| IMMULITE 2000 Anti-HBc (P010051/S013) | Siemens Healthcare Diagnostics Products, Ltd. | 2020-09-08 |
| IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 fPSA (P060005/S012) | Siemens Medical Solutions Diagnostics Limited | 2020-09-08 |
| Ascendra+ Delivery System, NovaFlex+ Delivery System (P130009/S111) | Edwards Lifesciences, LLC | 2020-09-07 |
| Commander Delivery System, Certitude Delivery System (P140031/S118) | Edwards Lifesciences, LLC | 2020-09-07 |
| EDWARDS INTUITY Elite Delivery System (P150036/S052) | Edwards Lifesciences, LLC | 2020-09-07 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S048) | Edwards Lifesciences, LLC | 2020-09-07 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S313) | Medtronic Neuromodulation | 2020-09-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S208) | Medtronic Neuromodulation | 2020-09-06 |
| Activa Deep Brain Stimulation Therapy System (P960009/S379) | Medtronic, Inc. | 2020-09-06 |
| Implantable System for Remodulin (P140032/S059) | Medtronic, Inc. | 2020-09-06 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S466) | Medtronic Neuromodulation | 2020-09-06 |
| MED-EL Cochlear Implant System (P000025/S118) | Med-El Corp. | 2020-09-04 |
| Integra Dermal Regeneration Template (P900033/S089) | Integra Lifesciences Corp. | 2020-09-04 |
| Biofinity Energys (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S114) | CooperVision, Inc. | 2020-09-04 |
| Oncomine Dx Target Test (P160045/S019) | Life Technologies Corporation | 2020-09-04 |
| AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment (N970012/S180) | Boston Scientific Corp | 2020-09-04 |
| CustomFlex ArtificialIris (P170039/S003) | Humanoptics AG | 2020-09-04 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostat Agent - Microfibrillar Form (P810006/S090) | Integra LifeSciences Corporation | 2020-09-04 |
| Helistat Absorbable Collagen Hemostatic Sponge (P850010/S090) | Integra LifeSciences Corporation | 2020-09-04 |
| HeartWare Ventricular Assist System (P100047/S170) | Medtronic | 2020-09-04 |
| ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers (P150012/S098) | Boston Scientific | 2020-09-03 |
| VICI VENOUS STENT System (P180013/S004) | Boston Scientific Corporation | 2020-09-03 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S015) | Berlin Heart, Inc. | 2020-09-03 |
| XACT Carotid Stent System (P040038/S036) | Abbott Vascular, Inc. | 2020-09-03 |
| Rapid fFN for the TLiIQ System (P920048/S016) | Hologic, Inc. | 2020-09-03 |
| ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 - Non MRI Pacemakers (N970003/S253) | Boston Scientific Corp | 2020-09-03 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 - Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S199) | Guidant Corp. | 2020-09-03 |
| HeartWare HVAD System (P100047/S166) | Medtronic | 2020-09-03 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S087) | Dexcom, Inc. | 2020-09-03 |
| MiniMed 630G System (P150001/S087) | Medtronic Minimed | 2020-09-02 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S036) | Boston Scientific Corp | 2020-09-02 |
| Innova Vascular Self-Expanding Stent System (P140028/S063) | Boston Scientific Corporation | 2020-09-02 |
| Guardian Connect System (P160007/S037) | Medtronic Minimed | 2020-09-02 |
| Praxis Extended RAS Panel (P160038/S017) | Illumina, Inc. | 2020-09-02 |
| MiniMed 670G System (P160017/S086) | Medtronic Minimed, Inc. | 2020-09-02 |
| Straumann Emdogain (P930021/S026) | The Straumann Company | 2020-09-02 |
| OPTIMIZER Smart System (P180036/S005) | Impulse Dynamics (Usa), Inc. | 2020-09-02 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S119) | W. L. Gore & Associates, Inc. | 2020-09-02 |
| Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S043) | The Cooper Companies | 2020-09-01 |
| Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S089) | CooperVision, Inc. | 2020-09-01 |
| Axonics Sacral Neuromodulation System (P180046/S015) | Boston Scientific Corporation | 2020-08-31 |
| Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S057) | CooperVision, Inc. | 2020-08-31 |
| Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints (P050031/S007) | CooperVision, Inc. | 2020-08-31 |
| Axonics Sacral Neuromodulation System (P190006/S015) | Boston Scientific Corporation | 2020-08-31 |
| Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints (P050031/S006) | CooperVision, Inc. | 2020-08-31 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015) | Edwards Lifesciences, LLC | 2020-08-31 |
| Nucleus Cochlear Implant System (P970051/S197) | Cochlear Americas | 2020-08-31 |
| MiniMed 770G System (P160017/S076) | Medtronic Minimed, Inc. | 2020-08-31 |
| Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti (P870024/S056) | CooperVision, Inc. | 2020-08-31 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049) | DiaSorin, Inc. | 2020-08-29 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017) | DiaSorin, Inc. | 2020-08-29 |
| Alinity m HBV (P200013) | Abbott Molecular, Inc. | 2020-08-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S064) | Boston Scientific Corporation | 2020-08-28 |
| AngelMed Guardian System (P150009/S003) | Avertix Medical, Inc. | 2020-08-28 |
| Restylane Refyne, Restylane Defyne, and Restylane Kysse Injectable Gels (P140029/S028) | Q-Med AB | 2020-08-28 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S037) | Boston Scientific Corp | 2020-08-28 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S053) | Mentor Corp. | 2020-08-28 |
| AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOLs (P040020/S095) | Alcon Research, Ltd. | 2020-08-28 |
| ARCHITECT Anti-HCV, Alinity i Anti-HCV (P050042/S044) | Abbott Laboratories, Inc. | 2020-08-28 |
| Epic Vascular Self-Expanding Stent System (P110035/S062) | Boston Scientific Corp | 2020-08-28 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S021) | Abbott Vascular, Inc. | 2020-08-28 |
| Floseal Hemostatic Matrix (P990009/S063) | Baxter Healthcare Corp | 2020-08-28 |
| CentriMag Circulatory Support System (P170038/S005) | Abbott | 2020-08-28 |
| Gambro Prismaflex TPE2000 Set (P830063/S017) | Vantive US Healthcare, LLC | 2020-08-27 |
| Micra AV TPS and Micra TPS (P150033/S084) | Medtronic, Inc. | 2020-08-27 |
| LIFEPAK CR2 Defibrillator (P170018/S007) | Physio-Control, Inc. | 2020-08-27 |
| VERSANT HCV Genotype 2.0 Assay (LiPA) (P160016/S006) | Fujirebio Europe N.V. | 2020-08-27 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S082) | Medtronic Sofamor Danek USA, Inc. | 2020-08-27 |
| SURGIFOAM Absorbable Gelatin Sponge U.S.P. (P990004/S042) | Ferrosan Meidcal Devices A/S | 2020-08-27 |
| Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S113) | CooperVision, Inc. | 2020-08-27 |
| TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs (P980040/S113) | Johnson & Johnson Surgical Vision, Inc. | 2020-08-27 |
| Infuse Bone Graft (P050053/S054) | Medtronic, Inc. | 2020-08-27 |
| Infuse Bone Graft (P000054/S063) | Medtronic Sofamor Danek USA, Inc. | 2020-08-27 |
| AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment (P000053/S115) | Boston Scientific Corp | 2020-08-26 |
| Cologuard (P130017/S042) | Exact Sciences Corporation | 2020-08-26 |
| cobas 4800 HPV Test (P100020/S053) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas KRAS Mutation Test (P140023/S023) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas HBV (P150014/S038) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas HCV (P150015/S040) | Roche Molecular Systems, Inc. | 2020-08-26 |
| Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S083) | Roche Molecular Systems, Inc. | 2020-08-26 |
| ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead (P150012/S096) | Boston Scientific | 2020-08-26 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S032) | Roche | 2020-08-26 |
| cobas HPV Test (P190028/S002) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas® EZH2 Mutation Test (P200014/S001) | Roche Molecular System, Inc. | 2020-08-26 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032) | Foundation Medicine, Inc. | 2020-08-26 |
| cobas BRAF V600 Mutation Test (P110020/S035) | Roche Molecular Systems, Inc. | 2020-08-26 |
| cobas CMV (P160041/S030) | Roche Molecular Systems, Inc. | 2020-08-26 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S084) | Roche Molecular Systems, Inc. | 2020-08-26 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S054) | Roche Molecular Systems, Inc. | 2020-08-26 |
| ADVIA Centaur aHBs2 Readypack Reagents and Quality Control Materials (P100039/S010) | Siemens Healthcare Diagnostics, Inc. | 2020-08-25 |
| ADVIA Centaur AFP Readypack Reagents (P930036/S015) | Siemens Healthcare Diagnostics, Inc. | 2020-08-25 |
| ADVIA Centaur HBeAg Readypack Reagents and Quality Control Material (P090024/S009) | Siemens Healthcare Diagnostics | 2020-08-25 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S064) | St Jude Medical | 2020-08-25 |
| MyCareLink Smart Monitor System (P890003/S431) | Medtronic, Inc. | 2020-08-25 |
| ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010) | Siemens Corp. | 2020-08-25 |
| ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls (P030049/S015) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials (P040004/S018) | Siemens Healthcare Diagnostics | 2020-08-25 |
| ZOLL X Series, Propaq MD, and X Series Advanced (P160022/S013) | ZOLL Medical Corporation | 2020-08-25 |