| Titan Inflatable Penile Prosthesis (IPP) (P000006/S064) | Coloplast Corp. | 2023-03-03 |
| VNS Therapy System (P970003/S239) | LivaNova USA, Inc. | 2023-03-02 |
| Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graft System (P100021/S112) | Medtronic Vascular | 2023-03-02 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S007) | Medtronic Vascular, Inc. | 2023-03-02 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro (P110010/S207) | Boston Scientific Corp | 2023-03-02 |
| Axonics Sacral Neuromodulation System (P190006/S065) | Boston Scientific Corporation | 2023-03-02 |
| Axonics Sacral Neuromodulation System (P180046/S065) | Boston Scientific Corporation | 2023-03-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S090) | Boston Scientific Corporation | 2023-03-02 |
| Perceval S Sutureless Heart Valve; Perceval Plus Sutureless Heart Valve (P150011/S027) | Corcym S.r.l. | 2023-03-02 |
| VNS Therapy System (P970003/S240) | LivaNova USA, Inc. | 2023-03-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S075) | Boston Scientific Corp | 2023-03-02 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S018) | Boston Scientific Corporation | 2023-03-02 |
| Wolverine Coronary Cutting Balloon (P950020/S133) | Boston Scientific Corp | 2023-03-02 |
| Express SD Renal Monorail Premounted Stent System (P060006/S105) | Boston Scientific Corp | 2023-03-02 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S042) | Medinol, Ltd. | 2023-03-01 |
| Vascade Vascular Closure System (VCS) (P120016/S029) | Cardiva Medical, Inc. | 2023-03-01 |
| Micra AV TPS (P150033/S165) | Medtronic, Inc. | 2023-03-01 |
| DiamondTemp Ablation System (P200028/S015) | Medtronic, Inc. | 2023-03-01 |
| INGEVITY and INGEVITY+ (P150012/S141) | Boston Scientific | 2023-03-01 |
| VENTANA PD-L1 (SP263) Assay (P160046/S013) | Ventana Medical Systems, Inc. | 2023-03-01 |
| LIPOSORBER LA-15 System (P910018/S035) | Kaneka Pharma America Corp. | 2023-03-01 |
| Juvéderm® Volux XC (P110033/S068) | Allergan | 2023-02-28 |
| Manual Retraction Kit (P100010/S136) | Medtronic Cryocath, LP | 2023-02-28 |
| Pipeline Flex Embolization Device, Pipeline Flex Embolization Device with Shield Technology (P100018/S038) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2023-02-28 |
| SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT, SURGICEL® POWDER) (N12159/S100) | ETHICON, Inc. | 2023-02-28 |
| TRUFILL n-BCA Liquid Embolic System (P990040/S030) | Cerenovus, Inc. | 2023-02-28 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S054) | ETHICON, Inc. | 2023-02-28 |
| Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S033) | Rayner Intraocular Lenses , Ltd. | 2023-02-27 |
| BD Onclarity HPV Assay (P160037/S015) | Becton, Dickinson and Company | 2023-02-27 |
| QDOT MICRO System, nGEN Generator (P210027/S001) | Biosense Webster, Inc. | 2023-02-24 |
| Organ Care System (OCS) Lung System (P160013/S010) | TransMedics, Inc. | 2023-02-24 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S082) | ABBOTT MEDICAL | 2023-02-24 |
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S014) | Cardiofocus, Inc. | 2023-02-24 |
| FoundationOne CDx (F1CDx) (P170019/S041) | Foundation Medicine, Inc. | 2023-02-24 |
| Organ Care System (OCS) Heart (P180051/S002) | TransMedics, Inc. | 2023-02-23 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone (P000053/S129) | Boston Scientific Corp | 2023-02-23 |
| Organ Care System (OCS) Lung (P160013/S011) | TransMedics, Inc. | 2023-02-23 |
| Coseal Surgical Sealant, Coseal Spray Set (P030039/S028) | Baxter Bio Science | 2023-02-23 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S844) | Medtronic Cardiac Rhythm Disease Management | 2023-02-23 |
| Collastat/INSTAT Absorbable Collagen Hemostatic Agent (P810006/S102) | Integra LifeSciences Corporation | 2023-02-23 |
| Vercise Genus DBS System (P150031/S052) | Boston Scientific Corp | 2023-02-23 |
| cobas® HBV (P150014/S043) | Roche Molecular Systems, Inc. | 2023-02-23 |
| Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S105) | Integra Lifesciences Corp. | 2023-02-23 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S810) | Medtronic Cardiac Rhythm Disease Management | 2023-02-23 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings (P840062/S087) | Integra Lifesciences Corp. | 2023-02-23 |
| Helistat/Helitene Absorbable Collagen Hemostatic Agent (P850010/S105) | Integra LifeSciences Corporation | 2023-02-23 |
| Organ Care System (OCS) Liver (P200031/S002) | TransMedics, Inc. | 2023-02-23 |
| Zilver Vena® Venous Self Expanding Stent (P200023/S003) | Cook Ireland, Ltd. | 2023-02-22 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S033) | Edwards Lifesciences, LLC | 2023-02-22 |
| Silikon 1000 (P950008/S017) | Alcon | 2023-02-22 |
| Birmingham Hip Resurfacing (BHR) System (P040033/S037) | Smith & Nephew, Inc. | 2023-02-22 |
| Zilver® Vascular Stent (P050017/S020) | Cook Ireland, Ltd. | 2023-02-22 |
| StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) (P220009) | Bausch Health Companies, Inc. | 2023-02-22 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S007) | Kestra Medical Technologies, Inc. | 2023-02-21 |
| Alinity m HBV (P200013/S010) | Abbott Molecular, Inc. | 2023-02-21 |
| EMBLEM S-ICD, EMBLEM MRI S-ICD, (P110042/S180) | Boston Scientific Corporation | 2023-02-21 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP (P910023/S449) | ABBOTT MEDICAL | 2023-02-21 |
| Alinity m CMV (P210022/S003) | Abbott Molecular, Inc. | 2023-02-21 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra (P030054/S403) | ABBOTT MEDICAL | 2023-02-21 |
| R Series MCU 20.01 software release (P160022/S032) | ZOLL Medical Corporation | 2023-02-17 |
| ClearView 3 (P200020/S003) | Lenstec, Inc. | 2023-02-17 |
| Sprint Quattro Lead (P920015/S275) | Medtronic, Inc. | 2023-02-17 |
| Praxis Extended RAS Panel (P160038/S025) | Illumina, Inc. | 2023-02-17 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S032) | Berlin Heart, Inc. | 2023-02-17 |
| NeuroPace® RNS® System (P100026/S093) | NeuroPace, Inc. | 2023-02-17 |
| Fluency Endovascular Stent Graft (P130029/S012) | Bard Peripheral Vascular, Inc. | 2023-02-17 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S212) | Medtronic Cardiac Rhythm Disease Management | 2023-02-17 |
| SURGICEL® SNOW Absorbable Hemostat (N12159/S099) | ETHICON, Inc. | 2023-02-16 |
| Reactiv8 Implantable Neurostimulation System (P190021/S004) | Mainstay Medical Limited | 2023-02-16 |
| MEL 80 Excimer Laser System (P060004/S004) | Carl Zeiss Meditec, Inc. | 2023-02-16 |
| M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge (P160029/S018) | Philips Medical Systems, Inc. | 2023-02-16 |
| MEL 80 Excimer Laser System (P060004/S005) | Carl Zeiss Meditec, Inc. | 2023-02-16 |
| DuraSeal Exact Spinal Sealant (P080013/S025) | Integra LifeSciences Corporation | 2023-02-16 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S053) | Boston Scientific Corp | 2023-02-16 |
| Light Adjustable Lens, Light Delivery Device (P160055/S027) | Rxsight, Inc. | 2023-02-16 |
| Innova Self-Expanding Stent System (P140028/S076) | Boston Scientific Corporation | 2023-02-16 |
| SURGICEL Absorbable Hemostats, SURGICEL Powder (N12159/S098) | ETHICON, Inc. | 2023-02-16 |
| DuraSeal Dural Sealant System (P040034/S036) | Integra LifeSciences Corporation | 2023-02-16 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S741) | Medtronic, Inc. | 2023-02-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S052) | ABBOTT MEDICAL | 2023-02-16 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys, Biofinity Toric and Biofinity XR Toric, Biofinity Multifoca (P080011/S154) | CooperVision, Inc. | 2023-02-15 |
| QUIK-PAK Electrodes (P160012/S005) | Physio-Control, Inc. | 2023-02-15 |
| Spatz3 Adjustable Balloon System (P190012/S002) | Spatz Fgia, Inc. | 2023-02-15 |
| Harmony Delivery Catheter System (P200046/S014) | Medtronic, Inc. | 2023-02-15 |
| HeartWare HVAD System (P100047/S207) | Medtronic | 2023-02-15 |
| Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa+ with Lidocaine 1.0 mL, Revanesse Versa+ with Lidocaine (P160042/S018) | Prollenium Medical Technologies, Inc. | 2023-02-15 |
| BD Onclarity HPV Assay (P160037/S012) | Becton, Dickinson and Company | 2023-02-15 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S066) | Coloplast Corp. | 2023-02-15 |
| INTUITY Delivery System - Accessories (P150036/S067) | Edwards Lifesciences, LLC | 2023-02-14 |
| OrganOx metra® System (P200035/S005) | Organox Limited | 2023-02-14 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S095) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S093) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S006) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S172) | Biotronik, Inc. | 2023-02-13 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S194) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (P160031/S004) | Fujifilm Medical Systems U.S.A, Inc. | 2023-02-13 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S156) | W. L. Gore & Associates, Inc. | 2023-02-13 |
| HeartWare Ventricular Assist System (P100047/S204) | Medtronic | 2023-02-13 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S025) | Cordis US Corporation | 2023-02-13 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S133) | W. L. Gore & Associates, Inc. | 2023-02-13 |