| Perceval Sutureless Heart Valve and Perceval PLUS Sutureless Heart Valve (P150011/S025) | Corcym S.r.l. | 2022-07-28 |
| Solo Smart Heart Valve (P130011/S011) | Corcym Canada Corp | 2022-07-28 |
| LIFEPAK Automated External Defibrillator (AED) (P160026/S031) | Physio-Control, Inc. | 2022-07-28 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S141) | Edwards Lifesciences, LLC | 2022-07-28 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S004) | ABBOTT MEDICAL | 2022-07-28 |
| Fineline II Sterox, Sterox EZ pace / sense leads (P960004/S100) | Boston Scientific | 2022-07-28 |
| LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK® 20e Defibrillator/Monitor (P160026/S032) | Physio-Control, Inc. | 2022-07-28 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S015) | Biotronik AG | 2022-07-27 |
| PG Essentio SR SL, PG Essentio DR SL, PG Essentio DR EL, PG Proponent SR SL, PG Proponent DR SL, PD Proponent DR EL, PG (N970003/S274) | Boston Scientific Corp | 2022-07-27 |
| HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507 (P160029/S017) | Philips Medical Systems, Inc. | 2022-07-27 |
| Harmony Transcatheter Pulmonary Valve (P200046/S011) | Medtronic, Inc. | 2022-07-27 |
| Micra AV TPS, Micra TPS (P150033/S148) | Medtronic, Inc. | 2022-07-27 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S008) | W. L. Gore and Associates, Inc. | 2022-07-27 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S015) | Biotronik AG | 2022-07-27 |
| PG Essentio MRI SR SL, PG Essentio MRI DR SL, PG Essentio MRI DR EL, PG Proponent MRI SR SL, PG Proponent MRI DR EL, PG (P150012/S127) | Boston Scientific | 2022-07-27 |
| PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C (P030005/S219) | Guidant Corp. | 2022-07-27 |
| VenaSeal Closure System (P140018/S032) | Medtronic Vascular, Inc. | 2022-07-27 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S024) | Biotronik AG | 2022-07-27 |
| Astron Pulsar Stent System, Pulsar-18 Stent System (P160025/S015) | Biotronik AG | 2022-07-27 |
| Micra AV TPS, Micra TPS (P150033/S147) | Medtronic, Inc. | 2022-07-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S829) | Medtronic Cardiac Rhythm Disease Management | 2022-07-25 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S724) | Medtronic, Inc. | 2022-07-25 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S795) | Medtronic Cardiac Rhythm Disease Management | 2022-07-25 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S023) | Edwards Lifesciences, LLC | 2022-07-25 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S503) | Medtronic, Inc. | 2022-07-25 |
| Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead (P150012/S128) | Boston Scientific | 2022-07-25 |
| Micra AV TPS, Micra TPS (P150033/S146) | Medtronic, Inc. | 2022-07-25 |
| Momentum CRT-D, Momentum X4 CRT-D, ICD Inogen CRT-D, ICD Dynagen CRT-D, Vigilant CRT-D, Vigilant X4 CRT-D, Resonate CRT- (P010012/S556) | Boston Scientific Corp | 2022-07-22 |
| ICD Inogen VR, ICD Dynagen VR, ICD Dynagen DR, Momentum EL ICD VR, Momentum EL ICD DR, Vigilant EL ICD VR, Vigilant EL I (P960040/S480) | Boston Scientific | 2022-07-22 |
| Abre Venous Self-expanding Stent System (P200026/S005) | Medtronic Vascular, Inc. | 2022-07-22 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S002) | W. L. Gore & Associates, Inc. | 2022-07-21 |
| Pulsar-18 T3 Stent System (P160025/S013) | Biotronik AG | 2022-07-20 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S824) | Medtronic Cardiac Rhythm Disease Management | 2022-07-20 |
| ENROUTE Transcarotid Stent System (P140026/S020) | Boston Scientific Corporation | 2022-07-20 |
| CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S791) | Medtronic Cardiac Rhythm Disease Management | 2022-07-20 |
| QUIK-PAK Electrodes (P160012/S006) | Physio-Control, Inc. | 2022-07-20 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S793) | Medtronic Cardiac Rhythm Disease Management | 2022-07-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S827) | Medtronic Cardiac Rhythm Disease Management | 2022-07-19 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S722) | Medtronic, Inc. | 2022-07-19 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S502) | Medtronic, Inc. | 2022-07-19 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S124) | Boston Scientific Corp | 2022-07-18 |
| Micra Transcatheter Pacemaker System (P150033/S098) | Medtronic, Inc. | 2022-07-15 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S019) | The Spectranetics Corp. | 2022-07-15 |
| Talent Occluder With Occluder Delivery System (P100021/S089) | Medtronic Vascular | 2022-07-15 |
| Micra AV TPS, Micra TPS (P150033/S144) | Medtronic, Inc. | 2022-07-15 |
| EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P (P130021/S088) | Medtronic, Inc. | 2022-07-15 |
| Integrity Coronary Stent Systems (P030009/S101) | Medtronic, Ireland | 2022-07-15 |
| Resolute Integrity Coronary Stent System (P110013/S109) | Medtronic Vascular | 2022-07-15 |
| Resolute Onyx Coronary Stent Systems (P160043/S045) | Medtronic Vascular | 2022-07-15 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S116) | Abbott Vascular, Inc. | 2022-07-14 |
| Assurity MRI, Endurity MRI, and Zenus MRI (P140033/S073) | ABBOTT MEDICAL | 2022-07-14 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR (P910023/S446) | ABBOTT MEDICAL | 2022-07-14 |
| Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF (P030054/S399) | ABBOTT MEDICAL | 2022-07-14 |
| Allure Quadra (P030035/S190) | ABBOTT MEDICAL | 2022-07-14 |
| Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus (P880086/S324) | ABBOTT MEDICAL | 2022-07-14 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S123) | Boston Scientific Corp | 2022-07-13 |
| XACT Carotid Stent System (P040038/S040) | Abbott Vascular, Inc. | 2022-07-13 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S126) | Boston Scientific | 2022-07-13 |
| PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT (N970003/S273) | Boston Scientific Corp | 2022-07-13 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD ORIGEN VR, ICD ORIGEN DR (P960040/S479) | Boston Scientific | 2022-07-13 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S218) | Guidant Corp. | 2022-07-13 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR (P010012/S555) | Boston Scientific Corp | 2022-07-13 |
| SICD Gen 2 A209, SICD MRI A219 (P110042/S171) | Boston Scientific Corporation | 2022-07-13 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S019) | Medtronic Vascular, Inc. | 2022-07-08 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist (P140003/S098) | Abiomed, Inc. | 2022-07-08 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S001) | W. L. Gore & Associates, Inc. | 2022-07-08 |
| Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S096) | Abiomed, Inc. | 2022-07-08 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut Pro System, Medtronic Evolut Pro+ System, Medtronic Evol (P130021/S115) | Medtronic, Inc. | 2022-07-08 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S066) | Medtronic, Inc. | 2022-07-08 |
| Portico Transcatheter Aortic Heart Valve (P190023/S008) | ABBOTT MEDICAL | 2022-07-07 |
| GORE® VIATORR® TIPS Endoprosthesis, GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S091) | W. L. Gore & Associates, Inc. | 2022-07-07 |
| Medtronic EnVeo R Delivery Catheter System, Medtronic EnVeo PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery (P130021/S118) | Medtronic, Inc. | 2022-07-07 |
| GORE CARDIOFORM Septal Occluder (P050006/S100) | W. L. Gore & Associates, Inc. | 2022-07-06 |
| Edwards Alterra Adaptive Prestent System (P200015/S022) | Edwards Lifesciences, LLC | 2022-07-06 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S035) | W. L. Gore & Associates, Inc. | 2022-07-05 |
| Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist (P170011/S042) | Abiomed, Inc. | 2022-07-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S049) | Boston Scientific Corp | 2022-07-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD (P140003/S101) | Abiomed, Inc. | 2022-07-01 |
| Micra AV TPS, Micra TPS (P150033/S143) | Medtronic, Inc. | 2022-06-30 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S816) | Medtronic Cardiac Rhythm Disease Management | 2022-06-29 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S783) | Medtronic Cardiac Rhythm Disease Management | 2022-06-29 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S059) | Boston Scientific Corporation | 2022-06-28 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S060) | Boston Scientific Scimed, Inc. | 2022-06-28 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S792) | Medtronic Cardiac Rhythm Disease Management | 2022-06-28 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S069) | Boston Scientific Corp | 2022-06-28 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S826) | Medtronic Cardiac Rhythm Disease Management | 2022-06-28 |
| HeartWare Ventricular Assist System (P100047/S201) | Medtronic | 2022-06-28 |
| MynxGrip Vascular Closure Device, Mynx Control Vascular Closure Device (VCD) (P040044/S092) | Cordis US Corporation | 2022-06-27 |
| Barostim System (P180050/S007) | Cvrx, Inc. | 2022-06-27 |
| ENROUTE® Transcarotid Stent System (P140026/S021) | Boston Scientific Corporation | 2022-06-24 |
| HeartWare Ventricular Assist System (P100047/S199) | Medtronic | 2022-06-24 |
| samaritan 350P (SAM350P) Automated External Defibrillator (P160008/S017) | Heartsine Technologies, Ltd. | 2022-06-23 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S021) | Edwards Lifesciences, LLC | 2022-06-23 |
| HeartMate II® Left Ventricular Assist System (P060040/S086) | ABBOTT MEDICAL | 2022-06-23 |
| Micra AV TPS, Micra TPS (P150033/S142) | Medtronic, Inc. | 2022-06-22 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S121) | Abbott Vascular | 2022-06-22 |
| Implantable Cardioverter Defibrillators (P910023/S445) | ABBOTT MEDICAL | 2022-06-22 |
| Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter (P160049/S018) | The Spectranetics Corp. | 2022-06-22 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S170) | Boston Scientific Corporation | 2022-06-21 |
| ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA (P960040/S478) | Boston Scientific | 2022-06-21 |