| OrganOx metra System (P200035/S009) | Organox Limited | 2023-09-06 |
| Vercise S8 Adapter (P150031/S055) | Boston Scientific Corp | 2023-09-06 |
| CardioMEMS HF System (P100045/S069) | ABBOTT MEDICAL | 2023-09-06 |
| MORCHER Capsular Tension Ring, EYEJET CTR, MORCHER Injector (P010059/S007) | Morcher GmbH | 2023-09-06 |
| DuraSeal Exact Spine Sealant System (P080013/S027) | Integra LifeSciences Corporation | 2023-09-05 |
| DuraSeal Dural Sealant System (P040034/S038) | Integra LifeSciences Corporation | 2023-09-05 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S459) | Medtronic, Inc. | 2023-09-05 |
| Rayner C-flex 570, C-flex Aspheric 970, 600 Aspheric Intraocular lenses, RayOne Aspheric RA0600, RayOne Spheric RAO100 a (P060011/S034) | Rayner Intraocular Lenses , Ltd. | 2023-09-05 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S759) | Medtronic, Inc. | 2023-09-05 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S038) | Medtronic Vascular, Inc. | 2023-09-05 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S548) | Medtronic Neuromodulation | 2023-09-05 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic (P840064/S081) | Alcon Laboratories | 2023-09-05 |
| modified 4.0-LP funnel component (P180002/S024) | Pulmonx Corporation | 2023-09-05 |
| Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy (P850022/S032) | Ahp Eos Buyer, Inc. | 2023-09-01 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S061) | Ferrosan Meidcal Devices A/S | 2023-09-01 |
| Philips Laser System (P910001/S120) | Spectranetics Corp. | 2023-08-31 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S062) | Ferrosan Meidcal Devices A/S | 2023-08-31 |
| Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC (P050047/S091) | Allergan | 2023-08-31 |
| Juvederm Voluma XC, Juvederm Vollure XC, and Juvederm Volux XC (P110033/S078) | Allergan | 2023-08-31 |
| VISCOAT Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscoelastic System, and DISCOVISC Ophthalmic Viscosurgic (P840064/S082) | Alcon Laboratories | 2023-08-31 |
| LIFEPAK® CR2 Defibrillator (P170018/S016) | Physio-Control, Inc. | 2023-08-31 |
| RHA® Redensity (P170002/S032) | Teoxane S.A. | 2023-08-31 |
| Express SD Renal (P060006/S108) | Boston Scientific Corp | 2023-08-31 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MR (P980035/S758) | Medtronic, Inc. | 2023-08-30 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S026) | Medtronic Vascular, Inc. | 2023-08-30 |
| Medtronic CoreValve TM EvolutTM R Transcatheter Aortic Valve, Medtronic CoreValveTM EvolutTM PRO Transcatheter Aortic V (P130021/S143) | Medtronic, Inc. | 2023-08-30 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, IN.PACT 018 Paclitaxel-C (P140010/S075) | Medtronic, Inc. | 2023-08-30 |
| Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive (P110033/S077) | Allergan | 2023-08-30 |
| IMMULITE® AFP, IMMULITE® 2000 AFP (P010007/S016) | Siemens Healthcare Diagnostics, Inc. | 2023-08-30 |
| MitraClip G4 Clip Delivery System (P100009/S057) | ABBOTT MEDICAL | 2023-08-30 |
| IMMULITE® 1000 Free PSA, IMMULITE® 2000 Free PSA (P060005/S015) | Siemens Medical Solutions Diagnostics Limited | 2023-08-30 |
| IMMULITE® 2000 HBsAg, IMMULITE® 2000 HBsAg Confirmatory (P010050/S020) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| LifeVest® Wearable Defibrillator (P010030/S165) | Zoll Manufacturing Corporation | 2023-08-30 |
| GORE TAG Thoracic Branch Endoprosthesis (P210032/S011) | W. L. Gore & Associates, Inc. | 2023-08-30 |
| IMMULITE® 2000 Anti-HBs (P010052/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| Ultra, Ultra XC, Ultra Plus XC, Ultra XC (P050047/S090) | Allergan | 2023-08-30 |
| IMMULITE® PSA, IMMULITE® 2000 PSA, IMMULITE® Third Generation PSA, IMMULITE® 2000 Third Generation PSA (P930027/S027) | Siemens Healthcare Diagnostics, Inc. | 2023-08-30 |
| IMMULITE® 2000 Anti-HBc IgM (P010053/S015) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| IMMULITE® 2000 Anti HBc (P010051/S016) | Siemens Healthcare Diagnostics Products, Ltd. | 2023-08-30 |
| Perfluoron (P950018/S024) | Alcon Laboratories | 2023-08-29 |
| VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S002) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S008) | Ventana Medical Systems, Inc. | 2023-08-29 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S039) | Ventana Medical Systems, Inc. | 2023-08-29 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S051) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA PD-Ll (SP263) Assay (P160046/S016) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA MMR RxDx Panel Solid Tumors with dMMR status) (P210001/S009) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2023-08-29 |
| Rotablator, ROTAPRO Rotational Atherectomy System (P900056/S210) | Boston Scientific Corp | 2023-08-29 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S029) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S021) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA PD-Ll (SP142) Assay (P160002/S021) | Ventana Medical Systems, Inc. | 2023-08-29 |
| CINtec PLUS Cytology (P190024/S010) | Ventana Medical Systems, Inc. | 2023-08-29 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S007) | Ventana Medical Systems | 2023-08-29 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S832) | Medtronic Cardiac Rhythm Disease Management | 2023-08-28 |
| NeuroPace® RNS® System (P100026/S094) | NeuroPace, Inc. | 2023-08-28 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S866) | Medtronic Cardiac Rhythm Disease Management | 2023-08-28 |
| Evolut FX Delivery Catheter System of the Medtronic Evolut FX System (P130021/S144) | Medtronic, Inc. | 2023-08-25 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S018) | Stryker Leibinger GmbH & Co KG | 2023-08-25 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S086) | ABBOTT MEDICAL | 2023-08-25 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S032) | Biotronik AG | 2023-08-25 |
| Infuse Bone Graft (P000058/S088) | Medtronic Sofamor Danek USA, Inc. | 2023-08-25 |
| Axonics Sacral Neuromodulation System (P190006/S072) | Boston Scientific Corporation | 2023-08-25 |
| Optilume BPH Catheter System (P220029/S001) | Urotronic, Inc. | 2023-08-25 |
| Edwards Crimper 9600CR (P140031/S163) | Edwards Lifesciences, LLC | 2023-08-25 |
| Edwards Crimper 9600CR (P200015/S045) | Edwards Lifesciences, LLC | 2023-08-25 |
| Axonics Sacral Neuromodulation System (P180046/S072) | Boston Scientific Corporation | 2023-08-25 |
| Barricaid® Annular Closure Device (P160050/S007) | Intrinsic Therapeutics | 2023-08-25 |
| Hydrus Microstent Delivery System (P170034/S010) | Alcon Research, LLC | 2023-08-24 |
| ORSIRO Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S031) | Biotronik AG | 2023-08-24 |
| ReActiv8 Implantable Neurostimulation System (P190021/S005) | Mainstay Medical Limited | 2023-08-24 |
| Aveir VR and DR Leadless Pacemakers (P150035/S005) | ABBOTT MEDICAL | 2023-08-24 |
| Rapid fFN for the TLilQ System (P920048/S024) | Hologic, Inc. | 2023-08-24 |
| cobas® HPV (P190028/S012) | Roche Molecular Systems, Inc. | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® HBV Test (P050028/S088) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® CMV (P160041/S038) | Roche Molecular Systems, Inc. | 2023-08-23 |
| VENTANA FOLR1 (FOLR1-2.1) RxDx Assay (P220006/S001) | Ventana Medical Systems, Inc. | 2023-08-23 |
| Saline-Filled and Spectrum Breast Implants (P990075/S053) | Mentor Worldwide, LLC | 2023-08-23 |
| MitraClip Clip Delivery System (P100009/S052) | ABBOTT MEDICAL | 2023-08-23 |
| COBAS® AmpliPrep/COBAS® TaqMan® CMV Test (P110037/S059) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® EGFR Mutation Test (P120019/S036) | Roche | 2023-08-23 |
| cobas® HBV (P150014/S046) | Roche Molecular Systems, Inc. | 2023-08-23 |
| WaveLight EX500 Laser System (P030008/S037) | Alcon Laboratories, Inc. | 2023-08-23 |
| ResQCPR System (P110024/S004) | ZOLL Medical Corporation | 2023-08-23 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S116) | Medtronic Vascular | 2023-08-23 |
| cobas® 4800 HPV Test (P100020/S057) | Roche Molecular Systems, Inc. | 2023-08-23 |
| cobas® EZH2 Mutation Test (P200014/S006) | Roche Molecular System, Inc. | 2023-08-23 |
| cobas® 4800 BRAF V600 Mutation Test (P110020/S039) | Roche Molecular Systems, Inc. | 2023-08-23 |
| WaveLight EX500 Laser System (P020050/S041) | Alcon Laboratories, Inc. | 2023-08-23 |
| Medtronic Avalus Bioprosthesis (P170006/S023) | Medtronic, Inc. | 2023-08-22 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg (P190017/S014) | DiaSorin, Inc. | 2023-08-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P200015/S044) | Edwards Lifesciences, LLC | 2023-08-22 |
| LCS Total Knee System (P830055/S308) | Depuy, Inc. | 2023-08-22 |
| EXCOR Blood pump (P160035/S035) | Berlin Heart, Inc. | 2023-08-22 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S213) | Edwards Lifesciences, LLC | 2023-08-22 |
| EDWARDS INTUITY Elite Valve System (P150036/S070) | Edwards Lifesciences, LLC | 2023-08-22 |
| TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st (P980052/S012) | Stryker Leibinger, GmbH & Co KG | 2023-08-22 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S074) | Edwards Lifesciences, LLC | 2023-08-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra (P140031/S161) | Edwards Lifesciences, LLC | 2023-08-22 |
| SENSAR® 1-piece IOL, AAB00, TECNIS® 1-Piece IOL with TECNIS Simplicity Delivery System, DCB00, TECNIS® 1-Piece OptiBlue (P980040/S162) | Johnson & Johnson Surgical Vision, Inc. | 2023-08-21 |
| PSW 2302.U, NEO 2302.U (P950037/S250) | Biotronik, Inc. | 2023-08-21 |
| INFUSE Bone Graft, Medtronic Interbody Fusion Device (P000058/S090) | Medtronic Sofamor Danek USA, Inc. | 2023-08-21 |