| Venovo Venous Stent System (P180037/S007) | Bard Peripheral Vascular, Inc. | 2021-11-19 |
| XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X (P110019/S119) | Abbott Vascular | 2021-11-19 |
| FreeStyle Libre Pro Flash Glucose Monitoring System (P150021/S050) | Abbott Diabetes Care, Inc. | 2021-11-19 |
| Endurant Stent Graft System; Endurant II Stent Graft System; Endurant IIS Stent Graft System (P100021/S096) | Medtronic Vascular | 2021-11-19 |
| Biofinity XR Toric; Biofinity Toric Multifocal (P080011/S134) | CooperVision, Inc. | 2021-11-19 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S001) | Kestra Medical Technologies, Inc. | 2021-11-19 |
| WaveLight EX500 Laser System (P030008/S035) | Alcon Laboratories, Inc. | 2021-11-19 |
| SenSight Burr Hole Device, SenSight Burr Hole Device Kit (P960009/S411) | Medtronic, Inc. | 2021-11-19 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S796) | Medtronic Cardiac Rhythm Disease Management | 2021-11-18 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S015) | Edwards Lifesciences, LLC | 2021-11-18 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S205) | Edwards Lifesciences, LLC | 2021-11-18 |
| 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/S761) | Medtronic Cardiac Rhythm Disease Management | 2021-11-18 |
| EDWARDS INTUITY Elite Valve System (P150036/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| PureVision2 (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S031) | Bausch & Lomb, Inc. | 2021-11-18 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S013) | The Spectranetics Corp. | 2021-11-18 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S023) | Berlin Heart, Inc. | 2021-11-18 |
| FoundationOne CDx (F1CDx) (P170019/S028) | Foundation Medicine, Inc. | 2021-11-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S137) | Edwards Lifesciences, LLC | 2021-11-18 |
| ResQCPR System (P110024/S003) | ZOLL Medical Corporation | 2021-11-17 |
| SUPARTZ FX, VISCO-3 (P980044/S058) | Seikagaku Corp. | 2021-11-17 |
| Arctic Front Advance®, Arctic Front Advance Pro® Cardiac CryoAblation Catheters (P100010/S121) | Medtronic Cryocath, LP | 2021-11-17 |
| DuraSeal Exact Spinal Sealant System. (P080013/S023) | Integra LifeSciences Corporation | 2021-11-17 |
| Gel-One (P080020/S046) | Seikagaku Corp. | 2021-11-17 |
| DuraSeal Dural Sealant System. (P040034/S034) | Integra LifeSciences Corporation | 2021-11-17 |
| AUGMENT Bone Graft and AUGMENT Injectable (P100006/S012) | Biomimetic Therapeutics, LLC | 2021-11-17 |
| Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S133) | CooperVision, Inc. | 2021-11-17 |
| Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua (P810031/S071) | Johnson & Johnson Surgical Vision, Inc. | 2021-11-17 |
| Proclaim SCS Neurostimulation System (P010032/S176) | ABBOTT MEDICAL | 2021-11-17 |
| LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus (P180047/S009) | DiaSorin, Inc. | 2021-11-16 |
| Elecsys free PSA Test System (P000027/S036) | Roche Diagnostics Corp. | 2021-11-16 |
| Integrity Coronary Stent System Rx and OTW (P030009/S106) | Medtronic, Ireland | 2021-11-16 |
| EMBLEM S-ICD pulse generator (PG) Models A209/A219 (P110042/S161) | Boston Scientific Corporation | 2021-11-16 |
| RelayPro Thoracic Stent-Graft System (P200045/S001) | Bolton Medical, Inc. | 2021-11-16 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S115) | Medtronic Vascular | 2021-11-16 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S003) | ABBOTT MEDICAL | 2021-11-16 |
| GORE® CARDIOFORM ASD Occluder (P050006/S095) | W. L. Gore & Associates, Inc. | 2021-11-16 |
| Proclaim DRG IPG (P150004/S054) | ABBOTT MEDICAL | 2021-11-16 |
| Restylane, Restylane Lyft with Lidocaine, Restylane Silk, Restylane-L, Perlane (P040024/S123) | Q-Med AB | 2021-11-16 |
| Infinity DBS IPG (P140009/S074) | ABBOTT MEDICAL | 2021-11-16 |
| Proclaim SCS IPG (P010032/S183) | ABBOTT MEDICAL | 2021-11-16 |
| therascreen FGFR RGQ RT-PCR Kit (P180043/S003) | QIAGEN GmbH | 2021-11-16 |
| Elecsys total PSA Test System (P990056/S038) | Roche Diagnostics Corp. | 2021-11-16 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S032) | Boston Scientific Corp | 2021-11-15 |
| Axonics Sacral Neuromodulation System (P190006/S042) | Boston Scientific Corporation | 2021-11-15 |
| Vercise, Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimulation Systems (P150031/S039) | Boston Scientific Corp | 2021-11-15 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S086) | Hologic, Inc. | 2021-11-15 |
| TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL, TECNIS Symfony Toric II OptiBlue Extended Range of Vision (E (P980040/S139) | Johnson & Johnson Surgical Vision, Inc. | 2021-11-15 |
| Axonics Sacral Neuromodulation System (P180046/S042) | Boston Scientific Corporation | 2021-11-15 |
| INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat (P900033/S095) | Integra Lifesciences Corp. | 2021-11-13 |
| Collastat Absorbable Collagen Hemostatic Sponge and Collastat Absorbable Collagen Hemostatic Agent Microfibrillar Form (P810006/S096) | Integra LifeSciences Corporation | 2021-11-13 |
| Helistat and Helitene Absorbable Collagen Hemostatic Agents (P850010/S098) | Integra LifeSciences Corporation | 2021-11-13 |
| CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery (P840062/S082) | Integra Lifesciences Corp. | 2021-11-13 |
| Prometra Programmable Infusion Pump System (P080012/S063) | Infusyn Therapeutics, LLC | 2021-11-12 |
| Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System (P190023/S001) | ABBOTT MEDICAL | 2021-11-12 |
| GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S089) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S147) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S086) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| VISITAG SURPOINT External Processing Unit (EPU) (P030031/S110) | Biosense Webster, Inc. | 2021-11-12 |
| Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S046) | Boston Scientific Corp | 2021-11-10 |
| Transvene CS/SVC Lead (P980050/S135) | Medtronic, Inc. | 2021-11-10 |
| Attain Stability Quad MRI Lead (P080006/S164) | Medtronic, Inc. | 2021-11-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S049) | Medtronic Vascular | 2021-11-10 |
| CapSureFix MRI Lead (P090013/S316) | Medtronic, Inc. | 2021-11-10 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S002) | Kestra Medical Technologies, Inc. | 2021-11-10 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S233) | Medtronic, Inc. | 2021-11-10 |
| WaveWriter Alpha Spinal Cord Stimulator (SCS) System (P030017/S348) | Boston Scientific Corp | 2021-11-10 |
| Epicardial Patch Lead (P900061/S166) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| FoundationOne CDx (P170019/S025) | Foundation Medicine, Inc. | 2021-11-10 |
| Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S260) | Medtronic, Inc. | 2021-11-10 |
| R3 Delta Ceramic Hip System (P150030/S013) | Smith & Nephew, Inc. | 2021-11-10 |
| LCS Total Knee System (P830055/S272) | Depuy, Inc. | 2021-11-10 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S158) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| MynxGrip Vascular Closure Device (SF, 6F/7F) ; Mynx Control Vascular Closure Device (SF, 6F/7F) (P040044/S089) | Cordis US Corporation | 2021-11-10 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S199) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| Arctic Front Advance Cardiac Cryoablation Catheter; Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S120) | Medtronic Cryocath, LP | 2021-11-09 |
| Atellica® IM Alpha Fetoprotein (AFP) Assay (P930036/S018) | Siemens Healthcare Diagnostics, Inc. | 2021-11-09 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S015) | Smith & Nephew, Inc. | 2021-11-09 |
| Infuse Bone Graft (P000054/S060) | Medtronic Sofamor Danek USA, Inc. | 2021-11-08 |
| Infuse Bone Graft (P050053/S051) | Medtronic, Inc. | 2021-11-08 |
| Neuro Cochlear Implant System (P200021/S002) | Oticon Medical | 2021-11-08 |
| Biofinity XR Toric; Biofinity Toric Multifocal (P080011/S132) | CooperVision, Inc. | 2021-11-08 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S079) | Medtronic Sofamor Danek USA, Inc. | 2021-11-08 |
| Abre Venous self-expanding stent system (P200026/S003) | Medtronic Vascular, Inc. | 2021-11-05 |
| Mynx Control and Mynx Grip Vascular Closure Device (P040044/S088) | Cordis US Corporation | 2021-11-05 |
| Arctic Front® Advance Cardiac Cryoablation Catheter (P100010/S119) | Medtronic Cryocath, LP | 2021-11-05 |
| Activa® Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S412) | Medtronic, Inc. | 2021-11-05 |
| CERAMAX Ceramic Total Hip System (P070026/S087) | DePuy Orthopaedics, Inc. | 2021-11-05 |
| Eon Mini IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P (P010032/S182) | ABBOTT MEDICAL | 2021-11-04 |
| LifeVest® Wearable Defibrillator (P010030/S154) | Zoll Manufacturing Corporation | 2021-11-04 |
| Neuro Cochlear Implant System (P200021/S009) | Oticon Medical | 2021-11-04 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S070) | St Jude Medical | 2021-11-04 |
| Inspire Model 4340 Respiratory Sensing Lead (P130008/S075) | Inspire Medical Systems | 2021-11-03 |
| XVIVO Perfusion System (XPS) with STEEN Solution Perfusate (P180014/S006) | Xvivo Perfusion, Inc. | 2021-11-03 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S036) | Boston Scientific Corporation | 2021-11-03 |
| Reveal LINQ Application Software (P890003/S448) | Medtronic, Inc. | 2021-11-03 |
| Genesis Neurostimulation System (P010032/S181) | ABBOTT MEDICAL | 2021-11-03 |
| MynxGrip Vascular Closure Device (VCD) (P040044/S087) | Cordis US Corporation | 2021-11-03 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S760) | Medtronic Cardiac Rhythm Disease Management | 2021-11-03 |