| Spectranetics Laser Sheaths SLS (P960042/S064) | Spectranetics (Philips) | 2018-10-15 |
| AngioSculpt PTCA Scoring Balloon Catheter (P050018/S025) | Spectranetics Corp. | 2018-10-15 |
| Astron Stent System (P140030/S008) | Biotronik AG | 2018-10-15 |
| CVX-300 Excimer Laser System and ELCA Coronary Atherectomy Catheters (P910001/S107) | Spectranetics Corp. | 2018-10-15 |
| TactiCath Quartz Equipment (P130026/S034) | St Jude Medical | 2018-10-15 |
| Pipeline Flex Embolization Device (P100018/S018) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-10-15 |
| Restore, Itrel, Synergy and Intellis; Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S407) | Medtronic Neuromodulation | 2018-10-13 |
| Activa Deep Brain Stimulation Therapy System (P960009/S325) | Medtronic, Inc. | 2018-10-13 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S317) | Medtronic, Inc. | 2018-10-12 |
| Medtronic DBS Therapy for Epilepsy (P960009/S318) | Medtronic, Inc. | 2018-10-12 |
| GORE TAG Thoracic Endoprosthesis (P040043/S104) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (P140015/S026) | Tandem Diabetes Care, Inc. | 2018-10-11 |
| AcrySof IQ ReSTOR Intraocular Lenses (P040020/S083) | Alcon Research, Ltd. | 2018-10-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S158) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System (P080004/S019) | Hoya Surgical Optics, Inc. | 2018-10-11 |
| FoundationOne CDx (F1CDx) (P170019/S003) | Foundation Medicine, Inc. | 2018-10-11 |
| ACRYSOF IQ RESTOR APODIZED + 3.0D MULTIFOCAL TORIC INTRAOCULAR LENS (P040020/S068) | Alcon Research, Ltd. | 2018-10-11 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Endoprosthesis (P040037/S122) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE TIGRIS Vascular Stent (P160004/S021) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| Flair Endovascular Stent Graft (P060002/S040) | Bard Peripheral Vascular | 2018-10-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S157) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S067) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S061) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| GORE VIABAHN VBX Balloon Expandable Endoprostheis (P160021/S014) | W. L. Gore & Associates, Inc. | 2018-10-11 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008/S005) | Tandem Diabetes Care, Inc. | 2018-10-11 |
| AcrySof Single Piece Intraocular Lenses (P930014/S115) | Alcon Laboratories, Inc. | 2018-10-11 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S003) | Bard Peripheral Vascular, Inc. | 2018-10-11 |
| G5 Mobile Continuous Glucose Monitoring System (P120005/S077) | Dexcom, Inc. | 2018-10-11 |
| Express LD Iliac Premounted System (P090003/S044) | Boston Scientific Corporation | 2018-10-10 |
| CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P010012/S490) | Boston Scientific Corp | 2018-10-10 |
| Express SD Renal Monorail Premounted System (P060006/S094) | Boston Scientific Corp | 2018-10-10 |
| ZENITH TX2 TAA ENDVASCULAR GRAFT (P070016/S009) | William Cook Europe Aps | 2018-10-10 |
| HEMOBLAST Bellows (P170012/S011) | Dilon Technologies, Inc. | 2018-10-10 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S115) | Boston Scientific Corporation | 2018-10-10 |
| ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055) | Cook, Inc. | 2018-10-10 |
| ICDs Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P960040/S429) | Boston Scientific | 2018-10-10 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S001) | Heartsine Technologies, Ltd. | 2018-10-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator) (P080025/S173) | Medtronic Neuromodulation | 2018-10-09 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Neurostimulator) (P970004/S278) | Medtronic Neuromodulation | 2018-10-09 |
| QuickFlex u 1258T LV Lead (P030054/S359) | ABBOTT MEDICAL | 2018-10-09 |
| Cervista HPV 16/18 Assay (P080015/S015) | Hologic, Inc. | 2018-10-09 |
| Cervista® HPV HR Assay (P080014/S023) | Hologic, Inc. | 2018-10-09 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S002) | MicroVention, Inc. | 2018-10-06 |
| Medtronic CareLink, CareLink Encore (P890003/S398) | Medtronic, Inc. | 2018-10-05 |
| NeuroPace RNS System (P100026/S060) | NeuroPace, Inc. | 2018-10-05 |
| Medtronic Core Valve Evolut R and PRO R System (P130021/S053) | Medtronic, Inc. | 2018-10-05 |
| Obalon Balloon System (P160001/S011) | Medtimo, Inc. | 2018-10-05 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S019) | Medtronic Vascular | 2018-10-05 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S013) | ABBOTT MEDICAL | 2018-10-05 |
| Integrity Coronary Stent Systems (P030009/S094) | Medtronic, Ireland | 2018-10-05 |
| Alair Bronchial Thermoplasty Catheter (P080032/S017) | Boston Scientific Corp | 2018-10-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S037) | Medtronic Vascular | 2018-10-05 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S092) | Medtronic Vascular | 2018-10-05 |
| Endurant, Endurant II and Endureant IIS Stent Graft Systems (P100021/S073) | Medtronic Vascular | 2018-10-05 |
| Venaseal Closure System (P140018/S013) | Medtronic Vascular, Inc. | 2018-10-05 |
| Obalon Balloon System (P160001/S023) | Medtimo, Inc. | 2018-10-05 |
| IN.PACT Admiral Paclitaxel-Coatede Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S041) | Medtronic, Inc. | 2018-10-05 |
| Surpass Streamline Flow Diverter (P170024/S001) | Stryker Neurovascular | 2018-10-05 |
| AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S113) | Alcon Laboratories, Inc. | 2018-10-04 |
| XACT Carotid Stent System (P040038/S033) | Abbott Vascular, Inc. | 2018-10-04 |
| VisuMax Femtosecond Laser (P150040/S003) | Carl Zeiss Meditec, Inc. | 2018-10-04 |
| G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System (P120005/S078) | Dexcom, Inc. | 2018-10-04 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIEN (P110019/S102) | Abbott Vascular | 2018-10-04 |
| MULTI-LINK 8 Coronary Stent System, MULTI-LINK 8 SV/ 8 LL Coronary Stent System (P020047/S070) | Abbott Vascular | 2018-10-04 |
| QuantiFERON TB Gold Test, QuantiFERON TB Gold Test (reference lab pack), QuantiFERON TB Gold Plus Test, QuantiFERON TB G (P010033/S040) | Qiagen | 2018-10-04 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S082) | Alcon Research, Ltd. | 2018-10-04 |
| Supera Peripheral Stent System, Supera Pro Interwoven Peripheral Stent System (P120020/S020) | Abbott Vascular (Idef Technologies Inc) | 2018-10-04 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S081) | Alcon Research, Ltd. | 2018-10-04 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S022) | Cardiovascular Systems, Inc. | 2018-10-04 |
| XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S143) | Abbott Vascular, Inc. | 2018-10-04 |
| AcrySof Posterior Chamber Single Piece Intraocular Lens (P930014/S114) | Alcon Laboratories, Inc. | 2018-10-04 |
| BioMimics 3D Vascular Stent System (P180003) | Veryan Medical, Ltd. | 2018-10-04 |
| Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters (P140009/S040) | ABBOTT MEDICAL | 2018-10-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI (P980016/S681) | Medtronic Cardiac Rhythm Disease Management | 2018-10-03 |
| Micra TPS (P150033/S039) | Medtronic, Inc. | 2018-10-03 |
| Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W (P950037/S196) | Biotronik, Inc. | 2018-10-03 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S100) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2018-10-03 |
| Revo MRI SureScan IPG (P090013/S288) | Medtronic, Inc. | 2018-10-03 |
| Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, (P980035/S558) | Medtronic, Inc. | 2018-10-03 |
| Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters (P010032/S143) | ABBOTT MEDICAL | 2018-10-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D and Compia MRI Quad C (P010031/S640) | Medtronic Cardiac Rhythm Disease Management | 2018-10-03 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S101) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-10-03 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S376) | Medtronic, Inc. | 2018-10-03 |
| ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S031) | The Cooper Companies | 2018-10-02 |
| comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S074) | CooperVision, Inc. | 2018-10-02 |
| AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom (P980037/S070) | Boston Scientific Corp | 2018-10-02 |
| Cardiva VASCADE VCS (P120016/S025) | Cardiva Medical, Inc. | 2018-10-02 |
| Aptima HBV Quant Assay (P170025/S001) | Hologic, Inc. | 2018-10-02 |
| polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S061) | CooperVision, Inc. | 2018-10-02 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S036) | ABBOTT MEDICAL | 2018-10-01 |
| Obalon Balloon System (P160001/S022) | Medtimo, Inc. | 2018-10-01 |
| Assurity / Assurity+ / Endurity (P880086/S302) | ABBOTT MEDICAL | 2018-10-01 |
| Misago RX Self-expanding Peripheral Stent (P140002/S014) | Terumo Medical Corporation | 2018-10-01 |
| Assurity MRI and Endurity MRI (P140033/S037) | ABBOTT MEDICAL | 2018-10-01 |
| Allura, Allure Quadra/ Quadra Allure MP (P030035/S173) | ABBOTT MEDICAL | 2018-10-01 |
| Micra Programmer Application Software Model SW022 (P150033/S038) | Medtronic, Inc. | 2018-10-01 |
| Closer Vascular Sealing System (VSS) (P150022/S007) | Rex Medical, L.P. | 2018-10-01 |
| CareLink Network DDMA Model 2491 (P890003/S394) | Medtronic, Inc. | 2018-10-01 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S017) | Medtronic Vascular | 2018-10-01 |
| Evera MRI DF-1 ICD, Evera MRI ICD (P980016/S687) | Medtronic Cardiac Rhythm Disease Management | 2018-09-28 |