| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter (P190008/S027) | Medtronic Vascular, Inc. | 2023-10-12 |
| CoreValve EnVeo Pro Delivery Catheter System, CoreValve EnVeo Pro Loading System, Evolut PRO+ Delivery Catheter System, (P130021/S147) | Medtronic, Inc. | 2023-10-12 |
| Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR Transcatheter Pacing System (P150033/S177) | Medtronic, Inc. | 2023-10-12 |
| DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet (P200028/S022) | Medtronic, Inc. | 2023-10-12 |
| Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus (P160043/S073) | Medtronic Vascular | 2023-10-12 |
| Venaseal Closure System (P140018/S040) | Medtronic Vascular, Inc. | 2023-10-12 |
| ANGIO-SEAL VIP Vascular Closure Device (P930038/S101) | Terumo Medical Corporation | 2023-10-11 |
| LifeVest® Wearable Defibrillator (P010030/S167) | Zoll Manufacturing Corporation | 2023-10-11 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S010) | Teleflex Medical, LLC | 2023-10-11 |
| LIFEPAK® CR2 Defibrillator (P170018/S018) | Physio-Control, Inc. | 2023-10-11 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S037) | Berlin Heart, Inc. | 2023-10-11 |
| Endurant Stent Graft System (P100021/S118) | Medtronic Vascular | 2023-10-10 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S013) | W. L. Gore and Associates, Inc. | 2023-10-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S059) | Medtronic Vascular | 2023-10-10 |
| Arctic Front Advance (P100010/S142) | Medtronic Cryocath, LP | 2023-10-06 |
| LifeVest Wearable Defibrillator (P010030/S169) | Zoll Manufacturing Corporation | 2023-10-06 |
| PG ACCOLADE MRI SR SL US, PG ACCOLADE MRI DR SL US, PG ACCOLADE MRI DR EL US, PG PROPONENT MRI SR SL US, PG PROPONENT MR (P150012/S151) | Boston Scientific | 2023-10-06 |
| PG VALITUDE CRT-P IS1 EL US, PG VALITUDE CRT-P IS4 EL US, PG VISIONIST CRT-P IS1 EL US, PG VISIONIST CRT-P LV1 EL US, PG (P030005/S233) | Guidant Corp. | 2023-10-06 |
| PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL (N970003/S288) | Boston Scientific Corp | 2023-10-06 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S036) | Berlin Heart, Inc. | 2023-10-05 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S023) | Boston Scientific Corporation | 2023-10-05 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S124) | Abbott Vascular | 2023-10-04 |
| HeartMate II Left Ventricular Assist System (P060040/S091) | ABBOTT MEDICAL | 2023-09-29 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S833) | Medtronic Cardiac Rhythm Disease Management | 2023-09-29 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S867) | Medtronic Cardiac Rhythm Disease Management | 2023-09-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S053) | ABBOTT MEDICAL | 2023-09-29 |
| Thermocool Smarttouch SF (P030031/S134) | Biosense Webster, Inc. | 2023-09-28 |
| ROTAPRO and Rotalink Rotational Atherectomy System (P900056/S211) | Boston Scientific Corp | 2023-09-28 |
| Thermocool Smarttouch (P040036/S096) | Biosense Webster, Inc. | 2023-09-28 |
| Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System (P020036/S050) | Cordis US Corporation | 2023-09-28 |
| Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System,Cordis® S.M.A.R.T. RADIANZTM Vascular Stent System (P120002/S025) | Cordis US Corporation | 2023-09-28 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent Systems, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S071) | Medtronic Vascular | 2023-09-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S059) | ABBOTT MEDICAL | 2023-09-27 |
| Cross-Seal Suture-Mediated Vascular Closure Device System (P210017) | Terumo Medical Corporation | 2023-09-26 |
| Avalus Bioprosthesis (P170006/S027) | Medtronic, Inc. | 2023-09-25 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S146) | Medtronic, Inc. | 2023-09-25 |
| Melody Transcatheter Pulmonary Valve (P140017/S025) | Medtronic, Inc. | 2023-09-25 |
| Harmony Transcatheter Pulmonary Valve (P200046/S021) | Medtronic, Inc. | 2023-09-25 |
| SAPIEN 3 Pulmonic Delivery System (P200015/S046) | Edwards Lifesciences, LLC | 2023-09-25 |
| OPTIMIZER® Smart System (P180036/S023) | Impulse Dynamics (Usa), Inc. | 2023-09-22 |
| Zilver® PTX® Peripheral Drug- Eluting Stent (P100022/S042) | Cook Ireland, Ltd. | 2023-09-22 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S024) | Boston Scientific Corporation | 2023-09-22 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S074) | Medtronic, Inc. | 2023-09-22 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, CareLink SmartSync Claria Amplia Compia Applicat (P010031/S829) | Medtronic Cardiac Rhythm Disease Management | 2023-09-22 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S006) | Cook Ireland, Ltd. | 2023-09-22 |
| Zilver® Vascular Stent (P050017/S022) | Cook Ireland, Ltd. | 2023-09-22 |
| CareLink SmartSync Visia AF Application Software, CareLink SmartSync Evera MRI Application Software, Cobalt MRI ICD, Cob (P980016/S863) | Medtronic Cardiac Rhythm Disease Management | 2023-09-22 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S026) | Terumo Medical Corporation | 2023-09-21 |
| Thoraflex Hybrid (P210006/S006) | Vascutek, Ltd. | 2023-09-21 |
| Eluvia Drug Eluting Stent System (P180011/S056) | Boston Scientific Corp | 2023-09-21 |
| Accent, Assurity, Assurity+ , Zenus, Zenex, Endurity Family of Pacemakers (P880086/S330) | ABBOTT MEDICAL | 2023-09-20 |
| Assurity MRI, Endurity MRI, Accent MRI, Zenus MRI and Zenex MRI (P140033/S081) | ABBOTT MEDICAL | 2023-09-20 |
| Fortify, Fortify Assura, Ellipse Family of ICD Devices (P910023/S456) | ABBOTT MEDICAL | 2023-09-20 |
| Anthem, Allure, Quadra Allure and Allure Quadra Family of CRT-Ps (P030035/S196) | ABBOTT MEDICAL | 2023-09-20 |
| Quadra Assura, Unify, Unify Assura and Unify Quadra Family of CRT-D (P030054/S411) | ABBOTT MEDICAL | 2023-09-20 |
| Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S140) | Medtronic Cryocath, LP | 2023-09-19 |
| QDOT MICRO System (P210027/S004) | Biosense Webster, Inc. | 2023-09-19 |
| Medtronic Avalus Bioprosthesis, Model 400 (P170006/S026) | Medtronic, Inc. | 2023-09-19 |
| Harmony Transcatheter Pulmonary Valve (P200046/S020) | Medtronic, Inc. | 2023-09-19 |
| Artegraft Collagen Vascular Graft (N16837/S032) | LeMaitre Vascular, Inc. | 2023-09-19 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S145) | Medtronic, Inc. | 2023-09-19 |
| Protégé RX Carotid Stent System, Protégé GPS Self-Expanding Peripheral Stent System (P060001/S036) | Medtronic Vascular, Inc. | 2023-09-18 |
| Abre Venous Self-expanding Stent System (P200026/S006) | Medtronic Vascular, Inc. | 2023-09-18 |
| Epic Self Expanding Stent System (P110035/S070) | Boston Scientific Corp | 2023-09-18 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S039) | Medtronic Vascular, Inc. | 2023-09-18 |
| OPTIMIZER® Smart Mini System (P180036/S022) | Impulse Dynamics (Usa), Inc. | 2023-09-18 |
| VenaSeal Closure System (P140018/S039) | Medtronic Vascular, Inc. | 2023-09-15 |
| Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste (P190023/S013) | ABBOTT MEDICAL | 2023-09-15 |
| CentriMag Circulatory Support System (P170038/S013) | Abbott | 2023-09-14 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon (P190008/S025) | Medtronic Vascular, Inc. | 2023-09-14 |
| Endurant, Endurant II and Endurant 11s Stent Graft System (P100021/S117) | Medtronic Vascular | 2023-09-13 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S164) | Edwards Lifesciences, LLC | 2023-09-12 |
| iCast Covered Stent System (P120003/S002) | Atrium Medical Corp. | 2023-09-12 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S040) | Medtronic Vascular, Inc. | 2023-09-12 |
| Protégé RX Carotid Stent System, Protégé GPS Self-Expanding Peripheral Stent System (P060001/S037) | Medtronic Vascular, Inc. | 2023-09-12 |
| HeartMate 3 Left Ventricular Assist System (P160054/S058) | ABBOTT MEDICAL | 2023-09-12 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S827) | Medtronic Cardiac Rhythm Disease Management | 2023-09-11 |
| LimFlow System (P220025) | LimFlow, Inc. | 2023-09-11 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S019) | Medtronic, Inc. | 2023-09-11 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S861) | Medtronic Cardiac Rhythm Disease Management | 2023-09-11 |
| GORE® CARDIOFORM Septal Occluder (P050006/S106) | W. L. Gore & Associates, Inc. | 2023-09-11 |
| LD Ingevity Plus AF IS1 (P150012/S149) | Boston Scientific | 2023-09-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S831) | Medtronic Cardiac Rhythm Disease Management | 2023-09-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S865) | Medtronic Cardiac Rhythm Disease Management | 2023-09-08 |
| HeartMate 3 Left Ventricular Assist System (P160054/S057) | ABBOTT MEDICAL | 2023-09-07 |
| Lutonix Drug Coated Balloon PTA Catheter (P170003/S027) | Lutonix | 2023-09-07 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S101) | W. L. Gore & Associates, Inc. | 2023-09-07 |
| Lutonix Drug Coated Balloon PTA Catheter (P130024/S043) | Lutonix | 2023-09-07 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S007) | ABBOTT MEDICAL | 2023-09-07 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S162) | W. L. Gore & Associates, Inc. | 2023-09-07 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S006) | ABBOTT MEDICAL | 2023-09-07 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S038) | Cardiovascular Systems, Inc. | 2023-09-07 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S057) | Boston Scientific Corp | 2023-09-06 |
| VenaSeal Closure System (P140018/S038) | Medtronic Vascular, Inc. | 2023-09-06 |
| CardioMEMS HF System (P100045/S069) | ABBOTT MEDICAL | 2023-09-06 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S759) | Medtronic, Inc. | 2023-09-05 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S038) | Medtronic Vascular, Inc. | 2023-09-05 |
| Philips Laser System (P910001/S120) | Spectranetics Corp. | 2023-08-31 |
| LIFEPAK® CR2 Defibrillator (P170018/S016) | Physio-Control, Inc. | 2023-08-31 |
| Express SD Renal (P060006/S108) | Boston Scientific Corp | 2023-08-31 |