| LIPOSORBER® LA-15 System (P910018/S030) | Kaneka Pharma America Corp. | 2021-04-29 |
| Rapid fFN for the TLilQ System (P920048/S020) | Hologic, Inc. | 2021-04-29 |
| Pipeline Flex Embolization Device (P100018/S029) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-04-29 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S091) | Medtronic, Inc. | 2021-04-29 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems (P130021/S093) | Medtronic, Inc. | 2021-04-29 |
| HiResolution Bionic Ear System (P960058/S153) | Advanced Bionics | 2021-04-29 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S073) | Boston Scientific Corporation | 2021-04-29 |
| Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter (P990025/S063) | Biosense Webster, Inc. | 2021-04-28 |
| EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca (P040036/S080) | Biosense Webster, Inc. | 2021-04-28 |
| IMMULITE/IMMULITE 1000 THIRD GENERATION PSA (P930027/S025) | Siemens Healthcare Diagnostics, Inc. | 2021-04-28 |
| IMMULITE/IMMULITE 1000 AFP (P010007/S014) | Siemens Healthcare Diagnostics, Inc. | 2021-04-28 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S036) | ABBOTT MEDICAL | 2021-04-28 |
| TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del (P980040/S124) | Johnson & Johnson Surgical Vision, Inc. | 2021-04-28 |
| Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, (P950005/S078) | Biosense Webster, Inc. | 2021-04-28 |
| Helistaf® and Helitene® Absorbable Collagen Hemostatic Agents (P850010/S096) | Integra LifeSciences Corporation | 2021-04-28 |
| EPi-Sense Guided Coagulation System (P200002) | AtriCure, Inc. | 2021-04-28 |
| Biosense Webster Cables (P990071/S048) | Biosense Webster, Inc. | 2021-04-28 |
| Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S116) | Biosense Webster, Inc. | 2021-04-28 |
| Sculptra and Sculptra Aesthetic (P030050/S036) | Q-Med AB | 2021-04-28 |
| IMMULITE / IMMULITE 1000 FREE PSA (P060005/S013) | Siemens Medical Solutions Diagnostics Limited | 2021-04-28 |
| Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT (P010068/S063) | Biosense Webster, Inc. | 2021-04-28 |
| ACUITY X4 Quadripolar Coronary Venous Pace/Sense Leads (P010012/S534) | Boston Scientific Corp | 2021-04-28 |
| Atellica IM Alpha Fetoprotein (AFP) Assay (P930036/S016) | Siemens Healthcare Diagnostics, Inc. | 2021-04-27 |
| Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf) (P110041/S012) | Siemens Corp. | 2021-04-27 |
| EZ STEERDS, EZ STEERNAV, EZ STEER, EZ STEERTHERMOCOOL NAV (P030031/S117) | Biosense Webster, Inc. | 2021-04-27 |
| Atellica IM Anti-Hepatitis B core Total (HBcT) Assay (P040004/S020) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Atellica IM Hepatitis B e Antigen (HBeAg) Assay (P090024/S010) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S002) | Cook Medical Incorporated | 2021-04-27 |
| NAVISTARRMT THERMOCOOL, NAVISTARDS, EZ STEERNAV DS (P990025/S064) | Biosense Webster, Inc. | 2021-04-27 |
| Surpass Evolve Flow Diverter System, Surpass Streamline Flow Diverter System (P170024/S007) | Stryker Neurovascular | 2021-04-27 |
| RMT THERMOCOOL, NAVISTAR, NAVISTARRMT, NAVISTARTHERMOCOOL (P010068/S064) | Biosense Webster, Inc. | 2021-04-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S059) | Medtronic, Inc. | 2021-04-27 |
| C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric (P060011/S026) | Rayner Intraocular Lenses , Ltd. | 2021-04-27 |
| Atellica IM Complexed PSA (cPSA) Assay (P990055/S023) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Atellica IM Prostate-Specific Antigen (PSA) Assay (P950021/S024) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Cerene® Cryotherapy Device (P180032/S005) | Channel Medsystems, Inc. | 2021-04-27 |
| CapSureFix Novus Lead (P930039/S225) | Medtronic, Inc. | 2021-04-27 |
| EZ STEERTHERMOCOOL, THERMOCOOLSF NAV, THERMOCOOLSF (P040036/S081) | Biosense Webster, Inc. | 2021-04-27 |
| Atellica IM Hepatitis B core IgM (aHBcM) Assay (P030040/S020) | Siemens Healthcare Diagnostics | 2021-04-27 |
| LIFEPAK® 1000 Defibrillator (P160026/S025) | Physio-Control, Inc. | 2021-04-27 |
| CELSIUS, CELSIUSDS, CELSIUSRMT, CELSIUSTHERMOCOOL, CELSIUS (P950005/S079) | Biosense Webster, Inc. | 2021-04-27 |
| Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay (P100039/S013) | Siemens Healthcare Diagnostics, Inc. | 2021-04-27 |
| Atellica IM Hepatitis C (aHCV) Assay (P030056/S020) | Siemens Healthcare Diagnostics | 2021-04-27 |
| Patient-Fitted TMJ Reconstruction Prosthesis System (P980052/S009) | Stryker Leibinger, GmbH & Co KG | 2021-04-27 |
| THERMOCOOLSMARTTOUCH, THERMOCOOLSMARTTOUCH SF (P990071/S049) | Biosense Webster, Inc. | 2021-04-27 |
| RHA 2, RHA 3, RHA 4 Dermal Fillers (P170002/S015) | Teoxane S.A. | 2021-04-26 |
| LifeVest Wearable Defibrillator (P010030/S147) | Zoll Manufacturing Corporation | 2021-04-26 |
| Alinity m HCV (P190025/S004) | Abbott Molecular, Inc. | 2021-04-26 |
| Alinity m HBV (P200013/S002) | Abbott Molecular, Inc. | 2021-04-26 |
| Deep Brain Stimulation (DBS) System (P140009/S068) | ABBOTT MEDICAL | 2021-04-23 |
| Dorsal Root Ganglion (DRG) System (P150004/S046) | ABBOTT MEDICAL | 2021-04-23 |
| Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL (P190018/S010) | Alcon Laboratories, LLC | 2021-04-23 |
| Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints (P870024/S058) | CooperVision, Inc. | 2021-04-23 |
| Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S010) | Biotronik AG | 2021-04-23 |
| Spinal Cord Stimulation (SCS) System (P010032/S174) | ABBOTT MEDICAL | 2021-04-23 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S033) | Cardiovascular Systems, Inc. | 2021-04-23 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S012) | Biotronik AG | 2021-04-23 |
| HiResolution Bionic Ear System (P960058/S152) | Advanced Bionics | 2021-04-23 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S015) | Biotronik AG | 2021-04-23 |
| Deep Brain Stimulation (DBS) Systems - Vercise PC, Gevia and Genus Systems (P150031/S041) | Boston Scientific Corp | 2021-04-23 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S343) | Boston Scientific Corp | 2021-04-23 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S012) | Biotronik AG | 2021-04-23 |
| ARCHITECT Anti-HCV Reagent Kit, Alinity i Anti-HCV Reagent Kit (P050042/S045) | Abbott Laboratories, Inc. | 2021-04-22 |
| CardioMEMS I3 Patient Electronics System (PES) (P100045/S051) | ABBOTT MEDICAL | 2021-04-22 |
| AcrySof Multifocal Intraocular Lenses (P040020/S098) | Alcon Research, Ltd. | 2021-04-22 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S191) | Boston Scientific Corp | 2021-04-22 |
| ARCHITECT AUSAB Reagent, ARCHITECT AUSAB Reagent Kit, Alinity i Anti-HBs Reagent Kit (P050051/S041) | Abbott Laboratories, Inc. | 2021-04-22 |
| ARCHITECT Free PSA Reagent Kit, Alinity i Free PSA Reagent Kit (P980007/S044) | Abbott Laboratories | 2021-04-22 |
| Open Pivot Heart Valves and Open Pivot Aortic Valved Graft (P990046/S058) | Medtronic Ats Medical, Inc. | 2021-04-22 |
| LIFEPAK Automated External Defibrillator (AED) (P160026/S023) | Physio-Control, Inc. | 2021-04-22 |
| ARCHITECT CORE Reagent Kit, Alinity i Anti-HBc Reagent Kit (P080023/S034) | Abbott Laboratories | 2021-04-22 |
| ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit (P910007/S055) | Abbott Laboratories | 2021-04-22 |
| ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit (P060035/S032) | Abbott Laboratories | 2021-04-22 |
| ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re (P110029/S034) | Abbott Laboratories | 2021-04-22 |
| VENTANA MMR RxDx Panel (P200019) | Ventana Medical Systems | 2021-04-22 |
| Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S011) | Alcon Laboratories, LLC | 2021-04-22 |
| ARCHITECT AFP Reagents, Alinity i AFP Reagent Kit (P120008/S017) | Abbott Laboratories | 2021-04-22 |
| Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S126) | CooperVision, Inc. | 2021-04-22 |
| AcrySof Intraocular Lenses (P930014/S135) | Alcon Laboratories, Inc. | 2021-04-22 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S040) | ETHICON, Inc. | 2021-04-21 |
| Mara Water Vapor System (P160047/S023) | CooperSurgical, Inc. | 2021-04-21 |
| Nucleus Cochlear Implant System (P970051/S203) | Cochlear Americas | 2021-04-21 |
| OraQuick HCV Rapid Antibody Test (P080027/S039) | OraSure Technologies, Inc. | 2021-04-20 |
| RxSight Light Adjustable Lens and Light Delivery Device (P160055/S015) | Rxsight, Inc. | 2021-04-20 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S008) | Boston Scientific Corporation | 2021-04-20 |
| MANTA Vascular Closure Device (P180025/S009) | Teleflex Medical, LLC | 2021-04-19 |
| Scandinavian Total Ankle Replacement (STAR Ankle) (P050050/S018) | Djo Global | 2021-04-19 |
| MiniMed 670G System, MiniMed 770G System (P160017/S089) | Medtronic Minimed, Inc. | 2021-04-19 |
| HeartStart Home Defibrillator and HeartStart Onsite Defibrillator (P160029/S011) | Philips Medical Systems, Inc. | 2021-04-19 |
| TREO Abdominal Stent-Graft System (P190015/S009) | Bolton Medical, Inc. | 2021-04-19 |
| Mara Water Vapor Ablation System, Mara Water Vapor System, Mara Console (P160047/S024) | CooperSurgical, Inc. | 2021-04-19 |
| Revanesse Versa, Revanesse Versa+, Revanesse Lips+ (P160042/S015) | Prollenium Medical Technologies, Inc. | 2021-04-16 |
| Adherus AutoSpray Dural Sealant, Adherus AutoSpray ET Dural Sealant (P130014/S011) | Stryker Leibinger GmbH & Co KG | 2021-04-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI D (P980016/S768) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S781) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| 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/S730) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| 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, Compia (P010031/S743) | Medtronic Cardiac Rhythm Disease Management | 2021-04-16 |
| Implantable Pulse Generator Test Magnet (P830060/S084) | Boston Scientific | 2021-04-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S035) | Medinol, Ltd. | 2021-04-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S009) | Edwards Lifesciences, LLC | 2021-04-16 |