| SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (P890003/S479) | Medtronic, Inc. | 2025-06-18 |
| PROGEL Pleural Air Leak Sealant (P010047/S071) | Neomend, Inc. | 2025-06-18 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (P980016/S927) | Medtronic Cardiac Rhythm Disease Management | 2025-06-18 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S444) | Medtronic, Inc. | 2025-06-18 |
| 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, Enitr (P070008/S168) | Biotronik, Inc. | 2025-06-18 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S081) | Mentor Corp. | 2025-06-18 |
| Aurora EV-ICD System (P220012/S051) | Medtronic, Inc. | 2025-06-18 |
| Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (P030054/S437) | ABBOTT MEDICAL | 2025-06-18 |
| Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (P950022/S149) | ABBOTT MEDICAL | 2025-06-18 |
| MI Cancer Seek (P240010/S005) | Caris Life Sciences | 2025-06-18 |
| Restore, Itrel®, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, and Vect (P840001/S595) | Medtronic Neuromodulation | 2025-06-18 |
| P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, (P880086/S344) | ABBOTT MEDICAL | 2025-06-18 |
| PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (P080012/S075) | Infusyn Therapeutics, LLC | 2025-06-18 |
| AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (P930014/S152) | Alcon Laboratories, Inc. | 2025-06-18 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S425) | Medtronic Neuromodulation | 2025-06-18 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060) | Bausch & Lomb, Inc. | 2025-06-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S507) | Medtronic, Inc. | 2025-06-18 |
| Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S015) | Edwards Lifesciences, LLC | 2025-06-18 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S111) | Alcon Research, Ltd. | 2025-06-18 |
| OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (P960013/S130) | ABBOTT MEDICAL | 2025-06-18 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra (P010031/S893) | Medtronic Cardiac Rhythm Disease Management | 2025-06-18 |
| PROPEL, PROPEL MINI and PROPEL CONTOUR (P100044/S057) | Intersect Ent. | 2025-06-18 |
| Gel-One (P080020/S054) | Seikagaku Corp. | 2025-06-18 |
| Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (P010015/S565) | Medtronic, Inc. | 2025-06-18 |
| Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI (P140033/S099) | ABBOTT MEDICAL | 2025-06-18 |
| CareLink SmartSync Device Manager Base, 24970A (P890003/S477) | Medtronic, Inc. | 2025-06-17 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S477) | ABBOTT MEDICAL | 2025-06-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S342) | ABBOTT MEDICAL | 2025-06-17 |
| Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (P980035/S813) | Medtronic, Inc. | 2025-06-17 |
| Neuspera Sacral Neuromodulation System (P240031) | Neuspera Medical, Inc. | 2025-06-17 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S096) | ABBOTT MEDICAL | 2025-06-17 |
| MiSight 1 Day (omafilcon A) (P180035/S029) | CooperVision, Inc. | 2025-06-17 |
| Synergy Ablation System (P100046/S019) | AtriCure, Inc. | 2025-06-17 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S208) | ABBOTT MEDICAL | 2025-06-17 |
| EPi-Sense Guided Coagulation System (P200002/S011) | AtriCure, Inc. | 2025-06-17 |
| Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (P010015/S564) | Medtronic, Inc. | 2025-06-17 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S433) | ABBOTT MEDICAL | 2025-06-17 |
| Aveir Leadless System (P150035/S023) | ABBOTT MEDICAL | 2025-06-17 |
| Microny family of Pacemakers (P970013/S097) | ABBOTT MEDICAL | 2025-06-17 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S028) | CooperVision, Inc. | 2025-06-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| VENTANA HER2 DualL ISH DNA Probe Cocktail (P190031/S013) | Ventana Medical Systems, Inc. | 2025-06-16 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S169) | Merz North America, Inc. | 2025-06-16 |
| COAPTITE® (P040047/S077) | Merz North America, Inc. | 2025-06-16 |
| RADIESSE® Injectable Implant (P050037/S145) | Merz North America, Inc. | 2025-06-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S170) | W. L. Gore & Associates, Inc. | 2025-06-13 |
| Aurora EV ICD DVEA3E4 (P220012/S049) | Medtronic, Inc. | 2025-06-13 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017/S006) | Medtronic, Inc. | 2025-06-13 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (P010031/S891) | Medtronic Cardiac Rhythm Disease Management | 2025-06-13 |
| Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi (P980035/S812) | Medtronic, Inc. | 2025-06-13 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S109) | W. L. Gore & Associates, Inc. | 2025-06-13 |
| Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser (P010015/S563) | Medtronic, Inc. | 2025-06-13 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S925) | Medtronic Cardiac Rhythm Disease Management | 2025-06-13 |
| Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S207) | Medtronic, Inc. | 2025-06-13 |
| C-flex lntraocular Lens; C-flex Aspheric lntraocular Lens; 6.0 mm Aspheric lntraocular Lens; RayOne Aspheric; RayOne Sph (P060011/S041) | Rayner Intraocular Lenses , Ltd. | 2025-06-12 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S042) | Medtronic, Inc. | 2025-06-12 |
| Sentus QP Pacing Leads (P050023/S193) | Biotronik, Inc. | 2025-06-12 |
| Cordella Pulmonary Artery Sensor System (CorPASS) (P230040/S016) | Endotronix, Inc. | 2025-06-12 |
| Endurant Stent Graft System (P100021/S130) | Medtronic Vascular | 2025-06-12 |
| Sentus QP Pacing Leads (P070008/S165) | Biotronik, Inc. | 2025-06-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073) | Medtronic Vascular | 2025-06-12 |
| Light Adjustable Lens, Light Delivery System (P160055/S046) | Rxsight, Inc. | 2025-06-11 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S199) | W. L. Gore & Associates, Inc. | 2025-06-11 |
| PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (P990081/S056) | Ventana Medical Systems, Inc. | 2025-06-11 |
| Artegraft Collagen Vascular Graft (N16837/S036) | LeMaitre Vascular, Inc. | 2025-06-11 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S020) | W. L. Gore & Associates, Inc. | 2025-06-11 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary Intravascular Lithotripsy (IVL) Cathete (P200039/S015) | Shockwave Medical, Inc. | 2025-06-10 |
| BIORA EMDOGAIN(R) (P930021/S033) | The Straumann Company | 2025-06-10 |
| OrganOx metra System (P200035/S022) | Organox Limited | 2025-06-10 |
| RADIESSE® Injectable Implant (P050037/S144) | Merz North America, Inc. | 2025-06-10 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (P050052/S168) | Merz North America, Inc. | 2025-06-10 |
| Avitene Flowable Collagen Hemostat (N17600/S043) | Davol Inc., Sub. C. R. Bard, Inc. | 2025-06-10 |
| Activa and Percept Deep Brain Stimulation Therapy System (P960009/S503) | Medtronic, Inc. | 2025-06-10 |
| Pain Rechargeable (RC) Spinal Cord Stimulation (SCS) System: Inceptiv LT Implantable Neurostimulator (Model 977117); Int (P840001/S591) | Medtronic Neuromodulation | 2025-06-09 |
| Liberta RC Deep Brain Stimulation Implantable Pulse Generator (P140009/S116) | ABBOTT MEDICAL | 2025-06-09 |
| Eterna Spinal Cord Stimulation Implantable Pulse Generator (P010032/S234) | ABBOTT MEDICAL | 2025-06-09 |
| HeartStart FRx Defibrillator (861304) (P180028/S016) | Philips Medical Systems | 2025-06-09 |
| SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S172) | Johnson & Johnson Surgical Vision, Inc. | 2025-06-09 |
| MI Cancer Seek (P240010/S004) | Caris Life Sciences | 2025-06-09 |
| HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (P160029/S027) | Philips Medical Systems, Inc. | 2025-06-09 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S014) | Edwards Lifesciences, LLC | 2025-06-06 |
| SurVeil Drug-Coated Balloon (P210025/S006) | Surmodics,Inc. | 2025-06-06 |
| Optune® (P100034/S040) | Novocure, GmbH | 2025-06-06 |
| Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC (P980016/S923) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S913) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| Altius® Direct Electrical Nerve Stimulation System (P230020/S004) | Neuros Medical, Inc. | 2025-06-05 |
| Simplify® Cervical Artificial Disc (P200022/S016) | Nuvasive, Inc. | 2025-06-05 |
| GORE® VIABAHN® Endoprosthesis (P040037/S169) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S268) | Medtronic, Inc. | 2025-06-05 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S108) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D (P010031/S889) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S200) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| VARIPULSE Bi-Directional Catheter (P240006/S008) | Biosense Webster, Inc. | 2025-06-05 |
| CapSureFix MRI Lead (P090013/S335) | Medtronic, Inc. | 2025-06-05 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S008) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S021) | W. L. Gore & Associates, Inc. | 2025-06-05 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (P200030/S021) | W. L. Gore and Associates, Inc. | 2025-06-05 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S879) | Medtronic Cardiac Rhythm Disease Management | 2025-06-05 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S229) | Medtronic | 2025-06-05 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S020) | W. L. Gore and Associates, Inc. | 2025-06-05 |