| LifeVest Wearable Defibrillator, Model 5100 (P010030/S184) | Zoll Manufacturing Corporation | 2024-07-18 |
| Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl (P860022/S060) | Bausch & Lomb | 2024-07-18 |
| Latitude NXT Patient Management System (P910077/S194) | Boston Scientific | 2024-07-18 |
| PerClot Polysaccharide Hemostatic System (P210036/S004) | Baxter Healthcare Corporation | 2024-07-18 |
| SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance (P970003/S244) | LivaNova USA, Inc. | 2024-07-18 |
| Latitude NXT Patient Management System (INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S157) | Boston Scientific | 2024-07-18 |
| Latitude NXT Patient Management System (INVIVE, INTUA, VISIONIST, VALITUDE) (P030005/S238) | Guidant Corp. | 2024-07-18 |
| Latitude NXT Patient Management System (TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P960040/S500) | Boston Scientific | 2024-07-18 |
| Latitude NXT Patient Management System (COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, (P010012/S582) | Boston Scientific Corp | 2024-07-18 |
| Latitude NXT Patient Management System (EMBLEM S-ICD) (P110042/S195) | Boston Scientific Corporation | 2024-07-18 |
| Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S013) | Bausch & Lomb | 2024-07-18 |
| Cerene Cryotherapy Device (P180032/S018) | Channel Medsystems, Inc. | 2024-07-17 |
| 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/S784) | Medtronic, Inc. | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P920047/S133) | Boston Scientific Corp | 2024-07-17 |
| Guardian 4 Sensor (P160007/S051) | Medtronic Minimed | 2024-07-17 |
| Percept RC BrainSense (P960009/S484) | Medtronic, Inc. | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P020025/S141) | Boston Scientific | 2024-07-17 |
| DRG Delivery Sheath (P150004/S075) | ABBOTT MEDICAL | 2024-07-17 |
| Restylane® Contour (P140029/S051) | Q-Med AB | 2024-07-17 |
| Guardian 4 Sensor (P160017/S119) | Medtronic Minimed, Inc. | 2024-07-17 |
| Inceptiv Spinal Cord Stimulation Systems (P840001/S566) | Medtronic Neuromodulation | 2024-07-17 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S542) | Medtronic, Inc. | 2024-07-17 |
| INTELLAGEN Cardiac Ablation System (P150005/S079) | Boston Scientific Corp | 2024-07-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S081) | ABBOTT MEDICAL | 2024-07-16 |
| Axonics Sacral Neuromodulation System (P190006/S085) | Boston Scientific Corporation | 2024-07-16 |
| HeartMate II Left Ventricular Assist System (P060040/S105) | ABBOTT MEDICAL | 2024-07-16 |
| MitraClip G4 Clip Delivery System (P100009/S066) | ABBOTT MEDICAL | 2024-07-16 |
| Symplicity G3 Renal RF Generator (P220026/S005) | Medtronic, Inc. | 2024-07-16 |
| Sientra Silicone Gel Breast Implants (P070004/S039) | Tiger Aesthetics Medical, LLC | 2024-07-16 |
| Synergy Everolimus-eluting Platinum Chromium Coronary Stent System (P150003/S099) | Boston Scientific Corporation | 2024-07-16 |
| Minitouch 3.8 Era System (Minitouch System) (P230002/S001) | Microcube, LLC | 2024-07-16 |
| QDOT MICRO Uni-Directional Navigation Catheter (P210027/S011) | Biosense Webster, Inc. | 2024-07-16 |
| Axonics Sacral Neuromodulation System (P180046/S085) | Boston Scientific Corporation | 2024-07-16 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilconA) (P080011/S166) | CooperVision, Inc. | 2024-07-16 |
| LifeVest Wearable Defibrillator (P010030/S183) | Zoll Manufacturing Corporation | 2024-07-15 |
| XACT Transcarotid Stent System (XACT TSS) (P040038/S045) | Abbott Vascular, Inc. | 2024-07-15 |
| CentriMag Circulatory Support System (P170038/S019) | Abbott | 2024-07-15 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S087) | Intera Oncology | 2024-07-12 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S032) | Alcon Laboratories, LLC | 2024-07-12 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual (P190017/S020) | DiaSorin, Inc. | 2024-07-12 |
| Aveir VR Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker (Right Ventricular) (P150035/S012) | ABBOTT MEDICAL | 2024-07-12 |
| LIAISON® QuantiFERON® - TB Gold Plus, LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S026) | DiaSorin, Inc. | 2024-07-12 |
| LIAISON® XL Murex Anti-HBc, LIAISON® XL MUREX Control anti-HBc (P180038/S019) | DiaSorin, Inc. | 2024-07-12 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs, LIAISON® XL Murex Anti-HBs Verifier (P180039/S018) | DiaSorin, Inc. | 2024-07-12 |
| Parvovirus B19 IgM Enzyme Immunoassay (P970055/S023) | Diasorin | 2024-07-12 |
| Parvovirus B19 IgG Enzyme Immunoassay (P970054/S021) | Diasorin | 2024-07-12 |
| Optune Gio (P100034/S034) | Novocure, GmbH | 2024-07-12 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S015) | DiaSorin, Inc. | 2024-07-12 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S149) | Alcon Laboratories, Inc. | 2024-07-12 |
| IntellaNav StablePoint Catheter and Open-Irrigated Catheter (P150005/S085) | Boston Scientific Corp | 2024-07-12 |
| LIAISON® Biotrin Parvovirus B 19 IgG Plus, LIAISON® Biotrin Control Parvovirus B 19 IgG Plus (P220034/S002) | DiaSorin, Inc. | 2024-07-12 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S016) | DiaSorin, Inc. | 2024-07-12 |
| AcrySof® ReSTOR Apodized Diffractive Optic Posterior Chamber IOL (P040020/S108) | Alcon Research, Ltd. | 2024-07-12 |
| Revanesse Versa, Revanesse Versa+ and Revanesse Lips+ (P160042/S026) | Prollenium Medical Technologies, Inc. | 2024-07-12 |
| LIAISON® XL MUREX Anti-HBe, LIAISON® XL MUREX Control Anti-HBe (P180049/S016) | DiaSorin, Inc. | 2024-07-12 |
| THIXO (P200020/S006) | Lenstec, Inc. | 2024-07-11 |
| AccelStim (P210035/S002) | Orthofix US, LLC | 2024-07-11 |
| LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft (P220025/S002) | LimFlow, Inc. | 2024-07-11 |
| MARA Water Vapor Ablation System (P160047/S035) | CooperSurgical, Inc. | 2024-07-11 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P980016/S896) | Medtronic Cardiac Rhythm Disease Management | 2024-07-11 |
| THIXO-1 Polishing Compound (P090022/S043) | Lenstec, Inc. | 2024-07-11 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S862) | Medtronic Cardiac Rhythm Disease Management | 2024-07-11 |
| RADIESSE Injectable Implant (P050037/S140) | Merz North America, Inc. | 2024-07-10 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S049) | Medtronic Vascular, Inc. | 2024-07-10 |
| M6-C Artificial Cervical Disc (P170036/S015) | Spinal Kinetics, LLC | 2024-07-10 |
| RADIESSE® Injectable Implant, RADIESSE Hands (P050052/S164) | Merz North America, Inc. | 2024-07-10 |
| Alinity m CMV Assay (P210022/S011) | Abbott Molecular, Inc. | 2024-07-10 |
| Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System (P060001/S043) | Medtronic Vascular, Inc. | 2024-07-10 |
| COAPTITE Injectable Implant (P040047/S075) | Merz North America, Inc. | 2024-07-10 |
| Alinity m HR HPV Assay (P230003/S003) | Abbott Molecular, Inc. | 2024-07-10 |
| Abre Venous Self-expanding Stent System (P200026/S010) | Medtronic Vascular, Inc. | 2024-07-10 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S020) | CooperVision, Inc. | 2024-07-10 |
| Alinity m HBV Assay (P200013/S020) | Abbott Molecular, Inc. | 2024-07-10 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S012) | Cook Medical Incorporated | 2024-07-09 |
| Biofinity Sphere, Biofinity XR Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys (P080011/S164) | CooperVision, Inc. | 2024-07-09 |
| Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor (P900060/S067) | Corcym S.r.l. | 2024-07-09 |
| MARA Water Vapor Ablation System (P160047/S038) | CooperSurgical, Inc. | 2024-07-09 |
| Titan Inflatable Penile Prosthesis (IPP) (P000006/S068) | Coloplast Corp. | 2024-07-09 |
| Zenith Dissection Endovascular System (P180001/S013) | William Cook Europe Aps | 2024-07-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S402) | Medtronic Neuromodulation | 2024-07-05 |
| Belotero Balance(+) Lidocaine Dermal Filler (BBL) (P090016/S060) | Merz North America, Inc. | 2024-07-05 |
| Envision Mammography Platform (P080003/S009) | Hologic, Inc. | 2024-07-05 |
| InterStim Therapy System, Verify Evaluation System (P080025/S297) | Medtronic Neuromodulation | 2024-07-05 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S006) | Boston Scientific Corporation | 2024-07-05 |
| NexGen® LPS-Flex LPS-Mobile Bearing Knee (P060037/S091) | Zimmer, Inc. | 2024-07-05 |
| Sprint Quattro Lead (P920015/S290) | Medtronic, Inc. | 2024-07-05 |
| FARAPULSE Pulsed Field Ablation System (P230030/S005) | Farapulse, Inc. | 2024-07-05 |
| Conformable GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S138) | W. L. Gore & Associates, Inc. | 2024-07-03 |
| Barricaid® Annular Closure Device - Model Number BAR-A8-8MM (2730815-A&), Barricaid® Annular Closure Device - Model Numb (P160050/S009) | Intrinsic Therapeutics | 2024-07-03 |
| FLEX34 Active Electrode, Insertion Electrode (IE) FLEX34, Insertion Probe, Insertion Probe L and Auditory Nerve Test Sys (P000025/S127) | Med-El Corp. | 2024-07-03 |
| Seprafilm Adhesion Barrier (P950034/S058) | Baxter Healthcare Corporation | 2024-07-03 |
| Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric, Biofinity XR Toric, Biofinity Multifo (P080011/S165) | CooperVision, Inc. | 2024-07-03 |
| HeartWare HVAD System (P100047/S217) | Medtronic | 2024-07-03 |
| Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S011) | Endomagnetics Ltd., | 2024-07-03 |
| Arctic Front Advance Pro (P100010/S148) | Medtronic Cryocath, LP | 2024-07-03 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S044) | Berlin Heart, Inc. | 2024-07-02 |
| Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) (P810002/S123) | ABBOTT MEDICAL | 2024-07-02 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S081) | Edwards Lifesciences, LLC | 2024-07-02 |
| TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System (P990040/S033) | Cerenovus, Inc. | 2024-07-02 |
| The Tendril MRI lead (P140033/S089) | ABBOTT MEDICAL | 2024-07-02 |