| PROVSIC Ophthalmic Viscosurgical Device (P890047/S067) | Alcon Research, Ltd. | 2025-02-26 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S917) | Medtronic Cardiac Rhythm Disease Management | 2025-02-26 |
| TX eco EXT Cable (P210027/S014) | Biosense Webster, Inc. | 2025-02-26 |
| Attain Ability Lead (P080006/S189) | Medtronic, Inc. | 2025-02-26 |
| DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088) | Alcon Laboratories | 2025-02-26 |
| Interface Cable for Multi-Electrode Ablation Catheters (nMARQ) (P240006/S002) | Biosense Webster, Inc. | 2025-02-26 |
| Thermocool Deflectable Diagnostic/ Ablation Catheter (P040036/S100) | Biosense Webster, Inc. | 2025-02-25 |
| LIAISON XL MUREX HBeAg; vLIAISON XL MUREX Control HBeAg (P180048/S019) | DiaSorin, Inc. | 2025-02-25 |
| NAVISTAR DS Electrophysiology Catheter (P010068/S075) | Biosense Webster, Inc. | 2025-02-25 |
| LIAISON XL MUREX HBsAg Qual; LIAISON XL MUREX Control HBsAg Qual; LIAISON XL MUREX HBsAg Confirmatory (P190017/S024) | DiaSorin, Inc. | 2025-02-25 |
| QDOT MICRO System (P210027/S015) | Biosense Webster, Inc. | 2025-02-25 |
| LIAISON MUREX Anti-HBc; LIAISON MUREX Control Anti-HBc (P180038/S022) | DiaSorin, Inc. | 2025-02-25 |
| LIAISON XL MUREX HBc IgM; LIAISON XL MUREX Control HBc IgM (P180045/S018) | DiaSorin, Inc. | 2025-02-25 |
| BIOFINITY (COMFILCON A) (P080011/S181) | CooperVision, Inc. | 2025-02-25 |
| LIAISON QuantiFERON-TB Gold Plus; LIAISON Control QuantiFERON-TB Gold Plus (P180047/S033) | DiaSorin, Inc. | 2025-02-25 |
| -LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S005) | DiaSorin, Inc. | 2025-02-25 |
| LIAISON XL MUREX Anti-HBe; LIAISON XL MUREX Control Anti-HBe (P180049/S019) | DiaSorin, Inc. | 2025-02-25 |
| LIAISON XL MUREX Anti-HBs; LIAISON XL MUREX Control Anti-HBs; LIAISON XL Murex Anti-HBs Verifiers (P180039/S021) | DiaSorin, Inc. | 2025-02-25 |
| Navistar Thermocool Catheter; Thermocool SmartTouch Catheter; Thermocool SmartTouch SF Catheter; Thermocool SF NAV Cathe (P030031/S139) | Biosense Webster, Inc. | 2025-02-25 |
| NAVISTAR Electrophysiology Catheter (P990025/S074) | Biosense Webster, Inc. | 2025-02-25 |
| Dimension FPSA Flex reagent cartridge (P020027/S041) | Siemens Healthcare Diagnostics | 2025-02-24 |
| INTEGRA DERMAL REGENERATION TEMPLATE (P900033/S114) | Integra Lifesciences Corp. | 2025-02-24 |
| Dimension TPSA Flex reagent cartridge (P000021/S046) | Siemens Healthcare Diagnostics | 2025-02-24 |
| Perclose ProGlide Suture-Mediated Closure (SMC) System; Perclose ProStyle Suture-Mediated Closure and Repair (SMCR) Syst (P960043/S126) | Abbott Vascular, Inc. | 2025-02-24 |
| iStent inject® W Trabecular Micro-Bypass System Model iS2 (P170043/S019) | Glaukos Corporation | 2025-02-24 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S060) | Edwards Lifesciences, LLC | 2025-02-24 |
| Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG (P140009/S114) | ABBOTT MEDICAL | 2025-02-21 |
| IMMULITE® 2000 Prostate-Specific Antigen (PSA) (P930027/S035) | Siemens Healthcare Diagnostics, Inc. | 2025-02-21 |
| Proclaim Dorsal Root Ganglion (DRG) IPG (P150004/S083) | ABBOTT MEDICAL | 2025-02-21 |
| Ceramax Ceramic Hip System (P070026/S117) | DePuy Orthopaedics, Inc. | 2025-02-21 |
| Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG (P010032/S232) | ABBOTT MEDICAL | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| GORE® VIABAHN® Endoprosthesis (P040037/S167) | W. L. Gore & Associates, Inc. | 2025-02-21 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S106) | W. L. Gore & Associates, Inc. | 2025-02-21 |
| LCS® Total Knee System (P830055/S338) | Depuy, Inc. | 2025-02-21 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S897) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S025) | CooperVision, Inc. | 2025-02-20 |
| EDWARDS INTUITY Elite Valve System, INSPIRIS RESILIA Aortic Valve, MITRIS RESILIA Mitral Valve, KONECT RESILIA Aortic Va (P150048/S087) | Edwards Lifesciences, LLC | 2025-02-20 |
| 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/S806) | Medtronic, Inc. | 2025-02-20 |
| LCS® Total Knee System (P830055/S339) | Depuy, Inc. | 2025-02-20 |
| RX Acculink Carotid Stent System (P040012/S065) | Abbott Vascular | 2025-02-20 |
| CapSureFix Novus Lead (P930039/S269) | Medtronic, Inc. | 2025-02-20 |
| CapSure Sense Lead (P830061/S229) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| Activa®, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S478) | Medtronic, Inc. | 2025-02-20 |
| Activa, Percept and SenSight Deep Brain Stimulation Therapy System (P960009/S483) | Medtronic, Inc. | 2025-02-20 |
| T SPOT-TB (P070006/S026) | Oxford Immunotec, Ltd. | 2025-02-20 |
| Attune Primary System (P830055/S334) | Depuy, Inc. | 2025-02-20 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S194) | Biotronik, Inc. | 2025-02-20 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S166) | Biotronik, Inc. | 2025-02-20 |
| Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses (P860057/S221) | Edwards Lifesciences, LLC | 2025-02-20 |
| Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield (P810002/S124) | ABBOTT MEDICAL | 2025-02-20 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S863) | Medtronic Cardiac Rhythm Disease Management | 2025-02-20 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S270) | Biotronik, Inc. | 2025-02-20 |
| Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S014) | Bausch & Lomb | 2025-02-20 |
| EDWARDS INTUITY Elite Valve System (P150036/S077) | Edwards Lifesciences, LLC | 2025-02-20 |
| Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medtronic Evolut Pro+ Transcatheter Aortic Valve, Medtroni (P130021/S170) | Medtronic, Inc. | 2025-02-19 |
| AVITENE (MICROFIBRILLAR COLLAGEN HOMOSTAT) (N17600/S041) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-02-18 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S003) | Biosense Webster, Inc. | 2025-02-18 |
| CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S095) | Integra Lifesciences Corp. | 2025-02-18 |
| Juvéderm Ultra, Ultra XC, Ultra Plus XC (P050047/S100) | Allergan | 2025-02-18 |
| FARAPULSE Pulsed Field Ablation System (P230030/S009) | Farapulse, Inc. | 2025-02-18 |
| INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regenera (P900033/S113) | Integra Lifesciences Corp. | 2025-02-18 |
| HeartMate 3 Left Ventricular Assist System (P160054/S096) | ABBOTT MEDICAL | 2025-02-18 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S115) | Integra LifeSciences Corporation | 2025-02-18 |
| Simplify Disc (P200022/S012) | Nuvasive, Inc. | 2025-02-18 |
| Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S093) | Allergan | 2025-02-18 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form (P810006/S111) | Integra LifeSciences Corporation | 2025-02-18 |
| HeartMate II Left Ventricular Assist System (P060040/S113) | ABBOTT MEDICAL | 2025-02-18 |
| SpineSeal Spine Sealant (P240027) | Pramand, LLC | 2025-02-14 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S065) | Nevro Corporation | 2025-02-14 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S023) | Biotronik AG | 2025-02-14 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S050) | Biotronik AG | 2025-02-14 |
| AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155) | Alcon Laboratories, Inc. | 2025-02-14 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S004) | Alcon Research, LLC | 2025-02-14 |
| Aurora EV-ICD (P220012/S040) | Medtronic, Inc. | 2025-02-14 |
| Inspire Upper Airway Stimulation (UAS) system (P130008/S118) | Inspire Medical Systems | 2025-02-14 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S078) | Mentor Corp. | 2025-02-14 |
| Light Adjustable Lens and Light Delivery Device (P160055/S042) | Rxsight, Inc. | 2025-02-14 |
| DETOUR System (P220021/S002) | Endologix, LLC | 2025-02-14 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S199) | Medtronic, Inc. | 2025-02-14 |
| AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113) | Alcon Research, Ltd. | 2025-02-14 |
| 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, Cobalt (P010031/S881) | Medtronic Cardiac Rhythm Disease Management | 2025-02-14 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S049) | Biotronik AG | 2025-02-14 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S004) | Alcon Research, LLC | 2025-02-14 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, (P980016/S915) | Medtronic Cardiac Rhythm Disease Management | 2025-02-14 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy (P080011/S179) | CooperVision, Inc. | 2025-02-14 |
| SONNET 3 (EAS) Audio Processor, MAESTRO 11 (P000025/S131) | Med-El Corp. | 2025-02-13 |
| LCS® Total Knee System (P830055/S337) | Depuy, Inc. | 2025-02-13 |
| Simplify Cervical Artificial Disc (P200022/S015) | Nuvasive, Inc. | 2025-02-13 |
| HeartMate 3 Left Ventricular Assist System (P160054/S095) | ABBOTT MEDICAL | 2025-02-13 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S431) | ABBOTT MEDICAL | 2025-02-13 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S475) | ABBOTT MEDICAL | 2025-02-13 |
| EVOLYSSE SMOOTH and EVOLYSSE FORM (P240022) | Symatese | 2025-02-13 |
| MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM (P860004/S439) | Medtronic, Inc. | 2025-02-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S408) | Medtronic Neuromodulation | 2025-02-12 |
| Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris S (P840001/S575) | Medtronic Neuromodulation | 2025-02-12 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S489) | Medtronic, Inc. | 2025-02-12 |
| Surpass Elite Flow Diverter System (P170024/S022) | Stryker Neurovascular | 2025-02-12 |
| nterStim Therapy System, Verify Evaluation System (P080025/S303) | Medtronic Neuromodulation | 2025-02-12 |