| Bard LifeStent 5F Vascular Stent System (P070014/S055) | Bard Peripheral Vascular, Inc. | 2018-08-01 |
| Misago RX Self-expanding Peripheral Stent (P140002/S011) | Terumo Medical Corporation | 2018-08-01 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S035) | St Jude Medical | 2018-07-31 |
| Celsius DS Electrophysiology Catheter (P010068/S057) | Biosense Webster, Inc. | 2018-07-30 |
| Smartablate Cable (P990071/S041) | Biosense Webster, Inc. | 2018-07-30 |
| Celsius ThermoCool Electrophysiology Catheter, Navistar RMT Thermocool and Celsius RMT THermocool (P030031/S089) | Biosense Webster, Inc. | 2018-07-30 |
| Covera Vascular Covered Stent (P170042) | C.R. Bard, Inc. | 2018-07-30 |
| Navistar RMT Electrophysiology Catheter (P990025/S056) | Biosense Webster, Inc. | 2018-07-30 |
| Webster Electrophysiology Catheter, Celsius Electrophysiology Catheter, Electrophysiology Catheter Deflectable braided t (P950005/S070) | Biosense Webster, Inc. | 2018-07-30 |
| FINELINE II Sterox Lead, FINELINE II Sterox EZ Lead abnd Suture Sleeve Accessory (for FINELINE II Leads) (P960004/S085) | Boston Scientific | 2018-07-27 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S065) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S011) | W. L. Gore & Associates, Inc. | 2018-07-27 |
| 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 |
| 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 |
| 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 |
| CVX-300 and CVX-300-P EXCIMER LASER SYSTEM (P910001/S089) | Spectranetics Corp. | 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 |
| 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 |
| 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 |
| Tridyne Vascular Sealent (P150016/S015) | Neomend, Inc. | 2018-07-26 |
| Ingevity, Ingevity MRI (P150012/S064) | Boston Scientific | 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 |
| 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 |
| GORE TIGRIS Vascular Stent (P160004/S015) | W. L. Gore & Associates, Inc. | 2018-07-25 |
| CardioMEMS HF System (P100045/S030) | ABBOTT MEDICAL | 2018-07-24 |
| 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 |
| 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 |
| 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 |
| 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 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S006) | Medinol, Ltd. | 2018-07-18 |
| Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis (P150048/S024) | Edwards Lifesciences, LLC | 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 |
| 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 |
| 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 |
| LifeVest Wearable Defibrillator (P010030/S106) | Zoll Manufacturing Corporation | 2018-07-16 |
| Edwards Certitude Introducer Sheath Set, Models 9600IS18, 9600IS21 (P140031/S069) | Edwards Lifesciences, LLC | 2018-07-15 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- (P010031/S638) | Medtronic Cardiac Rhythm Disease Management | 2018-07-13 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/ S VR ICD, Evera XT DR/ XT VR ICD, Primo MRI DR/VR ICD, Visia AF MRI DF1 I (P980016/S679) | Medtronic Cardiac Rhythm Disease Management | 2018-07-13 |
| Freezor Cardiac Cryoablation Catheter; Freezor Xtra Surgical Cardiac Cryoablation Device; Freezor MAX Cardiac Cryoablati (P020045/S088) | Medtronic Cryocath, LP | 2018-07-12 |
| Transvene CS/SVC Lead (P980050/S119) | Medtronic, Inc. | 2018-07-12 |
| Attain Bipolar OTW Lead; Attain OTW LV Lead (P010015/S375) | Medtronic, Inc. | 2018-07-12 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S002) | Celonova Biosciences, Inc. | 2018-07-12 |
| Attain StarFix Lead (P060039/S089) | Medtronic, Inc. | 2018-07-12 |
| Sprint Quattro Lead; Subcutaneous Lead; Transvene CS/SVC Lead (P920015/S216) | Medtronic, Inc. | 2018-07-12 |
| CapSureFix Lead; CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead (P930039/S190) | Medtronic, Inc. | 2018-07-12 |
| CapSure VDD 2 Lead; Vitatron Brilliant S+ VDD Lead (P890003/S393) | Medtronic, Inc. | 2018-07-12 |
| CapSure Sense Lead; CapSure SP Novus Lead; Vitatron Crystalline Lead (P830061/S161) | Medtronic Cardiac Rhythm Disease Management | 2018-07-12 |
| Freezor MAX Cardiac Cryoablation Catheter (P100010/S079) | Medtronic Cryocath, LP | 2018-07-12 |
| Attain Ability Lead; Attain Performa Lead (P080006/S125) | Medtronic, Inc. | 2018-07-12 |
| CapSure SP Novus Lead; CapSure SP Z Lead; CapSure SP Z Novus; CapSure SP Z Lead; CapSure Z Novus Lead; Vitatron Impulse (P850089/S135) | Medtronic Cardiac Rhythm Disease Management | 2018-07-12 |
| CapSureFix MRI Lead (P090013/S287) | Medtronic, Inc. | 2018-07-12 |
| Artegraft Collagen Vascular Graft (N16837/S025) | LeMaitre Vascular, Inc. | 2018-07-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S068) | Edwards Lifesciences, LLC | 2018-07-11 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S112) | Boston Scientific | 2018-07-11 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S091) | Edwards Lifesciences, LLC | 2018-07-11 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S086) | Boston Scientific Corp | 2018-07-11 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent S (P110010/S158) | Boston Scientific Corp | 2018-07-11 |
| Express SD Monorail Premounted Stent System (P060006/S092) | Boston Scientific Corp | 2018-07-11 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S052) | Boston Scientific Corp | 2018-07-11 |
| Heartware Ventricular Assist System (P100047/S125) | Medtronic | 2018-07-11 |
| Open Pivot Mechanical Heart Valve; Open Pivot Aortic Valved Graft (P990046/S054) | Medtronic Ats Medical, Inc. | 2018-07-11 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S038) | Boston Scientific Corp | 2018-07-11 |
| Rotablator Rotational Atherectomy System (P900056/S172) | Boston Scientific Corp | 2018-07-11 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S109) | Boston Scientific Corp | 2018-07-11 |
| DYNAGEN MINI, INOGEN MINI, ORIGEN MINI and PERCIVA MINI (P960040/S427) | Boston Scientific | 2018-07-11 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S032) | Corcym Canada Corp | 2018-07-11 |
| Carbomedics Prosthetic Heart Valve (P900060/S058) | Corcym S.r.l. | 2018-07-11 |
| HeartWare HVAD System (P100047/S112) | Medtronic | 2018-07-10 |
| MULTI-LINK Ultra Coronary Stent System (P970020/S083) | Abbott Vascular, Inc. | 2018-07-10 |
| CardioMEMS HF System (P100045/S029) | ABBOTT MEDICAL | 2018-07-10 |