| 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 |
| Alinity i AFP (P120008/S025) | Abbott Laboratories | 2023-09-25 |
| Alinity i Total PSA (P910007/S063) | Abbott Laboratories | 2023-09-25 |
| RADIESSE (P050052/S144) | Merz North America, 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 |
| Alinity i Free PSA (P980007/S052) | Abbott Laboratories | 2023-09-25 |
| SAPIEN 3 Pulmonic Delivery System (P200015/S046) | Edwards Lifesciences, LLC | 2023-09-25 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S203) | ABBOTT MEDICAL | 2023-09-22 |
| 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 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S066) | ABBOTT MEDICAL | 2023-09-22 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S024) | Boston Scientific Corporation | 2023-09-22 |
| Percept PC INS with BrainSense (Model B35200) (P960009/S445) | Medtronic, Inc. | 2023-09-22 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S090) | Hologic, Inc. | 2023-09-22 |
| Sequentia LT INS (Model 977005), Vanta INS with AdaptiveStim (Model 977006) (P840001/S535) | Medtronic Neuromodulation | 2023-09-22 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S074) | Medtronic, Inc. | 2023-09-22 |
| Belotero Balance Dermal Filler, Belotero Balance(+) Lidocaine Dermal Filler (P090016/S051) | Merz North America, Inc. | 2023-09-22 |
| Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S088) | ABBOTT MEDICAL | 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 |
| Spiration Valve System (P180007/S011) | Gyrus Acmi, Inc. | 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 |
| Saluda Medical Evoke® SCS System (P190002/S014) | Saluda Medical Pty, Ltd. | 2023-09-22 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S026) | Terumo Medical Corporation | 2023-09-21 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S031) | Rxsight, Inc. | 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 |
| RADIESSE® Injectable Implant (P050037/S131) | Merz North America, Inc. | 2023-09-20 |
| Accent, Assurity, Assurity+ , Zenus, Zenex, Endurity Family of Pacemakers (P880086/S330) | ABBOTT MEDICAL | 2023-09-20 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S153) | Merz North America, Inc. | 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 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe (N970012/S196) | Boston Scientific Corp | 2023-09-20 |
| Coaptite Injectable Implant (P040047/S072) | Merz North America, Inc. | 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 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO (P810031/S073) | Johnson & Johnson Surgical Vision, 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 |
| FoundationOne CDx (F1CDx) (P170019/S036) | Foundation Medicine, Inc. | 2023-09-18 |
| Abre Venous Self-expanding Stent System (P200026/S006) | Medtronic Vascular, Inc. | 2023-09-18 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S063) | Ferrosan Meidcal Devices A/S | 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 |
| Silikon 1000 (P950008/S019) | Alcon | 2023-09-15 |
| VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand (P970003/S241) | LivaNova USA, Inc. | 2023-09-15 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S199) | Boston Scientific Corp | 2023-09-15 |
| VenaSeal Closure System (P140018/S039) | Medtronic Vascular, Inc. | 2023-09-15 |
| Pipeline Vantage Embolization Device with Shield Technology (P100018/S034) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-09-15 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S005) | QIAGEN GmbH | 2023-09-15 |
| LCS® Total Knee System (P830055/S312) | Depuy, 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 |
| Alinity m HBV (P200013/S017) | Abbott Molecular, Inc. | 2023-09-14 |
| CentriMag Circulatory Support System (P170038/S013) | Abbott | 2023-09-14 |
| Alinity m CMV (P210022/S007) | Abbott Molecular, Inc. | 2023-09-14 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon (P190008/S025) | Medtronic Vascular, Inc. | 2023-09-14 |
| COAPTITE Injectable Implant (P040047/S071) | Merz North America, Inc. | 2023-09-13 |
| SURGICEL® Absorbable Hemostats (N12159/S105) | ETHICON, Inc. | 2023-09-13 |
| Endurant, Endurant II and Endurant 11s Stent Graft System (P100021/S117) | Medtronic Vascular | 2023-09-13 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S152) | Merz North America, Inc. | 2023-09-13 |
| RADIESSE® Injectable Implant (P050037/S130) | Merz North America, Inc. | 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 |
| Surpass Evolve Flow Diverter Stent System (P170024/S013) | Stryker Neurovascular | 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 |
| LungFit PH (P200044/S003) | Beyond Air, Inc. | 2023-09-10 |
| 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 |
| Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S109) | Integra Lifesciences Corp. | 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 |
| TOPS System (P220002/S002) | Premia Spine, Ltd. | 2023-09-07 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System, DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S038) | Cardiovascular Systems, Inc. | 2023-09-07 |
| Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology (P100018/S040) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-09-06 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S057) | Boston Scientific Corp | 2023-09-06 |
| MORCHER® Capsular Tension Rings (P010059/S011) | Morcher GmbH | 2023-09-06 |
| Ceramic TRANSCEND® Hip Articulation System (P010001/S026) | Ceramtec GmbH | 2023-09-06 |
| VenaSeal Closure System (P140018/S038) | Medtronic Vascular, Inc. | 2023-09-06 |