| ETI-AB-COREK PLUS Assay (P990045/S022) | DiaSorin, Inc. | 2018-03-14 |
| digene HC2 High-Risk HPB DNA Test and digene HC2 HPV DNA Test (P890064/S038) | Qiagen Gaithersburg, Inc. | 2018-03-14 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S094) | Vistakon, Division of Johnson & Johnson Vision Car | 2018-03-14 |
| SPF Implantable Spinal Fusion Stimulators (P850035/S047) | Ahp Eos Buyer, Inc. | 2018-03-14 |
| IDEAL IMPLANT Structured Breast Implant (P120011/S009) | Bimini Health Tech | 2018-03-13 |
| artus CMV RGQ MDx Kit and artus CMV QS-RGQ MDx Kit (P130027/S004) | Qiagen, Inc. | 2018-03-13 |
| Carotid WALLSTENT (P050019/S030) | Boston Scientific Corp | 2018-03-13 |
| Ultrasonic Cleaning Machine (P920015/S209) | Medtronic, Inc. | 2018-03-13 |
| Tendril MRI (P140033/S023) | ABBOTT MEDICAL | 2018-03-13 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S311) | Boston Scientific Corp | 2018-03-12 |
| Animas Vibe System (P130007/S034) | Animas Corp. | 2018-03-12 |
| UroVysion Bladder Cancer Kit (P030052/S022) | Abbott Molecular | 2018-03-12 |
| Precision Montage MRI Spinal Cord Stimulator System (P030017/S308) | Boston Scientific Corp | 2018-03-12 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S002) | The Spectranetics Corp. | 2018-03-12 |
| Amplatzer Septal Occluder / Amplatzer Multi-Fenestrated Septal Occluder-Cribriform Occluder (P000039/S062) | ABBOTT MEDICAL | 2018-03-12 |
| Amplatzer Muscular VSD Occluder (P040040/S033) | ABBOTT MEDICAL | 2018-03-12 |
| FlexAbility Ablation Catheter / FlexAbility Ablation Catheter Sensor Enabled (P110016/S054) | ABBOTT MEDICAL | 2018-03-12 |
| Subcutaneous ICD Device (S-ICD): EMBLEM, EMBLEM MRI (P110042/S104) | Boston Scientific Corporation | 2018-03-12 |
| Vysis ALK Break Apart Fish Probe Kit (P110012/S015) | Abbott Molecular, Inc. | 2018-03-12 |
| Carpentier - Edwards Perimount Magna East Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S174) | Edwards Lifesciences, LLC | 2018-03-12 |
| Implantable Cardioverter Defibrillator (ICD): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIG (P960040/S422) | Boston Scientific | 2018-03-12 |
| Path Vysion HER-2 DNA Probe Kit (P980024/S017) | Abbott Molecular, Inc. | 2018-03-12 |
| Vysis CLL FISH Probe Kit (P150041/S002) | Abbott Molecular, Inc. | 2018-03-12 |
| Livewire TC Ablation Catheter / Safire Bi-Directional Catheter (P960016/S072) | St Jude Medical | 2018-03-12 |
| Edwards Intuity Elite Valve System (P150036/S025) | Edwards Lifesciences, LLC | 2018-03-12 |
| Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, (P010012/S481) | Boston Scientific Corp | 2018-03-12 |
| Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S054) | Boston Scientific | 2018-03-12 |
| Edwards Pericardial Aortic Bioprosthesis (Resilia tissue) (P150048/S016) | Edwards Lifesciences, LLC | 2018-03-12 |
| Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VITALIO, ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S226) | Boston Scientific Corp | 2018-03-12 |
| Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: INVIVE TM, INTUA TM, VALITUDE, VALITUDE X4, VISION (P030005/S174) | Guidant Corp. | 2018-03-12 |
| Amplatzer Duct Occluder / Amplatzer Duct Occluder II (P020024/S051) | ABBOTT MEDICAL | 2018-03-12 |
| TatiCath Quartz Contact Force Ablation Catheter (P130026/S031) | St Jude Medical | 2018-03-12 |
| Amplatzer Patent foramen Ovale Occluder (P120021/S007) | ABBOTT MEDICAL | 2018-03-12 |
| PLATINIUM 4LV CRT-D (P060027/S093) | MicroPort CRM USA, Inc. | 2018-03-11 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimula (P840001/S376) | Medtronic Neuromodulation | 2018-03-11 |
| Infinity Family of Implantable Pulse Generators (P140009/S027) | ABBOTT MEDICAL | 2018-03-11 |
| Proclaim Family of Implantable Pulse Generators (P010032/S132) | ABBOTT MEDICAL | 2018-03-11 |
| Reply SR / Esprit SR / Reply DR / Esprit DR (P950029/S118) | MicroPort CRM USA, Inc. | 2018-03-11 |
| PLATINIUM VR / DR / CRT-D (P980049/S128) | MicroPort CRM USA, Inc. | 2018-03-11 |
| Activa Deep Brain Stimulation Therapy System (P960009/S293) | Medtronic, Inc. | 2018-03-11 |
| iPro System (P150029/S015) | Medtronic Minimed | 2018-03-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S356) | Medtronic, Inc. | 2018-03-09 |
| REVEL System with Enlite System (P150019/S038) | Medtronic Minimed | 2018-03-09 |
| Seprafilm Adhesion Barrier (P950034/S050) | Baxter Healthcare Corporation | 2018-03-09 |
| Astra XT DR, Astra S DR, Astra S SR, Astra XT SR MIR IPG and Azure S DR, Azure S SR, Azure XT DR, Azure XT SR MRI IPG (P980035/S535) | Medtronic, Inc. | 2018-03-09 |
| MiniMed 670G System (P160017/S036) | Medtronic Minimed, Inc. | 2018-03-09 |
| FlexAbility Ablation Catheter and FlexAbility Ablation Catheter, Sensor Enabled (P110016/S055) | ABBOTT MEDICAL | 2018-03-09 |
| MiniMed 530G System (P120010/S112) | Medtronic, Inc. | 2018-03-09 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S074) | Medtronic Cryocath, LP | 2018-03-09 |
| MiniMed 630G System (P150001/S038) | Medtronic Minimed | 2018-03-09 |
| AMPLATZER PFO Occluder (P120021/S006) | ABBOTT MEDICAL | 2018-03-08 |
| Therakos Cellex Procedural Kit (P860003/S098) | Therakos Development Limited | 2018-03-08 |
| Guardian Connect system (P160007) | Medtronic Minimed | 2018-03-08 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S050) | W. L. Gore & Associates, Inc. | 2018-03-08 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S014) | Gen-Probe Incorporated | 2018-03-08 |
| GORE VIABAHN Endoprosthesis (P040037/S111) | W. L. Gore & Associates, Inc. | 2018-03-08 |
| Aptima HPV Assay (P100042/S016) | Gen-Probe Incorporated | 2018-03-08 |
| Perceval Sutureless Heart Valve (P150011/S012) | Corcym S.r.l. | 2018-03-07 |
| TactiCath Quartz Ablation Catheter (P130026/S030) | St Jude Medical | 2018-03-07 |
| MiniMed 670G System (P160017/S037) | Medtronic Minimed, Inc. | 2018-03-07 |
| Paradigm Real-Time Revel System (P150019/S039) | Medtronic Minimed | 2018-03-07 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S094) | Med-El Corp. | 2018-03-07 |
| Ascendra+ and NovaFlex+ Delivery System, Crimper and Edwards Expandable Introducer Sheath Set (P130009/S086) | Edwards Lifesciences, LLC | 2018-03-07 |
| MiniMed 630G System with SmartGuard (P150001/S039) | Medtronic Minimed | 2018-03-07 |
| CervicalStim (P030034/S011) | Orthofix, Inc. | 2018-03-07 |
| Progensa PCA3 Assay (P100033/S008) | Gen-Probe Incorporated | 2018-03-07 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S014) | Edwards Lifesciences, LLC | 2018-03-07 |
| Cologuard (P130017/S022) | Exact Sciences Corporation | 2018-03-07 |
| MiniMed 530G System (P120010/S113) | Medtronic, Inc. | 2018-03-07 |
| PhysioStim and SpinalStim (P850007/S038) | Orthofix, Inc. | 2018-03-07 |
| ATTUNE Revision RP Tibia Base/LCS Total Knee System (P830055/S195) | Depuy, Inc. | 2018-03-07 |
| iPro2 CGM System with Enlite Sensor (P150029/S016) | Medtronic Minimed | 2018-03-07 |
| Edwards COmmander Delivery System (P140031/S061) | Edwards Lifesciences, LLC | 2018-03-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S024) | Medinol, Ltd. | 2018-03-07 |
| Pressure Sensor Test Limits (P130008/S032) | Inspire Medical Systems | 2018-03-07 |
| Solo Smart Stentless Heart Valve (P130011/S006) | Corcym Canada Corp | 2018-03-07 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP Generators (P060019/S042) | Irvine Biomedical, Inc. | 2018-03-06 |
| Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S040) | Irvine Biomedical,Inc.(Ibi) | 2018-03-06 |
| SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S101) | ABBOTT MEDICAL | 2018-03-06 |
| GORE VIABAHN Endoprosthesis (P040037/S110) | W. L. Gore & Associates, Inc. | 2018-03-06 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S049) | W. L. Gore & Associates, Inc. | 2018-03-06 |
| Therapy Ablation Catheters (P040014/S034) | Irvine Biomedical, Inc. | 2018-03-06 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter (P960016/S071) | St Jude Medical | 2018-03-06 |
| RF Conductr MC; RF Marinr 5Fr; RF Marinr 7Fr; and Unipolar Mapping RF Marinr 7Fr (P930029/S058) | Medtronic, Inc. | 2018-03-06 |
| TactiCath Quartz Set (P130026/S029) | St Jude Medical | 2018-03-06 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S053) | ABBOTT MEDICAL | 2018-03-06 |
| Lens Optic body diameter cut (P100016/S005) | Carl Zeiss Meditec Production, LLC | 2018-03-06 |
| CardioMEMS patient and hospital electronics (P100045/S022) | ABBOTT MEDICAL | 2018-03-06 |
| Current, Fortify, Fortify Assura, Ellipse (P910023/S405) | ABBOTT MEDICAL | 2018-03-05 |
| Assurity, Endurity (P880086/S296) | ABBOTT MEDICAL | 2018-03-05 |
| Assurity MRI, Endurity MRI (P140033/S026) | ABBOTT MEDICAL | 2018-03-05 |
| Oxford Partial Knee System (P010014/S070) | Biomet Manufacturing Corp | 2018-03-05 |
| Assure CRT-P (P030035/S167) | ABBOTT MEDICAL | 2018-03-05 |
| XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL) (P110019/S096) | Abbott Vascular | 2018-03-05 |
| XIENCE V/nano Everolimus Eluting Coronary Stent System (P070015/S139) | Abbott Vascular, Inc. | 2018-03-05 |
| MULTI-LINK 8 Coronary, 8 LL Coronary, and 8 SV Coronary Stent System (P020047/S067) | Abbott Vascular | 2018-03-05 |
| NexGen LPS-Flex / LPS-Mobile Bearing Knee (P060037/S054) | Zimmer, Inc. | 2018-03-05 |
| Ellipse (P910023/S404) | ABBOTT MEDICAL | 2018-03-05 |
| Elecsys HBeAg and PreciControl HBeAg (P130015/S013) | Roche Diagnostics Operations, Inc. | 2018-03-02 |
| LCS Total Knee System (P830055/S194) | Depuy, Inc. | 2018-03-02 |