) | Medtronic, Inc. | 2020-05-20 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S358) | Medtronic, Inc. | 2020-05-20 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S104) | Medtronic Cryocath, LP | 2020-05-20 |
| Guardian Connect System (P160007/S029) | Medtronic Minimed | 2020-05-20 |
| Surpass Evolve Flow Diverter System (P170024/S003) | Stryker Neurovascular | 2020-05-20 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S177) | Boston Scientific Corp | 2020-05-20 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S035) | ETHICON, Inc. | 2020-05-20 |
| LIFEPAK CR2 Automated External Defibrillator (AED) (P170018/S006) | Physio-Control, Inc. | 2020-05-20 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S112) | Boston Scientific Corp | 2020-05-20 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S092) | Boston Scientific Corp | 2020-05-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S059) | Boston Scientific Corporation | 2020-05-19 |
| enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL) (P910056/S043) | Bausch & Lomb, Inc. | 2020-05-19 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S126) | Boston Scientific | 2020-05-19 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S184) | Boston Scientific Corp | 2020-05-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S053) | Boston Scientific Corp | 2020-05-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S122) | Boston Scientific Corp | 2020-05-19 |
| Innova Self-Expanding Stent System (P140028/S056) | Boston Scientific Corporation | 2020-05-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S028) | Boston Scientific Corp | 2020-05-19 |
| Express SD Monorail Premounted Stent System (P060006/S100) | Boston Scientific Corp | 2020-05-19 |
| Epic Vascular Self-Expanding Stent System (P110035/S057) | Boston Scientific Corp | 2020-05-19 |
| FoundationOne CDx (P170019/S015) | Foundation Medicine, Inc. | 2020-05-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S106) | Boston Scientific Corp | 2020-05-19 |
| Hydro Thermablator Endometrial Ablation System (P000040/S038) | Axora Medical, Inc. | 2020-05-19 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S079) | Boston Scientific Corp | 2020-05-19 |
| BRACAnalysis CDx (P140020/S020) | Myriad Genetic Laboratories | 2020-05-19 |
| Barricaid Annular Closure Device (P160050/S006) | Intrinsic Therapeutics | 2020-05-19 |
| LCS® Total Knee System (P830055/S245) | Depuy, Inc. | 2020-05-19 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S067) | Boston Scientific Corp | 2020-05-19 |
| PROMUS Element PLUS/PREMIER/ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S176) | Boston Scientific Corp | 2020-05-19 |
| RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler (P050052/S122) | Merz North America, Inc. | 2020-05-18 |
| cobas KRAS Mutation Test (P140023/S022) | Roche Molecular Systems, Inc. | 2020-05-18 |
| SJM Masters HP Valved Graft (P810002/S108) | ABBOTT MEDICAL | 2020-05-18 |
| Ventana PD-L1 (SP142) Assay (P160002/S012) | Ventana Medical Systems, Inc. | 2020-05-18 |
| RADIESSE Injectable Implant (P050037/S104) | Merz North America, Inc. | 2020-05-18 |
| COAPTITE Injectable Implant (P040047/S058) | Merz North America, Inc. | 2020-05-18 |
| CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol (P010015/S430) | Medtronic, Inc. | 2020-05-17 |
| Durata and Optisure High Voltage Lead (P950022/S112) | ABBOTT MEDICAL | 2020-05-17 |
| CareLink SmartSync Azure Astra Application, Azure S DR MRI IPG Azure S sR MRI IRG and Azure XT DR/SR MRI IPG (P980035/S619) | Medtronic, Inc. | 2020-05-17 |
| CareLink SmartSync Platform and Common Application (P890003/S428) | Medtronic, Inc. | 2020-05-17 |
| MyCareLink Patient Monitor (P890003/S427) | Medtronic, Inc. | 2020-05-15 |
| Optisure High Voltage Leads (P950022/S131) | ABBOTT MEDICAL | 2020-05-15 |
| Straumann Emdogain (P930021/S024) | The Straumann Company | 2020-05-15 |
| 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/S616) | Medtronic, Inc. | 2020-05-15 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S033) | Boston Scientific Corp | 2020-05-15 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S345) | Medtronic, Inc. | 2020-05-15 |
| PD-L1 IHC 28-8 pharmDx (P150025/S013) | Agilent Technologies, Inc. | 2020-05-15 |
| 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/S730) | Medtronic Cardiac Rhythm Disease Management | 2020-05-15 |
| Micra TPS, Micra AV (P150033/S067) | Medtronic, Inc. | 2020-05-15 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S035) | Cook Ireland, Ltd. | 2020-05-15 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S428) | Medtronic, Inc. | 2020-05-15 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S337) | Boston Scientific Corp | 2020-05-15 |
| Nucleus 24 Cochlear Implant System (P970051/S198) | Cochlear Americas | 2020-05-15 |
| 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/S691) | Medtronic Cardiac Rhythm Disease Management | 2020-05-15 |
| cobas HPV Test (P100020/S051) | Roche Molecular Systems, Inc. | 2020-05-14 |
| cobas HBV (P150014/S036) | Roche Molecular Systems, Inc. | 2020-05-14 |
| COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 (P050028/S082) | Roche Molecular Systems, Inc. | 2020-05-14 |
| LeukoStrat CDx FLT3 Mutation Assay (P160040/S006) | Invivoscribe Technologies, Inc. | 2020-05-14 |
| COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 (P060030/S083) | Roche Molecular Systems, Inc. | 2020-05-14 |
| cobas HCV (P150015/S038) | Roche Molecular Systems, Inc. | 2020-05-14 |
| Implantable System for Remodulin (P140032/S054) | Medtronic, Inc. | 2020-05-14 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S017) | Lutonix | 2020-05-14 |
| cobas CMV (P160041/S029) | Roche Molecular Systems, Inc. | 2020-05-14 |
| SynchroMed Infusion System (P860004/S357) | Medtronic, Inc. | 2020-05-14 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S034) | Lutonix | 2020-05-14 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S053) | Roche Molecular Systems, Inc. | 2020-05-14 |
| LifeVest Wearable Defibrillator (P010030/S137) | Zoll Manufacturing Corporation | 2020-05-14 |
| LOTUS Edge Valve System (P180029/S023) | Boston Scientific Corporation | 2020-05-13 |
| VNS Therapy System (P970003/S231) | LivaNova USA, Inc. | 2020-05-13 |
| Assurity, Endurity Core Family of Pacemakers (P880086/S306) | ABBOTT MEDICAL | 2020-05-13 |
| LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator (P160012/S004) | Physio-Control, Inc. | 2020-05-13 |
| Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag (P030017/S336) | Boston Scientific Corp | 2020-05-13 |
| FoundationOne CDx (F1CDx) (P170019/S018) | Foundation Medicine, Inc. | 2020-05-13 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S048) | ABBOTT MEDICAL | 2020-05-13 |
| Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia) (P150031/S032) | Boston Scientific Corp | 2020-05-13 |
| Barricaid Annular Closure Device (P160050/S005) | Intrinsic Therapeutics | 2020-05-12 |
| Cologuard (P130017/S040) | Exact Sciences Corporation | 2020-05-12 |
| Elecsys total PSA (P990056/S037) | Roche Diagnostics Corp. | 2020-05-12 |
| Elecsys free PSA Test System, Biotin remediation (P000027/S035) | Roche Diagnostics Corp. | 2020-05-12 |