| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S432) | Medtronic, Inc. | 2025-02-12 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E (P130021/S169) | Medtronic, Inc. | 2025-02-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S037) | Boston Scientific Corporation | 2025-02-12 |
| Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (P050047/S101) | Allergan | 2025-02-12 |
| Harmony Transcatheter Pulmonary Valve (P200046/S036) | Medtronic, Inc. | 2025-02-12 |
| Propel®, Propel® Mini, Propel® Contour Sinus Implants (P100044/S056) | Intersect Ent. | 2025-02-12 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and Skinvive (P110033/S094) | Allergan | 2025-02-12 |
| PyloPlus UBT System (P170022/S005) | Arj Medical, Inc. | 2025-02-12 |
| LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft (P220025/S005) | LimFlow, Inc. | 2025-02-12 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S010) | Edwards Lifesciences, LLC | 2025-02-11 |
| Duo Venous Stent System (P230021/S001) | Philips Image Guided Therapy Corporation | 2025-02-11 |
| Puregraft Serene Breast Implant, IDEAL IMPLANT Structured Breast Implant (P120011/S028) | Bimini Health Tech | 2025-02-11 |
| SMARTABLATE Irrigation Tubing Set (P990071/S063) | Biosense Webster, Inc. | 2025-02-11 |
| Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters (P050026/S003) | Bausch + Lomb Ireland Limited | 2025-02-11 |
| Ceramax® Ceramic Total Hip System (P070026/S116) | DePuy Orthopaedics, Inc. | 2025-02-11 |
| CraniSeal Dural Sealant (P220014/S004) | Pramand, LLC | 2025-02-11 |
| XACT® Carotid Stent System (P040038/S046) | Abbott Vascular, Inc. | 2025-02-10 |
| Supera Peripheral Stent System (P120020/S032) | Abbott Vascular (Idef Technologies Inc) | 2025-02-10 |
| EXCLUDER BIFURCATED ENDOPROSTHESIS (P020004/S197) | W. L. Gore & Associates, Inc. | 2025-02-10 |
| SMARTFREEZE Cryo-Cable (P220032/S009) | Boston Scientific Corporation | 2025-02-10 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System (P100009/S070) | ABBOTT MEDICAL | 2025-02-10 |
| Perclose ProGlide® Suture-Mediated Closure System, Prostar® XL Percutaneous Vascular Surgical System (P960043/S124) | Abbott Vascular, Inc. | 2025-02-10 |
| TriClip G4 System, TriClip G5 Delivery System (P230007/S009) | ABBOTT MEDICAL | 2025-02-10 |
| StarClose SE® Vascular Surgical System (P050007/S045) | Abbott Vascular Devices | 2025-02-10 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S008) | Farapulse, Inc. | 2025-02-08 |
| Axonics Sacral Neuromodulation System (P190006/S097) | Boston Scientific Corporation | 2025-02-07 |
| Guardant360 CDx (P200010/S022) | Guardant Health, Inc. | 2025-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S097) | Boston Scientific Corporation | 2025-02-07 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S410) | Medtronic Neuromodulation | 2025-02-07 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S491) | Medtronic, Inc. | 2025-02-07 |
| Restore, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems, Pisces, Specify®, and Vectris® Spinal Cord St (P840001/S579) | Medtronic Neuromodulation | 2025-02-07 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S305) | Medtronic Neuromodulation | 2025-02-07 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S012) | Cerapedics, LLC | 2025-02-06 |
| Micra AV TPS, Micra TPS (P150033/S200) | Medtronic, Inc. | 2025-02-06 |
| TENEO 317 Model 2 (P990027/S025) | Technolas Perfect Vision GmbH | 2025-02-06 |
| MI Cancer Seek (P240010/S001) | Caris Life Sciences | 2025-02-06 |
| CardioMEMS HF System (P100045/S077) | ABBOTT MEDICAL | 2025-02-06 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S205) | ABBOTT MEDICAL | 2025-02-05 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S139) | Vistakon, Division of Johnson & Johnson Vision Car | 2025-02-05 |
| Tendril STS, UltiPace (P960013/S127) | ABBOTT MEDICAL | 2025-02-05 |
| WOLVERINE Coronary Cutting Balloon (P950020/S146) | Boston Scientific Corp | 2025-02-05 |
| Durata, Optisure (P950022/S146) | ABBOTT MEDICAL | 2025-02-05 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S470) | ABBOTT MEDICAL | 2025-02-05 |
| Vercise DBS Controller (P150031/S076) | Boston Scientific Corp | 2025-02-05 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR (P980023/S134) | Biotronik, Inc. | 2025-02-05 |
| RayOne EMV (P060011/S037) | Rayner Intraocular Lenses , Ltd. | 2025-02-05 |
| Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers (P140033/S093) | ABBOTT MEDICAL | 2025-02-05 |
| Aveir Leadless System (P150035/S017) | ABBOTT MEDICAL | 2025-02-05 |
| Microny family of Pacemakers (P970013/S096) | ABBOTT MEDICAL | 2025-02-05 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S117) | Biotronik, Inc. | 2025-02-05 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu (P030054/S426) | ABBOTT MEDICAL | 2025-02-05 |
| 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/S268) | Biotronik, Inc. | 2025-02-05 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S339) | ABBOTT MEDICAL | 2025-02-05 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 DF4 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T (P050023/S191) | Biotronik, Inc. | 2025-02-05 |
| SYNERGYXD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chr (P150003/S107) | Boston Scientific Corporation | 2025-02-05 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Optune Gio (P100034/S036) | Novocure, GmbH | 2025-02-04 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153) | Alcon Laboratories, Inc. | 2025-02-04 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S040) | Alcon Laboratories, LLC | 2025-02-04 |
| Impella CP with SmartAssist (P140003/S122) | Abiomed, Inc. | 2025-02-04 |
| SURGIFOAM Absorbable Gelatin Sponge, U.S.P. (P990004/S071) | Ferrosan Meidcal Devices A/S | 2025-02-04 |
| CentriMag Circulatory Support System (P170038/S017) | Abbott | 2025-02-04 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S112) | Alcon Research, Ltd. | 2025-02-04 |
| TENEO 317 Model 2 (P990027/S023) | Technolas Perfect Vision GmbH | 2025-02-04 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Torie and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energ (P080011/S178) | CooperVision, Inc. | 2025-02-04 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S003) | Medtronic, Inc. | 2025-02-03 |
| LIFEPAK® 1000 Defibrillator (P160026/S056) | Physio-Control, Inc. | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S094) | Boston Scientific Corporation | 2025-02-03 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S007) | Endotronix, Inc. | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P180046/S094) | Boston Scientific Corporation | 2025-02-03 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S055) | Physio-Control, Inc. | 2025-01-31 |
| Tula® System (P190016/S009) | Tusker Medical, Inc. | 2025-01-31 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| BAROSTIM NEO® System (P180050/S013) | Cvrx, Inc. | 2025-01-30 |
| SURGICEL® Absorbable Hemostats (N12159/S119) | ETHICON, Inc. | 2025-01-30 |
| Hydrus Microstent (P170034/S013) | Alcon Research, LLC | 2025-01-30 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S916) | Medtronic Cardiac Rhythm Disease Management | 2025-01-30 |
| AeroPace® System (P240012/S001) | Lungpacer Medical USA, Inc. | 2025-01-30 |
| Aurora EV ICD (P220012/S041) | Medtronic, Inc. | 2025-01-30 |
| Gynecare Interceed Absorbable Adhesion Barrier (P880047/S063) | ETHICON, Inc. | 2025-01-30 |
| Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt M (P010031/S882) | Medtronic Cardiac Rhythm Disease Management | 2025-01-30 |
| Avive Automated External Defibrillator (AED) System (P210015/S005) | Avive Solutions, Inc. | 2025-01-29 |
| Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S092) | Allergan | 2025-01-29 |
| UroVysion Bladder Cancer Kit (P030052/S029) | Abbott Molecular | 2025-01-29 |
| Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC (P050047/S099) | Allergan | 2025-01-29 |
| HiResolution Bionic Ear System (P960058/S165) | Advanced Bionics | 2025-01-29 |
| Thoraflex Hybrid (P210006/S011) | Vascutek, Ltd. | 2025-01-27 |
| LIFEPAK® 15 monitor (P160026/S054) | Physio-Control, Inc. | 2025-01-27 |
| Axonics Sacral Neuromodulation System (P190006/S079) | Boston Scientific Corporation | 2025-01-27 |
| PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S055) | Ventana Medical Systems, Inc. | 2025-01-27 |
| Axonics Sacral Neuromodulation System (P180046/S079) | Boston Scientific Corporation | 2025-01-27 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi (P150003/S105) | Boston Scientific Corporation | 2025-01-27 |
| cobas EGFR Mutation Test v2 (P120019/S027) | Roche | 2025-01-27 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S070) | Ferrosan Meidcal Devices A/S | 2025-01-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per (P140010/S088) | Medtronic, Inc. | 2025-01-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S037) | Medtronic Vascular, Inc. | 2025-01-24 |
| Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve (P150011/S030) | Corcym S.r.l. | 2025-01-24 |
| CELT ACD PLUS Vascular Closure Device (P150006/S006) | Vasorum, Ltd. | 2025-01-24 |