| MiniMed 630G System with SmartGuard (P150001/S046) | Medtronic Minimed | 2018-06-28 |
| Amplia MRI and Amplia MRI Quad CRT-D SureScan, Compia MRI and Compia MRI Quad CRT-D SureScan and Claria MRI and Claria M (P010031/S626) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Vitatron Crystalline Lead and Vitatron Excellence + Lead (P830061/S160) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Advisa MRI DR SureScan, Advisa MRI SR SureScan, Implantable Pulse Generators (IPGs), Attesta DR MRI SureScan (ATDR01), A (P980035/S549) | Medtronic, Inc. | 2018-06-28 |
| Transvene CS/SVC Lead (P980050/S118) | Medtronic, Inc. | 2018-06-28 |
| Innova Self-Expanding Stent System (P140028/S032) | Boston Scientific Corporation | 2018-06-28 |
| Algovita Spinal Cord Stimulation System (SCS), Trial Lead: 8/12 Electrode Percutaneous Lead Kit (P130028/S021) | Nuvectra Corporation | 2018-06-28 |
| Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan (P980016/S668) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| SelectSecure Lead (P030036/S102) | Medtronic Cardiac Rhythm Disease Management | 2018-06-28 |
| Attain Ability Lead / Attain Performa Lead (P080006/S124) | Medtronic, Inc. | 2018-06-27 |
| LCS Total Knee System (P830055/S198) | Depuy, Inc. | 2018-06-27 |
| HeartWare Ventricular Assist System (P100047/S123) | Medtronic | 2018-06-27 |
| NATRELLE Silicon-Filled Breast Implants (P020056/S046) | Allergan | 2018-06-27 |
| Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S032) | The Cooper Companies | 2018-06-27 |
| THxID BRAF assay kit (P120014/S008) | bioMerieux, Inc. | 2018-06-27 |
| Durata and Optisure Leads (P950022/S119) | ABBOTT MEDICAL | 2018-06-27 |
| NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046/S027) | Allergan | 2018-06-27 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S005) | Edwards Lifesciences, LLC | 2018-06-27 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S026) | Cerenovus, Inc. | 2018-06-26 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S047) | Mentor Corp. | 2018-06-26 |
| Mentor MemoryShape Breast Implants (P060028/S029) | Mentor Worldwide, LLC | 2018-06-26 |
| Guardian Sensor (3) System (P160007/S005) | Medtronic Minimed | 2018-06-26 |
| Zilver Vascular Stent (P050017/S016) | Cook Ireland, Ltd. | 2018-06-26 |
| Mentor Saline-Filled and SPECTRUM Breast Implants (P990075/S044) | Mentor Worldwide, LLC | 2018-06-26 |
| Precision Spinal cord Stimulator System, Precision spectra Spinal cord Stimulator System, Spectra WaveWriter Spinal cord (P030017/S314) | Boston Scientific Corp | 2018-06-25 |
| BioGlue Surgical Adhesive (P010003/S030) | Cryolife, Inc. | 2018-06-25 |
| LCS Total Knee System (P830055/S202) | Depuy, Inc. | 2018-06-25 |
| ATTUNE Revision RP Tibial Base (P830055/S204) | Depuy, Inc. | 2018-06-25 |
| Praxis Extended RAS Panel (P160038/S004) | Illumina, Inc. | 2018-06-25 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S400) | Medtronic Neuromodulation | 2018-06-23 |
| Obalon Balloon Kit (P160001/S015) | Medtimo, Inc. | 2018-06-22 |
| Restylane Refyne, Restylane Defyne (P140029/S010) | Q-Med AB | 2018-06-22 |
| LCS Total Knee System: TRUMATCH Personalized Solutions (P830055/S197) | Depuy, Inc. | 2018-06-22 |
| HeartWare HVAD System (P100047/S110) | Medtronic | 2018-06-22 |
| Selenia Dimensions / 3Dimensions (P080003/S007) | Hologic, Inc. | 2018-06-22 |
| Brava Quad CRT-D, Viva Quad S/XT CRT-D (P010031/S635) | Medtronic Cardiac Rhythm Disease Management | 2018-06-22 |
| G5 Mobile Continuous Glucose Monitoring Systems (P120005/S076) | Dexcom, Inc. | 2018-06-22 |
| iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043) | Glaukos Corporation | 2018-06-21 |
| EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM (P160048) | Senseonics, Incorporated | 2018-06-21 |
| MiniMed 670G System (P160017/S031) | Medtronic Minimed, Inc. | 2018-06-21 |
| Paradigm Spine Coflex Interlaminar Stabilization Device (P110008/S009) | Companion Spine France | 2018-06-21 |
| Minerva Endometrial Ablation System (P140013/S010) | Axora Medical, Inc. | 2018-06-21 |
| Abbott RealTime HCV Genotype II Assay (P120012/S017) | Abbott Molecular | 2018-06-21 |
| t:slim X2 Insulin Pump with Basal-IQ Technology (P180008) | Tandem Diabetes Care, Inc. | 2018-06-21 |
| RESTYLANE REYNE and RESTYLANE DEFYNE INJECFTABLE GELS (P140029/S011) | Q-Med AB | 2018-06-21 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S401) | Medtronic Neuromodulation | 2018-06-21 |
| PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S157) | Boston Scientific Corp | 2018-06-21 |
| BD PrepStain System (P970018/S036) | Bd Diagnostic Systems | 2018-06-21 |
| Abbott RealTime HCV Assay (P100017/S021) | Abbott Molecular, Inc. | 2018-06-21 |
| LifeStent 5mm Vascular Stent System (P070014/S056) | Bard Peripheral Vascular, Inc. | 2018-06-20 |
| Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A (P150048/S021) | Edwards Lifesciences, LLC | 2018-06-20 |
| Evia DR,DR-T,SR,SR-T; Entovis DR,DR-T,SR-T; Estella DR,DR-T,SR,SR-T; Effecta D,S; Edora 8 DR, 8 SR; Etrinsa 8 DR-T,SR-T, (P950037/S187) | Biotronik, Inc. | 2018-06-19 |
| Evia HF, HF-T, Entovis HF, HF-T, Edora 8 HF-T, Enitra HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, (P070008/S091) | Biotronik, Inc. | 2018-06-19 |
| EMBLEM S-ICD Pulse Generator (PG), EMBLEM MRI S-ICD Pulse Generator (PG) (P110042/S110) | Boston Scientific Corporation | 2018-06-19 |
| AspireAssist (P150024/S011) | Aspire Bariatrics, Inc. | 2018-06-19 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S098) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-06-19 |
| SynchroMed Infusion System (P860004/S310) | Medtronic, Inc. | 2018-06-19 |
| lesto 7 DR-T, lperia 7 DR-T, lforia 7 DR-T, lnventra 7 DR-T, llesto 5 DR-T, ltrevia 5 DR-T, lforia 5 DR-T, lperia 5 DR-T (P050023/S117) | Biotronik, Inc. | 2018-06-19 |
| OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators (P910066/S029) | Djo, LLC | 2018-06-19 |
| Implantable System for Remodulin (P140032/S012) | Medtronic, Inc. | 2018-06-19 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S006) | Boston Scientific Corp | 2018-06-19 |
| Allure, Allure Quadra, Quadra Allure MP, and Anthem (P030035/S170) | ABBOTT MEDICAL | 2018-06-15 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S018) | Bolton Medical, Inc. | 2018-06-15 |
| Implantable System for Remodulin (P140032/S010) | Medtronic, Inc. | 2018-06-15 |
| InterStim Therapy System, and Verify Evaluation System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S273) | Medtronic Neuromodulation | 2018-06-15 |
| Pipeline Flex Embolization Device (PFED) (P100018/S017) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-06-15 |
| SynchroMed Infusion System, and Ascenda Intrathecal Catheters (P860004/S309) | Medtronic, Inc. | 2018-06-15 |
| Ellipse, Fortify, Fortify Assura and Quadra Assura MP (P910023/S409) | ABBOTT MEDICAL | 2018-06-15 |
| SmartAblate System (P990071/S039) | Biosense Webster, Inc. | 2018-06-15 |
| Quadra Assura, Unify, Unify Assura and Unify Quadra (P030054/S354) | ABBOTT MEDICAL | 2018-06-15 |
| 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/S633) | Medtronic Cardiac Rhythm Disease Management | 2018-06-15 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S675) | Medtronic Cardiac Rhythm Disease Management | 2018-06-15 |
| Activa Deep Brain Stimulation Therapy System (P960009/S317) | Medtronic, Inc. | 2018-06-15 |
| InterStim Therapy System, and Verify Evaluation System (SNS Urinary Screening) (P970004/S274) | Medtronic Neuromodulation | 2018-06-15 |
| Activa Deep Brain Stimulation Therapy System (P960009/S316) | Medtronic, Inc. | 2018-06-15 |
| iDESIGNRefractive Studio, STAR Excimer Laser System (P930016/S053) | Amo Manufacturing USA, LLC | 2018-06-15 |
| Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System (P120005/S075) | Dexcom, Inc. | 2018-06-15 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S168) | Medtronic Neuromodulation | 2018-06-15 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Screening) (P080025/S169) | Medtronic Neuromodulation | 2018-06-15 |
| Implantable System for Remodulin (ISR) (P140032/S011) | Medtronic, Inc. | 2018-06-15 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter (P170003/S002) | Lutonix | 2018-06-15 |
| Assurity, Assurity +, Endurity, Accent and Victory XL (P880086/S300) | ABBOTT MEDICAL | 2018-06-15 |
| Assurity MRI and Endurity MRI (P140033/S032) | ABBOTT MEDICAL | 2018-06-15 |
| Mastr Restore, Itrel, Synergy and Intellis Spinal COrd Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S399) | Medtronic Neuromodulation | 2018-06-15 |
| Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MIR IPG (P980035/S557) | Medtronic, Inc. | 2018-06-14 |
| HEMOBLAST Bellows (P170012/S004) | Dilon Technologies, Inc. | 2018-06-14 |
| GORE Viabahn Balloon Expandable VBX Endoprosthesis (P160021/S009) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| Roche CBAS TaqMan HBV Test, v2.0 (P050028/S065) | Roche Molecular Systems, Inc. | 2018-06-14 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S005) | Medinol, Ltd. | 2018-06-14 |
| GORE Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S054) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S030) | Medinol, Ltd. | 2018-06-14 |
| Organ Care System (OCS) Lung System (P160013/S001) | TransMedics, Inc. | 2018-06-14 |
| GORE Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S115) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| GORE Tigris Vascular Stent (P160004/S012) | W. L. Gore & Associates, Inc. | 2018-06-14 |
| Restylane Refyne, Restylane Defyne (P140029/S009) | Q-Med AB | 2018-06-14 |
| SynchroMed Infusion System (P860004/S300) | Medtronic, Inc. | 2018-06-13 |
| Progel Pleural Air Leak Sealant (P010047/S058) | Neomend, Inc. | 2018-06-13 |
| Elecsys HBsAg Immunoassay (P990012/S032) | Roche Diagnostics Corp. | 2018-06-13 |
| Elecsys Anti-HCV II (P140021/S014) | Roche Diagnostics Operations, Inc. | 2018-06-13 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis / with ThermalFix tissue process/ RSR Pericardial Aortic B (P860057/S172) | Edwards Lifesciences, LLC | 2018-06-13 |