| Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters (P150005/S083) | Boston Scientific Corp | 2024-03-25 |
| Saluda Medical Evoke SCS System (P190002/S020) | Saluda Medical Pty, Ltd. | 2024-03-25 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S058) | ETHICON, Inc. | 2024-03-25 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S053) | Edwards Lifesciences, LLC | 2024-03-25 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S135) | Vistakon, Division of Johnson & Johnson Vision Car | 2024-03-25 |
| QDOT Micro Navigation Catheter (P210027/S007) | Biosense Webster, Inc. | 2024-03-25 |
| Vivistim® System (P210007/S002) | Mobia Medical, Inc. | 2024-03-25 |
| EDWARDS INTUITY Elite Valve System (P150036/S074) | Edwards Lifesciences, LLC | 2024-03-25 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S171) | Edwards Lifesciences, LLC | 2024-03-25 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S217) | Edwards Lifesciences, LLC | 2024-03-25 |
| QDOT MICRO System (P210027/S006) | Biosense Webster, Inc. | 2024-03-25 |
| Arctic Front Cardiac Cryoablation Catheter System (P100010/S141) | Medtronic Cryocath, LP | 2024-03-25 |
| Harmony TPV System (P200046/S031) | Medtronic, Inc. | 2024-03-22 |
| ARCHITECT CORE/ Alinity i Anti-HBc (P080023/S045) | Abbott Laboratories | 2024-03-22 |
| ARCHITECT AUSAB / Alinity i Anti-HBs (P050051/S059) | Abbott Laboratories, Inc. | 2024-03-22 |
| GEM 21S (GROWTH-FACTOR ENHANCED MATRIX (P040013/S031) | Lynch Biologics, LLC | 2024-03-22 |
| ARCHITECT AFP / Alinity i AFP (P120008/S029) | Abbott Laboratories | 2024-03-22 |
| ARCHITECT HBsAg Next Qualitative I Qualitative Confirmatory/ Alinity i HBsAg Next Qualitative I Alinity i HBsAg Next Con (P210003/S011) | Abbott Laboratories | 2024-03-22 |
| LungFit PH (P200044/S007) | Beyond Air, Inc. | 2024-03-22 |
| Zephyr Endobronchial Valve System (P180002/S025) | Pulmonx Corporation | 2024-03-22 |
| iDesign Refractive Studio (P930016/S066) | Amo Manufacturing USA, LLC | 2024-03-22 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S029) | Boston Scientific Corporation | 2024-03-22 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S001) | W. L. Gore & Associates, Inc. | 2024-03-22 |
| Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS (P130021/S155) | Medtronic, Inc. | 2024-03-22 |
| Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta (P220007/S003) | Alcon Laboratories, Inc. | 2024-03-21 |
| Navitor Transcatheter Aortic Valve, Navitor Loading System , FlexNav Delivery System, Navitor Titan Transcatheter A (P190023/S018) | ABBOTT MEDICAL | 2024-03-21 |
| iDesign Refractive Studio (iDesign/G301) (P930016/S064) | Amo Manufacturing USA, LLC | 2024-03-21 |
| HeartWare® HVAD System (P100047/S216) | Medtronic | 2024-03-21 |
| Mynx Control Vascular Closure Device (5F, 6F/7F), MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S100) | Cordis US Corporation | 2024-03-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S101) | ABBOTT MEDICAL | 2024-03-21 |
| MiniMed 670G Pump, MiniMed 770G Pump, Guardian Link (3) Transmitter, Guardian Sensor (3), Contour Next Link 2.4 Meter, R (P160017/S117) | Medtronic Minimed, Inc. | 2024-03-21 |
| Model 3028 Implantable Pulse Generator (IPG) (P130008/S103) | Inspire Medical Systems | 2024-03-21 |
| SURGIFOAM Absorbable Gelatin Powder, and SURGIFOAM Absorbable Gelatin Powder Kit (P990004/S065) | Ferrosan Meidcal Devices A/S | 2024-03-21 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S159) | Medtronic, Inc. | 2024-03-21 |
| Belotero Balance Dermal Filler & Belotero Balance(+) L1docame Dermal Filler (P090016/S057) | Merz North America, Inc. | 2024-03-20 |
| Ascension MCP (P000057/S012) | Smith & Nephew, Inc. | 2024-03-20 |
| GORE® CARDIOFORM ASD Occluder (P050006/S107) | W. L. Gore & Associates, Inc. | 2024-03-20 |
| R3 Delta Ceramic Hip System (P150030/S039) | Smith & Nephew, Inc. | 2024-03-20 |
| Saluda Medical Evoke® SCS System (P190002/S019) | Saluda Medical Pty, Ltd. | 2024-03-20 |
| Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S035) | Rayner Intraocular Lenses , Ltd. | 2024-03-19 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S028) | Boston Scientific Corporation | 2024-03-19 |
| Evoke SCS System (P190002/S021) | Saluda Medical Pty, Ltd. | 2024-03-19 |
| Light Adjustable Lens, Light Delivery Device (P160055/S034) | Rxsight, Inc. | 2024-03-19 |
| Cryo Cable (P220032/S003) | Boston Scientific Corporation | 2024-03-18 |
| Guardant360 CDx (P200010/S016) | Guardant Health, Inc. | 2024-03-18 |
| VisuMax & VISUMAX 800 (P150040/S015) | Carl Zeiss Meditec, Inc. | 2024-03-18 |
| TVL(TM) Lead System (P950022/S145) | ABBOTT MEDICAL | 2024-03-18 |
| LCS® Total Knee System (P830055/S313) | Depuy, Inc. | 2024-03-15 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S216) | Boston Scientific Corp | 2024-03-15 |
| BioMimics 3D Vascular Stent System (P180003/S008) | Veryan Medical, Ltd. | 2024-03-15 |
| Puregraft Serene Breast Implant (P120011/S026) | Bimini Health Tech | 2024-03-15 |
| SenTiva Generator, SenTiva Duo Generator (P970003/S243) | LivaNova USA, Inc. | 2024-03-15 |
| EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S001) | Edwards Lifesciences, LLC | 2024-03-15 |
| Synergy Ablation System (P100046/S018) | AtriCure, Inc. | 2024-03-15 |
| Epic Vascular Self-Expanding Stent System (P110035/S072) | Boston Scientific Corp | 2024-03-13 |
| RADIESSE® Injectable Implant (P050037/S135) | Merz North America, Inc. | 2024-03-13 |
| Prospera SCS System, Resilience Surgical Lead (P210037/S003) | Biotronik Nro, Inc. | 2024-03-13 |
| Wallstent ILIAC RP Endoprosthesis (P940019/S065) | Boston Scientific Scimed, Inc. | 2024-03-13 |
| Vercise Deep Brain Stimulation (DBS) Systems (Vercise Genus R32, Vercise Genus R16) (P150031/S071) | Boston Scientific Corp | 2024-03-13 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S065) | Boston Scientific Corporation | 2024-03-13 |
| Rotablator Rotational Atherectomy System (P900056/S215) | Boston Scientific Corp | 2024-03-13 |
| Scandinavian Total Ankle Replacement (STAR) (P050050/S026) | Djo Global | 2024-03-13 |
| Farapulse Pulsed Field Ablation System (P230030/S001) | Farapulse, Inc. | 2024-03-13 |
| MEL 80 Excimer Laser (P060004/S007) | Carl Zeiss Meditec, Inc. | 2024-03-13 |
| Express LD Iliac Premounted Stent System (P090003/S056) | Boston Scientific Corporation | 2024-03-13 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S075) | Boston Scientific Corp | 2024-03-13 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S079) | Boston Scientific Corporation | 2024-03-13 |
| Precision Spinal Cord Stimulator (SCS) Systems (WaveWriter Alpha, WaveWriter Alpha 16) (P030017/S373) | Boston Scientific Corp | 2024-03-13 |
| Inspire Model 3028 Implantable Pulse Generator (IPG) (P130008/S107) | Inspire Medical Systems | 2024-03-13 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S091) | Boston Scientific Corp | 2024-03-13 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S157) | Merz North America, Inc. | 2024-03-13 |
| Surpass Evolve Flow Diverter System (P170024/S014) | Stryker Neurovascular | 2024-03-12 |
| Metriq Tubing Set and Metriq Footswitch (P150005/S082) | Boston Scientific Corp | 2024-03-12 |
| 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/S882) | Medtronic Cardiac Rhythm Disease Management | 2024-03-11 |
| Alto Abdominal Stent Graft System (P120006/S039) | Endologix, LLC | 2024-03-11 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S534) | Medtronic, Inc. | 2024-03-11 |
| RHA® Redensity , RHA®2, RHA®3, RHA®4, RHA® Redensity Mepi, RHA® 2 Mepi, RHA® 3 Mepi, RHA® 4 Mepi (P170002/S038) | Teoxane S.A. | 2024-03-11 |
| 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/S848) | Medtronic Cardiac Rhythm Disease Management | 2024-03-11 |
| Mentor MemoryGel® Silicone Gel-Filled Breast Implant (P030053/S073) | Mentor Corp. | 2024-03-11 |
| 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/S775) | Medtronic, Inc. | 2024-03-11 |
| Mentor MemoryShape® Silicone Gel-Filled Breast Implant (P060028/S051) | Mentor Worldwide, LLC | 2024-03-11 |
| Mentor Saline-Filled and SPECTRUM® Breast Implants (P990075/S060) | Mentor Worldwide, LLC | 2024-03-11 |
| Aurora EV ICD (P220012/S015) | Medtronic, Inc. | 2024-03-11 |
| Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR2/AV2 Transcatheter Pacing System (P150033/S184) | Medtronic, Inc. | 2024-03-08 |
| Diamond Temp Catheter (P200028/S023) | Medtronic, Inc. | 2024-03-08 |
| Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin (P160043/S078) | Medtronic Vascular | 2024-03-08 |
| Harmony Transcatheter Pulmonary Valve (P200046/S029) | Medtronic, Inc. | 2024-03-08 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S157) | Medtronic, Inc. | 2024-03-08 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S040) | Boston Scientific Corp | 2024-03-08 |
| Melody Transcatheter Pulmonary Valve (P140017/S029) | Medtronic, Inc. | 2024-03-08 |
| Trident® Acetabular System (P000013/S025) | Howmedica Osteonics Corp. | 2024-03-08 |
| Harmony Delivery Catheter System (P200046/S030) | Medtronic, Inc. | 2024-03-08 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S158) | Medtronic, Inc. | 2024-03-08 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S027) | Boston Scientific Corporation | 2024-03-07 |
| SCULPTRA® (P030050/S049) | Q-Med AB | 2024-03-07 |
| 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 (P980035/S776) | Medtronic, Inc. | 2024-03-06 |
| Aurora EV ICD (P220012/S016) | Medtronic, Inc. | 2024-03-06 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S011) | Teleflex Medical, LLC | 2024-03-06 |
| SIR-Spheres Y-90 resin microspheres (P990065/S015) | Sirtex Medical, Inc. | 2024-03-06 |
| MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S099) | Cordis US Corporation | 2024-03-06 |