| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sol (P010015/S535) | Medtronic, Inc. | 2024-03-06 |
| 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/S851) | Medtronic Cardiac Rhythm Disease Management | 2024-03-06 |
| 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/S885) | Medtronic Cardiac Rhythm Disease Management | 2024-03-06 |
| Guardant360 CDx (P200010/S018) | Guardant Health, Inc. | 2024-03-06 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S774) | Medtronic, Inc. | 2024-03-06 |
| Aveir Delivery Catheter (P150035/S006) | ABBOTT MEDICAL | 2024-03-06 |
| PROGEL Pleural Air Leak Sealant (P010047/S069) | Neomend, Inc. | 2024-03-05 |
| TRIDYNE Vascular Sealant (P150016/S024) | Neomend, Inc. | 2024-03-05 |
| Clareon PanOptix Pro Trifocal IOLs (P190018/S030) | Alcon Laboratories, LLC | 2024-03-05 |
| On-X Prosthetic Heart Valve (P000037/S062) | On-X Life Technologies, Inc. | 2024-03-05 |
| Cobalt MRI CRT-D, CobaltXT MRI CRT-D, Crome MRI CRT-D (P010031/S849) | Medtronic Cardiac Rhythm Disease Management | 2024-03-04 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S883) | Medtronic Cardiac Rhythm Disease Management | 2024-03-04 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S089) | Syncardia Systems, LLC | 2024-03-04 |
| MITRIS RESILIA Mitral Valve (P150048/S079) | Edwards Lifesciences, LLC | 2024-03-01 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S850) | Medtronic Cardiac Rhythm Disease Management | 2024-03-01 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S884) | Medtronic Cardiac Rhythm Disease Management | 2024-03-01 |
| Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain (P160042/S019) | Prollenium Medical Technologies, Inc. | 2024-03-01 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S026) | Pulmonx Corporation | 2024-03-01 |
| EUFLEXXA (P010029/S037) | Ferring Pharmaceuticals, Inc. | 2024-03-01 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S084) | Intera Oncology | 2024-03-01 |
| prodisc - C and prodisc - C Nova (Indicated for Single Level Use) (P070001/S026) | Centinel Spine, LLC | 2024-03-01 |
| MORCHER® EYEJET® CTR Single-Use Injector (P010059/S012) | Morcher GmbH | 2024-03-01 |
| 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/S846) | Medtronic Cardiac Rhythm Disease Management | 2024-02-29 |
| Superion Indirect Decompression System (IDS) (P140004/S032) | Boston Scientific Neuromodulation | 2024-02-29 |
| Consulta CRT-P, Syncra CRT-P (P010015/S532) | Medtronic, Inc. | 2024-02-29 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035) | Boston Scientific Corporation | 2024-02-29 |
| Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy (P850022/S034) | Ahp Eos Buyer, Inc. | 2024-02-29 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S473) | Medtronic, Inc. | 2024-02-29 |
| Evoke® SCS System (P190002/S024) | Saluda Medical Pty, Ltd. | 2024-02-29 |
| Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S004) | Medtronic, Inc. | 2024-02-29 |
| Evoke® SCS System (P190002/S026) | Saluda Medical Pty, Ltd. | 2024-02-29 |
| Aurora EV ICD (P220012/S013) | Medtronic, Inc. | 2024-02-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S069) | ABBOTT MEDICAL | 2024-02-29 |
| RHA 3 (P170002/S036) | Teoxane S.A. | 2024-02-29 |
| 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/S880) | Medtronic Cardiac Rhythm Disease Management | 2024-02-29 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S772) | Medtronic, Inc. | 2024-02-29 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S002) | Surmodics,Inc. | 2024-02-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S075) | ABBOTT MEDICAL | 2024-02-29 |
| Vercise PC DBS System, Vercise Gervia DBS System, Vercise Genus DBS System (P150031/S064) | Boston Scientific Corp | 2024-02-29 |
| Spatz3 Adjustable Balloon System (P190012/S004) | Spatz Fgia, Inc. | 2024-02-29 |
| HeartMate II Left Ventricular Assist System (P060040/S100) | ABBOTT MEDICAL | 2024-02-29 |
| Endurity, Assurity, Endurity Core, Zenus, Zenex (P880086/S332) | ABBOTT MEDICAL | 2024-02-28 |
| Symplicity Spyral Multi Electrode Renal Denervation Catheter (P220026/S003) | Medtronic, Inc. | 2024-02-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S164) | W. L. Gore & Associates, Inc. | 2024-02-28 |
| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S083) | ABBOTT MEDICAL | 2024-02-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S103) | W. L. Gore & Associates, Inc. | 2024-02-28 |
| LIFEPAK® 1000 Defibrillator, LIFEPAK® 15 Monitor/Defibrillator (P160026/S046) | Physio-Control, Inc. | 2024-02-27 |
| RADIESSE® Injectable Implant (P050037/S134) | Merz North America, Inc. | 2024-02-27 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S156) | Merz North America, Inc. | 2024-02-27 |
| Bellafill Dermal Filler (P020012/S046) | Tiger Aesthetics Medical, LLC | 2024-02-27 |
| LCS® Total Knee System (P830055/S311) | Depuy, Inc. | 2024-02-27 |
| Exablate (P150038/S034) | Insightec | 2024-02-27 |
| External Paulse Generator (EPG) Patient Cable (P820003/S143) | Medtronic Cardiac Rhythm Disease Management | 2024-02-27 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S070) | Boston Scientific Corp | 2024-02-26 |
| Exablate Model 4000 Type 1.0 & Type 1.1 System, Exablate Neuro (P150038/S035) | Insightec | 2024-02-26 |
| RelayPro Thoracic Stent-Graft System (P200045/S010) | Bolton Medical, Inc. | 2024-02-26 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S372) | Boston Scientific Corp | 2024-02-26 |
| INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System (P150005/S074) | Boston Scientific Corp | 2024-02-26 |
| Organ Care System (OCS®) Liver (P200031/S006) | TransMedics, Inc. | 2024-02-23 |
| cobas® HPV (P100020/S059) | Roche Molecular Systems, Inc. | 2024-02-23 |
| COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0 (P050028/S092) | Roche Molecular Systems, Inc. | 2024-02-23 |
| DBS Neurostimulator Implantable (P960009/S471) | Medtronic, Inc. | 2024-02-23 |
| COBAS® AmpliPrep®, COBAS® TaqMan® CMV Test (P110037/S062) | Roche Molecular Systems, Inc. | 2024-02-23 |
| SCS Neurostimulator Implantable (P840001/S560) | Medtronic Neuromodulation | 2024-02-23 |
| DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Activa F (P960009/S469) | Medtronic, Inc. | 2024-02-22 |
| SNS Bowel Neurostimulators Implantable InterStim (P080025/S291) | Medtronic Neuromodulation | 2024-02-22 |
| enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S050) | Bausch & Lomb, Inc. | 2024-02-22 |
| Drug Delivery Infusion Pump (P860004/S423) | Medtronic, Inc. | 2024-02-22 |
| SCS Neurostimulators External, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore F (P840001/S558) | Medtronic Neuromodulation | 2024-02-22 |
| OrganOx metra System (P200035/S011) | Organox Limited | 2024-02-22 |
| LINX Reflux Management System (P100049/S037) | Torax Medical | 2024-02-22 |
| Injectable poly-L Lactic acid (P030050/S048) | Q-Med AB | 2024-02-22 |
| SNS Urinary Neurostimulator Implantable InterStim (P970004/S396) | Medtronic Neuromodulation | 2024-02-22 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S027) | Senseonics, Incorporated | 2024-02-22 |
| LCS(R) Total Knee System (P830055/S319) | Depuy, Inc. | 2024-02-22 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S073) | ABBOTT MEDICAL | 2024-02-22 |
| HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) (P160029/S024) | Philips Medical Systems, Inc. | 2024-02-21 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S109) | Integra LifeSciences Corporation | 2024-02-21 |
| TREO® Abdominal Stent-Graft System (P190015/S014) | Bolton Medical, Inc. | 2024-02-21 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S072) | ABBOTT MEDICAL | 2024-02-21 |
| DBS System - Lead and Extension (P140009/S084) | ABBOTT MEDICAL | 2024-02-21 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S417) | ABBOTT MEDICAL | 2024-02-21 |
| RelayPlus Thoracic Stent-Graft System (P110038/S030) | Bolton Medical, Inc. | 2024-02-21 |
| RelayPro Thoracic Stent-Graft System (P200045/S009) | Bolton Medical, Inc. | 2024-02-21 |
| HeartSines Samaritan® Public Access Automated External Defibrillators (P160008/S023) | Heartsine Technologies, Ltd. | 2024-02-21 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S055) | Nevro Corporation | 2024-02-21 |
| Prestige LP Cervical Disc (P090029/S018) | Medtronic Sofamor Danek USA, Inc. | 2024-02-21 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S091) | Integra Lifesciences Corp. | 2024-02-21 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo (P810006/S106) | Integra LifeSciences Corporation | 2024-02-21 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S462) | ABBOTT MEDICAL | 2024-02-21 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S064) | Boston Scientific Scimed, Inc. | 2024-02-20 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S074) | Boston Scientific Corp | 2024-02-20 |
| 3100 High Frequency Oscillating Ventilator (HFOV), Vyaire Model 31008 Oscillatory Ventilator (P890057/S028) | ZOLL Medical Corporation | 2024-02-20 |
| INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S111) | Integra Lifesciences Corp. | 2024-02-20 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S064) | Boston Scientific Corporation | 2024-02-20 |
| Saluda Medical Evoke SCS System; Active Anchor Kit-L (P190002/S023) | Saluda Medical Pty, Ltd. | 2024-02-20 |
| SmartAblate Irrigation Tubing Set (P990071/S059) | Biosense Webster, Inc. | 2024-02-19 |
| INTELLANAV MIFI Open-Irrigated Ablation Catheters (P150005/S081) | Boston Scientific Corp | 2024-02-16 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S422) | Medtronic, Inc. | 2024-02-16 |