| Master InterStim Therapy System, Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S247) | Medtronic Neuromodulation | 2017-09-25 |
| CRT-Ps: Invive, Valitude, and Visionist (P030005/S160) | Guidant Corp. | 2017-09-25 |
| Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI (P150012/S037) | Boston Scientific | 2017-09-25 |
| Lotrafilcon A Soft Contact Lenses for Daily and Extended wear (P010019/S059) | Alcon Laboratories, Inc. | 2017-09-25 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel Programming Systems) (P080025/S142) | Medtronic Neuromodulation | 2017-09-25 |
| Biocor and Epic Heart Valves (P040021/S032) | ABBOTT MEDICAL | 2017-09-22 |
| AMPLATZER PFO OCCLUDER (P120021/S002) | ABBOTT MEDICAL | 2017-09-22 |
| PD-L1 IHC 22C3 pharmDx (P150013/S006) | Agilent Technologies, Inc. | 2017-09-22 |
| Synergy Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire (P150003/S034) | Boston Scientific Corporation | 2017-09-22 |
| Restore, Itrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S375) | Medtronic Neuromodulation | 2017-09-22 |
| Attain Performa Lead Models 4298, 4398, 4598 (P080006/S115) | Medtronic, Inc. | 2017-09-22 |
| Promus Element plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire/ Promus Premie (P110010/S146) | Boston Scientific Corp | 2017-09-22 |
| NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S021) | Cochlear Americas | 2017-09-22 |
| Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software (P140033/S006) | ABBOTT MEDICAL | 2017-09-21 |
| Impella 2.5 System and Impella Ventricular Support Sustems (P140003/S023) | Abiomed, Inc. | 2017-09-21 |
| Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear (P010019/S058) | Alcon Laboratories, Inc. | 2017-09-21 |
| ST JUDE MEDICAL EPIC HF SYSTEM (P030054/S326) | ABBOTT MEDICAL | 2017-09-21 |
| Infuse (R) Bone Graft (P000058/S065) | Medtronic Sofamor Danek USA, Inc. | 2017-09-21 |
| ELCA Coronary Laser Atherectomy Catheters (P910001/S099) | Spectranetics Corp. | 2017-09-21 |
| Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D (P010031/S599) | Medtronic Cardiac Rhythm Disease Management | 2017-09-21 |
| AcrySof IQ Tonic Lenses (P930014/S103) | Alcon Laboratories, Inc. | 2017-09-21 |
| Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P040037/S102) | W. L. Gore & Associates, Inc. | 2017-09-21 |
| AcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor (P040020/S070) | Alcon Research, Ltd. | 2017-09-21 |
| ALTRUA 2 /ESSENTIO/ PROPONENT/ ACCOLADE (N970003/S209) | Boston Scientific Corp | 2017-09-21 |
| AMPLATZER Duct Occluder II (P020024/S048) | ABBOTT MEDICAL | 2017-09-21 |
| Dexcon G5 Mobile Continuous Glucose Monitoring System (P120005/S065) | Dexcom, Inc. | 2017-09-21 |
| VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 (P030005/S157) | Guidant Corp. | 2017-09-21 |
| CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S384) | ABBOTT MEDICAL | 2017-09-21 |
| Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S041) | W. L. Gore & Associates, Inc. | 2017-09-21 |
| LifeVest Wearable Defibrillator (P010030/S099) | Zoll Manufacturing Corporation | 2017-09-21 |
| ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI (P150012/S034) | Boston Scientific | 2017-09-21 |
| Surgifoam Absorbable Gelatin Sponge, U.S.P. (P990004/S032) | Ferrosan Meidcal Devices A/S | 2017-09-21 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S001) | Edwards Lifesciences, LLC | 2017-09-21 |
| Maximo II ICD, Protecta ICD, Protecta VR ICD, Protecta XT ICD, Secura DR ICD, Secura ICD, Virtuoso II DR/VR ICD (P980016/S638) | Medtronic Cardiac Rhythm Disease Management | 2017-09-21 |
| TVL(TM) LEAD SYSTEM (P950022/S105) | ABBOTT MEDICAL | 2017-09-21 |
| Impella RP System (P170011) | Abiomed, Inc. | 2017-09-20 |
| ENDOTAK RELIANCE, (Defibrillation Leads) (P910073/S142) | Boston Scientific | 2017-09-20 |
| Nucleus 24 Cochlear Implant System (P970051/S166) | Cochlear Americas | 2017-09-20 |
| RESONATE, VIGILANT, PERCIVA NG4 ICDs AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 ICDs (P960040/S395) | Boston Scientific | 2017-09-20 |
| INGEVITY MRI Leads, Slit Suture Sleeve Accessory for INGEVITY Leads (Pacing Leads and Accessories) (P150012/S032) | Boston Scientific | 2017-09-20 |
| RESONATE, VIGILANT NG4 CRT-Ds, AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 CRT-Ds, ACUITY X4 Leads, Slit Suture Sleeve Accesso (P010012/S453) | Boston Scientific Corp | 2017-09-20 |
| Nucleus Auditory Brainstem Implant System (P000015/S023) | Cochlear Americas | 2017-09-20 |
| Aorfix AAA Flexible Stent Graft System with Aorflex Delivery Device (P110032/S013) | Lombard Medical Limited | 2017-09-20 |
| LCS Total Knee System (P830055/S187) | Depuy, Inc. | 2017-09-20 |
| Multi-Application Utility Model, (Non-Implantable Accessories) (P910077/S161) | Boston Scientific | 2017-09-20 |
| FINELINE II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories) (P960004/S081) | Boston Scientific | 2017-09-20 |
| Nucleus Hybrid Implant System (P130016/S030) | Cochlear Americas | 2017-09-20 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S025) | Medinol, Ltd. | 2017-09-19 |
| Activa Deep Brain Stimulation Therapy System (P960009/S295) | Medtronic, Inc. | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042) | Zeus Scientific, Inc. | 2017-09-19 |
| Master Restore, Intrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord (P840001/S378) | Medtronic Neuromodulation | 2017-09-19 |
| ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045) | Zeus Scientific, Inc. | 2017-09-19 |
| LCS(R) Total Knee System (P830055/S186) | Depuy, Inc. | 2017-09-18 |
| Radiesse Injectable Implant (P050052/S096) | Merz North America, Inc. | 2017-09-18 |
| ATTUNE Revision Knee System (P830055/S184) | Depuy, Inc. | 2017-09-18 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S083) | Boston Scientific Corp | 2017-09-18 |
| FlexAbility Ablation Catheter & FlexAbility Ablation Catheter, Sensor Enabled (P110016/S049) | ABBOTT MEDICAL | 2017-09-18 |
| VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S011) | Ortho-Clinical Diagnostics | 2017-09-15 |
| Artegraft Collagen Vascular Graft (N16837/S022) | LeMaitre Vascular, Inc. | 2017-09-15 |
| PD-L1 IHC 28-8 PHARMDX (P150025/S003) | Agilent Technologies, Inc. | 2017-09-15 |
| Blazer OI and IntellaNav OI (P150005/S026) | Boston Scientific Corp | 2017-09-15 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S079) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-09-15 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S082) | Boston Scientific Corp | 2017-09-14 |
| CELLEX PHOTOPHERESIS SYSTEM (P860003/S095) | Therakos Development Limited | 2017-09-14 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S006) | Medtronic Vascular | 2017-09-13 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S145) | Boston Scientific Corp | 2017-09-13 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S044) | Boston Scientific Corp | 2017-09-13 |
| Express LD LLiac Premounted Stent System (P090003/S043) | Boston Scientific Corporation | 2017-09-13 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S082) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-09-13 |
| Synerg Everolimus Eluting Conronary Stent System (P150003/S033) | Boston Scientific Corporation | 2017-09-13 |
| HeartWare Left Ventricular Assist System (P100047/S107) | Medtronic | 2017-09-13 |
| Express SD Renal Premounted Stent System (P060006/S086) | Boston Scientific Corp | 2017-09-13 |
| BioGlue Surgical Adhesive (P010003/S028) | Cryolife, Inc. | 2017-09-12 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS (P090028/S010) | Ortho-Clinical Diagnostics, Inc. | 2017-09-12 |
| VITROS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS (P100001/S010) | Ortho-Clinical Diagnostics | 2017-09-12 |
| LCS(R) TOTAL KNEE SYSTEM (P830055/S183) | Depuy, Inc. | 2017-09-12 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent, Altrua 2 Pacemakers (N970003/S204) | Boston Scientific Corp | 2017-09-11 |
| Torque Wrench (N970003/S208) | Boston Scientific Corp | 2017-09-11 |
| Quadra Assura MP CRT-D, Quadra Assura CRT-D, Unify Assura CRT-D, Unify Quadra CRT-D, Promote Quadra CRT-D, Promote Q CRT (P030054/S336) | ABBOTT MEDICAL | 2017-09-11 |
| PK-222 and PK-Electrode Clip (accessory to Renamic) (P950037/S180) | Biotronik, Inc. | 2017-09-11 |
| Endurity MRI ,Assurity MRI Pacemaker (P140033/S013) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P010012/S458) | Boston Scientific Corp | 2017-09-11 |
| Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs (P910023/S392) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P960040/S398) | Boston Scientific | 2017-09-11 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-Ds (P010012/S448) | Boston Scientific Corp | 2017-09-11 |
| OUS Vitatron Application Software (P890003/S377) | Medtronic, Inc. | 2017-09-11 |
| Invive, Intua, Visionist, Valitude (P030005/S152) | Guidant Corp. | 2017-09-11 |
| Torque Wrench (P110042/S088) | Boston Scientific Corporation | 2017-09-11 |
| Quadra Allura MP RF CRT-P. Quadra Allure MP CRT-P, Allura Quadra CRT-P, Anthem RF CRT-P, Frontier II CRT-P Pacemakers (P030035/S159) | ABBOTT MEDICAL | 2017-09-11 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI (P150012/S039) | Boston Scientific | 2017-09-11 |
| EXOGEN Ultrasound Bone Healing System (P900009/S042) | Bioventus, LLC | 2017-09-11 |
| Torque Wrench (P030005/S156) | Guidant Corp. | 2017-09-11 |
| Prometra Programmable Infusion Pump System (P080012/S046) | Infusyn Therapeutics, LLC | 2017-09-11 |
| HeartWare Ventricular Assist System (P100047/S108) | Medtronic | 2017-09-11 |
| Inspire II Upper Airway Stimulator (P130008/S022) | Inspire Medical Systems | 2017-09-11 |
| Microny Pacemakers (P970013/S072) | ABBOTT MEDICAL | 2017-09-11 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S389) | ABBOTT MEDICAL | 2017-09-11 |
| Allure. Allure Quadra (P030035/S158) | ABBOTT MEDICAL | 2017-09-11 |
| Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa (P880086/S287) | ABBOTT MEDICAL | 2017-09-11 |
| LATITUDE Programming System (P910077/S159) | Boston Scientific | 2017-09-11 |