| ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025) | Siemens Healthcare Diagnostics, Inc. | 2025-07-16 |
| ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030) | Siemens Healthcare Diagnostics | 2025-07-16 |
| CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B (P930039/S273) | Medtronic, Inc. | 2025-07-16 |
| print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 (P920015/S301) | Medtronic, Inc. | 2025-07-16 |
| InterStim Therapy System, Verify Evaluation System (P080025/S323) | Medtronic Neuromodulation | 2025-07-16 |
| eCoin Peripheral Neurostimulator (P200036/S008) | Boston Scientific Corporation | 2025-07-16 |
| InterStim Therapy System, Verify Evaluation System (P970004/S429) | Medtronic Neuromodulation | 2025-07-16 |
| LifeVest® Wearable Defibrillator (P010030/S195) | Zoll Manufacturing Corporation | 2025-07-16 |
| GORE® TAG® Conformable Thoracic Endoprosthesis (P040043/S143) | W. L. Gore & Associates, Inc. | 2025-07-16 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S074) | Boston Scientific Corp | 2025-07-16 |
| Astron (P140030/S019) | Biotronik AG | 2025-07-16 |
| Restore; Itrel; Synergy Intellis; Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces; Specify; and Vectris Sp (P840001/S600) | Medtronic Neuromodulation | 2025-07-16 |
| ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029) | Siemens Healthcare Diagnostics | 2025-07-16 |
| CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L (P890003/S480) | Medtronic, Inc. | 2025-07-16 |
| CapSure SP Z Lead 5033; Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB (P850089/S172) | Medtronic Cardiac Rhythm Disease Management | 2025-07-16 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S194) | Zoll Manufacturing Corporation | 2025-07-16 |
| CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 (P950024/S115) | Medtronic, Inc. | 2025-07-16 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S512) | Medtronic, Inc. | 2025-07-16 |
| Cobalt MRI, CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome (P010031/S896) | Medtronic Cardiac Rhythm Disease Management | 2025-07-15 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S506) | Medtronic, Inc. | 2025-07-15 |
| SmartSync Pacing System Analyzer (P890003/S476) | Medtronic, Inc. | 2025-07-15 |
| OPTIMIZER Smart System (P180036/S038) | Impulse Dynamics (Usa), Inc. | 2025-07-15 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S096) | Medtronic, Inc. | 2025-07-15 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S043) | Medtronic Vascular, Inc. | 2025-07-15 |
| Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DVPA2D1); Cobalt XT MRI ICD (DDPA2D4, D (P980016/S930) | Medtronic Cardiac Rhythm Disease Management | 2025-07-15 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S140) | Boston Scientific Corp | 2025-07-14 |
| Biofinity XR Toric (comfilcon A) (P080011/S190) | CooperVision, Inc. | 2025-07-14 |
| RADIESSE (+) Lidocaine (P050052/S171) | Merz North America, Inc. | 2025-07-14 |
| RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (P160055/S051) | Rxsight, Inc. | 2025-07-14 |
| Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (hereafter referred to as Ultra, Ultra XC and Ultra Plus X (P050047/S104) | Allergan | 2025-07-14 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, Juvéderm Volbella XC, Juvéderm Volux XC and SKINVIVE by Juvéderm (hereafter ref (P110033/S100) | Allergan | 2025-07-14 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (N970012/S209) | Boston Scientific Corp | 2025-07-14 |
| BAROSTIM NEO® System (P180050/S015) | Cvrx, Inc. | 2025-07-11 |
| VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Models U225, U226); VISIONIST X4 (Model U228) (P030005/S246) | Guidant Corp. | 2025-07-11 |
| ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models L200, L201, L221); ACCOLADE (N970003/S300) | Boston Scientific Corp | 2025-07-11 |
| FreeStyle Libre 14-Day Flash Glucose Monitoring System (P160030/S057) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S023) | Edwards Lifesciences, LLC | 2025-07-11 |
| ESSENTIO MRI (Models L110, L111, L131); PROPONENT MRI (Models L210, L211, L231); ACCOLADE MRI (Models L310, L311, L33 (P150012/S168) | Boston Scientific | 2025-07-11 |
| AED Plus and Fully Automatic AED Plus (P160015/S021) | ZOLL Medical Corporation | 2025-07-11 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S108) | ABBOTT MEDICAL | 2025-07-11 |
| X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (P160022/S043) | ZOLL Medical Corporation | 2025-07-11 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S060) | Abbott Diabetes Care, Inc. | 2025-07-11 |
| VENTANA MET (SP44) RxDx Assay (P240037/S001) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2025-07-11 |
| ReShape Lap-Band System (P000008/S051) | Medtimo, Inc. | 2025-07-11 |
| EXOSEAL Vascular Closure Device (P100013/S031) | Cordis US Corporation | 2025-07-11 |
| Orbera® Intragastric Balloon (IGB) System (P140008/S027) | Boston Scientific Corporation | 2025-07-11 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S041) | Medtronic Vascular, Inc. | 2025-07-10 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S057) | Biotronik AG | 2025-07-10 |
| TOUCH® CMC 1 Prosthesis (P240020) | Keri Medical SA | 2025-07-10 |
| EndoForce Connector for Endovascular Venous Anastomosis (P240004/S002) | Phraxis, Inc. | 2025-07-10 |
| Saluda Medical Evoke SCS System (P190002/S043) | Saluda Medical Pty, Ltd. | 2025-07-10 |
| Astron Pulsar; Pulsar-18; Pulsar-18 T3 (P160025/S020) | Biotronik AG | 2025-07-10 |
| Astron (P140030/S018) | Biotronik AG | 2025-07-10 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S025) | Biotronik AG | 2025-07-10 |
| Preveleak Surgical Sealant (P100030/S021) | Baxter Healthcare Corporation | 2025-07-10 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (P140010/S094) | Medtronic, Inc. | 2025-07-10 |
| Cobalt MRI ICD, Cobalt XT MRI ICD (P980016/S929) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
| Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035) | Bausch & Lomb, Inc. | 2025-07-09 |
| alfapump System (P230044/S001) | Sequana Medical NV | 2025-07-09 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra (P010031/S892) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| SURGIFLO Hemostatic Matrix Kit with Thrombin (P990004/S073) | Ferrosan Meidcal Devices A/S | 2025-07-09 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S895) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| LimFlow System (P220025/S006) | LimFlow, Inc. | 2025-07-09 |
| Epsila EV Extravascular Lead EV2401 (P220012/S053) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S042) | Medtronic Vascular, Inc. | 2025-07-09 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax (P140010/S095) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S040) | Medtronic Vascular, Inc. | 2025-07-09 |
| Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr (P920015/S300) | Medtronic, Inc. | 2025-07-09 |
| Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 (P150033/S211) | Medtronic, Inc. | 2025-07-09 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S093) | Medtronic, Inc. | 2025-07-09 |
| Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (P980016/S926) | Medtronic Cardiac Rhythm Disease Management | 2025-07-09 |
| Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29) (P200015/S067) | Edwards Lifesciences, LLC | 2025-07-08 |
| Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (P140031/S191) | Edwards Lifesciences, LLC | 2025-07-08 |
| Sphere-9 Catheter and Affera Ablation System (P240013/S011) | Medtronic, Inc. | 2025-07-07 |
| iCast Covered Stent System (P120003/S006) | Atrium Medical Corp. | 2025-07-07 |
| Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E (P160032/S013) | Defibtech, LLC | 2025-07-03 |
| Exablate Model 4000 Type-1 System (P150038/S037) | Insightec | 2025-07-03 |
| Nucleus® 22 Cochlear Implant System (P890027/S064) | Cochlear Americas | 2025-07-03 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S509) | Medtronic, Inc. | 2025-07-03 |
| Nucleus® 24 Cochlear Implant System (P970051/S225) | Cochlear Americas | 2025-07-03 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C (P230030/S007) | Farapulse, Inc. | 2025-07-03 |
| MENTOR MemoryGel Enhance Breast Implants (P030053/S077) | Mentor Corp. | 2025-07-03 |
| Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify (P840001/S597) | Medtronic Neuromodulation | 2025-07-03 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S058) | Medinol, Ltd. | 2025-07-03 |
| Nucleus® 22 Cochlear Implant System (P840024/S096) | Cochlear Americas | 2025-07-03 |
| Nucleus® 24 Auditory Brainstem Implant System (P000015/S053) | Cochlear Americas | 2025-07-03 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S056) | Cochlear Americas | 2025-07-03 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S044) | Cook Ireland, Ltd. | 2025-07-03 |
| ColoSense® (P230001/S008) | Geneoscopy, Inc. | 2025-07-03 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S210) | Medtronic, Inc. | 2025-07-02 |
| RX HERCULINK ELITE RENAL STENT SYSTEM (P110001/S021) | Abbott Vascular | 2025-07-02 |
| Proclaim SCS IPG (P010032/S239) | ABBOTT MEDICAL | 2025-07-02 |
| MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (P980035/S816) | Medtronic, Inc. | 2025-07-02 |
| Aurora EV-ICD System (P220012/S052) | Medtronic, Inc. | 2025-07-02 |
| Aveir VR and DR Delivery Catheters (P150035/S024) | ABBOTT MEDICAL | 2025-07-02 |
| Proclaim DRG IPG (P150004/S086) | ABBOTT MEDICAL | 2025-07-02 |
| CraniSeal Dural Sealant (P220014/S005) | Pramand, LLC | 2025-07-02 |
| MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM (P010015/S566) | Medtronic, Inc. | 2025-07-02 |
| Infinity DBS IPG (P140009/S120) | ABBOTT MEDICAL | 2025-07-02 |