| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S367) | Boston Scientific Corp | 2023-10-25 |
| PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S050) | Alcon Laboratories | 2023-10-25 |
| Nucleus® 24 Cochlear Implant System (P970051/S222) | Cochlear Americas | 2023-10-25 |
| MARA Water Vapor Ablation System (P160047/S033) | CooperSurgical, Inc. | 2023-10-25 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S147) | Alcon Laboratories, Inc. | 2023-10-25 |
| LIFEPAK® CR2 defibrillator (P170018/S017) | Physio-Control, Inc. | 2023-10-25 |
| Lead Repair Kit Model 6946 (P910073/S174) | Boston Scientific | 2023-10-24 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S028) | Alcon Laboratories, LLC | 2023-10-24 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S039) | Cardiovascular Systems, Inc. | 2023-10-24 |
| HeartMate II Left Ventricular Assist System (P060040/S094) | ABBOTT MEDICAL | 2023-10-24 |
| Abbott RealTime IDH1 (P170041/S007) | Abbott Molecular, Inc. | 2023-10-24 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S146) | Alcon Laboratories, Inc. | 2023-10-24 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S106) | Alcon Research, Ltd. | 2023-10-24 |
| Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, Enticos 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Edora 8 HF-T QP, Edora (P070008/S154) | Biotronik, Inc. | 2023-10-24 |
| Light Adjustable Lens, Light Delivery Device (P160055/S032) | Rxsight, Inc. | 2023-10-24 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S010) | ABBOTT MEDICAL | 2023-10-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S062) | ABBOTT MEDICAL | 2023-10-24 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos (P950037/S254) | Biotronik, Inc. | 2023-10-24 |
| Axonics Sacral Neuromodulation System (P190006/S071) | Boston Scientific Corporation | 2023-10-23 |
| Barostim System Heart Failure (P180050/S010) | Cvrx, Inc. | 2023-10-23 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S152) | Biotronik, Inc. | 2023-10-23 |
| Pulse Generator, Permanent, Implantable (P950037/S253) | Biotronik, Inc. | 2023-10-23 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S132) | Vistakon, Division of Johnson & Johnson Vision Car | 2023-10-23 |
| OPTIMIZER Smart Mini Implantable Pulse Generation (IPG) (P180036/S020) | Impulse Dynamics (Usa), Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S178) | Biotronik, Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S122) | Biotronik, Inc. | 2023-10-23 |
| Defibrillator, implantable, dual-chamber (P000009/S106) | Biotronik, Inc. | 2023-10-23 |
| Axonics Sacral Neuromodulation System (P180046/S071) | Boston Scientific Corporation | 2023-10-23 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S037) | Medinol, Ltd. | 2023-10-20 |
| HeartMate II Left Ventricular Assist System (P060040/S093) | ABBOTT MEDICAL | 2023-10-20 |
| Silikon 1000 (P950008/S022) | Alcon | 2023-10-20 |
| TherOx Downstream System (P170027/S007) | Zoll Circulation, Inc. | 2023-10-20 |
| LungFit PH (P200044/S005) | Beyond Air, Inc. | 2023-10-20 |
| Aurora EV-ICD System (P220012) | Medtronic, Inc. | 2023-10-20 |
| BioGlue® Surgical Adhesive (P010003/S041) | Cryolife, Inc. | 2023-10-20 |
| HeartMate 3 Left Ventricular Assist System (P160054/S060) | ABBOTT MEDICAL | 2023-10-20 |
| Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) (P010012/S570) | Boston Scientific Corp | 2023-10-19 |
| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S033) | Spectranetics Corp. | 2023-10-19 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S465) | Medtronic, Inc. | 2023-10-19 |
| Micra AV TPS, Micra TPS (P150033/S179) | Medtronic, Inc. | 2023-10-19 |
| DML 3000 Microplate Luminometer, 5000-00031, digene® HC2 High-Risk HPV DNA Test (I plate), 5199-1220, digene® HC2 High-R (P890064/S042) | Qiagen Gaithersburg, Inc. | 2023-10-19 |
| Master Intellis Spinal Cord Stimulation Systems (P840001/S553) | Medtronic Neuromodulation | 2023-10-19 |
| TECNIS Simplicity Delivery System, SmartLOAD Delivery Technology, TECNIS iTec Preloaded Delivery System (P980040/S163) | Johnson & Johnson Surgical Vision, Inc. | 2023-10-19 |
| Master IntellisTM and VantaTM Spinal Cord Stimulation Systems (P840001/S554) | Medtronic Neuromodulation | 2023-10-19 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S289) | Boston Scientific Corp | 2023-10-18 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S234) | Guidant Corp. | 2023-10-18 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S013) | Edwards Lifesciences, LLC | 2023-10-18 |
| SICD Gen 2, SICD MRI (P110042/S190) | Boston Scientific Corporation | 2023-10-18 |
| 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/S760) | Medtronic, Inc. | 2023-10-18 |
| Model 4340 Sensing Lead (P130008/S102) | Inspire Medical Systems | 2023-10-18 |
| SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, SJM Masters Series Aortic Valved Graft (P810002/S120) | ABBOTT MEDICAL | 2023-10-18 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S152) | Boston Scientific | 2023-10-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S464) | Medtronic, Inc. | 2023-10-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S525) | Medtronic, Inc. | 2023-10-18 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S497) | Boston Scientific | 2023-10-18 |
| HeartWare HVAD System (P100047/S214) | Medtronic | 2023-10-18 |
| Epic Supra Valve, Epic Valve, Epic Plus Stented Tissue Valve, Epic Plus Supra Valve, Epic Max Valve (P040021/S053) | ABBOTT MEDICAL | 2023-10-18 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S043) | Physio-Control, Inc. | 2023-10-18 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S576) | Boston Scientific Corp | 2023-10-18 |
| iCast Covered Stent System (P120003/S003) | Atrium Medical Corp. | 2023-10-18 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S087) | Syncardia Systems, LLC | 2023-10-18 |
| SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters (P860004/S417) | Medtronic, Inc. | 2023-10-18 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S178) | Medtronic, Inc. | 2023-10-18 |
| Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec (P840001/S552) | Medtronic Neuromodulation | 2023-10-18 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S059) | ABBOTT MEDICAL | 2023-10-17 |
| MynxGrip and Mynx Control Vascular Closure Device (P040044/S095) | Cordis US Corporation | 2023-10-17 |
| Sientra Silicone Gel Breast Implants (P070004/S040) | Tiger Aesthetics Medical, LLC | 2023-10-17 |
| SYNERGY SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom (P150003/S098) | Boston Scientific Corporation | 2023-10-17 |
| ENROUTE® Transcarotid Stent System (P140026/S028) | Boston Scientific Corporation | 2023-10-16 |
| iDesign Refractive Studio (P930016/S063) | Amo Manufacturing USA, LLC | 2023-10-16 |
| RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi (P170002/S026) | Teoxane S.A. | 2023-10-13 |
| InterStim Therapy System, Verify Evaluation System (P970004/S387) | Medtronic Neuromodulation | 2023-10-13 |
| Nucleus® 22 Cochlear Implant System (P840024/S095) | Cochlear Americas | 2023-10-13 |
| Nucleus® 24 Auditory Brainstem Implant System (P000015/S050) | Cochlear Americas | 2023-10-13 |
| Nucleus® 22 Cochlear Implant System (P890027/S063) | Cochlear Americas | 2023-10-13 |
| Nucleus® 24 Cochlear Implant System (P970051/S221) | Cochlear Americas | 2023-10-13 |
| Nucleus® Hybrid L24 Cochlear Implant System (P130016/S053) | Cochlear Americas | 2023-10-13 |
| TactiFlex SE Ablation Catheter, Sensor Enabled (P220013/S009) | ABBOTT MEDICAL | 2023-10-13 |
| CALCIVIS Imaging System (P170029/S003) | Calcivis Limited | 2023-10-13 |
| InterStim Therapy System, Verify Evaluation System (P080025/S282) | Medtronic Neuromodulation | 2023-10-13 |
| INGEVITY and INGEVITY+TM active leads (P150012/S150) | Boston Scientific | 2023-10-13 |
| TREO Abdominal Stent-Graft System (P190015/S012) | Bolton Medical, Inc. | 2023-10-12 |
| Koning Breast CT, KBCT (Model CBCT1000) (P130025/S004) | Koning Corporation | 2023-10-12 |
| COAPTITE Injectable Implant (P040047/S073) | Merz North America, Inc. | 2023-10-12 |
| Activa® Deep Brain Stimulation Therapy System, Percept BrainSense (P960009/S463) | Medtronic, Inc. | 2023-10-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S076) | Medtronic, Inc. | 2023-10-12 |
| RelayPlus Thoracic Stent-Graft System (P110038/S029) | Bolton Medical, Inc. | 2023-10-12 |
| RelayPro Thoracic Stent-Graft System (P200045/S008) | Bolton Medical, Inc. | 2023-10-12 |
| LimFlow System (P220025/S001) | LimFlow, Inc. | 2023-10-12 |
| MitraClip G4 Delivery System (P100009/S058) | ABBOTT MEDICAL | 2023-10-12 |
| Exablate Model 400 Type 1.0 & Type 1.1 (Exablate Neuro) (P150038/S025) | Insightec | 2023-10-12 |
| Harmony Delivery Catheter System (P200046/S022) | Medtronic, Inc. | 2023-10-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, CoreValve EnVeo R Delivery Catheter (P190008/S027) | Medtronic Vascular, Inc. | 2023-10-12 |
| RADIESSE® Injectable Implant, RADIESSE® (+) Lidocaine, RADIESSE® Hands, RADIESSE® (+) Jawline (P050052/S154) | Merz North America, Inc. | 2023-10-12 |
| CoreValve EnVeo Pro Delivery Catheter System, CoreValve EnVeo Pro Loading System, Evolut PRO+ Delivery Catheter System, (P130021/S147) | Medtronic, Inc. | 2023-10-12 |
| Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR Transcatheter Pacing System (P150033/S177) | Medtronic, Inc. | 2023-10-12 |
| DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet (P200028/S022) | Medtronic, Inc. | 2023-10-12 |
| Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® Spinal C (P840001/S551) | Medtronic Neuromodulation | 2023-10-12 |
| Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus (P160043/S073) | Medtronic Vascular | 2023-10-12 |
| RADIESSE® Injectable Implant (P050037/S132) | Merz North America, Inc. | 2023-10-12 |