| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S060) | Edwards Lifesciences, LLC | 2022-12-29 |
| NeuroPace® RNS® System (P100026/S091) | NeuroPace, Inc. | 2022-12-29 |
| Saluda Medical Evoke® SCS System (P190002/S015) | Saluda Medical Pty, Ltd. | 2022-12-29 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S059) | Allergan | 2022-12-29 |
| NATRELLE Saline-Filled Breast Implants (P990074/S050) | Allergan | 2022-12-29 |
| LungFit® PH (P200044/S001) | Beyond Air, Inc. | 2022-12-28 |
| EPi-Sense®, EPi-Sense ST Guided Coagulation System (P200002/S004) | AtriCure, Inc. | 2022-12-27 |
| Senza Spinal Cord Stimulation (SCS) System, Senza HFX iQ System (P130022/S047) | Nevro Corporation | 2022-12-23 |
| Restlyane® Refyne Injectable Gel (P140029/S047) | Q-Med AB | 2022-12-23 |
| IC-8® Apthera Intraocular Lens (IOL) (P210005/S003) | Acu Focus, Inc. | 2022-12-23 |
| Restylane® Silk Injectable Gel (P040024/S136) | Q-Med AB | 2022-12-23 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S051) | Intersect Ent. | 2022-12-22 |
| Seprafilm Adhesion Barrier (P950034/S055) | Baxter Healthcare Corporation | 2022-12-22 |
| FoundationOne Liquid CDx (F1LCDx) (P190032/S004) | Foundation Medicine, Inc. | 2022-12-22 |
| Alto Abdominal Stent Graft System (P120006/S041) | Endologix, LLC | 2022-12-22 |
| Alinity m HBV (P200013/S011) | Abbott Molecular, Inc. | 2022-12-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S094) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear (P080011/S152) | CooperVision, Inc. | 2022-12-21 |
| SURGIFOAM Absorabable Gelatin Sponge, U.S.P., SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic MatrixKit with Thrombin (P990004/S055) | Ferrosan Meidcal Devices A/S | 2022-12-21 |
| LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg (P180048/S010) | DiaSorin, Inc. | 2022-12-21 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S036) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc (P180038/S013) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software (P180047/S020) | DiaSorin, Inc. | 2022-12-21 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S105) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S005) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test (P190017/S008) | DiaSorin, Inc. | 2022-12-21 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039/S012) | DiaSorin, Inc. | 2022-12-21 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S155) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe (P180049/S010) | DiaSorin, Inc. | 2022-12-21 |
| VisuMax Femtosecond Laser (P150040/S011) | Carl Zeiss Meditec, Inc. | 2022-12-21 |
| LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM (P180045/S010) | DiaSorin, Inc. | 2022-12-21 |
| SURGICEL® Absorbable Hemostats (N12159/S096) | ETHICON, Inc. | 2022-12-20 |
| MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S566) | Boston Scientific Corp | 2022-12-20 |
| Restylane Injectable Gel (P040024/S132) | Q-Med AB | 2022-12-20 |
| ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR (N970003/S282) | Boston Scientific Corp | 2022-12-20 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S052) | ETHICON, Inc. | 2022-12-20 |
| ICD Devices (P960040/S483) | Boston Scientific | 2022-12-20 |
| Cordis® PALMAZ® Balloon-Expandable Stent (P890017/S023) | Cordis US Corporation | 2022-12-20 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S138) | Boston Scientific | 2022-12-20 |
| CRT-D Resynchronization Devices (P010012/S559) | Boston Scientific Corp | 2022-12-20 |
| ADVIA Centaur Anti-HBc Total 2 (HBcT2), ADVIA Centaur® HBcT2 Quality Control (HBcT2 QC) (P210019/S001) | Siemens Healthcare Diagnostics, Inc. | 2022-12-20 |
| Restylane Refyne, Restylane Defyne, Restylane Kysse and Restylane Contour (P140029/S045) | Q-Med AB | 2022-12-20 |
| Supera Peripheral Stent System Nylon Pouch (P120020/S029) | Abbott Vascular (Idef Technologies Inc) | 2022-12-20 |
| Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S021) | Alcon Laboratories, LLC | 2022-12-20 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S005) | Edwards Lifesciences, LLC | 2022-12-20 |
| ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S489) | Boston Scientific | 2022-12-20 |
| Pacemaker Devices (N970003/S277) | Boston Scientific Corp | 2022-12-20 |
| AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S144) | Alcon Laboratories, Inc. | 2022-12-20 |
| AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S104) | Alcon Research, Ltd. | 2022-12-20 |
| Pacemaker Devices (P150012/S131) | Boston Scientific | 2022-12-20 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S227) | Guidant Corp. | 2022-12-20 |
| Subcutaneous ICD Devices (P110042/S173) | Boston Scientific Corporation | 2022-12-20 |
| CRT-P Resynchronization Devices (P030005/S222) | Guidant Corp. | 2022-12-20 |
| LATITUDE NXT Release 7.1.5 (P910077/S188) | Boston Scientific | 2022-12-20 |
| Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu (P160022/S014) | ZOLL Medical Corporation | 2022-12-20 |
| Helistat® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S104) | Integra LifeSciences Corporation | 2022-12-19 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S008) | Foundation Medicine, Inc. | 2022-12-19 |
| Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera (P160022/S016) | ZOLL Medical Corporation | 2022-12-19 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S062) | Boston Scientific Corporation | 2022-12-19 |
| VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S129) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-12-19 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent - Microfibrillar Fo (P810006/S101) | Integra LifeSciences Corporation | 2022-12-19 |
| Wave Writer Alpha Spinal Cord Stimulator (SCS) System, Spectra Wave Writer Spinal Cord Stimulator (SCS) System, Precis (P030017/S353) | Boston Scientific Corp | 2022-12-19 |
| Axonics Sacral Neuromodulation System (bowel) (P190006/S062) | Boston Scientific Corporation | 2022-12-19 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S355) | Boston Scientific Corp | 2022-12-17 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S053) | Boston Scientific Corp | 2022-12-17 |
| Prostar XL Percutaneous Vascular Surgical System, Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle (P960043/S119) | Abbott Vascular, Inc. | 2022-12-16 |
| MiniMed 630G System (P150001/S102) | Medtronic Minimed | 2022-12-16 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application (P010032/S186) | ABBOTT MEDICAL | 2022-12-16 |
| ENROUTE Transcarotid Stent System (P140026/S026) | Boston Scientific Corporation | 2022-12-16 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S117) | Biotronik, Inc. | 2022-12-16 |
| Cordis® PRECISE® Nitinol Stent Systems (P030047/S046) | Cordis US Corporation | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |
| Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, (P020036/S048) | Cordis US Corporation | 2022-12-16 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S243) | Biotronik, Inc. | 2022-12-16 |
| Guardian Sensor 3 (P160017/S096) | Medtronic Minimed, Inc. | 2022-12-16 |
| Inspire II Upper Airway Stimulator (P130008/S093) | Inspire Medical Systems | 2022-12-16 |
| Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems (P120002/S023) | Cordis US Corporation | 2022-12-16 |
| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S047) | Irvine Biomedical, Inc. | 2022-12-16 |
| Access Hybritech p2PSA Reagents on the Access Immunoassay Systems (P090026/S031) | Beckman Coulter, Inc. | 2022-12-16 |
| StarClose SE Vascular Closure System (P050007/S042) | Abbott Vascular Devices | 2022-12-16 |
| Guardian Sensor 3 (P160007/S043) | Medtronic Minimed | 2022-12-16 |
| MiniMed 670G System, MiniMedTM 770G System (P160017/S106) | Medtronic Minimed, Inc. | 2022-12-16 |
| Guardian Sensor 3 (P150001/S094) | Medtronic Minimed | 2022-12-16 |
| VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S110) | Vistakon, Johnson & Johnson Vision Products, Inc. | 2022-12-16 |
| Access Hybritech Free PSA Reagents on the Access Immunoassay Systems (P970038/S045) | Beckman Coulter, Inc. | 2022-12-16 |
| Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S053) | Irvine Biomedical,Inc.(Ibi) | 2022-12-16 |
| ENROUTE® Transcarotid Stent System (P140026/S025) | Boston Scientific Corporation | 2022-12-16 |
| INGEVITY+ and INGEVITY MRI (P150012/S137) | Boston Scientific | 2022-12-15 |
| RADIESSE® Injectable Implant (P050037/S120) | Merz North America, Inc. | 2022-12-15 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S050) | ABBOTT MEDICAL | 2022-12-15 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S141) | Merz North America, Inc. | 2022-12-15 |
| TactiSys Quartz Equipment (P130026/S082) | St Jude Medical | 2022-12-15 |
| Nucleus 24 Cochlear Implant System (P970051/S216) | Cochlear Americas | 2022-12-15 |
| Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System (P060001/S035) | Medtronic Vascular, Inc. | 2022-12-15 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S036) | Medtronic Vascular, Inc. | 2022-12-15 |
| Tula® System (P190016/S006) | Tusker Medical, Inc. | 2022-12-15 |
| GORE® CARDIOFORM ASD Occluder (P050006/S104) | W. L. Gore & Associates, Inc. | 2022-12-15 |
| COAPTITE® Injectable Implant (P040047/S068) | Merz North America, Inc. | 2022-12-15 |
| Saluda Medical Evoke® SCS System (P190002/S013) | Saluda Medical Pty, Ltd. | 2022-12-15 |