| 4340 Sensing Lead and 4063 Stimulation Lead (P130008/S105) | Inspire Medical Systems | 2023-12-08 |
| EluNIR-PERLTM Ridaforolimus Eluting Coronary Stent System (P170008/S047) | Medinol, Ltd. | 2023-12-08 |
| EMBLEM S-ICD VI Electrode (Lead) (P110042/S192) | Boston Scientific Corporation | 2023-12-08 |
| Gel-One (P080020/S052) | Seikagaku Corp. | 2023-12-08 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CR T-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S837) | Medtronic Cardiac Rhythm Disease Management | 2023-12-07 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S155) | Merz North America, Inc. | 2023-12-07 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S009) | Abbott Laboratories | 2023-12-07 |
| Solesta® Injectable Gel (P100014/S035) | Palette Life Sciences | 2023-12-07 |
| EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi (P980016/S871) | Medtronic Cardiac Rhythm Disease Management | 2023-12-07 |
| EV ICD - Aurora (P220012/S003) | Medtronic, Inc. | 2023-12-07 |
| ARCHITECT HBsAg Qualitative/Confirmatory, Alinity i HBsAg Qualitative II/Confirmatory (P110029/S048) | Abbott Laboratories | 2023-12-07 |
| MicraAVTPS, Miera TPS (P150033/S180) | Medtronic, Inc. | 2023-12-07 |
| Deflux® Injectable Gel (P000029/S097) | Palette Life Sciences | 2023-12-07 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S057) | Abbott Laboratories, Inc. | 2023-12-07 |
| RADIESSE® Injectable Implant (P050037/S133) | Merz North America, Inc. | 2023-12-07 |
| SCULPTRA® (P030050/S044) | Q-Med AB | 2023-12-07 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S527) | Medtronic, Inc. | 2023-12-07 |
| Astra S DR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG,Azure S SR MRI IPG, Azure XT DR MRI IPG (P980035/S764) | Medtronic, Inc. | 2023-12-07 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S215) | Edwards Lifesciences, LLC | 2023-12-06 |
| Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Cartridge (P220023/S001) | Recor Medical, Inc. | 2023-12-06 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S214) | Boston Scientific Corp | 2023-12-06 |
| Vistakon (senofilcon A) Brand Contact Lenses (P040045/S133) | Vistakon, Division of Johnson & Johnson Vision Car | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S168) | Edwards Lifesciences, LLC | 2023-12-06 |
| EDWARDS INTUITY Elite Valve (P150036/S072) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S076) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve for Pulmonic Indication (P200015/S050) | Edwards Lifesciences, LLC | 2023-12-06 |
| Surpass Evolve Flow Diverter Systems (P170024/S015) | Stryker Neurovascular | 2023-12-05 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S022) | The Spectranetics Corp. | 2023-12-05 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S026) | Senseonics, Incorporated | 2023-12-05 |
| SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S119) | ABBOTT MEDICAL | 2023-12-04 |
| T-SPOT®.TB Test (P070006/S021) | Oxford Immunotec, Ltd. | 2023-12-04 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S063) | Boston Scientific Corp | 2023-12-04 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S459) | ABBOTT MEDICAL | 2023-12-01 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S765) | Medtronic, Inc. | 2023-12-01 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S414) | ABBOTT MEDICAL | 2023-12-01 |
| OPTIhome Remote Patient Monitoring System (P180036/S024) | Impulse Dynamics (Usa), Inc. | 2023-12-01 |
| FoundationOne CDx (F1CDx) (P170019/S050) | Foundation Medicine, Inc. | 2023-12-01 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S062) | ABBOTT MEDICAL | 2023-12-01 |
| Vercise Genus DBS System (P150031/S062) | Boston Scientific Corp | 2023-11-30 |
| Harmony Transcatheter Pulmonary Valve (P200046/S026) | Medtronic, Inc. | 2023-11-30 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S555) | Medtronic Neuromodulation | 2023-11-30 |
| Freezer MAX (P100010/S143) | Medtronic Cryocath, LP | 2023-11-29 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRTP, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S528) | Medtronic, Inc. | 2023-11-29 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S115) | Abiomed, Inc. | 2023-11-29 |
| (LGW, QRB) - Master Restore Spinal Cord Stimulation Systems (P840001/S549) | Medtronic Neuromodulation | 2023-11-29 |
| Lead EV ICD Extravascular - Epsila (P220012/S007) | Medtronic, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P220013/S001) | ABBOTT MEDICAL | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P040042/S055) | Irvine Biomedical,Inc.(Ibi) | 2023-11-29 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI, Compia MRI CRT-D, (P010031/S838) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| 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/S874) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P040014/S048) | Irvine Biomedical, Inc. | 2023-11-29 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S466) | Medtronic, Inc. | 2023-11-29 |
| 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,Ev (P980016/S872) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S391) | Medtronic Neuromodulation | 2023-11-29 |
| Aurora EV ICD (P220012/S006) | Medtronic, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P960016/S090) | St Jude Medical | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P110016/S084) | ABBOTT MEDICAL | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P030054/S412) | ABBOTT MEDICAL | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P950022/S144) | ABBOTT MEDICAL | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P060019/S055) | Irvine Biomedical, Inc. | 2023-11-29 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S284) | Medtronic, Inc. | 2023-11-29 |
| Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spin (P840001/S556) | Medtronic Neuromodulation | 2023-11-29 |
| Nucleus® 24 Cochlear Implant System (P970051/S223) | Cochlear Americas | 2023-11-29 |
| MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM (P960009/S461) | Medtronic, Inc. | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P910023/S457) | ABBOTT MEDICAL | 2023-11-29 |
| 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/S766) | Medtronic, Inc. | 2023-11-29 |
| Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips (P100030/S018) | Baxter Healthcare Corporation | 2023-11-29 |
| 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/S840) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| Freezer, Freezer Xtra (P020045/S106) | Medtronic Cryocath, LP | 2023-11-29 |
| EV ICD - Aurora (P220012/S004) | Medtronic, Inc. | 2023-11-29 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S286) | Medtronic Neuromodulation | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P130026/S086) | St Jude Medical | 2023-11-29 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S419) | Medtronic, Inc. | 2023-11-28 |
| Freestyle Bioprosthesis (P970031/S072) | Medtronic, Inc. | 2023-11-28 |
| LCS® Total Knee System (P830055/S317) | Depuy, Inc. | 2023-11-28 |
| Axonics Sacral Neuromodulation System (P180046/S075) | Boston Scientific Corporation | 2023-11-28 |
| Axonics Sacral Neuromodulation System (P190006/S075) | Boston Scientific Corporation | 2023-11-28 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S415) | Medtronic, Inc. | 2023-11-28 |
| Fourier-Transform Infrared Spectroscopy (FTIR) (P010012/S578) | Boston Scientific Corp | 2023-11-28 |
| Hancock II Bioprosthesis (P980043/S078) | Medtronic, Inc. | 2023-11-28 |
| Mosaic Bioprosthesis (P990064/S087) | Medtronic, Inc. | 2023-11-28 |
| Perfluoron (P950018/S026) | Alcon Laboratories | 2023-11-28 |
| Avalus Bioprosthesis (P170006/S030) | Medtronic, Inc. | 2023-11-28 |
| Tendril STS, UltiPace (P960013/S123) | ABBOTT MEDICAL | 2023-11-28 |
| LifeVest® Wearable Defibrillator (P010030/S172) | Zoll Manufacturing Corporation | 2023-11-27 |
| Proclaim DRG IPG (P150004/S052) | ABBOTT MEDICAL | 2023-11-27 |
| DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) (P130005/S041) | Cardiovascular Systems, Inc. | 2023-11-27 |
| Woven EndoBridge (WEB) Aneurysm Embolization System (P170032/S014) | MicroVention, Inc. | 2023-11-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S026) | Boston Scientific Corporation | 2023-11-24 |
| Aptima HBV Quant Assay (P170025/S020) | Hologic, Inc. | 2023-11-24 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S288) | Medtronic Neuromodulation | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S385) | Medtronic Neuromodulation | 2023-11-22 |
| AMS 700 Implantable Penile Prosthesis without lnhibiZone (N970012/S200) | Boston Scientific Corp | 2023-11-22 |
| EPi-Sense Guided Coagulation System (P200002/S007) | AtriCure, Inc. | 2023-11-22 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S132) | Boston Scientific Corp | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S280) | Medtronic Neuromodulation | 2023-11-22 |
| Synergy Ablation System (P100046/S017) | AtriCure, Inc. | 2023-11-22 |
| TECHNOLAS TENEO 317 (MODEL 2) Excimer Laser System (P990027/S021) | Technolas Perfect Vision GmbH | 2023-11-22 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S393) | Medtronic Neuromodulation | 2023-11-22 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S577) | Boston Scientific Corp | 2023-11-21 |