| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S013) | ABBOTT MEDICAL | 2018-10-05 |
| Integrity Coronary Stent Systems (P030009/S094) | Medtronic, Ireland | 2018-10-05 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S037) | Medtronic Vascular | 2018-10-05 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S092) | Medtronic Vascular | 2018-10-05 |
| Endurant, Endurant II and Endureant IIS Stent Graft Systems (P100021/S073) | Medtronic Vascular | 2018-10-05 |
| Venaseal Closure System (P140018/S013) | Medtronic Vascular, Inc. | 2018-10-05 |
| IN.PACT Admiral Paclitaxel-Coatede Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S041) | Medtronic, Inc. | 2018-10-05 |
| XACT Carotid Stent System (P040038/S033) | Abbott Vascular, Inc. | 2018-10-04 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIEN (P110019/S102) | Abbott Vascular | 2018-10-04 |
| MULTI-LINK 8 Coronary Stent System, MULTI-LINK 8 SV/ 8 LL Coronary Stent System (P020047/S070) | Abbott Vascular | 2018-10-04 |
| Supera Peripheral Stent System, Supera Pro Interwoven Peripheral Stent System (P120020/S020) | Abbott Vascular (Idef Technologies Inc) | 2018-10-04 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (P130005/S022) | Cardiovascular Systems, Inc. | 2018-10-04 |
| XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S143) | Abbott Vascular, Inc. | 2018-10-04 |
| BioMimics 3D Vascular Stent System (P180003) | Veryan Medical, Ltd. | 2018-10-04 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI (P980016/S681) | Medtronic Cardiac Rhythm Disease Management | 2018-10-03 |
| Micra TPS (P150033/S039) | Medtronic, Inc. | 2018-10-03 |
| Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W (P950037/S196) | Biotronik, Inc. | 2018-10-03 |
| Revo MRI SureScan IPG (P090013/S288) | Medtronic, Inc. | 2018-10-03 |
| Advisa DR MRI IPG, Advisa SR MRI IPG, Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, (P980035/S558) | Medtronic, Inc. | 2018-10-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D and Compia MRI Quad C (P010031/S640) | Medtronic Cardiac Rhythm Disease Management | 2018-10-03 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S376) | Medtronic, Inc. | 2018-10-03 |
| AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom (P980037/S070) | Boston Scientific Corp | 2018-10-02 |
| Cardiva VASCADE VCS (P120016/S025) | Cardiva Medical, Inc. | 2018-10-02 |
| Trifecta Valve with Glide Technology (Trifecta GT) (P100029/S036) | ABBOTT MEDICAL | 2018-10-01 |
| Assurity / Assurity+ / Endurity (P880086/S302) | ABBOTT MEDICAL | 2018-10-01 |
| Misago RX Self-expanding Peripheral Stent (P140002/S014) | Terumo Medical Corporation | 2018-10-01 |
| Assurity MRI and Endurity MRI (P140033/S037) | ABBOTT MEDICAL | 2018-10-01 |
| Allura, Allure Quadra/ Quadra Allure MP (P030035/S173) | ABBOTT MEDICAL | 2018-10-01 |
| Micra Programmer Application Software Model SW022 (P150033/S038) | Medtronic, Inc. | 2018-10-01 |
| Closer Vascular Sealing System (VSS) (P150022/S007) | Rex Medical, L.P. | 2018-10-01 |
| CareLink Network DDMA Model 2491 (P890003/S394) | Medtronic, Inc. | 2018-10-01 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S017) | Medtronic Vascular | 2018-10-01 |
| Evera MRI DF-1 ICD, Evera MRI ICD (P980016/S687) | Medtronic Cardiac Rhythm Disease Management | 2018-09-28 |
| ProCol Vascular Bioprosthesis (P020049/S006) | LeMaitre Vascular, Inc. | 2018-09-28 |
| Adapta Versa Sensia IPG / Attesta IPG / Sphera IPG (P980035/S563) | Medtronic, Inc. | 2018-09-28 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S093) | Medtronic Vascular | 2018-09-27 |
| Endurant, Endurant II, and Endurant IIs Stent Graft Systems (P100021/S074) | Medtronic Vascular | 2018-09-27 |
| Integrity Coro0nary Stent System. (P030009/S095) | Medtronic, Ireland | 2018-09-27 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S020) | Medtronic Vascular | 2018-09-27 |
| GORE VIATORR Tips Endoprosthesis (P040027/S066) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P040037/S121) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| GORE VIABAHN Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (AV Access) (P130006/S060) | W. L. Gore & Associates, Inc. | 2018-09-26 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S085) | Medtronic Cryocath, LP | 2018-09-25 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S082) | Medtronic Cryocath, LP | 2018-09-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S379) | Medtronic, Inc. | 2018-09-25 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S005) | Great Batch Medical | 2018-09-25 |
| Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI and Az (P980035/S562) | Medtronic, Inc. | 2018-09-25 |
| Impella RP System (P170011/S008) | Abiomed, Inc. | 2018-09-25 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S040) | Abiomed, Inc. | 2018-09-25 |
| CVX-300 and CVX-300-P Excimer Laser Systems (P910001/S106) | Spectranetics Corp. | 2018-09-25 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S083) | Medtronic Cryocath, LP | 2018-09-24 |
| HV Steroid Eluting Cardiac Leads (P950022/S107) | ABBOTT MEDICAL | 2018-09-24 |
| LifeVest Wearable Defibrillator (P010030/S104) | Zoll Manufacturing Corporation | 2018-09-21 |
| MISAGO RX Self-expanding Peripheral Stent (P140002/S017) | Terumo Medical Corporation | 2018-09-20 |
| Supera Self-Expanding Stent System (P120020/S019) | Abbott Vascular (Idef Technologies Inc) | 2018-09-20 |
| Misago RX Self-expanding Peripheral Stent (P140002/S013) | Terumo Medical Corporation | 2018-09-20 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S071) | ABBOTT MEDICAL | 2018-09-20 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S055) | Boston Scientific Corp | 2018-09-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S040) | Boston Scientific Corp | 2018-09-19 |
| Express SD Monorail Premounted Stent System (P060006/S093) | Boston Scientific Corp | 2018-09-19 |
| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S159) | Boston Scientific Corp | 2018-09-19 |
| Rotablator Rotational Atherectomy System (P900056/S173) | Boston Scientific Corp | 2018-09-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-wire) (P150003/S042) | Boston Scientific Corporation | 2018-09-19 |
| 6726 Y Adaptor/Extender Kit (P920015/S217) | Medtronic, Inc. | 2018-09-19 |
| Femoral Introducer Sheath and Hemostasis(FISH) Device (P050043/S008) | Morris Innovative Research, Inc. | 2018-09-19 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S088) | Boston Scientific Corp | 2018-09-19 |
| ProCol Vascular Bioprosthesis (P020049/S007) | LeMaitre Vascular, Inc. | 2018-09-19 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S154) | Boston Scientific Corp | 2018-09-19 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S114) | Boston Scientific | 2018-09-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S111) | Boston Scientific Corp | 2018-09-19 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S013) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| GORE TIGRIS Vascular Stent (P160004/S020) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S059) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011) | Boston Scientific Corp | 2018-09-18 |
| HeartWare Ventricular Assist System (P100047/S127) | Medtronic | 2018-09-18 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S120) | W. L. Gore & Associates, Inc. | 2018-09-18 |
| RF Contactr, RF Enhancr II, RF Marinr, RF Conductr, Cardiac Ablation Percutaneous Catheters (P930029/S061) | Medtronic, Inc. | 2018-09-17 |
| WOLVERINE Coronary Cutting Balloon Microsurgical Dilation Device (MR) (P950020/S090) | Boston Scientific Corp | 2018-09-14 |
| REBEL Platinum Chromium Coronary Stent System (MR) (P130030/S054) | Boston Scientific Corp | 2018-09-13 |
| Toray Inoue Balloon Catheter (P910054/S006) | Toray Industries (America), Inc. | 2018-09-13 |
| Tridyne Vascular Sealant (P150016/S016) | Neomend, Inc. | 2018-09-13 |
| Tridyne Vascular Sealant (P150016/S010) | Neomend, Inc. | 2018-09-12 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S011) | ABBOTT MEDICAL | 2018-09-12 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S012) | ABBOTT MEDICAL | 2018-09-12 |
| Mynx Control Vascular Closure Device (P040044/S079) | Cordis US Corporation | 2018-09-10 |
| Trifecta Valve / Trifecta Valve with Glide Technology (Trifecta GT ) (P100029/S035) | ABBOTT MEDICAL | 2018-09-10 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S004) | Celonova Biosciences, Inc. | 2018-09-10 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S024) | Lutonix | 2018-09-10 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S027) | Cook Ireland, Ltd. | 2018-09-10 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S111) | Boston Scientific | 2018-09-07 |
| Impella CP/Impella CP with SmartAssist (P140003/S039) | Abiomed, Inc. | 2018-09-07 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Eeverolimus-Eluting Platinum Chromium Coronary Stent (P110010/S155) | Boston Scientific Corp | 2018-09-07 |
| Express SD Monorail Premounted Stent Systemt (P060006/S091) | Boston Scientific Corp | 2018-09-07 |
| Rotablator Rotational Atherectomy System (P900056/S170) | Boston Scientific Corp | 2018-09-07 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S108) | Boston Scientific Corp | 2018-09-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S085) | Boston Scientific Corp | 2018-09-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S036) | Boston Scientific Corp | 2018-09-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S050) | Boston Scientific Corp | 2018-09-07 |
| VenaSeal Closure System (P140018/S012) | Medtronic Vascular, Inc. | 2018-09-06 |
| MynxGrip Vascular Closure Device, Mynx Ace Vascular Closure Device (P040044/S082) | Cordis US Corporation | 2018-09-06 |