| Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013) | Siemens Healthcare Diagnostics | 2025-10-17 |
| Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (P110041/S017) | Siemens Corp. | 2025-10-17 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System (P160054/S094) | ABBOTT MEDICAL | 2025-10-17 |
| Atellica IM Hepatitis B surface Antigen II (HBsII) (P110041/S016) | Siemens Corp. | 2025-10-17 |
| Alinity m HR HPV (P230003/S009) | Abbott Molecular, Inc. | 2025-10-17 |
| cobas® HBV (P150014/S056) | Roche Molecular Systems, Inc. | 2025-10-17 |
| Atellica IM Anti-HBe2 (aHBe2) (P200017/S005) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010) (P920047/S138) | Boston Scientific Corp | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (P150005/S091) | Boston Scientific Corp | 2025-10-17 |
| Altaviva Implantable Neurostimulator (P240011/S001) | Medtronic Neuromodulation | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (P020025/S147) | Boston Scientific | 2025-10-17 |
| Alinity m HBV (P200013/S027) | Abbott Molecular, Inc. | 2025-10-17 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S004) | Siemens Healthcare Diagnostics, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| TriClip G4 System (P230007/S018) | ABBOTT MEDICAL | 2025-10-17 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S089) | ABBOTT MEDICAL | 2025-10-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (P140031/S195) | Edwards Lifesciences, LLC | 2025-10-16 |
| INSPIRIS RESILIA Aortic Valve; MITRIS RESILIA Mitral Valve (P150048/S093) | Edwards Lifesciences, LLC | 2025-10-16 |
| Ilivia Neo 7 DR-T 429529; Intica Neo 7 DR-T 429558; Intica Neo 5 DR-T 429568 (P000009/S123) | Biotronik, Inc. | 2025-10-16 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S333) | Medtronic Neuromodulation | 2025-10-16 |
| VISUMAX 800 Femtosecond Laser (P150040/S023) | Carl Zeiss Meditec, Inc. | 2025-10-16 |
| Ilivia Neo 7 VR-T DX 429530; Intica Neo 7 VR-T DX 429559; Intica Neo 5 VR-T DX 429569 (P980023/S139) | Biotronik, Inc. | 2025-10-16 |
| EDWARDS INTUITY Elite Valve (P150036/S078) | Edwards Lifesciences, LLC | 2025-10-16 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S438) | Medtronic Neuromodulation | 2025-10-16 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S522) | Medtronic, Inc. | 2025-10-16 |
| Thoraflex Hybrid (P210006/S014) | Vascutek, Ltd. | 2025-10-16 |
| Restore, Itrel®, Synergy IntellisTM, VantaTM and InceptivTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and (P840001/S611) | Medtronic Neuromodulation | 2025-10-16 |
| Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards PERIMOUNT Plus Mitral Bioprosthesi (P860057/S223) | Edwards Lifesciences, LLC | 2025-10-16 |
| Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (P950037/S278) | Biotronik, Inc. | 2025-10-16 |
| Medtronic MiniMed 630G System (P150001/S110) | Medtronic Minimed | 2025-10-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S071) | Edwards Lifesciences, LLC | 2025-10-16 |
| Simplera Sync Sensor, Guardian 4 Sensor (P250012/S004) | Medtronic Minimed, Inc. | 2025-10-16 |
| Edora 8 HF-T QP 407137 Edora 8 HF-T 407138 Evity 8 HF-T QP 407139 Evity 8 HF-T 407140 Enitra 8 HF-T QP 407141 Enitra 8 H (P070008/S171) | Biotronik, Inc. | 2025-10-16 |
| MiniMed 670G System; MiniMed 770G System; MiniMed 780G System (P160017/S130) | Medtronic Minimed, Inc. | 2025-10-16 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S452) | Medtronic, Inc. | 2025-10-16 |
| Ilivia 7 VR-T DX 404624; Intica 7 VR-T DX 404633; Intica 5 VR-T DX 404688; Ilivia 7 VR-T 404625; Intica 7 VR-T 404634; I (P050023/S203) | Biotronik, Inc. | 2025-10-16 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S058) | Cochlear Americas | 2025-10-16 |
| Guardian Connect System Simplera System (P160007/S056) | Medtronic Minimed | 2025-10-16 |
| EUFLEXXA® (1% SODIUM HYALURONATE) (P010029/S042) | Ferring Pharmaceuticals, Inc. | 2025-10-16 |
| Nucleus® 24 Cochlear Implant System (P970051/S236) | Cochlear Americas | 2025-10-16 |
| Masters Series Mechanical Heart Valve (P810002/S125) | ABBOTT MEDICAL | 2025-10-15 |
| GORE® TAG® Conformable Thoracic Endoprosthesis (P040043/S147) | W. L. Gore & Associates, Inc. | 2025-10-15 |
| Ophthalin; Nuvisc; Anikavisc (P000046/S031) | Anika Therapeutics, Inc. | 2025-10-15 |
| Oncomine Dx Express Test (P240040/S002) | Life Technologies Corporation | 2025-10-15 |
| FlexNav Delivery System; Navitor Transcatheter Aortic Valves (P190023/S028) | ABBOTT MEDICAL | 2025-10-15 |
| LIFEPAK 1000 defibrillator (P160026/S062) | Physio-Control, Inc. | 2025-10-14 |
| HiResolution Bionic Ear System (P960058/S172) | Advanced Bionics | 2025-10-14 |
| Shockwave lntravascular Lithotripsy {IVL) System with Shockwave C2/ C2+/ C2 Aero Coronary IVL Catheter (P200039/S018) | Shockwave Medical, Inc. | 2025-10-14 |
| Belotero Balance (+) Lidocaine Dermal Filler (P090016/S066) | Merz North America, Inc. | 2025-10-10 |
| RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S033) | Bolton Medical, Inc. | 2025-10-10 |
| LIAISON® XL Murex Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier (P180039/S023) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe (P180049/S021) | DiaSorin, Inc. | 2025-10-10 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S056) | Biotronik AG | 2025-10-10 |
| LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG Plus (P220034/S007) | DiaSorin, Inc. | 2025-10-10 |
| CraniSeal Dural Sealant (P220014/S009) | Pramand, LLC | 2025-10-10 |
| SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES (P140031/S194) | Edwards Lifesciences, LLC | 2025-10-10 |
| LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM (P180045/S020) | DiaSorin, Inc. | 2025-10-10 |
| prodisc C SK and prodisc C Vivo (P070001/S025) | Centinel Spine, LLC | 2025-10-10 |
| LIAISON® QuantiFERON® - TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus (P180047/S037) | DiaSorin, Inc. | 2025-10-10 |
| DiamondTemp Ablation System (P200028/S026) | Medtronic, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg (P180048/S021) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL Murex Anti-HBc and LIAISON® XL MUREX Control anti-HBc (P180038/S025) | DiaSorin, Inc. | 2025-10-10 |
| LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual (P190017/S026) | DiaSorin, Inc. | 2025-10-10 |
| RayOne EMV Toric (P060011/S039) | Rayner Intraocular Lenses , Ltd. | 2025-10-09 |
| Barricaid® Annular Closure Device (P160050/S010) | Intrinsic Therapeutics | 2025-10-09 |
| GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (P020004/S204) | W. L. Gore & Associates, Inc. | 2025-10-09 |
| MiniMed 780G System (P160017/S127) | Medtronic Minimed, Inc. | 2025-10-09 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| HeartMate 3 Left Ventricular Assist System (P160054/S113) | ABBOTT MEDICAL | 2025-10-09 |
| DETOUR System (P220021/S006) | Endologix, LLC | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| Guardian Connect System (P160007/S054) | Medtronic Minimed | 2025-10-09 |
| Guardian 4 Sensor (P250012/S002) | Medtronic Minimed, Inc. | 2025-10-09 |
| MEDTRONIC SELECTSECURE LEAD MODEL 3830 (P030036/S154) | Medtronic Cardiac Rhythm Disease Management | 2025-10-09 |
| LINX Reflux Management System (P100049/S038) | Torax Medical | 2025-10-08 |
| Light Adjustable Lens and Light Delivery Device (P160055/S052) | Rxsight, Inc. | 2025-10-08 |
| Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (P980035/S824) | Medtronic, Inc. | 2025-10-08 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S573) | Medtronic, Inc. | 2025-10-08 |
| Optune Lua® (P230042/S004) | Novocure, GmbH | 2025-10-08 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S008) | Medtronic, Inc. | 2025-10-08 |
| Aptima HPV 16 18/45 Genotype Assay (Box 1); Aptima HPV 16 18/45 Genotype Assay (Box 2); Aptima HPV 16 18/45 Genotype Ass (P120007/S033) | Gen-Probe Incorporated | 2025-10-07 |
| Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023) | Hologic, Inc. | 2025-10-07 |
| RelayPro Thoracic Stent-Graft System (P200045/S018) | Bolton Medical, Inc. | 2025-10-07 |
| Cologuard® (P130017/S065) | Exact Sciences Corporation | 2025-10-07 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S017) | Medtronic, Inc. | 2025-10-07 |
| EPi-Sense Guided Coagulation System (P200002/S012) | AtriCure, Inc. | 2025-10-07 |
| Aptima HPV Assay 250T (Panther) Box 1; Aptima HPV Assay 250T (Panther) Box 2; Aptima HPV Assay Calibrators; Aptima HPV A (P100042/S039) | Gen-Probe Incorporated | 2025-10-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S104) | ABBOTT MEDICAL | 2025-10-06 |
| CorPASS System (P230040/S022) | Endotronix, Inc. | 2025-10-06 |
| Capsular Tension Ring (275,276); RingJect (375,376) (P030023/S012) | Ophtec BV | 2025-10-06 |
| Tendyne Transcatheter Mitral Valve System (P240042/S002) | ABBOTT MEDICAL | 2025-10-04 |
| Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (P010031/S903) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR (P010031/S904) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S069) | Alcon Research, Ltd. | 2025-10-03 |
| QIAGEN therascreen® FGFR RGQ RT-PCR Kit (P180043/S007) | QIAGEN GmbH | 2025-10-03 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (P980016/S937) | Medtronic Cardiac Rhythm Disease Management | 2025-10-03 |
| Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (P010015/S572) | Medtronic, Inc. | 2025-10-03 |
| Genio® System 2.1 (P240024/S001) | Nyxoah S.A. | 2025-10-03 |