| LCS Total Knee System (P830055/S343) | Depuy, Inc. | 2025-05-02 |
| Biofinity Family (comfilcon A) soft (hydrophilic) contact lenses for extended wear (P080011/S187) | CooperVision, Inc. | 2025-05-02 |
| AngioJet Thrombectomy System - AutoElite Console (P980037/S094) | Boston Scientific Corp | 2025-05-01 |
| Micra Transcatheter Pacing System: MC1AVR1; MC2AVR1; MC1VR01; MC2VR01 (P150033/S206) | Medtronic, Inc. | 2025-05-01 |
| BLU-U Blue Light Photodynamic Therapy Illuminator (P990019/S009) | Sun Pharmaceutical Industries, Inc. | 2025-05-01 |
| HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S078) | Johnson & Johnson Surgical Vision, Inc. | 2025-05-01 |
| iCast Covered Stent System (P120003/S008) | Atrium Medical Corp. | 2025-05-01 |
| SKINVIVE by Juvéderm (P110033/S097) | Allergan | 2025-05-01 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S006) | Alcon Research, LLC | 2025-04-30 |
| Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (P230022) | Element Science, Inc. | 2025-04-30 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S006) | Alcon Research, LLC | 2025-04-30 |
| Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system (P140031/S182) | Edwards Lifesciences, LLC | 2025-04-30 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S006) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-29 |
| Bellafill® Dermal Filler (P020012/S049) | Tiger Aesthetics Medical, LLC | 2025-04-29 |
| Shield (P230009/S006) | Guardant Health, Inc. | 2025-04-28 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S004) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-26 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S003) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-04-25 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S017) | DiaSorin, Inc. | 2025-04-25 |
| LIAISON XL MUREX HBsAg Qual, LIAISON MUREX Control HBsAg, and LIAISON XL MUREX HBsAg Confirmatory Test (P190017/S023) | DiaSorin, Inc. | 2025-04-25 |
| IC-8 Apthera Intraocular Lens (IOL) (P210005/S007) | Acu Focus, Inc. | 2025-04-25 |
| Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; (P980016/S922) | Medtronic Cardiac Rhythm Disease Management | 2025-04-25 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S016) | Kestra Medical Technologies, Inc. | 2025-04-25 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON XL Control QuantiFERON - TB Gold Plus (P180047/S032) | DiaSorin, Inc. | 2025-04-25 |
| Aurora EV ICD DVEA3E4 (P220012/S048) | Medtronic, Inc. | 2025-04-25 |
| Micra AV TPS MC1AVR1, MC2AVR1 Micra TPS MC1VR01 Micra VR TPS MC2VR01 (P150033/S205) | Medtronic, Inc. | 2025-04-25 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S071) | Boston Scientific Corp | 2025-04-25 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S018) | DiaSorin, Inc. | 2025-04-25 |
| Consulta CRT-P C4TR01 Percepta Bipolar CRT-P W1TR01 Percepta Quadripolar CRT-P W4TR01 Serena Bipolar CRTP W1TR02 Serena (P010015/S561) | Medtronic, Inc. | 2025-04-25 |
| PerClot® Polysaccharide Hemostatic System (P210036/S005) | Baxter Healthcare Corporation | 2025-04-25 |
| Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR (P980035/S810) | Medtronic, Inc. | 2025-04-25 |
| CINtec PLUS Cytology (P190024/S013) | Ventana Medical Systems, Inc. | 2025-04-25 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049/S018) | DiaSorin, Inc. | 2025-04-25 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava CRT-D DTBC1D1 Brava Q (P010031/S888) | Medtronic Cardiac Rhythm Disease Management | 2025-04-25 |
| LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus (P220034/S004) | DiaSorin, Inc. | 2025-04-25 |
| LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S021) | DiaSorin, Inc. | 2025-04-25 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S020) | DiaSorin, Inc. | 2025-04-25 |
| HeartWare® HVAD System (P100047/S225) | Medtronic | 2025-04-24 |
| COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S135) | Med-El Corp. | 2025-04-24 |
| Exoseal Vascular Closure Device (P100013/S029) | Cordis US Corporation | 2025-04-24 |
| DIAMONDBACK 360® and Diamondback 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S045) | Cardiovascular Systems, Inc. | 2025-04-24 |
| Vivistim System (P210007/S005) | Mobia Medical, Inc. | 2025-04-24 |
| Edwards Commander Delivery System (P200015/S064) | Edwards Lifesciences, LLC | 2025-04-23 |
| Ceramic TRANSCEND® Hip Articulation System (P010001/S029) | Ceramtec GmbH | 2025-04-23 |
| Edwards Commander Delivery System (P140031/S187) | Edwards Lifesciences, LLC | 2025-04-23 |
| Inspire® Upper Airway Stimulation (UAS) (P130008/S120) | Inspire Medical Systems | 2025-04-23 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S009) | ABBOTT MEDICAL | 2025-04-22 |
| OmniaSecure MRI SureScan Lead Model 3930M (P240036) | Medtronic, Inc. | 2025-04-22 |
| RHA Redensity Mepi; RHA2 Mepi; RHA3 Mepi; RHA4 Mepi (P170002/S049) | Teoxane S.A. | 2025-04-22 |
| MiniMed 780G System (P160017/S118) | Medtronic Minimed, Inc. | 2025-04-18 |
| MONOLISA ANTI-HBS EIA (P050048/S010) | Bio-Rad Laboratories | 2025-04-18 |
| Occlutech® ASD Occluder and Occlutech® Pistol Pusher (P200032/S002) | Occlutech Holding AG | 2025-04-18 |
| TruSight Oncology Comprehensive (P230011/S003) | Illumina, Inc. | 2025-04-18 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S109) | Boston Scientific Corporation | 2025-04-18 |
| MitraClip Systems (P100009/S073) | ABBOTT MEDICAL | 2025-04-18 |
| Alinity m HR HPV (P230003/S007) | Abbott Molecular, Inc. | 2025-04-18 |
| Abbott RealTime HBV (P080026/S026) | Abbott Molecular, Inc. | 2025-04-18 |
| TriClip Systems (P230007/S011) | ABBOTT MEDICAL | 2025-04-18 |
| Alinity m HBV (P200013/S025) | Abbott Molecular, Inc. | 2025-04-18 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| Light Adjustable Lens, Light Delivery Device (P160055/S043) | Rxsight, Inc. | 2025-04-17 |
| VENTANA MMR RxDx Panel (P200019/S011) | Ventana Medical Systems | 2025-04-17 |
| AED Plus (P160015/S019) | ZOLL Medical Corporation | 2025-04-17 |
| VENTANA MMR RxDx Panel (P210001/S014) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2025-04-17 |
| Hancock II Bioprosthesis (P980043/S082) | Medtronic, Inc. | 2025-04-16 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S010) | ABBOTT MEDICAL | 2025-04-16 |
| OrganOx metra System (P200035/S018) | Organox Limited | 2025-04-16 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S006) | Biosense Webster, Inc. | 2025-04-16 |
| Micra AV TPS MC1AVR1, MC2AVR1; Micra TPS MC1VR01; Micra VR TPS MC2VR01 (P150033/S204) | Medtronic, Inc. | 2025-04-16 |
| Hancock Modified Orifice Valved Conduit (P790007/S067) | Medtronic Heart Valves | 2025-04-16 |
| Freestyle Bioprosthesis (P970031/S074) | Medtronic, Inc. | 2025-04-16 |
| INGEVITY+ Active Fixation (P150012/S167) | Boston Scientific | 2025-04-16 |
| Mosaic Bioprosthesis (P990064/S091) | Medtronic, Inc. | 2025-04-16 |
| LIAISON® XL Murex HBsAg (REF 318250), LIAISON® Control XL Murex HBsAg (REF 318251) and LIAISON® XL Murex HBsAg Confirmat (P190017/S018) | DiaSorin, Inc. | 2025-04-16 |
| Home Monitoring System Version 3.52.0 (P050023/S162) | Biotronik, Inc. | 2025-04-15 |
| Vega Endocardial Pacing Leads (P130010/S003) | MicroPort CRM USA, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P000009/S095) | Biotronik, Inc. | 2025-04-15 |
| Ultra, Ultra XC, Ultra Plus XC, Ultra XC (P050047/S103) | Allergan | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P980023/S108) | Biotronik, Inc. | 2025-04-15 |
| Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant (P910023/S476) | ABBOTT MEDICAL | 2025-04-15 |
| Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra (P030054/S432) | ABBOTT MEDICAL | 2025-04-15 |
| Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S096) | Allergan | 2025-04-15 |
| OrganOx metra System (P200035/S023) | Organox Limited | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P950037/S229) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P070008/S131) | Biotronik, Inc. | 2025-04-15 |
| Minerva Endometrial Ablation System (P140013/S016) | Axora Medical, Inc. | 2025-04-14 |
| Harmony TPV System (P200046/S040) | Medtronic, Inc. | 2025-04-14 |
| HeartMate II Left Ventricular Assist System (P060040/S117) | ABBOTT MEDICAL | 2025-04-14 |
| Diamondback 360 Coronary Orbital Atherectomy System, Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S046) | Cardiovascular Systems, Inc. | 2025-04-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S103) | ABBOTT MEDICAL | 2025-04-14 |
| Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P (P030005/S245) | Guidant Corp. | 2025-04-11 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S504) | Medtronic, Inc. | 2025-04-11 |
| Essentio SR; Essentio DR; Essentio EL DR; Proponent SR; Proponent DR; Proponent EL DR; Accolade SR; Accolade DR; Accolad (N970003/S299) | Boston Scientific Corp | 2025-04-11 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028) | EBR Systems, Inc. | 2025-04-11 |
| Alinity m HBV Assay (P200013/S024) | Abbott Molecular, Inc. | 2025-04-11 |
| IMMULITE 2000 Alpha-Fetoprotein (AFP) (P010007/S023) | Siemens Healthcare Diagnostics, Inc. | 2025-04-11 |
| Coseal Surgical Sealant (P030039/S030) | Baxter Bio Science | 2025-04-11 |
| Abbott RealTime HBV Assay (P080026/S025) | Abbott Molecular, Inc. | 2025-04-11 |
| Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020) | Baxter Healthcare Corporation | 2025-04-11 |
| Axonics Sacral Neuromodulation System (P180046/S098) | Boston Scientific Corporation | 2025-04-11 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S018) | ABBOTT MEDICAL | 2025-04-11 |