| ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, ACUITY X4 Lead Spiral L and Suture Sleeve Accessory (P010012/S484) | Boston Scientific Corp | 2018-07-27 |
| Oxford Partial Knee System (P010014/S080) | Biomet Manufacturing Corp | 2018-07-27 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI Pacemakers, INGEVITY MRI Lead, Slit Sutu (P150012/S060) | Boston Scientific | 2018-07-27 |
| GORE TAG Thoracic Endoprosthesis (P040043/S103) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| Elecsys free PSA, free PSA CalSet, and free PSA CalCheck (P000027/S027) | Roche Diagnostics Corp. | 2018-07-27 |
| GORE CARDIOFORM Septal Occluder (P050006/S070) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S156) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| FreeStyle Libre Flash Glucose Monitoring System (P160030/S018) | Abbott Diabetes Care, Inc. | 2018-07-27 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S049) | Coloplast Corp. | 2018-07-27 |
| CVX-300 and CVX-300-P EXCIMER LASER SYSTEM (P910001/S089) | Spectranetics Corp. | 2018-07-27 |
| VNS Therapy SenTiva Model 1000 Generator, VNS Therapy Model 2000 Programming Wand, VNS Therapy Model 3000 Programmer (P970003/S218) | LivaNova USA, Inc. | 2018-07-27 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S071) | Edwards Lifesciences, LLC | 2018-07-27 |
| GORE TIGRIS Vascular Stent (P160004/S016) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| INVIVE CRT-P, INTUA CRT-P, VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P, and Programmer Softwa (P030005/S176) | Guidant Corp. | 2018-07-27 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE Pacemaker and Programmer Software Applica (N970003/S229) | Boston Scientific Corp | 2018-07-27 |
| Carpentier-Edwards PERIMOUNT Magna Pericardial Aortic Bioprosthesis, PERIMOUNT Magna Pericardial Aortic BIoprosthesis wi (P860057/S181) | Edwards Lifesciences, LLC | 2018-07-27 |
| Remodulin (P140032/S001) | Medtronic, Inc. | 2018-07-27 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S118) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S057) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| Sapien 3 Transcatheter Heart Valve (P140031/S064) | Edwards Lifesciences, LLC | 2018-07-26 |
| Progel Pleural Air Leak Sealant (P010047/S059) | Neomend, Inc. | 2018-07-26 |
| COBAS TaqMan HBV Test for use with the High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 (P050028/S068) | Roche Molecular Systems, Inc. | 2018-07-26 |
| EDWARDS INTUITY Elite Valve System (P150036/S032) | Edwards Lifesciences, LLC | 2018-07-26 |
| Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator (P030039/S023) | Baxter Bio Science | 2018-07-26 |
| ThermoCool SmartTouch Uni-Bi-Directional Navigation Catheter (P040036/S063) | Biosense Webster, Inc. | 2018-07-26 |
| ThermoCool SmartTouch SF Catheters Uni/Bi-Directional Naviation Catheter (P030031/S090) | Biosense Webster, Inc. | 2018-07-26 |
| Artic Front Advance Cardiac Cryoablation Catheter, 23/28mm, US (P100010/S080) | Medtronic Cryocath, LP | 2018-07-26 |
| HeartWare HVAD System (P100047/S115) | Medtronic | 2018-07-26 |
| Cobas BRAF V600 Mutation Test (P110020/S027) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Tridyne Vascular Sealent (P150016/S015) | Neomend, Inc. | 2018-07-26 |
| Cobas HPV Test (P100020/S036) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Bellafill Dermal Filler (P020012/S026) | Tiger Aesthetics Medical, LLC | 2018-07-26 |
| Cobas HCV (P150015/S017) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Ingevity, Ingevity MRI (P150012/S064) | Boston Scientific | 2018-07-26 |
| COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 (P060030/S067) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas HBV (P150014/S018) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Fineline II (P960004/S086) | Boston Scientific | 2018-07-26 |
| Acuity Steerable (P050046/S029) | Guidant Corp. | 2018-07-26 |
| Flextend (P960006/S048) | Boston Scientific | 2018-07-26 |
| COBAS AmpliPrep/COBAS TaqMan CMV Test (P110037/S039) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Cobas CMV (P160041/S011) | Roche Molecular Systems, Inc. | 2018-07-26 |
| Endotak Reliance, Reliance 4-Front (P910073/S150) | Boston Scientific | 2018-07-26 |
| Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4 (P010012/S488) | Boston Scientific Corp | 2018-07-26 |
| Supera Pro Interwoven Peripheral Stent System (P120020/S018) | Abbott Vascular (Idef Technologies Inc) | 2018-07-26 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S182) | Edwards Lifesciences, LLC | 2018-07-26 |
| Emblem S-ICD Electrode (P110042/S111) | Boston Scientific Corporation | 2018-07-26 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S071) | Hologic, Inc. | 2018-07-25 |
| MED-EL Cochlear Implant System (P000025/S101) | Med-El Corp. | 2018-07-25 |
| GORE TIGRIS Vascular Stent (P160004/S015) | W. L. Gore & Associates, Inc. | 2018-07-25 |
| Vercise Deep Brain Stimulation (DBS)System (P150031/S007) | Boston Scientific Corp | 2018-07-25 |
| Belotero Balance Dermal Filler (P090016/S030) | Merz North America, Inc. | 2018-07-25 |
| Restylane Refyne, Restylane Defyne (P140029/S007) | Q-Med AB | 2018-07-25 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S314) | Medtronic, Inc. | 2018-07-24 |
| CardioMEMS HF System (P100045/S030) | ABBOTT MEDICAL | 2018-07-24 |
| MagtraceTM and Sentimag(R) Magnetic Locatization System (P160053) | Endomagnetics Ltd., | 2018-07-24 |
| Maestro System Software 7.0 (P000025/S097) | Med-El Corp. | 2018-07-24 |
| Lotrafilcon A and Lotrafilcon B Soft Contact Lenses (P010019/S066) | Alcon Laboratories, Inc. | 2018-07-24 |
| TECNIS 1-Piece IOL with TECNIS iTEC Preloaded Delivery System (PCB00), TECNIS Multifocal 1-Piece IOL with TECNIS iTEC Pr (P980040/S092) | Johnson & Johnson Surgical Vision, Inc. | 2018-07-24 |
| Freestyle Libre Pro Flash Glucose Monitoring System (P150021/S024) | Abbott Diabetes Care, Inc. | 2018-07-23 |
| FreeStyle Libre 14 Day Flash Glucose Monitoring System (P160030/S017) | Abbott Diabetes Care, Inc. | 2018-07-23 |
| Amplia MRI CRT-D / Quad CRT-D; Brava CRT-D /Quad CRT-D; Claria MRI CRT-D / Quad CRT-D ; Compia MRI CRT-D / Quad CRT-D; V (P010031/S636) | Medtronic Cardiac Rhythm Disease Management | 2018-07-23 |
| Freestyle Libre Flash Glucose Monitoring System (P160030/S014) | Abbott Diabetes Care, Inc. | 2018-07-23 |
| CyPass Ultra System (P150037/S010) | Alcon Research, Ltd. | 2018-07-23 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S091) | Boston Scientific Corp | 2018-07-23 |
| LINX Reflux Management System (P100049/S022) | Torax Medical | 2018-07-23 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S147) | Boston Scientific Corp | 2018-07-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S067) | Edwards Lifesciences, LLC | 2018-07-23 |
| Evera MRI DF-I ICD / Evera MRI ICD/ S DR ICD / S VR ICD / XT DR ICD /XT VR ICD ; Mirro MRI DR ICD / MRI VR ICD; Primo MR (P980016/S678) | Medtronic Cardiac Rhythm Disease Management | 2018-07-23 |
| Abbott RealTime IDH1 (P170041) | Abbott Molecular, Inc. | 2018-07-20 |
| LAP-BAND Adjustable Gastric Banding System (P000008/S043) | Medtimo, Inc. | 2018-07-20 |
| Cheatham Platinum (CP) Stent System (Covered CP Stent, Covered Mounted CP Stent, CP Stent, Mounted CP Stent) (P150028/S003) | NuMED, Inc. | 2018-07-20 |
| Zenith AAA Endovascular Graft (P020018/S058) | Cook, Inc. | 2018-07-20 |
| SJM Infinity Deep Brain Stimulation (DBS) Neurostimulation System (P140009/S037) | ABBOTT MEDICAL | 2018-07-19 |
| Tendril MRI (P140033/S035) | ABBOTT MEDICAL | 2018-07-19 |
| QuickFlex u and Quartet (P030054/S357) | ABBOTT MEDICAL | 2018-07-19 |
| Durata and Optisure (P950022/S120) | ABBOTT MEDICAL | 2018-07-19 |
| Tendril SDX, OptiSense, Tendril STS and Tendril ST (P960013/S100) | ABBOTT MEDICAL | 2018-07-19 |
| IsoFlex (P960030/S059) | ABBOTT MEDICAL | 2018-07-19 |
| Spinal Cord Stimulation (SCS) External Programmer Apps (P010032/S141) | ABBOTT MEDICAL | 2018-07-19 |
| Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment (P010062/S011) | Bausch & Lomb | 2018-07-19 |
| Proclaim Dorsal Root Ganglion (DRG) External Programmer Apps (P150004/S020) | ABBOTT MEDICAL | 2018-07-19 |
| Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S071) | Integra Lifesciences Corp. | 2018-07-19 |
| Activa Deep Brain Stimulation Therapy System (P960009/S319) | Medtronic, Inc. | 2018-07-18 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S006) | Medinol, Ltd. | 2018-07-18 |
| InterStim Therapy System (Bowel ) (P080025/S170) | Medtronic Neuromodulation | 2018-07-18 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S024) | Edwards Lifesciences, LLC | 2018-07-18 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimula (P840001/S402) | Medtronic Neuromodulation | 2018-07-18 |
| Implantable System for Remodulin (P140032/S014) | Medtronic, Inc. | 2018-07-18 |
| EDWARDS INTUITY ELITE Valve System (P150036/S031) | Edwards Lifesciences, LLC | 2018-07-18 |
| SAPIEN XT Transcatheter Heart Valve (P130009/S092) | Edwards Lifesciences, LLC | 2018-07-18 |
| InterStim Therapy System (Urinary) (P970004/S275) | Medtronic Neuromodulation | 2018-07-18 |
| ThermoCool Smart Touch SF Bi-Directional Navigation Catheter & ThermoCool Smart Touch SF Uni-Direcional Navigation Cathe (P030031/S088) | Biosense Webster, Inc. | 2018-07-18 |
| SAPIEN 3 Transcatheter Heart Valve (P140031/S070) | Edwards Lifesciences, LLC | 2018-07-18 |
| SynchroMed Infusion System (P860004/S312) | Medtronic, Inc. | 2018-07-18 |
| ARCHITECT HBsAG Qualitative Reagent Kit (100/500 Test), ARCHITECT HBsAG Qualitative Confirmatory Reagent Kit (P110029/S027) | Abbott Laboratories | 2018-07-18 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, PERIMOUNT Theon/Magna Pericardial Aortic Bioprosthesis wi (P860057/S180) | Edwards Lifesciences, LLC | 2018-07-18 |
| ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE (N970003/S231) | Boston Scientific Corp | 2018-07-17 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S007) | Medinol, Ltd. | 2018-07-17 |
| ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S062) | Boston Scientific | 2018-07-17 |
| Oxford Partial Knee System (P010014/S079) | Biomet Manufacturing Corp | 2018-07-17 |