| samaritan 350P (SAM350P) Automated External Defibrillator (P160008/S017) | Heartsine Technologies, Ltd. | 2022-06-23 |
| LIAISON® XL MUREX HBeAg assay and Control (P180048/S009) | DiaSorin, Inc. | 2022-06-23 |
| Vercise Genus R32, Vercise Genus R16 (P150031/S050) | Boston Scientific Corp | 2022-06-23 |
| LIAISON® XL MUREX HBsAg Qual assay and Control (P190017/S006) | DiaSorin, Inc. | 2022-06-23 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S021) | Edwards Lifesciences, LLC | 2022-06-23 |
| LIAISON® XL MUREX Anti-HBc assay and Control (P180038/S012) | DiaSorin, Inc. | 2022-06-23 |
| HeartMate II® Left Ventricular Assist System (P060040/S086) | ABBOTT MEDICAL | 2022-06-23 |
| LIAISON® XL MUREX Anti-HBe assay and Control (P180049/S009) | DiaSorin, Inc. | 2022-06-23 |
| LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers (P180039/S011) | DiaSorin, Inc. | 2022-06-23 |
| WaveWriter Alpha, WaveWriter Alpha 16 (P030017/S350) | Boston Scientific Corp | 2022-06-23 |
| LIAISON® QuantiFERON TB-Gold Plus assay and Control (P180047/S016) | DiaSorin, Inc. | 2022-06-23 |
| LIAISON® XL MUREX HBc IgM assay and Control (P180045/S009) | DiaSorin, Inc. | 2022-06-23 |
| Intera 3000 Hepatic Artery Infusion Pump (P890055/S081) | Intera Oncology | 2022-06-22 |
| Micra AV TPS, Micra TPS (P150033/S142) | Medtronic, Inc. | 2022-06-22 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S121) | Abbott Vascular | 2022-06-22 |
| Implantable Cardioverter Defibrillators (P910023/S445) | ABBOTT MEDICAL | 2022-06-22 |
| Stellarex 035 Drug Coated Ballon Percutaneous Transluminal Angioplasty Catheter (P160049/S018) | The Spectranetics Corp. | 2022-06-22 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S126) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-06-22 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S170) | Boston Scientific Corporation | 2022-06-21 |
| ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA (P960040/S478) | Boston Scientific | 2022-06-21 |
| Pulse Generator, Permanent, Implantable (P950037/S236) | Biotronik, Inc. | 2022-06-21 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-DP) (P070008/S137) | Biotronik, Inc. | 2022-06-21 |
| ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D (P010012/S554) | Boston Scientific Corp | 2022-06-21 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S064) | Medtronic, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S114) | Biotronik, Inc. | 2022-06-21 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic Def (P050023/S167) | Biotronik, Inc. | 2022-06-21 |
| Reflection Ceramic Hip System (P030022/S047) | Smith & Nephew, Inc. | 2022-06-21 |
| Defibrillator, Implantable, dual-chamber (P000009/S098) | Biotronik, Inc. | 2022-06-21 |
| R3 Delta Ceramic Acetabular System (P150030/S022) | Smith & Nephew, Inc. | 2022-06-21 |
| Neuro Cochlear Implant System (P200021/S014) | Oticon Medical | 2022-06-17 |
| therascreen KRAS RGQ PCR Kit (P110027/S014) | QIAGEN GmbH | 2022-06-17 |
| ActaStim-S Spine Fusion Stimulator (P190030/S001) | Theragen, Inc. | 2022-06-17 |
| Imagio® Breast Imaging system (P200003/S001) | Seno Medical Instruments, Inc. | 2022-06-17 |
| VisuMax Femtosecond Laser (P150040/S010) | Carl Zeiss Meditec, Inc. | 2022-06-17 |
| FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid (P870024/S060) | CooperVision, Inc. | 2022-06-16 |
| Thoraflex Hybrid (P210006/S002) | Vascutek, Ltd. | 2022-06-16 |
| ConMed PadPro Multifunction Electrodes (P200004/S001) | Conmed Corporation | 2022-06-16 |
| HeartWare Ventricular Assist System (P100047/S198) | Medtronic | 2022-06-16 |
| Impella RP, Impella RP with Smart Assist (P170011/S041) | Abiomed, Inc. | 2022-06-16 |
| Inspire Silicone Stimulation Lead, Inspire Silicone Sensing Lead (P130008/S084) | Inspire Medical Systems | 2022-06-16 |
| Nucleus Hybrid L24 Implant System (P130016/S049) | Cochlear Americas | 2022-06-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with Smart Assist (P140003/S100) | Abiomed, Inc. | 2022-06-16 |
| VENTANA MMR RxDx Panel (P210001/S002) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-06-16 |
| DiamondTemp Ablation Catheters (P200028/S011) | Medtronic, Inc. | 2022-06-15 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S026) | Berlin Heart, Inc. | 2022-06-15 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S125) | Vistakon, Division of Johnson & Johnson Vision Car | 2022-06-15 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S061) | Medtronic Vascular | 2022-06-15 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S046) | ETHICON, Inc. | 2022-06-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S424) | Medtronic, Inc. | 2022-06-15 |
| CervicalStim® (P030034/S017) | Orthofix, Inc. | 2022-06-14 |
| RHA Redensity, RHA 2, RHA 3, and RHA 4 dermal fillers (P170002/S021) | Teoxane S.A. | 2022-06-14 |
| Barostim System (P180050/S006) | Cvrx, Inc. | 2022-06-14 |
| PhysioStim®, SpinalStim® (P850007/S046) | Orthofix, Inc. | 2022-06-14 |
| Augment® Bone Graft (P100006/S013) | Biomimetic Therapeutics, LLC | 2022-06-13 |
| VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) (P200019/S003) | Ventana Medical Systems | 2022-06-10 |
| VENTANA ALK (D5F3) CDx Assay (P140025/S016) | Ventana Medical Systems, Inc. | 2022-06-10 |
| VENTANA MMR RxDx Panel (P210001/S003) | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | 2022-06-10 |
| VENTANA PD-L1 (SP263) Assay (P160046/S011) | Ventana Medical Systems, Inc. | 2022-06-10 |
| VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031/S003) | Ventana Medical Systems, Inc. | 2022-06-10 |
| Optilume Urethral Drug Coated Balloon (P210020/S005) | Urotronic, Inc. | 2022-06-10 |
| CINtec PLUS Cytology (P190024/S005) | Ventana Medical Systems, Inc. | 2022-06-10 |
| PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody (P990081/S045) | Ventana Medical Systems, Inc. | 2022-06-10 |
| VENTANA PD-L1(SP142) Assay (P160002/S016) | Ventana Medical Systems, Inc. | 2022-06-10 |
| INFORM HER2 Dual ISH DNA Probe Cocktail (P100027/S035) | Ventana Medical Systems, Inc. | 2022-06-10 |
| PATHWAY Anti-c-KIT (9.7) Primary Antibody (P020055/S025) | Ventana Medical Systems, Inc. | 2022-06-10 |
| LINX Reflux Management System (P100049/S034) | Torax Medical | 2022-06-09 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S430) | Medtronic, Inc. | 2022-06-09 |
| Infuse Bone Graft (P000054/S067) | Medtronic Sofamor Danek USA, Inc. | 2022-06-09 |
| InterStim SNS Urinary Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (P970004/S365) | Medtronic Neuromodulation | 2022-06-09 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S392) | Medtronic, Inc. | 2022-06-09 |
| IsoMed Infusion System (P990034/S041) | Medtronic, Inc. | 2022-06-09 |
| Biofinity Toric Multifocal (P080011/S139) | CooperVision, Inc. | 2022-06-09 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea (P840001/S519) | Medtronic Neuromodulation | 2022-06-09 |
| InterStim SNS Bowel Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (P080025/S260) | Medtronic Neuromodulation | 2022-06-09 |
| Abbott RealTime CMV Amplification Kit (09N21-090), Abbott RealTime CMV Control Kit (09N21-080), Abbott RealTime CMV Cali (P160044/S004) | Abbott Molecular | 2022-06-09 |
| Infuse Bone Graft (P050053/S058) | Medtronic, Inc. | 2022-06-09 |
| SmartAblate Irrigation Tubing Set and nGEN Pump (P990071/S054) | Biosense Webster, Inc. | 2022-06-08 |
| HeartStart OnSite Defibrillator, HeartStart Home Defibrillator and HeartStart FRx Defibrillator (P160029/S016) | Philips Medical Systems, Inc. | 2022-06-08 |
| Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S059) | CooperVision, Inc. | 2022-06-08 |
| Alinity m HBV (P200013/S008) | Abbott Molecular, Inc. | 2022-06-08 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S086) | Medtronic Sofamor Danek USA, Inc. | 2022-06-08 |
| Medtronic Evolut FX Delivery Catheter System (P130021/S117) | Medtronic, Inc. | 2022-06-08 |
| EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System (P110023/S034) | Medtronic Vascular, Inc. | 2022-06-07 |
| Ceramax Ceramic Total Hip System (P070026/S098) | DePuy Orthopaedics, Inc. | 2022-06-07 |
| Exablate 4000 (Exablate Neuro) (P150038/S021) | Insightec | 2022-06-07 |
| FoundationOne CDx (P170019/S014) | Foundation Medicine, Inc. | 2022-06-07 |
| 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/S720) | Medtronic, Inc. | 2022-06-07 |
| SenTiva Model 1000 and SenTiva Duo Model 1000-D Generator Rhodium Reed Switch (P970003/S236) | LivaNova USA, Inc. | 2022-06-06 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent System with Entrust Delivery S (P110023/S035) | Medtronic Vascular, Inc. | 2022-06-03 |
| Protégé GPS Self Expanding Peripheral Stent System (P060001/S034) | Medtronic Vascular, Inc. | 2022-06-03 |
| Abbott RealTime IDH1 (P170041/S004) | Abbott Molecular, Inc. | 2022-06-02 |
| Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal Cord Sti (P840001/S521) | Medtronic Neuromodulation | 2022-06-02 |
| Zenith Dissection Endovascular System (P180001/S005) | William Cook Europe Aps | 2022-06-02 |
| Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator (P960009/S432) | Medtronic, Inc. | 2022-06-02 |
| Arctic Front Advance, Arctic Front Advance Pro (P100010/S128) | Medtronic Cryocath, LP | 2022-06-01 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead A (P920015/S269) | Medtronic, Inc. | 2022-06-01 |
| CapSureFix MRI Lead (P090013/S322) | Medtronic, Inc. | 2022-06-01 |
| Micra AV TPS, Micra TPS (P150033/S141) | Medtronic, Inc. | 2022-06-01 |
| Attain StarFix Lead (P060039/S111) | Medtronic, Inc. | 2022-06-01 |
| Attain Bipolar OTW Lead,Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B (P010015/S500) | Medtronic, Inc. | 2022-06-01 |