| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S705) | Medtronic, Inc. | 2022-02-25 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S250) | Medtronic Neuromodulation | 2022-02-25 |
| S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S045) | Cordis US Corporation | 2022-02-25 |
| Promus PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S202) | Boston Scientific Corp | 2022-02-25 |
| Micra AV TPS, Micra TPS (P150033/S134) | Medtronic, Inc. | 2022-02-25 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S773) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S197) | Boston Scientific Corp | 2022-02-25 |
| SelectSecure Lead (P030036/S135) | Medtronic Cardiac Rhythm Disease Management | 2022-02-25 |
| Blazer Open Irrigated Catheter, IntellNav MiFi OI Catheter, IntellaNav OI Catheter, and IntellaTip MiFi OI Catheter, Ste (P150005/S070) | Boston Scientific Corp | 2022-02-25 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S355) | Medtronic Neuromodulation | 2022-02-25 |
| Aptima HPV Assay (P100042/S032) | Gen-Probe Incorporated | 2022-02-25 |
| Aptima HPV 16 18/45 Genotype Assay (P120007/S029) | Gen-Probe Incorporated | 2022-02-25 |
| WOLVERINE Coronary Cutting Balloon (P950020/S116) | Boston Scientific Corp | 2022-02-25 |
| Chilli II Cooled Catheter, Sterile Cables, Tubing Kit (P980003/S093) | Boston Scientific Corp | 2022-02-25 |
| LCS® Total Knee System (P830055/S280) | Depuy, Inc. | 2022-02-24 |
| RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S020) | Teoxane S.A. | 2022-02-24 |
| CRT-D Resynchronization Devices (P010012/S548) | Boston Scientific Corp | 2022-02-24 |
| Subcutaneous ICD Devices (P110042/S167) | Boston Scientific Corporation | 2022-02-24 |
| ELCA Coronary Atherectomy Catheters (P910001/S114) | Spectranetics Corp. | 2022-02-24 |
| CRT-P Resynchronization Devices (P030005/S215) | Guidant Corp. | 2022-02-24 |
| Pacemaker Devices (P150012/S120) | Boston Scientific | 2022-02-24 |
| Model 3300 LATITUDE Programming System (P910077/S187) | Boston Scientific | 2022-02-24 |
| Pacemaker Devices (N970003/S270) | Boston Scientific Corp | 2022-02-24 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIS Stent Graft System (P100021/S101) | Medtronic Vascular | 2022-02-24 |
| ICD Devices (P960040/S473) | Boston Scientific | 2022-02-24 |
| ORSIRO Sirolimus Eluting Coronary Stent System and Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S021) | Biotronik AG | 2022-02-23 |
| Mosaic Bioprosthesis (P990064/S077) | Medtronic, Inc. | 2022-02-22 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S130) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S098) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® Excluder® Conformable AAA Endoprosthesis (P200030/S007) | W. L. Gore and Associates, Inc. | 2022-02-22 |
| InterStim Therapy System (P970004/S340) | Medtronic Neuromodulation | 2022-02-22 |
| IntellaNav ST Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II HTD Temperature Ablation Catheter (P920047/S126) | Boston Scientific Corp | 2022-02-22 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S240) | Medtronic Neuromodulation | 2022-02-22 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S033) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S150) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Freestyle Bioprosthesis (P970031/S064) | Medtronic, Inc. | 2022-02-22 |
| Blazer II XP Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, IntellaTip MiFi XP Tempera (P020025/S134) | Boston Scientific | 2022-02-22 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S187) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Melody TPV (P140017/S013) | Medtronic, Inc. | 2022-02-22 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D (P010031/S771) | Medtronic Cardiac Rhythm Disease Management | 2022-02-22 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, IntellaNav MiFi Open-Irrigated (P150005/S069) | Boston Scientific Corp | 2022-02-22 |
| Hancock II Bioprosthesis (P980043/S069) | Medtronic, Inc. | 2022-02-22 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S089) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Hancock Valved Conduit MO (P790007/S059) | Medtronic Heart Valves | 2022-02-22 |
| CoreValve TAV, Evolut-R TAV, Evolut PRO TAV (P130021/S056) | Medtronic, Inc. | 2022-02-22 |
| InterStim Therapy System (P080025/S235) | Medtronic Neuromodulation | 2022-02-22 |
| Avalus Bioprosthesis (P170006/S007) | Medtronic, Inc. | 2022-02-22 |
| Hancock Valved Conduit LP (P870078/S044) | Medtronic, Inc. | 2022-02-22 |
| CERAMAX® Ceramic Total Hip System (P070026/S091) | DePuy Orthopaedics, Inc. | 2022-02-22 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S090) | W. L. Gore & Associates, Inc. | 2022-02-22 |
| Cobalt MRI ICD, Cobalt XT MRI ICD and Crome MRI ICD (P980016/S805) | Medtronic Cardiac Rhythm Disease Management | 2022-02-22 |
| Master InterStim® Therapy System, Verify® Evaluation System (P970004/S345) | Medtronic Neuromodulation | 2022-02-22 |
| Ranger Over-The-Wire Paclitaxel-Coated Balloon Catheter (P190019/S012) | Boston Scientific Corporation | 2022-02-22 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S056) | Edwards Lifesciences, LLC | 2022-02-22 |
| Restore, Itrel®, Synergy® and Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectris Sp (P840001/S500) | Medtronic Neuromodulation | 2022-02-18 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S081) | Medtronic Sofamor Danek USA, Inc. | 2022-02-18 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S342) | Medtronic Neuromodulation | 2022-02-18 |
| Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (P960009/S408) | Medtronic, Inc. | 2022-02-18 |
| LCS® Total Knee System (P830055/S281) | Depuy, Inc. | 2022-02-18 |
| Infuse Bone Graft (P000054/S062) | Medtronic Sofamor Danek USA, Inc. | 2022-02-18 |
| INFUSE Bone Graft (P050053/S057) | Medtronic, Inc. | 2022-02-18 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S378) | Medtronic, Inc. | 2022-02-18 |
| FoundationOne CDx (F1CDx) (P170019/S029) | Foundation Medicine, Inc. | 2022-02-18 |
| CardioMEMs HF System (P100045/S056) | ABBOTT MEDICAL | 2022-02-18 |
| Infuse Bone Graft (P050053/S053) | Medtronic, Inc. | 2022-02-18 |
| ORSIRO Sirolimus Eluting Coronary Stent System, ORSIRO Mission Sirolimus Eluting Coronary Stent System (P170030/S019) | Biotronik AG | 2022-02-18 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S237) | Medtronic Neuromodulation | 2022-02-18 |
| iStent® Trabecular Micro-Bypass Stent System (P080030/S023) | Glaukos Corporation | 2022-02-18 |
| Alair Bronchial Thermoplasty System (P080032/S019) | Boston Scientific Corp | 2022-02-18 |
| Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter (P020045/S098) | Medtronic Cryocath, LP | 2022-02-18 |
| iStent inject® Trabecular Micro-Bypass System Model (P170043/S012) | Glaukos Corporation | 2022-02-18 |
| Intellis Spinal Cord Stimulation System (SCS Systems) (P840001/S510) | Medtronic Neuromodulation | 2022-02-17 |
| VenaSeal Closure System (P140018/S031) | Medtronic Vascular, Inc. | 2022-02-17 |
| Bellafill Dermal Filler (P020012/S039) | Tiger Aesthetics Medical, LLC | 2022-02-17 |
| Dorsal Root Ganglion (DRG) System (P150004/S055) | ABBOTT MEDICAL | 2022-02-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S806) | Medtronic Cardiac Rhythm Disease Management | 2022-02-17 |
| TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs, (P980040/S145) | Johnson & Johnson Surgical Vision, Inc. | 2022-02-17 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S772) | Medtronic Cardiac Rhythm Disease Management | 2022-02-17 |
| Spinal Cord Stimulation (SCS) System (P010032/S184) | ABBOTT MEDICAL | 2022-02-17 |
| Infinity Deep Brain Stimulation (DBS) System (P140009/S075) | ABBOTT MEDICAL | 2022-02-17 |
| INFUSE BoneGraft/Medtronic lnterbody Fusion Device (P000058/S085) | Medtronic Sofamor Danek USA, Inc. | 2022-02-17 |
| INFUSE Bone Graft (P000054/S066) | Medtronic Sofamor Danek USA, Inc. | 2022-02-17 |
| HeartMate 3 Left Ventricular Assist System (P160054/S042) | ABBOTT MEDICAL | 2022-02-16 |
| i-FACTOR Peptide Enhanced Bone Graft (P140019/S006) | Cerapedics, LLC | 2022-02-16 |
| Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) (P810031/S070) | Johnson & Johnson Surgical Vision, Inc. | 2022-02-16 |
| Biofinity Energys (P080011/S138) | CooperVision, Inc. | 2022-02-16 |
| MicroTransponder® Vivistim® Paired VNS System (Vivistim® System) (P210007/S001) | Mobia Medical, Inc. | 2022-02-16 |
| Patient Cable (P820003/S139) | Medtronic Cardiac Rhythm Disease Management | 2022-02-16 |
| ADVIA Centaur anti-HBs2 (aHBs2), Atellica IM aHBs2 (P100039/S014) | Siemens Healthcare Diagnostics, Inc. | 2022-02-16 |
| Flow Re-Direction Endoluminal Device (FRED) and FRED X System (P180027/S006) | MicroVention, Inc. | 2022-02-15 |
| CERAMAX Ceramic Total Hip System (P070026/S090) | DePuy Orthopaedics, Inc. | 2022-02-14 |
| Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I (P190018/S012) | Alcon Laboratories, LLC | 2022-02-14 |
| The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th (P980040/S144) | Johnson & Johnson Surgical Vision, Inc. | 2022-02-14 |
| Adherus AutoSpray Dural Sealant, NUS-106 (P130014/S014) | Stryker Leibinger GmbH & Co KG | 2022-02-14 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S043) | Cordis US Corporation | 2022-02-11 |
| Abre Venous Self-expanding Stent System (P200026/S004) | Medtronic Vascular, Inc. | 2022-02-11 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S188) | W. L. Gore & Associates, Inc. | 2022-02-11 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S011) | Bard Peripheral Vascular, Inc. | 2022-02-11 |
| Inspire Implantable Pulse Generator (IPG) Model 2580 Patient Remote (P130008/S078) | Inspire Medical Systems | 2022-02-11 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S083) | Boston Scientific Corporation | 2022-02-10 |