| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S038) | Edwards Lifesciences, LLC | 2019-10-10 |
| Cobas TaqMan HCV Test, v2.0, for Use with the High Pure System and Cobas AmpliPrep, Cobas TaqMan HCV Test, v2.0 (P060030/S080) | Roche Molecular Systems, Inc. | 2019-10-10 |
| InterStim Therapy System, Verify Evaluation System (P080025/S195) | Medtronic Neuromodulation | 2019-10-10 |
| cobas BRAF V600 Mutation Test (P110020/S034) | Roche Molecular Systems, Inc. | 2019-10-10 |
| cobas HPV Test (P100020/S050) | Roche Molecular Systems, Inc. | 2019-10-10 |
| AcrySof Posterior Chamber Intraocular Lens (P930014/S128) | Alcon Laboratories, Inc. | 2019-10-10 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S092) | Alcon Research, Ltd. | 2019-10-10 |
| cobas CMV Test (P160041/S026) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Interstim Therapy System, Verify Evaluation System (P970004/S300) | Medtronic Neuromodulation | 2019-10-10 |
| cobas EGFR Mutation Test and cobas EGFR Mutation Test v2 (P120019/S030) | Roche | 2019-10-10 |
| Ultra (samfilcon A) Contact Lens (P170035/S005) | Bausch and Lomb, Inc., | 2019-10-10 |
| cobas HCV Test (P150015/S035) | Roche Molecular Systems, Inc. | 2019-10-10 |
| EMBLEM S-ICD Electrode (P110042/S128) | Boston Scientific Corporation | 2019-10-10 |
| cobas KRAS Mutation Test (P140023/S021) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.0 (P050028/S079) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Silsoft (elastofilcon A) Contact Lens (P850068/S013) | Bausch & Lomb, Inc. | 2019-10-10 |
| Cobas AmpliPrep and Cobas TaqMan CMV Test (P110037/S050) | Roche Molecular Systems, Inc. | 2019-10-10 |
| Filshie Clip (Mark VI) System (P920046/S011) | Femcare , Ltd. | 2019-10-09 |
| Oxford Partial Knee System (P010014/S094) | Biomet Manufacturing Corp | 2019-10-09 |
| Biofinity Toric (P080011/S099) | CooperVision, Inc. | 2019-10-09 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S027) | Cardiovascular Systems, Inc. | 2019-10-09 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S051) | St Jude Medical | 2019-10-09 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S064) | ABBOTT MEDICAL | 2019-10-09 |
| Freezor Cardiac Cryoablation System (P020045/S090) | Medtronic Cryocath, LP | 2019-10-09 |
| Raindrop Near Vision Inlay (P150034/S008) | Rvo 2.0, Inc. (D.B.A. Optics Medical) | 2019-10-09 |
| CervicalStim (P030034/S015) | Orthofix, Inc. | 2019-10-08 |
| Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants (P100044/S044) | Intersect Ent. | 2019-10-08 |
| Hydrus Microstent (P170034/S001) | Alcon Research, LLC | 2019-10-08 |
| Cologaurd (P130017/S034) | Exact Sciences Corporation | 2019-10-08 |
| SURGICEL Original Absorbable Hemostat (N12159/S064) | ETHICON, Inc. | 2019-10-08 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S336) | Medtronic, Inc. | 2019-10-08 |
| ENDOLOGIX POWERLINK SYSTEM (P040002/S062) | Endologix, LLC | 2019-10-08 |
| PhysioStim and SpinalStim (P850007/S043) | Orthofix, Inc. | 2019-10-08 |
| RESTYLANE Injectable Gels (P040024/S116) | Q-Med AB | 2019-10-08 |
| Nucleus 24 Cochlear Implant System (EA22 Stiffener) (P970051/S192) | Cochlear Americas | 2019-10-08 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S170) | W. L. Gore & Associates, Inc. | 2019-10-08 |
| Wallstent Venous RP & Endoprosthesis with Unistep Plus (P980033/S056) | Boston Scientific Corporation | 2019-10-07 |
| LOTUS Edge Valve System (P180029/S013) | Boston Scientific Corporation | 2019-10-07 |
| Epic Vascular Self Expanding Stent System (P110035/S053) | Boston Scientific Corp | 2019-10-07 |
| SLS/GlideLight (P960042/S067) | Spectranetics (Philips) | 2019-10-07 |
| Wallstent RP Endoprosthesis Iliac (P940019/S057) | Boston Scientific Scimed, Inc. | 2019-10-07 |
| Wallstent Endoprostheis TIPS with Unistep Plus (P930031/S066) | Boston Scientific Corp | 2019-10-07 |
| HeartWare Ventricular Assist System (P100047/S147) | Medtronic | 2019-10-07 |
| Innova Vascular Self Expanding Stent System (P140028/S046) | Boston Scientific Corporation | 2019-10-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S016) | Boston Scientific Corp | 2019-10-07 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S039) | Abbott Diabetes Care, Inc. | 2019-10-07 |
| IntellaTip MiFi Open Irrigated (P150005/S048) | Boston Scientific Corp | 2019-10-07 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S030) | Abbott Diabetes Care, Inc. | 2019-10-07 |
| Corox OTW BP (P070008/S107) | Biotronik, Inc. | 2019-10-04 |
| Arista AH Absorbable Hemostat (P050038/S033) | Davol, Inc. | 2019-10-04 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S106) | Biotronik, Inc. | 2019-10-04 |
| TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD (P050023/S134) | Biotronik, Inc. | 2019-10-04 |
| 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 M (P010031/S680) | Medtronic Cardiac Rhythm Disease Management | 2019-10-04 |
| Evera MRI DF1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR (P980016/S719) | Medtronic Cardiac Rhythm Disease Management | 2019-10-04 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S007) | Lutonix | 2019-10-04 |
| DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037/S204) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX AV ICD SYSTEM (P000009/S081) | Biotronik, Inc. | 2019-10-04 |
| PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM (P980023/S094) | Biotronik, Inc. | 2019-10-04 |
| CustomFlex Artificial Iris (P170039/S002) | Humanoptics AG | 2019-10-03 |
| MynxGrip, Mynx Ace, and Mynx Control Vascular Closure Device (VCD) (P040044/S085) | Cordis US Corporation | 2019-10-03 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S033) | Alcon Laboratories, Inc. | 2019-10-03 |
| LOTUS Edge Valve System (P180029/S014) | Boston Scientific Corporation | 2019-10-03 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S096) | Edwards Lifesciences, LLC | 2019-10-03 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems (P140003/S058) | Abiomed, Inc. | 2019-10-03 |
| Impella RP System (P170011/S016) | Abiomed, Inc. | 2019-10-03 |
| WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S029) | Alcon Laboratories, Inc. | 2019-10-03 |
| Implantable System for Remodulin (P140032/S036) | Medtronic, Inc. | 2019-10-02 |
| GORE TAG Thoracic Endoprosthesis (P040043/S110) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| Zephyr Valve Registry (ZEVR) (P180002/S009) | Pulmonx Corporation | 2019-10-02 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter (P170003/S012) | Lutonix | 2019-10-02 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S020) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S069) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S164) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S072) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE CARDIOFORM Septal Occulder (P050006/S075) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S130) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| GORE TIGRIS Vascular Stent (P160004/S027) | W. L. Gore & Associates, Inc. | 2019-10-02 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S002) | MicroVention, Inc. | 2019-10-01 |
| Novasure Impedance Controlled Endometrial Ablation System (P010013/S078) | Hologic, Inc. | 2019-10-01 |
| Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens (P980040/S098) | Johnson & Johnson Surgical Vision, Inc. | 2019-10-01 |
| Bellafill Dermal Filler (P020012/S034) | Tiger Aesthetics Medical, LLC | 2019-10-01 |
| Azure and Astra MRI SureScan IPG and Pacing System (P980035/S601) | Medtronic, Inc. | 2019-10-01 |
| SynchroMed (SM) Infusion System (P860004/S342) | Medtronic, Inc. | 2019-10-01 |
| TriageHF (P890003/S418) | Medtronic, Inc. | 2019-10-01 |
| Restylane Refyne, Restylane Defyne (P140029/S019) | Q-Med AB | 2019-09-30 |
| RESTYLANE INJECTABLE GELS (P040024/S115) | Q-Med AB | 2019-09-30 |
| Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System (P140031/S095) | Edwards Lifesciences, LLC | 2019-09-30 |
| AngioJet Ultra Thrombectomy System (P980037/S076) | Boston Scientific Corp | 2019-09-30 |
| MitraClip G4 Clip Delivery System (P100009/S036) | ABBOTT MEDICAL | 2019-09-30 |
| ETI-AB-EBK PLUS assay (P990041/S029) | DiaSorin, Inc. | 2019-09-27 |
| Amplia, Claria MRI CRT-D, Amplia, Claria and Compia MRI Quad CRT-D, Brava Quad CRT-D, Brava, Consulta and Protecta CRT-D (P010031/S681) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| Implantable System for Remodulin (P140032/S041) | Medtronic, Inc. | 2019-09-27 |
| ETI-AB-COREK PLUS assay (P990045/S027) | DiaSorin, Inc. | 2019-09-27 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S236) | Medtronic, Inc. | 2019-09-27 |
| Evera/Visia AF MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR (P980016/S720) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| CapSure Sense Leand and CapSure SP Novus Lead (P830061/S175) | Medtronic Cardiac Rhythm Disease Management | 2019-09-27 |
| CapSure Epicardial Pacing Lead (P950024/S088) | Medtronic, Inc. | 2019-09-27 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify (P840001/S443) | Medtronic Neuromodulation | 2019-09-27 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S298) | Medtronic Neuromodulation | 2019-09-27 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead (P890003/S419) | Medtronic, Inc. | 2019-09-27 |