| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP (P030054/S333) | ABBOTT MEDICAL | 2017-09-11 |
| Assurity, Assurity+, and Endurity (P880086/S286) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P150012/S033) | Boston Scientific | 2017-09-11 |
| S-ICD (Subcutaneous-ICD) Telemetry Wand (P110042/S083) | Boston Scientific Corporation | 2017-09-11 |
| Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen (P960040/S391) | Boston Scientific | 2017-09-11 |
| Dexcom G5 Mobile Continuous Glucose Monitoring System (P120005/S066) | Dexcom, Inc. | 2017-09-09 |
| Gore Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S040) | W. L. Gore & Associates, Inc. | 2017-09-08 |
| Viabhan Endoprosthesis and endoprosthesis with Heparin Bioactive Surface (P040037/S101) | W. L. Gore & Associates, Inc. | 2017-09-08 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S277) | Boston Scientific Corp | 2017-09-08 |
| Titan Inflatable Penile Prosthesis (P000006/S047) | Coloplast Corp. | 2017-09-08 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S063) | Integra Lifesciences Corp. | 2017-09-08 |
| TMR Holmium Laser System (P970029/S036) | Cryolife, Inc. | 2017-09-08 |
| Oxford Partial Knee System - Femoral Components, Tibial Tray Components, Meniscal Bearings (P010014/S065) | Biomet Manufacturing Corp | 2017-09-08 |
| OraQuick HCV Rapid Antibody Test (P080027/S029) | OraSure Technologies, Inc. | 2017-09-07 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S168) | Edwards Lifesciences, LLC | 2017-09-07 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S116) | MicroPort CRM USA, Inc. | 2017-09-07 |
| Flextome Cutting Balloon Microsurgical Dilation Device (P950020/S083) | Boston Scientific Corp | 2017-09-07 |
| Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve (P150048/S004) | Edwards Lifesciences, LLC | 2017-09-07 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Edwards Intuity Elite Valve System (P150036/S018) | Edwards Lifesciences, LLC | 2017-09-07 |
| Axium Neurostimulator System (P150004/S012) | ABBOTT MEDICAL | 2017-09-06 |
| Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI (P150005/S025) | Boston Scientific Corp | 2017-09-06 |
| Cardiomems HF Pressure Measurement System (P100045/S024) | ABBOTT MEDICAL | 2017-09-06 |
| Genesis And Eon Family Neurostimulation (IPG) Systems (P010032/S133) | ABBOTT MEDICAL | 2017-09-06 |
| Brio Neurostimulation System (P140009/S028) | ABBOTT MEDICAL | 2017-09-06 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear (P040029/S005) | Euclid Vision Corporation | 2017-09-05 |
| Ovation iX Abdominal Stent Graft System (P120006/S029) | Endologix, LLC | 2017-09-05 |
| AIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear (P010019/S056) | Alcon Laboratories, Inc. | 2017-09-05 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S081) | Vistakon, Division of Johnson & Johnson Vision Car | 2017-09-05 |
| HV splitter/adaptor kit 5019 (P920015/S202) | Medtronic, Inc. | 2017-09-05 |
| Necleus Auditory Brainstem Impant System (P000015/S025) | Cochlear Americas | 2017-09-05 |
| Nucleus 24 Cochlear Implant System (P970051/S169) | Cochlear Americas | 2017-09-05 |
| Resolute Onyx Coronary Stent Systems (P160043/S005) | Medtronic Vascular | 2017-09-01 |
| Abbott Real Time HBV Amplification Reagent Kit / HBV Control Kit / HBV Calibrator Kit (P080026/S021) | Abbott Molecular, Inc. | 2017-09-01 |
| ELCA Coronary Laser Atherectomy Catheters (P910001/S098) | Spectranetics Corp. | 2017-09-01 |
| EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF (P980016/S616) | Medtronic, Inc. | 2017-09-01 |
| AMPLIA MRI CRT-D /QUAD CRT-D; CLARIA MRI CRT-D/QUAD CRT-D; COMPIA MRI CRT-D /QUAD CRT-D; CONCERTO ICD & II CRT-D; CONSUL (P010031/S575) | Medtronic, Inc. | 2017-09-01 |
| Restore, Intrel and Synergy Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S365) | Medtronic Neuromodulation | 2017-09-01 |
| Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit (P100017/S020) | Abbott Molecular, Inc. | 2017-09-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S289) | Medtronic, Inc. | 2017-09-01 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent Systems (P110013/S081) | Medtronic Vascular | 2017-09-01 |
| Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit (P120012/S016) | Abbott Molecular | 2017-09-01 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v 2.0 (P060030/S059) | Roche Molecular Systems, Inc. | 2017-09-01 |
| SYNERGYST II PULSE GENERATOR (P890003/S372) | Medtronic, Inc. | 2017-09-01 |
| VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S024) | Ortho-Clinical Diagnostics | 2017-09-01 |
| Activa Deep Brain Stimulation Therapy System (P960009/S284) | Medtronic, Inc. | 2017-09-01 |
| Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit. (P160044/S001) | Abbott Molecular | 2017-09-01 |
| Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028/S025) | Mentor Worldwide, LLC | 2017-09-01 |
| CONSULTA CRT-P & VIVA CRT-P (P010015/S318) | Medtronic, Inc. | 2017-09-01 |
| EDWARDS INTUITY Elite Valve System (P150036/S017) | Edwards Lifesciences, LLC | 2017-08-31 |
| Arctic Front Advance Catheters (P100010/S066) | Medtronic Cryocath, LP | 2017-08-31 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S164) | Boston Scientific Corp | 2017-08-31 |
| Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S043) | Boston Scientific Corp | 2017-08-31 |
| Elecsys Anti-HBc (P100031/S019) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HCV (P090008/S018) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBs (P010054/S031) | Roche Diagnostics Corp. | 2017-08-31 |
| Restore, Itrel, Synergy and Intellis Sprinal Cord Stimulation Systems and Pisces, Specify,adn Vectris Sprinal Cord Stimu (P840001/S370) | Medtronic Neuromodulation | 2017-08-31 |
| Elecsys Anit-HCV (P090007/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| PSW 1703.U (P000009/S074) | Biotronik, Inc. | 2017-08-31 |
| Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc (P840001/S371) | Medtronic Neuromodulation | 2017-08-31 |
| Master Restore, Itrel and Synergy Spinal Cord Stimulation Systems, Intellis Implantable Neurostimulation System and Pisc (P840001/S372) | Medtronic Neuromodulation | 2017-08-31 |
| Express SD Monorail Premounted Stent System (P060006/S085) | Boston Scientific Corp | 2017-08-31 |
| Elecsys HBsAg II (P160019/S005) | Roche Diagnostics, Inc. | 2017-08-31 |
| Collastat Absorbable Collagen Hemostatic Sponge and Agent-Microfibrillar Form (P810006/S077) | Integra LifeSciences Corporation | 2017-08-31 |
| Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire) (P950020/S082) | Boston Scientific Corp | 2017-08-31 |
| Helistat, Helitene Absorbable Collagen Hemostatic Agents (P850010/S076) | Integra LifeSciences Corporation | 2017-08-31 |
| Elecsys Anit-HCV II (P140021/S011) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Chilli II Cooled RF Ablation system (P980003/S078) | Boston Scientific Corp | 2017-08-31 |
| Elecsys HBsAg (P990012/S028) | Roche Diagnostics Corp. | 2017-08-31 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S288) | Medtronic, Inc. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110031/S019) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110025/S020) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys HBeAg (P130015/S012) | Roche Diagnostics Operations, Inc. | 2017-08-31 |
| Blazer II Cardiac Ablation System (P920047/S101) | Boston Scientific Corp | 2017-08-31 |
| Elecsys Anit-HCV (P090009/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| PSW 1703.U (P070008/S085) | Biotronik, Inc. | 2017-08-31 |
| Blazer II XP Cardiac RF Ablation System (P020025/S105) | Boston Scientific | 2017-08-31 |
| En Veo R Delivery Catheter System (P130021/S040) | Medtronic, Inc. | 2017-08-31 |
| Elecsys Anit-HBc IgM (P110022/S023) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Free PSA Immunoassay (P000027/S026) | Roche Diagnostics Corp. | 2017-08-31 |
| PSW 1703.U (P950037/S179) | Biotronik, Inc. | 2017-08-31 |
| PSW 1703.U (P050023/S112) | Biotronik, Inc. | 2017-08-31 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S144) | Boston Scientific Corp | 2017-08-31 |
| TMR Holmium Laser System (P970029/S034) | Cryolife, Inc. | 2017-08-31 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S024) | Boston Scientific Corp | 2017-08-31 |
| Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, Precision Montage, MRI Spinal Cord Stimulator (P030017/S301) | Boston Scientific Corp | 2017-08-31 |
| Elesys Total PSA Immunoassay (P990056/S027) | Roche Diagnostics Corp. | 2017-08-31 |
| Elecsys Anti-HBc (P100032/S016) | Roche Diagnostics Corp. | 2017-08-31 |
| Accolade MRI Pacemakers, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S035) | Boston Scientific | 2017-08-30 |
| Accolade Cardiac Resynchronization Therapy Pacemaker Devices- Valitude, Valitude X4, Visionist and Visionist X4 (P030005/S158) | Guidant Corp. | 2017-08-30 |
| Vistakon (Etafilcon A) Brand contact lenses (N18033/S094) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2017-08-30 |
| Accolade Non-MRI Pacemakers , Altrua, Essentio, Proponent, Accolade (N970003/S210) | Boston Scientific Corp | 2017-08-30 |
| PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips (P100030/S011) | Baxter Healthcare Corporation | 2017-08-30 |
| NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S399) | Boston Scientific | 2017-08-30 |
| ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF (P960040/S401) | Boston Scientific | 2017-08-30 |
| NG3 Cardiac Resynchronization Therapy- Defibrillator Devices , Autogen Dynagen, Inogen, Origen , Momentum, Vigilant, Res (P010012/S459) | Boston Scientific Corp | 2017-08-30 |
| CRT-P VALITUDE, VISIONIST (P030005/S159) | Guidant Corp. | 2017-08-30 |
| Pacemakers: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S036) | Boston Scientific | 2017-08-30 |
| CRT-Ds: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, VIGILANT, MOMENTUM, RESONATE, PUNCTUA, ENERGEN, INCEPTA (P010012/S460) | Boston Scientific Corp | 2017-08-30 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S270) | Boston Scientific Corp | 2017-08-30 |