| DiamondTemp Ablation System (P200028/S024) | Medtronic, Inc. | 2024-08-06 |
| Heart Ware HVAD System (P100047/S218) | Medtronic | 2024-08-06 |
| TREO Abdominal Stent-Graft System (P190015/S021) | Bolton Medical, Inc. | 2024-08-06 |
| CERAMAX® Ceramic Total Hip System (P070026/S112) | DePuy Orthopaedics, Inc. | 2024-08-06 |
| LCS® Total Knee System (P830055/S327) | Depuy, Inc. | 2024-08-06 |
| Surpass Evolve Flow Diverter Systems (P170024/S019) | Stryker Neurovascular | 2024-08-05 |
| Cologuard (P130017/S059) | Exact Sciences Corporation | 2024-08-05 |
| AngioJet Ultra 5000A Console (P980037/S093) | Boston Scientific Corp | 2024-08-05 |
| Axonics Sacral Neuromodulation System (P180046/S078) | Boston Scientific Corporation | 2024-08-02 |
| Lacrosse NSE ALPHA Coronary Dilatation Catheter (P230026/S001) | Goodman Co., Ltd. | 2024-08-02 |
| Avant, Entrant, Gallant, Neutrino NxT (P030054/S422) | ABBOTT MEDICAL | 2024-08-02 |
| Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1 (P140009/S099) | ABBOTT MEDICAL | 2024-08-02 |
| Patient Controller Application Version 2.0.2 (P010032/S218) | ABBOTT MEDICAL | 2024-08-02 |
| Avant, Entrant, Gallant, Neutrino NxT (P910023/S467) | ABBOTT MEDICAL | 2024-08-02 |
| Axonics Sacral Neuromodulation System (P190006/S078) | Boston Scientific Corporation | 2024-08-02 |
| Inspire Upper Airway Stimulation (UAS) System (P130008/S098) | Inspire Medical Systems | 2024-08-01 |
| Scoreflex NC Scoring PTCA Catheter (P200041/S002) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-01 |
| Capsular Tension Ring (CTR) and RingJect (P030023/S009) | Ophtec BV | 2024-08-01 |
| MiSight 1 Day (omafilcon A) (P180035/S022) | CooperVision, Inc. | 2024-08-01 |
| Thoraflex Hybrid (P210006/S009) | Vascutek, Ltd. | 2024-08-01 |
| MAGE-A4 IHC 1F9 pharmDx (P230016) | Agilent Technologies, Inc. | 2024-08-01 |
| CapSureFix Novus Lead (P930039/S261) | Medtronic, Inc. | 2024-08-01 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S185) | Medtronic, Inc. | 2024-08-01 |
| Cochlear Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear Nucleus® CI532 cochlear implant with S (P970051/S228) | Cochlear Americas | 2024-08-01 |
| LCS(R) Total Knee System (P830055/S328) | Depuy, Inc. | 2024-08-01 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S017) | Foundation Medicine, Inc. | 2024-08-01 |
| CapSureFix Novus Lead (P930039/S257) | Medtronic, Inc. | 2024-07-31 |
| Pulse Generator, Permanent Implantable (P950037/S259) | Biotronik, Inc. | 2024-07-31 |
| SCS Implantable Neurostimulators (P840001/S569) | Medtronic Neuromodulation | 2024-07-31 |
| Eterna SCS IPG (P010032/S219) | ABBOTT MEDICAL | 2024-07-31 |
| RHA® Redensity, RHA® 2, RHA® 3, RHA® 4 (P170002/S037) | Teoxane S.A. | 2024-07-31 |
| CapSure Sense Lead (P830061/S220) | Medtronic Cardiac Rhythm Disease Management | 2024-07-31 |
| Liberta RC DBS IPG (P140009/S100) | ABBOTT MEDICAL | 2024-07-31 |
| Biofinity Sphere (comfilcon A), Biofinity Toric (P080011/S169) | CooperVision, Inc. | 2024-07-30 |
| Bulkamid Urethral Bulking System (P170023/S017) | Boston Scientific Corporation | 2024-07-30 |
| Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C (P140031/S175) | Edwards Lifesciences, LLC | 2024-07-30 |
| EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S006) | Edwards Lifesciences, LLC | 2024-07-30 |
| Edwards SAPIEN 3 Pulmonic Delivery System (P200015/S055) | Edwards Lifesciences, LLC | 2024-07-30 |
| PASCAL Precision Implant System, PASCAL Precision Guide Sheath (P220003/S017) | Edwards Lifesciences, LLC | 2024-07-30 |
| POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S (P220032/S005) | Boston Scientific Corporation | 2024-07-30 |
| TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (P980052/S014) | Stryker Leibinger, GmbH & Co KG | 2024-07-30 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S404) | Medtronic Neuromodulation | 2024-07-29 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S299) | Medtronic Neuromodulation | 2024-07-29 |
| Intellis Spinal Cord Stimulation Systems (P840001/S570) | Medtronic Neuromodulation | 2024-07-29 |
| enVista hydrophobic acrylic IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista (P910056/S054) | Bausch & Lomb, Inc. | 2024-07-29 |
| Light Adjustable Lens and Light Delivery Device (P160055/S038) | Rxsight, Inc. | 2024-07-29 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S059) | Nevro Corporation | 2024-07-27 |
| Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S075) | Boston Scientific Corp | 2024-07-26 |
| Esprit BTK Everolimus Eluting Resorbable Scaffold System (P230036/S005) | ABBOTT MEDICAL | 2024-07-26 |
| Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (P140009/S101) | ABBOTT MEDICAL | 2024-07-26 |
| SYNERGY MEGATRON Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System (P950020/S143) | Boston Scientific Corp | 2024-07-26 |
| Pipeline Flex Embolization Device with Shield Technology, Pipeline Vantage Embolization Device with Shield Technology (P100018/S046) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2024-07-26 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S010) | Medtronic Vascular, Inc. | 2024-07-26 |
| Onyx Liquid Embolic System (P030004/S033) | Ev3 Neurovascular | 2024-07-26 |
| Aptima HPV-GT Assay (P120007/S031) | Gen-Probe Incorporated | 2024-07-26 |
| HeartMate 3 Left Ventricular Assist System (P160054/S074) | ABBOTT MEDICAL | 2024-07-26 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S220) | ABBOTT MEDICAL | 2024-07-26 |
| WaterWriter Alpha Spinal Cord Stimulator (SCS) Systems (P030017/S376) | Boston Scientific Corp | 2024-07-26 |
| Shield (P230009) | Guardant Health, Inc. | 2024-07-26 |
| Aptima HPV Assay (P100042/S036) | Gen-Probe Incorporated | 2024-07-26 |
| SYNERGY, XD, SHIELD and MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S101) | Boston Scientific Corporation | 2024-07-26 |
| Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (P840001/S568) | Medtronic Neuromodulation | 2024-07-25 |
| LCS( Total Knee System (P830055/S326) | Depuy, Inc. | 2024-07-25 |
| Axonics Sacral Neuromodulation System (P180046/S086) | Boston Scientific Corporation | 2024-07-25 |
| Axonics Sacral Neuromodulation System (P190006/S086) | Boston Scientific Corporation | 2024-07-25 |
| Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Sp (P840001/S567) | Medtronic Neuromodulation | 2024-07-25 |
| SUPARTZ FX, VISCO-3 (P980044/S062) | Seikagaku Corp. | 2024-07-25 |
| Epic Plus Tissue Heart Valves, Epic Max Tissue Heart Valves, Epic Tissue Heart Valves (P040021/S058) | ABBOTT MEDICAL | 2024-07-25 |
| Prostar XL Percutaneous Vascular Surgical System (P960043/S123) | Abbott Vascular, Inc. | 2024-07-25 |
| SofLens (polymacon) Contact Lens Family (N16895/S106) | Bausch & Lomb, Inc. | 2024-07-25 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S040) | Biotronik AG | 2024-07-24 |
| Genesis and EON Family Neurostimulation (IPG) System (P010032/S216) | ABBOTT MEDICAL | 2024-07-24 |
| RelayPlus Thorade Stent Graft System (P110038/S032) | Bolton Medical, Inc. | 2024-07-24 |
| Collastat Absorbable Collagen Hemostatic Sponge, Collastat Absorbable Collagen Hemostatic Agent-Microfibrillar Form (I (P810006/S108) | Integra LifeSciences Corporation | 2024-07-24 |
| iCast Covered Stent System (P120003/S004) | Atrium Medical Corp. | 2024-07-24 |
| RelayPro Thoracic Stent-Graft System (P200045/S013) | Bolton Medical, Inc. | 2024-07-24 |
| CollaCote®, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S092) | Integra Lifesciences Corp. | 2024-07-24 |
| Helistat® Absorbable Collagen Hemostatic Agent, Helitene® Absorbable Collagen Hemostatic Agent-Fibrillar Form (P850010/S111) | Integra LifeSciences Corporation | 2024-07-24 |
| Simplera System (P160007/S047) | Medtronic Minimed | 2024-07-24 |
| Brio Neurostimulation System (P140009/S098) | ABBOTT MEDICAL | 2024-07-24 |
| Axium Neurostimulator System (P150004/S073) | ABBOTT MEDICAL | 2024-07-24 |
| CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX Delivery Catheter System (P130021/S165) | Medtronic, Inc. | 2024-07-24 |
| R3 DELTA Ceramic Hip System (P150030/S041) | Smith & Nephew, Inc. | 2024-07-23 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S033) | Boston Scientific Corporation | 2024-07-23 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S092) | Hologic, Inc. | 2024-07-23 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007) | Roche Diagnostics | 2024-07-23 |
| Biofinity (comflicon A) (P080011/S168) | CooperVision, Inc. | 2024-07-23 |
| MT PAS ACUITY X4 (P010012/S581) | Boston Scientific Corp | 2024-07-22 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S185) | Medtronic, Inc. | 2024-07-22 |
| Atellica IM HBc Total 2 (HBcT2) (P210019/S003) | Siemens Healthcare Diagnostics, Inc. | 2024-07-22 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S785) | Medtronic, Inc. | 2024-07-21 |
| TactiCath Ablation Catheter, Sensor Enabled (P130026/S089) | St Jude Medical | 2024-07-21 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S543) | Medtronic, Inc. | 2024-07-21 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S012) | ABBOTT MEDICAL | 2024-07-21 |
| COLOGUARD (P130017/S057) | Exact Sciences Corporation | 2024-07-20 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S013) | Cook Medical Incorporated | 2024-07-19 |
| Zenith Dissection Endovascular System (P180001/S014) | William Cook Europe Aps | 2024-07-19 |
| RelayPro Thoracic Stent-Graft System (P200045/S012) | Bolton Medical, Inc. | 2024-07-18 |
| Latitude NXT Patient Management System (ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, AL (N970003/S293) | Boston Scientific Corp | 2024-07-18 |
| TREO Abdominal Stent-Graft System (P190015/S020) | Bolton Medical, Inc. | 2024-07-18 |