| EXCOR® Pediatric Ventricular Assist Device (P160035/S033) | Berlin Heart, Inc. | 2023-06-30 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S058) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| Mara Water Vapor Ablation System (P160047/S030) | CooperSurgical, Inc. | 2023-06-30 |
| FreeStyle Libre 14 day Flash Glucose Monitoring System (P160030/S053) | Abbott Diabetes Care, Inc. | 2023-06-30 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S059) | Boston Scientific Corp | 2023-06-30 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S364) | Boston Scientific Corp | 2023-06-30 |
| Optilume BPH Catheter System (P220029) | Urotronic, Inc. | 2023-06-30 |
| LifeVest Wearable Defibrillator (P010030/S162) | Zoll Manufacturing Corporation | 2023-06-30 |
| MitraClip Clip Delivery System (P100009/S056) | ABBOTT MEDICAL | 2023-06-29 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S084) | St Jude Medical | 2023-06-29 |
| Scoreflex NC (P200041/S001) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2023-06-29 |
| INGEVITY MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY+ Pace/Sense Lead (P150012/S146) | Boston Scientific | 2023-06-29 |
| SURGIFOAM® Absorbable Gelatin Sponge, U.S.P., Oral Sponge, Hemorrhoidectomy Sponge (P990004/S060) | Ferrosan Meidcal Devices A/S | 2023-06-29 |
| Artegraft Collagen Vascular Graft (N16837/S031) | LeMaitre Vascular, Inc. | 2023-06-29 |
| Magtrace® and Sentimag® Magnetic Locatization System (PUV) (P160053/S007) | Endomagnetics Ltd., | 2023-06-29 |
| SURGIFLO® Hemostatic Matrix, SURGIFLO® Hemostatic Matrix Kit with Thrombin (P990004/S059) | Ferrosan Meidcal Devices A/S | 2023-06-29 |
| therascreen PDGFRA RGQ PCR Kit (P210002) | QIAGEN GmbH | 2023-06-29 |
| Light Adjustable Lens, Light Delivery Device (P160055/S028) | Rxsight, Inc. | 2023-06-29 |
| FINELINE®II EZ Sterox Bipolar IS-1 Atrial/Ventricular, J shaped Lead Stylets Limber, J shaped Lead Stylets Firm, J shape (P960004/S102) | Boston Scientific | 2023-06-29 |
| HiResolution Bionic Ear System (P960058/S160) | Advanced Bionics | 2023-06-29 |
| AAV5 DetectCDx (P190033) | ARUP Laboratories | 2023-06-29 |
| Skinvive by Juvéderm (P110033/S074) | Allergan | 2023-06-29 |
| Aveir DR Leadless System (P150035/S003) | ABBOTT MEDICAL | 2023-06-29 |
| Organ Care System (OCS) Liver (P200031/S004) | TransMedics, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT non-implanted components (P050023/S171) | Biotronik, Inc. | 2023-06-28 |
| AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S198) | Boston Scientific Corp | 2023-06-28 |
| Organ Care System (OCS) Heart (P180051/S004) | TransMedics, Inc. | 2023-06-28 |
| Organ Care System (OCS) Lung System (P160013/S013) | TransMedics, Inc. | 2023-06-28 |
| Pacemaker/ICD/CRT nonimplanted components (P000009/S101) | Biotronik, Inc. | 2023-06-28 |
| Permanent Defibrillator Electrodes (P980023/S121) | Biotronik, Inc. | 2023-06-28 |
| RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline (P050052/S149) | Merz North America, Inc. | 2023-06-28 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S249) | Biotronik, Inc. | 2023-06-28 |
| Defibrillator, Implantable, Dual- Chamber, Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchroniza (P050023/S175) | Biotronik, Inc. | 2023-06-28 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P950037/S244) | Biotronik, Inc. | 2023-06-28 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode (P070008/S149) | Biotronik, Inc. | 2023-06-28 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S131) | Boston Scientific Corp | 2023-06-28 |
| Pacemaker/ICD/CRT non-implanted components (P070008/S144) | Biotronik, Inc. | 2023-06-28 |
| Organ Care System (OCS) Lung (P160013/S014) | TransMedics, Inc. | 2023-06-28 |
| RADIESSE® Injectable Implant (P050037/S127) | Merz North America, Inc. | 2023-06-28 |
| EUFLEXXA (P010029/S035) | Ferring Pharmaceuticals, Inc. | 2023-06-27 |
| SleepSync Programmer (P130008/S092) | Inspire Medical Systems | 2023-06-27 |
| Impella CP with SmartAssist (P140003/S112) | Abiomed, Inc. | 2023-06-27 |
| therascreen BRAF V600E RGQ PCR Kit (P190026/S001) | QIAGEN GmbH | 2023-06-27 |
| HiResolution Bionic Ear System (P960058/S161) | Advanced Bionics | 2023-06-27 |
| SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) (N12159/S103) | ETHICON, Inc. | 2023-06-26 |
| Silikon 1000 (P950008/S021) | Alcon | 2023-06-26 |
| ARCHITECT HBsAg Qualitative/HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative/HBsAg Qualitative Confirmatory (P110029/S043) | Abbott Laboratories | 2023-06-23 |
| Impella RP Flex with SmartAssist (P170011/S050) | Abiomed, Inc. | 2023-06-23 |
| Reactiv8 Implantable Neurostimulation System (P190021/S003) | Mainstay Medical Limited | 2023-06-23 |
| Skinvive by Juvéderm® (P110033/S073) | Allergan | 2023-06-23 |
| HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads (P200007) | Graphic Controls D.B.A. Vermed | 2023-06-23 |
| ARCHITECT AUSAB, Alinity i Anti-HBs (P050051/S052) | Abbott Laboratories, Inc. | 2023-06-22 |
| ARCHITECT AFP, Alinity i AFP (P120008/S023) | Abbott Laboratories | 2023-06-22 |
| TriVisc® (P160057/S002) | Channel-Markers Medical, LLC | 2023-06-22 |
| iSert Preloaded IOL System, IPure Preloaded IOL System (P080004/S045) | Hoya Surgical Optics, Inc. | 2023-06-22 |
| ARCHITECT Free PSA, Alinity i Free PSA (P980007/S050) | Abbott Laboratories | 2023-06-22 |
| GenVisc® 850 (P140005/S005) | Channel-Markers Medical, LLC | 2023-06-22 |
| ARCHITECT Total PSA, Alinity i Total PSA (P910007/S061) | Abbott Laboratories | 2023-06-22 |
| CERAMAX Ceramic Total Hip System (P070026/S108) | DePuy Orthopaedics, Inc. | 2023-06-22 |
| ARCHITECT HBsAg Qualitative, HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S044) | Abbott Laboratories | 2023-06-22 |
| HeartMate 3 Left Ventricular Assist System (P160054/S055) | ABBOTT MEDICAL | 2023-06-22 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S044) | Bausch & Lomb, Inc. | 2023-06-22 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S012) | Edwards Lifesciences, LLC | 2023-06-22 |
| Axonics Sacral Neuromodulation System (P180046/S069) | Boston Scientific Corporation | 2023-06-21 |
| Straumann Emdogain (P930021/S032) | The Straumann Company | 2023-06-21 |
| Precision7, Precision7 for Astigmatism, Precision7 Multifocal, and Precision7 Multifocal Toric (P220007/S001) | Alcon Laboratories, Inc. | 2023-06-21 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, Vectris® S (P840001/S543) | Medtronic Neuromodulation | 2023-06-21 |
| Axonics Sacral Neuromodulation System (P190006/S069) | Boston Scientific Corporation | 2023-06-21 |
| Zoll OneStep CPR Cable, R Series OneStep Pacing Cable, X Series OneStep Cable, X Series/Propaq MD Multifunction Therapy (P160022/S015) | ZOLL Medical Corporation | 2023-06-21 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S279) | Medtronic Neuromodulation | 2023-06-21 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S453) | Medtronic, Inc. | 2023-06-21 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S412) | Medtronic, Inc. | 2023-06-21 |
| MemoryGel® BOOST Silicone Gel-Filled Breast Implant (P030053/S068) | Mentor Corp. | 2023-06-21 |
| HeartWare® Ventricular Assist System, HeartWare® System (P100047/S210) | Medtronic | 2023-06-21 |
| DiamondTemp Irrigation Tubing Set (P200028/S018) | Medtronic, Inc. | 2023-06-21 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S384) | Medtronic Neuromodulation | 2023-06-21 |
| Guardant360 CDx (P200010/S015) | Guardant Health, Inc. | 2023-06-20 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S009) | W. L. Gore & Associates, Inc. | 2023-06-20 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S012) | W. L. Gore and Associates, Inc. | 2023-06-20 |
| Conformable GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S135) | W. L. Gore & Associates, Inc. | 2023-06-20 |
| R3 Delta Ceramic Hip System (P150030/S033) | Smith & Nephew, Inc. | 2023-06-20 |
| Adapta, Versa, Sensia IPG (P980035/S749) | Medtronic, Inc. | 2023-06-20 |
| Inspire Model 3028 Implantable Pulse Generator (IPG) and Model 4340 Inspire Sensing Lead (P130008/S097) | Inspire Medical Systems | 2023-06-20 |
| LifeVest® Wearable Defibrillator (P010030/S166) | Zoll Manufacturing Corporation | 2023-06-20 |
| Therakos CELLEX Photopheresis Kit (P860003/S103) | Therakos Development Limited | 2023-06-16 |
| ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti (P990018/S010) | Menicon Co, Ltd. | 2023-06-16 |
| Alinity m CMV Assay (P210022/S005) | Abbott Molecular, Inc. | 2023-06-16 |
| Alinity m HBV Assay (P200013/S014) | Abbott Molecular, Inc. | 2023-06-16 |
| SurVeil Drug-Coated Balloon (P210025) | Surmodics,Inc. | 2023-06-16 |
| ENROUTE® Transcarotid Stent System (P140026/S024) | Boston Scientific Corporation | 2023-06-16 |
| Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r (P200039/S012) | Shockwave Medical, Inc. | 2023-06-15 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S454) | ABBOTT MEDICAL | 2023-06-15 |
| EMBLEM S-ICD Programmer Software Application, EMBLEM S-ICD Pulse Generator, EMBLEM MRI S-ICD Pulse Generator (P110042/S181) | Boston Scientific Corporation | 2023-06-15 |
| MiniMed 780G System (P160017/S110) | Medtronic Minimed, Inc. | 2023-06-15 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S407) | ABBOTT MEDICAL | 2023-06-15 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems/ Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S070) | Medtronic Vascular | 2023-06-15 |
| TOPS System (P220002) | Premia Spine, Ltd. | 2023-06-15 |
| Bellafill Dermal Filler (P020012/S045) | Tiger Aesthetics Medical, LLC | 2023-06-15 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S029) | Biotronik AG | 2023-06-15 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S170) | Medtronic Cardiac Rhythm Disease Management | 2023-06-14 |