| enVista Hydrophobic Acrylic Intraocular Lens (P910056/S051) | Bausch & Lomb, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P050023/S176) | Biotronik, Inc. | 2023-08-21 |
| INFUSE Bone Graft (P050053/S060) | Medtronic, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P070008/S150) | Biotronik, Inc. | 2023-08-21 |
| INFUSE Bone Graft (P050053/S061) | Medtronic, Inc. | 2023-08-21 |
| INFUSE Bone Graft (P000054/S069) | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |
| Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S (P900033/S108) | Integra Lifesciences Corp. | 2023-08-21 |
| Arctic Front Advance Cardiac Cryoablation Catheter, Arctic Front Advance PRO Cardiac Cryoablation Catheter (P100010/S139) | Medtronic Cryocath, LP | 2023-08-21 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S111) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2023-08-21 |
| Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (P080011/S156) | CooperVision, Inc. | 2023-08-21 |
| INFUSE Bone Graft, Medtronic Interbody Fusion Device (P000058/S089) | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |
| INFUSE Bone Graft (P000054/S070) | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P000009/S104) | Biotronik, Inc. | 2023-08-21 |
| HeartWare Ventricular Assist System or HeartWare System (P100047/S211) | Medtronic | 2023-08-20 |
| Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test (P110020/S038) | Roche Molecular Systems, Inc. | 2023-08-17 |
| MORCHER ® EYEJET ® CTR (P010059/S010) | Morcher GmbH | 2023-08-17 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S009) | Kestra Medical Technologies, Inc. | 2023-08-17 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S005) | Shockwave Medical, Inc. | 2023-08-17 |
| Oncomine Dx Target Test (P160045/S042) | Life Technologies Corporation | 2023-08-17 |
| cobas® HBV (P150014/S044) | Roche Molecular Systems, Inc. | 2023-08-17 |
| Rotaglide Lubricant (P900056/S201) | Boston Scientific Corp | 2023-08-17 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S087) | St Jude Medical | 2023-08-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S097) | Boston Scientific Corporation | 2023-08-17 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S085) | ABBOTT MEDICAL | 2023-08-17 |
| cobas® HPV (P190028/S010) | Roche Molecular Systems, Inc. | 2023-08-17 |
| Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD (P120019/S035) | Roche | 2023-08-17 |
| cobas® EZH2 Mutation Test (P200014/S005) | Roche Molecular System, Inc. | 2023-08-17 |
| cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests (P100020/S056) | Roche Molecular Systems, Inc. | 2023-08-17 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S004) | ABBOTT MEDICAL | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0 (P050028/S087) | Roche Molecular Systems, Inc. | 2023-08-17 |
| cobas® CMV (P160041/S036) | Roche Molecular Systems, Inc. | 2023-08-17 |
| Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit (P140023/S026) | Roche Molecular Systems, Inc. | 2023-08-17 |
| COBAS® AmpliPrep, COBAS® TaqMan® CMV Test (P110037/S058) | Roche Molecular Systems, Inc. | 2023-08-17 |
| LIFEPAK® 15 Defibrillator (P160026/S041) | Physio-Control, Inc. | 2023-08-16 |
| cobas® HBV (P150014/S045) | Roche Molecular Systems, Inc. | 2023-08-16 |
| cobas® CMV (P160041/S037) | Roche Molecular Systems, Inc. | 2023-08-16 |
| 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/S251) | Biotronik, Inc. | 2023-08-16 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S003) | ABBOTT MEDICAL | 2023-08-16 |
| PRO-KINETIC ENERGY CORONARY STENT SYSTEM (P160003/S018) | Biotronik AG | 2023-08-16 |
| cobas® HPV (P190028/S011) | Roche Molecular Systems, Inc. | 2023-08-16 |
| Chocolate Touch Paclitaxel Drug-Coated PTA Balloon Catheter (Chocolate Touch) (P210039/S001) | Trireme Medical, LLC | 2023-08-16 |
| Reactiv8 Implantable Neurostimulation System (P190021/S006) | Mainstay Medical Limited | 2023-08-15 |
| INSPIRE II UPPER AIRWAY STIMULATOR (P130008/S100) | Inspire Medical Systems | 2023-08-15 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S009) | Cerapedics, LLC | 2023-08-15 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), (P840064/S080) | Alcon Laboratories | 2023-08-15 |
| GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis (P020004/S195) | W. L. Gore & Associates, Inc. | 2023-08-15 |
| VisuMax Femtosecond Laser Accessory Treatment Pack (P150040/S014) | Carl Zeiss Meditec, Inc. | 2023-08-15 |
| PROVISC Ophthalmic Viscosurgical Device (P890047/S061) | Alcon Research, Ltd. | 2023-08-15 |
| Optune System (P100034/S031) | Novocure, GmbH | 2023-08-14 |
| Precision7 , Precision7 for Astigmatism, Precision7 Multifocal, Precision7 Multifocal Toric (P220007/S002) | Alcon Laboratories, Inc. | 2023-08-11 |
| TOPS System (P220002/S001) | Premia Spine, Ltd. | 2023-08-11 |
| FoundationOne CDx (F1CDx) (P170019/S042) | Foundation Medicine, Inc. | 2023-08-11 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S005) | ABBOTT MEDICAL | 2023-08-11 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S035) | Smith & Nephew, Inc. | 2023-08-11 |
| CERAMAX Ceramic Total Hip System (P070026/S107) | DePuy Orthopaedics, Inc. | 2023-08-11 |
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S015) | Cardiofocus, Inc. | 2023-08-11 |
| Mosaic Bioprosthesis (P990064/S085) | Medtronic, Inc. | 2023-08-10 |
| Hancock II Bioprosthesis (P970031/S070) | Medtronic, Inc. | 2023-08-10 |
| Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S026) | Alcon Laboratories, LLC | 2023-08-10 |
| THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAK (P860003/S110) | Therakos Development Limited | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S389) | Medtronic Neuromodulation | 2023-08-10 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S458) | Medtronic, Inc. | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S283) | Medtronic Neuromodulation | 2023-08-10 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S546) | Medtronic Neuromodulation | 2023-08-10 |
| Guardian System (P150009/S009) | Avertix Medical, Inc. | 2023-08-10 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S457) | Medtronic, Inc. | 2023-08-10 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S414) | Medtronic, Inc. | 2023-08-10 |
| Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris® Spin (P840001/S547) | Medtronic Neuromodulation | 2023-08-10 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S034) | Berlin Heart, Inc. | 2023-08-10 |
| FoundationOne CDx (P170019/S046) | Foundation Medicine, Inc. | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S388) | Medtronic Neuromodulation | 2023-08-10 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S284) | Medtronic Neuromodulation | 2023-08-10 |
| Oncomine Dx Target Test (P160045/S043) | Life Technologies Corporation | 2023-08-10 |
| Avalus Bioprosthesis (P170006/S022) | Medtronic, Inc. | 2023-08-10 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S039) | Boston Scientific Corp | 2023-08-10 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S025) | Berlin Heart, Inc. | 2023-08-10 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S018) | Medtronic, Inc. | 2023-08-10 |
| Freestyle Bioprosthesis (P980043/S076) | Medtronic, Inc. | 2023-08-10 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S086) | Syncardia Systems, LLC | 2023-08-09 |
| Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (P010032/S201) | ABBOTT MEDICAL | 2023-08-09 |
| Biofinity Sphere (P080011/S155) | CooperVision, Inc. | 2023-08-09 |
| Arista AH (P050038/S040) | Davol, Inc. | 2023-08-09 |
| DETOUR System (P220021/S001) | Endologix, LLC | 2023-08-09 |
| Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) (P150004/S064) | ABBOTT MEDICAL | 2023-08-09 |
| SIR-Spheres Y-90 resin microspheres (P990065/S013) | Sirtex Medical, Inc. | 2023-08-09 |
| OrganOx metra® System (P200035/S010) | Organox Limited | 2023-08-09 |
| 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/S755) | Medtronic, Inc. | 2023-08-09 |
| XVIVO Perfusion System (XPS) with STEEN Solution (P180014/S010) | Xvivo Perfusion, Inc. | 2023-08-09 |
| Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S066) | Medtronic Vascular | 2023-08-08 |
| Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028/S049) | Mentor Worldwide, LLC | 2023-08-08 |
| Master Intellis Spinal Cord Stimulation Systems (P840001/S529) | Medtronic Neuromodulation | 2023-08-08 |
| QuickFlex µ, Quartet (P030054/S410) | ABBOTT MEDICAL | 2023-08-08 |
| Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053/S070) | Mentor Corp. | 2023-08-08 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032) | Boston Scientific Corporation | 2023-08-08 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S090) | Boston Scientific Corp | 2023-08-08 |
| Monovisc (P090031/S016) | Anika Therapeutics, Inc. | 2023-08-08 |
| OrganOx metra® System (P200035/S006) | Organox Limited | 2023-08-08 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S017) | Biotronik AG | 2023-08-07 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S030) | Biotronik AG | 2023-08-07 |
| Edwards Commander Delivery System (P200015/S043) | Edwards Lifesciences, LLC | 2023-08-05 |