| WALLSTENT ILIAC RP Endoprosthesis (P940019/S063) | Boston Scientific Scimed, Inc. | 2023-06-14 |
| CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S216) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| CapSureFix MRI Lead (P090013/S327) | Medtronic, Inc. | 2023-06-14 |
| CapSure Epicardial Pacing Lead (P950024/S106) | Medtronic, Inc. | 2023-06-14 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S176) | Medtronic, Inc. | 2023-06-14 |
| Adapta, Versa, Sensia IPG (P980035/S751) | Medtronic, Inc. | 2023-06-14 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S143) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S062) | Boston Scientific Corporation | 2023-06-14 |
| M6-C Artificial Cervical Disc (P170036/S013) | Spinal Kinetics, LLC | 2023-06-14 |
| StarClose SE Vascular Closure System (P050007/S044) | Abbott Vascular Devices | 2023-06-14 |
| Micra AV TPS, Micra TPS (P150033/S174) | Medtronic, Inc. | 2023-06-14 |
| Sculptra and Sculptra Aesthetic (P030050/S043) | Q-Med AB | 2023-06-14 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S165) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| Transvene CS/SVC Lead (P980050/S140) | Medtronic, Inc. | 2023-06-14 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S461) | Medtronic, Inc. | 2023-06-14 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System (XIENCE Alpine) (P110019/S126) | Abbott Vascular | 2023-06-14 |
| Myocardial Pacing Lead (P120017/S032) | Medtronic, Inc. | 2023-06-14 |
| SURGIFOAM® Absorbable Gelatin Powder, SURGIFOAM® Absorbable Gelatin Powder Kit, SURGIFLO® Hemostatic Matrix, SURGIFLO® H (P990004/S058) | Ferrosan Meidcal Devices A/S | 2023-06-14 |
| 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/S826) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S020) | Abbott Vascular | 2023-06-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, M (P980016/S860) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S278) | Medtronic, Inc. | 2023-06-14 |
| MULTI-LINK VISION® RX Coronary Stent System, MULTI-LINK MINI VISION® RX Coronary Stent System (P020047/S076) | Abbott Vascular | 2023-06-14 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S038) | Boston Scientific Corp | 2023-06-14 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S278) | Medtronic Neuromodulation | 2023-06-14 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S383) | Medtronic Neuromodulation | 2023-06-14 |
| Attain Bipolar OTW Lead, OTW LV Lead (P010015/S521) | Medtronic, Inc. | 2023-06-14 |
| WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S072) | Boston Scientific Corp | 2023-06-14 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S252) | Medtronic, Inc. | 2023-06-14 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S113) | Abiomed, Inc. | 2023-06-14 |
| XACT Carotid Stent System (P040038/S042) | Abbott Vascular, Inc. | 2023-06-14 |
| Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S025) | Alcon Laboratories, LLC | 2023-06-13 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S519) | Medtronic, Inc. | 2023-06-13 |
| Evolut R TAV, Evolut PRO TAV, Evolut PRO+ TAV, Evolut FX TAV (P130021/S139) | Medtronic, Inc. | 2023-06-13 |
| Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck (P190034/S002) | Roche Diagnostics | 2023-06-13 |
| Axonics Sacral Neuromodulation System (P180046/S063) | Boston Scientific Corporation | 2023-06-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S041) | Edwards Lifesciences, LLC | 2023-06-13 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S145) | Alcon Laboratories, Inc. | 2023-06-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S172) | Medtronic, Inc. | 2023-06-13 |
| 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/S823) | Medtronic Cardiac Rhythm Disease Management | 2023-06-13 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S105) | Alcon Research, Ltd. | 2023-06-13 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S158) | Edwards Lifesciences, LLC | 2023-06-13 |
| 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/S857) | Medtronic Cardiac Rhythm Disease Management | 2023-06-13 |
| Axonics Sacral Neuromodulation System (P190006/S063) | Boston Scientific Corporation | 2023-06-13 |
| Harmony TPV (P200046/S017) | Medtronic, Inc. | 2023-06-13 |
| 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/S748) | Medtronic, Inc. | 2023-06-13 |
| Celsius DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter, EZ Steer Nav DS Catheter, Interface Cables (P010068/S071) | Biosense Webster, Inc. | 2023-06-12 |
| Belotero Balance® Dermal Filler, Belotero Balance® (+) Lidocaine Dermal Filler (P090016/S054) | Merz North America, Inc. | 2023-06-12 |
| Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, Deflectable Diagnostic/Ablation Catheter, Celsius Catheter, (P950005/S086) | Biosense Webster, Inc. | 2023-06-12 |
| NaviStar Catheter, NaviStar RMT Catheter, EZ Steer Nav Catheter, Interface Cables (P990025/S071) | Biosense Webster, Inc. | 2023-06-12 |
| Interface Cables (P990071/S057) | Biosense Webster, Inc. | 2023-06-12 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4 (P170002/S031) | Teoxane S.A. | 2023-06-12 |
| ThermoCool SmartTouch Catheters, EZ Steer ThermoCool Nav Catheter, Celsius RMT ThermoCool Catheter, ThermoCool SF NAV Ca (P030031/S133) | Biosense Webster, Inc. | 2023-06-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail®), SYNERGY SHIELD Everolimus-Eluting Plat (P150003/S093) | Boston Scientific Corporation | 2023-06-12 |
| 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/S747) | Medtronic, Inc. | 2023-06-12 |
| eCoin implanted tibial stimulator (P200036/S006) | Boston Scientific Corporation | 2023-06-12 |
| EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoCool Catheter, ThermoCool SmartTouch Catheters (P040036/S095) | Biosense Webster, Inc. | 2023-06-12 |
| MULTI-LINK VISION RX Coronary Stent System, MULTI-LINK MINI VISION Coronary Stent System (P020047/S077) | Abbott Vascular | 2023-06-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S518) | Medtronic, Inc. | 2023-06-12 |
| QDOT MICRO Catheter, Interface Cables (P210027/S003) | Biosense Webster, Inc. | 2023-06-12 |
| SECURE®-C Cervical Artificial Disc (P100003/S008) | Globus Medical, Inc. | 2023-06-12 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S019) | CooperVision, Inc. | 2023-06-09 |
| 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/S859) | Medtronic Cardiac Rhythm Disease Management | 2023-06-09 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S520) | Medtronic, Inc. | 2023-06-09 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S173) | Medtronic, Inc. | 2023-06-09 |
| 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/S825) | Medtronic Cardiac Rhythm Disease Management | 2023-06-09 |
| Simplify Disc (P200022/S011) | Nuvasive, Inc. | 2023-06-09 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S018) | CooperVision, Inc. | 2023-06-09 |
| Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert (P160048/S025) | Senseonics, Incorporated | 2023-06-09 |
| 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/S750) | Medtronic, Inc. | 2023-06-09 |
| Nucleus 24 Cochlear Implant System (P970051/S218) | Cochlear Americas | 2023-06-08 |
| Juvéderm® Hyaluronate Gel Implants (P050047/S088) | Allergan | 2023-06-08 |
| Radiesse® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Lidocaine Jawline (P050052/S148) | Merz North America, Inc. | 2023-06-08 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S010) | Foundation Medicine, Inc. | 2023-06-08 |
| Radiesse® Injectable Implant (P050037/S126) | Merz North America, Inc. | 2023-06-08 |
| Juvéderm® Hyaluronate Gel Implants (P110033/S071) | Allergan | 2023-06-08 |
| Inspire Upper Airway Stimulation System (P130008/S090) | Inspire Medical Systems | 2023-06-08 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S411) | Medtronic, Inc. | 2023-06-07 |
| xT CDx (P210011/S001) | Tempus AI, Inc. | 2023-06-07 |
| Micra AV TPS, Micra TPS (P150033/S166) | Medtronic, Inc. | 2023-06-07 |
| Zenith Dissection Endovascular System (P180001/S007) | William Cook Europe Aps | 2023-06-07 |
| DETOUR System (P220021) | Endologix, LLC | 2023-06-07 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S006) | Cook Medical Incorporated | 2023-06-07 |
| LIAISON® XL MUREX HBsAg Qual Assay (P190017/S012) | DiaSorin, Inc. | 2023-06-07 |
| Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template Sterilized (P900033/S107) | Integra Lifesciences Corp. | 2023-06-07 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S410) | Medtronic, Inc. | 2023-06-07 |
| Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, (P100040/S057) | Medtronic Vascular | 2023-06-06 |
| Precision Passing Elevator (P030017/S351) | Boston Scientific Corp | 2023-06-06 |
| Valiant Thoracic Stent Graft with Captivia Delivery System, Endurant Stent Graft System, Endurant II Stent Graft System, (P100021/S114) | Medtronic Vascular | 2023-06-06 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S822) | Medtronic Cardiac Rhythm Disease Management | 2023-06-06 |
| Revanesse Versa 1.0 mL, Revanesse Versa 1.2 mL, Revanesse Versa + with Lidocaine 1.0 mL, Revanesse Versa + with Lidocain (P160042/S022) | Prollenium Medical Technologies, Inc. | 2023-06-06 |
| OPTIMZER Smart Mini IPG Firmware (P180036/S017) | Impulse Dynamics (Usa), Inc. | 2023-06-06 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S856) | Medtronic Cardiac Rhythm Disease Management | 2023-06-06 |
| Axonics Sacral Neuromodulation System (P190006/S066) | Boston Scientific Corporation | 2023-06-02 |
| LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device (P220024) | Advanced Medical Solutions Limited | 2023-06-02 |
| Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) (P150004/S061) | ABBOTT MEDICAL | 2023-06-02 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S452) | Medtronic, Inc. | 2023-06-02 |
| Axonics Sacral Neuromodulation System (P180046/S066) | Boston Scientific Corporation | 2023-06-02 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S030) | Gen-Probe Incorporated | 2023-06-02 |
| Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® Spinal C (P840001/S542) | Medtronic Neuromodulation | 2023-06-02 |