| Assurity, Assurity +, Endurity, Endurity Core (P880086/S328) | ABBOTT MEDICAL | 2023-05-01 |
| Assurity MRI, Endurity MRI (P140033/S079) | ABBOTT MEDICAL | 2023-05-01 |
| Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP, Quadra Allure MP RF (P030035/S194) | ABBOTT MEDICAL | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P030005/S230) | Guidant Corp. | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (N970003/S285) | Boston Scientific Corp | 2023-05-01 |
| Ellipse DR, Ellipse VR (P910023/S453) | ABBOTT MEDICAL | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P010012/S569) | Boston Scientific Corp | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P110042/S184) | Boston Scientific Corporation | 2023-05-01 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S092) | ABBOTT MEDICAL | 2023-04-29 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S054) | ABBOTT MEDICAL | 2023-04-29 |
| CardioMEMS HF System (P100045/S065) | ABBOTT MEDICAL | 2023-04-28 |
| Spinal Cord Stimulation (SCS) System (P010032/S192) | ABBOTT MEDICAL | 2023-04-28 |
| ADVIA Centaur Anti-HBc Total (HBcT2) and Atellica IM Anti-HBc Total (HBcT2) (P210019/S002) | Siemens Healthcare Diagnostics, Inc. | 2023-04-28 |
| xT CDx (P210011) | Tempus AI, Inc. | 2023-04-28 |
| Preveleak Surgical Sealant (P100030/S017) | Baxter Healthcare Corporation | 2023-04-28 |
| Medtronic Core Valve Evolut R Transcatheter Aortic Valve, Medtronic Core Valve Evolut Pro Transcatheter Aortic Valve (P130021/S137) | Medtronic, Inc. | 2023-04-28 |
| Model 2740 Programmer Cable Printed Circuit Board Assembly (P130008/S095) | Inspire Medical Systems | 2023-04-28 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4 Dermal Fillers (P170002/S027) | Teoxane S.A. | 2023-04-27 |
| RHA® Redensity, RHA®2, RHA®3, RHA®4 Dermal Fillers (P170002/S028) | Teoxane S.A. | 2023-04-27 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S206) | Boston Scientific Corp | 2023-04-27 |
| Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S131) | Medtronic Cryocath, LP | 2023-04-27 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S071) | Edwards Lifesciences, LLC | 2023-04-27 |
| MiniMed 770G System (P160017/S093) | Medtronic Minimed, Inc. | 2023-04-27 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S075) | Boston Scientific Corp | 2023-04-27 |
| Impella RP, Impella RP with Smart Assist, Impella $.0/LD (P170011/S049) | Abiomed, Inc. | 2023-04-27 |
| EDWARDS INTUITY Elite Valve System (P150036/S069) | Edwards Lifesciences, LLC | 2023-04-27 |
| Blazer II Cardiac Ablation System (P920047/S130) | Boston Scientific Corp | 2023-04-27 |
| Blazer IITM XP Cardiac RF Ablation System (also branded as Blazer II Prime XP, IntellaTip MiFi XP, IntellaTip MiFi OI, I (P020025/S138) | Boston Scientific | 2023-04-27 |
| Chilli II Cooled RF Ablation System (P980003/S095) | Boston Scientific Corp | 2023-04-27 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S212) | Edwards Lifesciences, LLC | 2023-04-27 |
| Impella 2.5, Impella CP and CP with SmartAssist (P140003/S110) | Abiomed, Inc. | 2023-04-27 |
| HeartWare® Ventricular Assist System (P100047/S209) | Medtronic | 2023-04-26 |
| Hydrus® Microstent (P170034/S009) | Alcon Research, LLC | 2023-04-26 |
| Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System (P190023/S014) | ABBOTT MEDICAL | 2023-04-26 |
| EUFLEXXA (P010029/S033) | Ferring Pharmaceuticals, Inc. | 2023-04-26 |
| RHA®2 (P170002/S024) | Teoxane S.A. | 2023-04-26 |
| Medtronic CoreValve EnVeo PRO Loading System, Medtronic Evolut PRO+ Loading System, Medtronic Evolut FX Loading Syst (P130021/S133) | Medtronic, Inc. | 2023-04-26 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S137) | Boston Scientific Corp | 2023-04-26 |
| RADIESSE® Injectable Implant (P050037/S123) | Merz North America, Inc. | 2023-04-26 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S155) | Edwards Lifesciences, LLC | 2023-04-26 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S057) | Ferrosan Meidcal Devices A/S | 2023-04-26 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S008) | Cerapedics, LLC | 2023-04-26 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S037) | Edwards Lifesciences, LLC | 2023-04-26 |
| BRACAnalysis CDx (P140020/S027) | Myriad Genetic Laboratories | 2023-04-26 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S744) | Medtronic, Inc. | 2023-04-26 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (P050052/S145) | Merz North America, Inc. | 2023-04-26 |
| Sculptra (P030050/S039) | Q-Med AB | 2023-04-25 |
| Medtronic Evolut FX Delivery Catheter System (P130021/S134) | Medtronic, Inc. | 2023-04-25 |
| Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta (P220007) | Alcon Laboratories, Inc. | 2023-04-25 |
| Artegraft Collagen Vascular Graft (N16837/S030) | LeMaitre Vascular, Inc. | 2023-04-25 |
| Optilume Urethral Drug Coated Balloon (P210020/S008) | Urotronic, Inc. | 2023-04-25 |
| Avitene Microfibrillar Collagen Hemostat (N17600/S038) | Davol Inc., Sub. C. R. Bard, Inc. | 2023-04-25 |
| EUFLEXXA (P010029/S032) | Ferring Pharmaceuticals, Inc. | 2023-04-25 |
| MiSight 1 day (omafilcon A) (P180035/S017) | CooperVision, Inc. | 2023-04-24 |
| Elecsys HBsAg II, PreciControl HBsAg II, Elecsys HBsAg Confirmatory Test, Elecsys HBsAg II Auto Confirm, PreciControl HB (P160019/S014) | Roche Diagnostics, Inc. | 2023-04-24 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S038) | W. L. Gore & Associates, Inc. | 2023-04-24 |
| Nucleus 24 Cochlear Implant System (P970051/S217) | Cochlear Americas | 2023-04-24 |
| Nucleus 24 Auditory Brainstem Implant System (P000015/S049) | Cochlear Americas | 2023-04-24 |
| LATITUDE NXT Release 7.3 (P910077/S191) | Boston Scientific | 2023-04-21 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S140) | Boston Scientific | 2023-04-21 |
| LungFit PH (P200044/S002) | Beyond Air, Inc. | 2023-04-21 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S228) | Guidant Corp. | 2023-04-21 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (N970003/S283) | Boston Scientific Corp | 2023-04-21 |
| MiniMed 780G System (P160017/S091) | Medtronic Minimed, Inc. | 2023-04-21 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S490) | Boston Scientific | 2023-04-21 |
| OPRA System (P190009/S003) | Integrum AB | 2023-04-21 |
| EMBLEM S-ICD (P110042/S178) | Boston Scientific Corporation | 2023-04-21 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S567) | Boston Scientific Corp | 2023-04-21 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S046) | Cordis US Corporation | 2023-04-20 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S450) | Medtronic, Inc. | 2023-04-20 |
| Silikon 1000 (P950008/S018) | Alcon | 2023-04-20 |
| Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software (P150033/S161) | Medtronic, Inc. | 2023-04-20 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S (P840001/S539) | Medtronic Neuromodulation | 2023-04-20 |
| TECNIS® 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS® OptiBlue 1-Piece IOL with TECNIS Simplicity Deliv (P980040/S158) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-20 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S (P840001/S540) | Medtronic Neuromodulation | 2023-04-20 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S021) | Cordis US Corporation | 2023-04-20 |
| CareLink Instruments & DDMA, CareLink SmartSync Common Application (P890003/S457) | Medtronic, Inc. | 2023-04-20 |
| Cerene Cryotherapy Device (P180032/S012) | Channel Medsystems, Inc. | 2023-04-19 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S136) | Medtronic, Inc. | 2023-04-19 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S205) | Boston Scientific Corp | 2023-04-19 |
| Bulkamid Urethral Bulking System (P170023/S014) | Boston Scientific Corporation | 2023-04-19 |
| INGEVITY MRI, INGEVITY+ (P150012/S139) | Boston Scientific | 2023-04-19 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System, (P160043/S067) | Medtronic Vascular | 2023-04-18 |
| MiniMed 670G System (P160017/S108) | Medtronic Minimed, Inc. | 2023-04-18 |
| OrganOx metra System (P200035/S008) | Organox Limited | 2023-04-18 |
| Helistat® Absorbable Collagen Hemostatic Agent and Helitene® Absorbable Collagen Hemostatic Agent Fibrillar Form (P850010/S106) | Integra LifeSciences Corporation | 2023-04-18 |
| Elecsys HBeAg Test System (P130015/S017) | Roche Diagnostics Operations, Inc. | 2023-04-18 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S020) | Boston Scientific Corporation | 2023-04-18 |
| INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template (P900033/S106) | Integra Lifesciences Corp. | 2023-04-18 |
| MiniMed 630G System (P150001/S104) | Medtronic Minimed | 2023-04-18 |
| Straumann Emdogain (P930021/S031) | The Straumann Company | 2023-04-18 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Fo (P810006/S103) | Integra LifeSciences Corporation | 2023-04-18 |
| LIFEPAK CR® Plus defibrillator; LIFEPAK EXPRESS® defibrillator; LIFEPAK 1000® defibrillator (P160026/S038) | Physio-Control, Inc. | 2023-04-18 |
| CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S088) | Integra Lifesciences Corp. | 2023-04-18 |
| LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and LIFEPAK 1000® defibrillator (P160012/S007) | Physio-Control, Inc. | 2023-04-18 |
| TactiSys Quartz Equipment (P130026/S083) | St Jude Medical | 2023-04-17 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S326) | ABBOTT MEDICAL | 2023-04-14 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S405) | ABBOTT MEDICAL | 2023-04-14 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S192) | ABBOTT MEDICAL | 2023-04-14 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S451) | ABBOTT MEDICAL | 2023-04-14 |