| HeartMate II Left Ventricular Assist System (P060040/S122) | ABBOTT MEDICAL | 2025-12-17 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S132) | Inspire Medical Systems | 2025-12-17 |
| Astron (P140030/S022) | Biotronik AG | 2025-12-17 |
| Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S023) | Biotronik AG | 2025-12-17 |
| MENTOR Saline-Filled and SPECTRUM Breast Implants (P990075/S066) | Mentor Worldwide, LLC | 2025-12-17 |
| DuraSeal Dural Sealant System (P040034/S040) | Integra LifeSciences Corporation | 2025-12-17 |
| Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros (P900060/S069) | Corcym S.r.l. | 2025-12-17 |
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
| VNS THERAPY SYSTEM (P970003/S252) | LivaNova USA, Inc. | 2025-12-17 |
| On-X Ascending Aortic Prosthesis (P000037/S067) | On-X Life Technologies, Inc. | 2025-12-17 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| MENTOR MemoryGel Silicone Gel-Filled Breast Implants (P030053/S084) | Mentor Corp. | 2025-12-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S116) | ABBOTT MEDICAL | 2025-12-17 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc (P140031/S196) | Edwards Lifesciences, LLC | 2025-12-17 |
| DuraSeal Exact Spine Sealant System (P080013/S029) | Integra LifeSciences Corporation | 2025-12-17 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390) | Boston Scientific Corp | 2025-12-17 |
| Organ Care System (OCS) Heart (P180051/S009) | TransMedics, Inc. | 2025-12-16 |
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| ACUVUE CONTACT LENS (N18033/S112) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2025-12-16 |
| Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD); Healon Duet PRO II Dual Pack Sodium Hyaluronate Opht (P810031/S081) | Johnson & Johnson Surgical Vision, Inc. | 2025-12-16 |
| Organ Care System (OCS) Liver (P200031/S012) | TransMedics, Inc. | 2025-12-16 |
| Organ Care System (OCS) Lung System (P160013/S020) | TransMedics, Inc. | 2025-12-16 |
| Boston Equalens (itaflurofocon A) and Boston Equalens II (oprifocon A) (P860022/S061) | Bausch & Lomb | 2025-12-16 |
| Boston Orthokeratology (oprifocon A) (P010062/S015) | Bausch & Lomb | 2025-12-16 |
| TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set (P990040/S034) | Cerenovus, Inc. | 2025-12-16 |
| Protégé GPS Self-expanding Peripheral Stent System (P060001/S053) | Medtronic Vascular, Inc. | 2025-12-16 |
| LifeStent® Vascular Stent Systems (P070014/S066) | Bard Peripheral Vascular, Inc. | 2025-12-16 |
| TECNIS SIMPLICITY Delivery System (P980040/S179) | Johnson & Johnson Surgical Vision, Inc. | 2025-12-16 |
| VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S141) | Vistakon, Division of Johnson & Johnson Vision Car | 2025-12-16 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028/S004) | EBR Systems, Inc. | 2025-12-15 |
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| Nevisense (P150046/S006) | Scibase AB | 2025-12-15 |
| Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD (P980016/S942) | Medtronic Cardiac Rhythm Disease Management | 2025-12-15 |
| Optilume BPH Catheter System (P220029/S003) | Urotronic, Inc. | 2025-12-15 |
| PATHWAY anti- HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S059) | Ventana Medical Systems, Inc. | 2025-12-15 |
| LCS Total Knee System (P830055/S355) | Depuy, Inc. | 2025-12-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079) | Boston Scientific Corp | 2025-12-15 |
| HER2 Dual ISH DNA Probe Cocktail (P190031/S014) | Ventana Medical Systems, Inc. | 2025-12-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078) | Boston Scientific Corp | 2025-12-15 |
| MediBeacon® Transdermal GFR Measurement System (TGFR) (P230019/S001) | Medibeacon, Inc. | 2025-12-15 |
| COBAS HPV TEST (P100020/S063) | Roche Molecular Systems, Inc. | 2025-12-15 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| 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/S909) | Medtronic Cardiac Rhythm Disease Management | 2025-12-15 |
| Optilume BPH Catheter System (P220029/S004) | Urotronic, Inc. | 2025-12-12 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| RADIESSE 1.3CC AND 0.3CC (P050037/S148) | Merz North America, Inc. | 2025-12-12 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S045) | Alcon Laboratories, LLC | 2025-12-12 |
| Abre Venous Self-expanding Stent System (P200026/S015) | Medtronic Vascular, Inc. | 2025-12-12 |
| AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S159) | Alcon Laboratories, Inc. | 2025-12-12 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage ( (P130013/S080) | Boston Scientific Corp | 2025-12-12 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S031) | Terumo Medical Corporation | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S117) | Alcon Research, Ltd. | 2025-12-12 |
| COAPTITE (P040047/S079) | Merz North America, Inc. | 2025-12-12 |
| RADIESSE INJECTABLE IMPLANT (P050052/S173) | Merz North America, Inc. | 2025-12-12 |
| LifeVest® Wearable Defibrillator (P010030/S198) | Zoll Manufacturing Corporation | 2025-12-11 |
| Zenflow Spring® Implant and Delivery System (P250007) | Zenflow, Inc. | 2025-12-11 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| PearlMatrix P-15 Peptide Enhanced Bone Graft (PearlMatrix Bone Graft) (P240001/S001) | Cerapedics, Inc. | 2025-12-11 |
| Biornedics 55 Asphere and Biornedies Torie (Ocuftlcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S056) | The Cooper Companies | 2025-12-11 |
| LCS® Total Knee System (P830055/S354) | Depuy, Inc. | 2025-12-11 |
| MiniMed 780G System (P160017/S125) | Medtronic Minimed, Inc. | 2025-12-11 |
| Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S089) | Boston Scientific Corp | 2025-12-10 |
| MiniMed 670G system MiniMed 770G system MiniMed 780G system (P160017/S131) | Medtronic Minimed, Inc. | 2025-12-10 |
| DIAM Spinal Stabilization System (P240043) | Companion Spine France Sas | 2025-12-10 |
| Sentus ProMRI OTW QP S-75; Sentus ProMRI OTW QP S-85; Sentus ProMRI OTW QP S-95; Sentus ProMRI OTW QP L-75; Sentus ProMR (P070008/S173) | Biotronik, Inc. | 2025-12-10 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53; Siello S 45; Sie (P950037/S281) | Biotronik, Inc. | 2025-12-10 |
| WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems (P030017/S389) | Boston Scientific Corp | 2025-12-10 |
| Simplera Sync Sensor; Guardian 4 Sensor (P250012/S005) | Medtronic Minimed, Inc. | 2025-12-10 |
| Visian® Toric Implantable Collamer® Lens (TICL) (P030016/S049) | STAAR Surgical Company | 2025-12-10 |
| LCS® Total Knee System (P830055/S353) | Depuy, Inc. | 2025-12-09 |
| ProVee System for BPH (P250011) | Proverum, Ltd. | 2025-12-09 |
| LifeVest® Wearable Defibrillator (P010030/S197) | Zoll Manufacturing Corporation | 2025-12-09 |
| Durata Leads; Optisure Leads (P950022/S151) | ABBOTT MEDICAL | 2025-12-09 |
| Supera Peripheral Stent System (P120020/S034) | Abbott Vascular (Idef Technologies Inc) | 2025-12-09 |
| ZOLL Zenix Monitor/Defibrillator; ZOLL Zenix Multi-function Cable; ZOLL Zenix CPR Complete Electrodes; ZOLL OneStep Paci (P160022/S048) | ZOLL Medical Corporation | 2025-12-09 |
| Tendril STS Leads; Ultipace Leads (P960013/S132) | ABBOTT MEDICAL | 2025-12-09 |
| StarClose SE® Vascular Surgical System (P050007/S047) | Abbott Vascular Devices | 2025-12-09 |
| Perclose ProGlide® Suture-Mediated Closure System; Prostar® XL Percutaneous Vascular Surgical System (P960043/S127) | Abbott Vascular, Inc. | 2025-12-09 |
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| XACT® Carotid Stent System (P040038/S048) | Abbott Vascular, Inc. | 2025-12-09 |
| MiniMed 780G System (P160017/S134) | Medtronic Minimed, Inc. | 2025-12-08 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |
| Onyx Liquid Embolic System (LES) (P030004/S035) | Ev3 Neurovascular | 2025-12-08 |
| Simplera Sync Sensor (P250012/S007) | Medtronic Minimed, Inc. | 2025-12-08 |
| Simplera System (P160007/S059) | Medtronic Minimed | 2025-12-08 |
| Flow FL-100 (P230024) | Flow Neuroscience AB | 2025-12-08 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S023) | W. L. Gore and Associates, Inc. | 2025-12-05 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| Simplera Sync Sensor (P250012/S006) | Medtronic Minimed, Inc. | 2025-12-05 |
| MiniMed 780G System (P160017/S132) | Medtronic Minimed, Inc. | 2025-12-05 |
| Simplera System (P160007/S057) | Medtronic Minimed | 2025-12-05 |
| Intellagen Irrigation Tubing Set (P150005/S090) | Boston Scientific Corp | 2025-12-05 |
| Softec HD; Softec I; Softec HDO; Softec HDM (P090022/S047) | Lenstec, Inc. | 2025-12-04 |
| ClearView 3 (P200020/S010) | Lenstec, Inc. | 2025-12-04 |
| S.M.A.R.T. and S.M.A.R.T.® CONTROL® Vascular Stent Systems (P120002/S033) | Cordis US Corporation | 2025-12-04 |
| Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses (P170035/S019) | Bausch and Lomb, Inc., | 2025-12-04 |
| S.M.A.R.T.® CONTROL® Nitinol Stent System (P020036/S058) | Cordis US Corporation | 2025-12-04 |
| LIFEPAK® 35 Defibrillator/monitor (P160026/S063) | Physio-Control, Inc. | 2025-12-04 |