| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S530) | Medtronic, Inc. | 2024-01-30 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S770) | Medtronic, Inc. | 2024-01-30 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030) | Farapulse, Inc. | 2024-01-30 |
| Architect AFP and Alinity i AFP (P120008/S028) | Abbott Laboratories | 2024-01-30 |
| Sculptra® (P030050/S046) | Q-Med AB | 2024-01-30 |
| Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC (P050047/S093) | Allergan | 2024-01-30 |
| The 4Kscore Test (P190022/S002) | Opko Health, Inc. | 2024-01-30 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella, Juvéderm Volux XC, Skinvive (P110033/S081) | Allergan | 2024-01-30 |
| Evolut FX Delivery Catheter System (P130021/S154) | Medtronic, Inc. | 2024-01-29 |
| CERAMAX® Ceramic Total Hip System (P070026/S111) | DePuy Orthopaedics, Inc. | 2024-01-29 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S009) | Ventana Medical Systems | 2024-01-26 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S023) | Ventana Medical Systems, Inc. | 2024-01-26 |
| CINtec PLUS Cytology (P190024/S012) | Ventana Medical Systems, Inc. | 2024-01-26 |
| VENTANA MMR RxDx Panel (Solid Tumors with dMMR status) (P210001/S011) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2024-01-26 |
| VENTANA PD-Ll (SP263) Assay (P160046/S018) | Ventana Medical Systems, Inc. | 2024-01-26 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S053) | Ventana Medical Systems, Inc. | 2024-01-26 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S010) | Ventana Medical Systems, Inc. | 2024-01-26 |
| activL Artificial Disc (P120024/S013) | Highridge Medical, LLC | 2024-01-26 |
| VENTANA PD-Ll (SP142) Assay (P160002/S023) | Ventana Medical Systems, Inc. | 2024-01-26 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S031) | Ventana Medical Systems, Inc. | 2024-01-26 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S041) | Ventana Medical Systems, Inc. | 2024-01-26 |
| ReShape Lap-Band System (P000008/S049) | Medtimo, Inc. | 2024-01-26 |
| VENTANA FOLR1 (FOLR-2.1) RxDx Assay (P220006/S005) | Ventana Medical Systems, Inc. | 2024-01-26 |
| Coaptite Injectable Implant (P040047/S070) | Merz North America, Inc. | 2024-01-25 |
| Radiesse Injectable Implant (P050037/S122) | Merz North America, Inc. | 2024-01-25 |
| Guardian System (P150009/S011) | Avertix Medical, Inc. | 2024-01-25 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S370) | Boston Scientific Corp | 2024-01-25 |
| Radiesse® Injectable Implant, Radiesse® Hands (P050052/S143) | Merz North America, Inc. | 2024-01-25 |
| Avalus Bioprosthesis (P170006/S031) | Medtronic, Inc. | 2024-01-24 |
| Harmony Transcatheter Pulmonary Valve (P200046/S027) | Medtronic, Inc. | 2024-01-24 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S153) | Medtronic, Inc. | 2024-01-24 |
| MelodyTM Transcatheter Pulmonary Valve (P140017/S027) | Medtronic, Inc. | 2024-01-24 |
| Infinion Pro Leads (P030017/S354) | Boston Scientific Corp | 2024-01-24 |
| Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P140009/S087) | ABBOTT MEDICAL | 2024-01-24 |
| Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application (P010032/S202) | ABBOTT MEDICAL | 2024-01-24 |
| Minerva Endometrial Ablation System (P140013/S015) | Axora Medical, Inc. | 2024-01-24 |
| Epic Plus and Epic Plus Supra (P040021/S056) | ABBOTT MEDICAL | 2024-01-23 |
| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S022) | Philips Medical Systems, Inc. | 2024-01-23 |
| Trident(R), ABC(R) (P000013/S024) | Howmedica Osteonics Corp. | 2024-01-23 |
| DRG System - Leads and Extensions (P150004/S065) | ABBOTT MEDICAL | 2024-01-22 |
| MitraClip G4 Clip Delivery System (P100009/S061) | ABBOTT MEDICAL | 2024-01-22 |
| Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro) (P150038/S033) | Insightec | 2024-01-21 |
| Alinity m HR HPV Assay (P230003/S002) | Abbott Molecular, Inc. | 2024-01-20 |
| Alinity m HBV Assay (P200013/S019) | Abbott Molecular, Inc. | 2024-01-20 |
| Alinity m CMV Assay (P210022/S010) | Abbott Molecular, Inc. | 2024-01-20 |
| R3 Delta Ceramic Hip System (P150030/S037) | Smith & Nephew, Inc. | 2024-01-19 |
| Birmingham Hip Resurfacing (BHR) System (P040033/S038) | Smith & Nephew, Inc. | 2024-01-19 |
| Lead Repair Kit Model 6946 (P910073/S175) | Boston Scientific | 2024-01-19 |
| ARCHITECT AUSAB (P050051/S050) | Abbott Laboratories, Inc. | 2024-01-19 |
| Medical Adhesive Model 6517 (P830060/S090) | Boston Scientific | 2024-01-19 |
| Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S106) | Inspire Medical Systems | 2024-01-19 |
| CardioMEMS HF System (P100045/S071) | ABBOTT MEDICAL | 2024-01-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co (P150003/S096) | Boston Scientific Corporation | 2024-01-19 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S055) | Boston Scientific Corp | 2024-01-19 |
| Avitene Microfibrillar Collagen Hemostat (MCH) (N17600/S039) | Davol Inc., Sub. C. R. Bard, Inc. | 2024-01-18 |
| cobas® HBV (P150014/S049) | Roche Molecular Systems, Inc. | 2024-01-18 |
| ARTISAN Phakic lntraocular Lens (IOL), (P030028/S012) | Ophtec BV | 2024-01-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Capsular Tension Ring (CTR) (P030023/S011) | Ophtec BV | 2024-01-18 |
| LifeVest® Wearable Defibrillator (P010030/S173) | Zoll Manufacturing Corporation | 2024-01-18 |
| Durasphere® Injectable Bulking Agent (P980053/S020) | Carbon Medical Technologies, Inc. | 2024-01-18 |
| LVIS (P170013/S011) | MicroVention, Inc. | 2024-01-17 |
| Bond Oracle HER2 IHC System (P090015/S013) | Leica Biosystems | 2024-01-17 |
| XACT Carotid Stent System (P040038/S044) | Abbott Vascular, Inc. | 2024-01-17 |
| FRED (P180027/S010) | MicroVention, Inc. | 2024-01-17 |
| XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE Xpedition Everolimus Eluting Coronary Stent System, XIEN (P110019/S131) | Abbott Vascular | 2024-01-17 |
| Supera Peripheral Stent System (P120020/S031) | Abbott Vascular (Idef Technologies Inc) | 2024-01-17 |
| Optune (P100034/S030) | Novocure, GmbH | 2024-01-16 |
| INSPIRIS RESILIA Aortic Valve, KONECT RESILIA Aortic Valve Conduit (AVC), MITRIS RESILIA Mitral Valve (P150048/S077) | Edwards Lifesciences, LLC | 2024-01-16 |
| Alinity m CMV (P210022/S008) | Abbott Molecular, Inc. | 2024-01-16 |
| Optilume Urethral Drug Coated Balloon catheter (P210020/S009) | Urotronic, Inc. | 2024-01-13 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S769) | Medtronic, Inc. | 2024-01-12 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR IC (P980016/S878) | Medtronic Cardiac Rhythm Disease Management | 2024-01-12 |
| Aurora EV ICD (P220012/S011) | Medtronic, Inc. | 2024-01-12 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023) | W. L. Gore & Associates, Inc. | 2024-01-12 |
| FoundationOne CDx (F1CDx) (P170019/S051) | Foundation Medicine, Inc. | 2024-01-12 |
| LCS Total Knee System (P830055/S318) | Depuy, Inc. | 2024-01-12 |
| 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,Compia M (P010031/S844) | Medtronic Cardiac Rhythm Disease Management | 2024-01-12 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S467) | Medtronic, Inc. | 2024-01-11 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S394) | Medtronic Neuromodulation | 2024-01-11 |
| Thoraflex Hybrid (P210006/S007) | Vascutek, Ltd. | 2024-01-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S056) | ABBOTT MEDICAL | 2024-01-11 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S421) | Medtronic, Inc. | 2024-01-11 |
| T-SPOT®.TB Test (P070006/S022) | Oxford Immunotec, Ltd. | 2024-01-11 |
| Guardant360 CDx (P200010/S017) | Guardant Health, Inc. | 2024-01-11 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S557) | Medtronic Neuromodulation | 2024-01-11 |
| PyloPlus® UBT System (P170022/S003) | Arj Medical, Inc. | 2024-01-11 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S289) | Medtronic Neuromodulation | 2024-01-11 |
| BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Le (P180050/S012) | Cvrx, Inc. | 2024-01-11 |
| Gelsyn-3 (P110005/S014) | Ibsa Institut Biochimique SA | 2024-01-11 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S066) | Boston Scientific Corp | 2024-01-10 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Dorsal Root Ganglion (DRG) SlimTip Trial Lead Kit and DRG SlimTip Implant Lead Kit (P150004/S068) | ABBOTT MEDICAL | 2024-01-10 |
| Prismaflex TPE2000 Set (P830063/S027) | Vantive US Healthcare, LLC | 2024-01-10 |
| VISUMAX 800 (P150040/S012) | Carl Zeiss Meditec, Inc. | 2024-01-10 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S182) | Medtronic, Inc. | 2024-01-10 |
| HiResolution Bionic Ear System (P960058/S162) | Advanced Bionics | 2024-01-10 |
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005) | Tz Medical, Inc. | 2024-01-09 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S369) | Boston Scientific Corp | 2024-01-09 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S069) | Boston Scientific Corp | 2024-01-09 |