| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S078) | ABBOTT MEDICAL | 2024-10-24 |
| Shockwave Intravascular System with the C2/C2+ Coronary IVL Catheter (P200039/S013) | Shockwave Medical, Inc. | 2024-10-24 |
| Sphere-9 Catheter and Affera Ablation System (P240013) | Medtronic, Inc. | 2024-10-24 |
| Gambro Prismaflex TPE 2000 Set (P830063/S028) | Vantive US Healthcare, LLC | 2024-10-24 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S242) | Guidant Corp. | 2024-10-23 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S161) | Boston Scientific | 2024-10-23 |
| Aptima HPV-GT Assay (P120007/S032) | Gen-Probe Incorporated | 2024-10-23 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| VENTANA PD-L1 (SP263) CDx Assay (P160046/S019) | Ventana Medical Systems, Inc. | 2024-10-23 |
| Aptima HPV Assay (P100042/S037) | Gen-Probe Incorporated | 2024-10-23 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S296) | Boston Scientific Corp | 2024-10-23 |
| Organ Care System (OCS) Heart System (P180051/S007) | TransMedics, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S199) | Boston Scientific Corporation | 2024-10-23 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S009) | QIAGEN GmbH | 2024-10-23 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4 (P170002/S046) | Teoxane S.A. | 2024-10-23 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S586) | Boston Scientific Corp | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S502) | Boston Scientific | 2024-10-23 |
| Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans (P160048/S028) | Senseonics, Incorporated | 2024-10-23 |
| CERAMAX Ceramic Total Hip System (P070026/S113) | DePuy Orthopaedics, Inc. | 2024-10-23 |
| OPTIMIZER Smart System (P180036/S035) | Impulse Dynamics (Usa), Inc. | 2024-10-23 |
| MitraClip G4 Clip Delivery System (P100009/S068) | ABBOTT MEDICAL | 2024-10-22 |
| Navitor Titan Valve (P190023/S023) | ABBOTT MEDICAL | 2024-10-22 |
| UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S001) | Alcon Research, LLC | 2024-10-22 |
| TriClip G4 Clip Delivery System (P230007/S006) | ABBOTT MEDICAL | 2024-10-22 |
| UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S001) | Alcon Research, LLC | 2024-10-22 |
| Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy (P080011/S173) | CooperVision, Inc. | 2024-10-22 |
| Solia S 45, Solia S 53, Solia S 60, Solia JT 45, Solia JT 53, Solia T 53, Solia T 60 (P950037/S265) | Biotronik, Inc. | 2024-10-21 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S085) | Medtronic, Inc. | 2024-10-21 |
| Axonics Sacral Neuromodulation System (P180046/S090) | Boston Scientific Corporation | 2024-10-21 |
| Impella 5.5 with SmartAssist (P140003/S119) | Abiomed, Inc. | 2024-10-21 |
| Axonics Sacral Neuromodulation System (P190006/S090) | Boston Scientific Corporation | 2024-10-21 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S034) | Medtronic Vascular, Inc. | 2024-10-21 |
| VENTANA CLDN18 (43-14A) RxDx Assay (P230018) | Ventana Medical Systems, Inc. | 2024-10-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S061) | Boston Scientific Corp | 2024-10-18 |
| SMARTFREEZETM Catheter Extension Cable (P220032/S004) | Boston Scientific Corporation | 2024-10-18 |
| Abre Venous Self-expanding Stent System (P200026/S012) | Medtronic Vascular, Inc. | 2024-10-18 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S044) | Teoxane S.A. | 2024-10-18 |
| FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Pulsed Field Ablation (P230030/S003) | Farapulse, Inc. | 2024-10-18 |
| RHA® Redensity, RHA® Redensity Mepi (P170002/S045) | Teoxane S.A. | 2024-10-18 |
| LifeVest Wearable Defibrillator (P010030/S187) | Zoll Manufacturing Corporation | 2024-10-18 |
| Shield (P230009/S002) | Guardant Health, Inc. | 2024-10-18 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S044) | Biotronik AG | 2024-10-17 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S547) | Medtronic, Inc. | 2024-10-17 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S264) | Medtronic, Inc. | 2024-10-17 |
| Cerene Cryotherapy Device (P180032/S021) | Channel Medsystems, Inc. | 2024-10-17 |
| Aurora EV ICD, Epsila EV Extravascular Lead (P220012/S032) | Medtronic, Inc. | 2024-10-17 |
| Aveir VR Delivery Catheter (P150035/S018) | ABBOTT MEDICAL | 2024-10-17 |
| Myocardial Pacing Lead (P120017/S036) | Medtronic, Inc. | 2024-10-17 |
| Perceval Plus Sutureless Heart Valve (P150011/S029) | Corcym S.r.l. | 2024-10-17 |
| Micra TPS, Micra VR TPS (P150033/S192) | Medtronic, Inc. | 2024-10-17 |
| Transvene CS/SVC Lead (P980050/S143) | Medtronic, Inc. | 2024-10-17 |
| 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/S794) | Medtronic, Inc. | 2024-10-17 |
| Elecsys total PSA Test System (P990056/S042) | Roche Diagnostics Corp. | 2024-10-17 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S225) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| SelectSecure Lead (P030036/S149) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S113) | W. L. Gore & Associates, Inc. | 2024-10-17 |
| 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/S869) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| CapSure Epicardial Pacing Lead (P950024/S112) | Medtronic, Inc. | 2024-10-17 |
| Epicardial Patch Lead, Upsizing Sleeve (P900061/S173) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| Artegraft Collagen Vascular Graft (N16837/S034) | LeMaitre Vascular, Inc. | 2024-10-17 |
| LIFEPAK CR2 Defibrillator (P170018/S021) | Physio-Control, Inc. | 2024-10-17 |
| Attain StarFix Lead (P060039/S116) | Medtronic, Inc. | 2024-10-17 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S186) | Medtronic, Inc. | 2024-10-17 |
| CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead (P850089/S169) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| Oncomine Dx Target Test (P160045/S046) | Life Technologies Corporation | 2024-10-17 |
| NIT-OCCLUD PDA (P120009/S004) | Pfm Medical, Inc. | 2024-10-17 |
| Elecsys free PSA Test System (P000027/S040) | Roche Diagnostics Corp. | 2024-10-17 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C (P920015/S293) | Medtronic, Inc. | 2024-10-17 |
| 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/S903) | Medtronic Cardiac Rhythm Disease Management | 2024-10-17 |
| Epic Plus, Epic Max Tissue Heart Valves (P040021/S054) | ABBOTT MEDICAL | 2024-10-17 |
| ColoSense (P230001/S006) | Geneoscopy, Inc. | 2024-10-16 |
| Transcend® Hip Articulation System (P010001/S028) | Ceramtec GmbH | 2024-10-16 |
| VisuMax Femtosecond Laser (P150040/S018) | Carl Zeiss Meditec, Inc. | 2024-10-16 |
| AED Plus and Fully Automatic AED Plus (P160015/S017) | ZOLL Medical Corporation | 2024-10-16 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S051) | Nevro Corporation | 2024-10-16 |
| Surpass Elite Flow Diverter System (P170024/S018) | Stryker Neurovascular | 2024-10-16 |
| HYMOVIS® (High Molecular Weight Viscoelastic Hyaluronan) (P150010/S004) | Fidia Farmaceutici | 2024-10-16 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin, SURGIFOAM® Absorbable Gelatin Sponge, U.S.P. (P990004/S069) | Ferrosan Meidcal Devices A/S | 2024-10-15 |
| Safire TX Ablation Catheter, Safire TX, Catheter Extension Cable, Therapy Dual-8 Ablation Catheter, Cables 16- 17- 1 (P040042/S056) | Irvine Biomedical,Inc.(Ibi) | 2024-10-15 |
| Optune Lua (P230042) | Novocure, GmbH | 2024-10-15 |
| LCS Total Knee System (P830055/S335) | Depuy, Inc. | 2024-10-15 |
| Therapy Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19- (P040014/S049) | Irvine Biomedical, Inc. | 2024-10-15 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S045) | Biotronik AG | 2024-10-15 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor (P100044/S054) | Intersect Ent. | 2024-10-11 |
| Organ Care System (OCS) Heart (P180051/S006) | TransMedics, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P880086/S334) | ABBOTT MEDICAL | 2024-10-11 |
| Vanta Spinal Cord Stimulation Systems (P840001/S573) | Medtronic Neuromodulation | 2024-10-11 |
| DETOUR System (P220021/S003) | Endologix, LLC | 2024-10-11 |
| InterStim® Therapy System (P080025/S302) | Medtronic Neuromodulation | 2024-10-11 |
| MFK IOL (P200020/S007) | Lenstec, Inc. | 2024-10-11 |
| InterStim® Therapy System (P970004/S407) | Medtronic Neuromodulation | 2024-10-11 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S141) | W. L. Gore & Associates, Inc. | 2024-10-11 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S017) | W. L. Gore & Associates, Inc. | 2024-10-11 |
| HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM (P090022/S044) | Lenstec, Inc. | 2024-10-11 |
| VisuMax (P150040/S016) | Carl Zeiss Meditec, Inc. | 2024-10-11 |
| Organ Care System (OCS) Lung (P160013/S018) | TransMedics, Inc. | 2024-10-11 |
| Solia S Leads (P950037/S261) | Biotronik, Inc. | 2024-10-11 |
| Merlin.net MN5000 (P140033/S086) | ABBOTT MEDICAL | 2024-10-11 |