| Endurant, Endurant II and Endurant IIs Stent Graft System, Talent Occluder with Occluder Delivery System (P100021/S090) | Medtronic Vascular | 2021-04-15 |
| Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S125) | CooperVision, Inc. | 2021-04-15 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S144) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S083) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| SUPARTZ device family, SUPARTZ FX and VISCO-3 (P980044/S055) | Seikagaku Corp. | 2021-04-15 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S087) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE TAG Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S126) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| BioMimics 3D Vascular Stent System (P180003/S004) | Veryan Medical, Ltd. | 2021-04-15 |
| Gel-One (P080020/S042) | Seikagaku Corp. | 2021-04-15 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System (P100040/S046) | Medtronic Vascular | 2021-04-15 |
| RHA 2, RHA 3, RHA 4 dermal fillers (P170002/S014) | Teoxane S.A. | 2021-04-15 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S092) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S181) | W. L. Gore & Associates, Inc. | 2021-04-15 |
| Micra Transcatheter Pacing System (TPS) (P150033/S101) | Medtronic, Inc. | 2021-04-15 |
| GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S002) | W. L. Gore and Associates, Inc. | 2021-04-15 |
| RESILIA Solutions System (P150048/S053) | Edwards Lifesciences, LLC | 2021-04-15 |
| Micra AV TPS and Micra TPS (P150033/S100) | Medtronic, Inc. | 2021-04-14 |
| Restylane Kysse Injectable Gel (P140029/S037) | Q-Med AB | 2021-04-14 |
| Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis SR, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, (P950037/S221) | Biotronik, Inc. | 2021-04-14 |
| EXOGEN Ultrasound Bone Healing System (P900009/S046) | Bioventus, LLC | 2021-04-14 |
| Evia HF-T, Etrinsa 8 HF-T, Epyra 8 HF-T, Eluna 8 HF-T, Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Eni (P070008/S123) | Biotronik, Inc. | 2021-04-14 |
| Restylane Kysse Injectable Gel (P140029/S038) | Q-Med AB | 2021-04-13 |
| Pipeline Flex Embolization Device with Shield Technology (P100018/S026) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-04-13 |
| ADVIA Centaur aHBs2 Assay (P100039/S012) | Siemens Healthcare Diagnostics, Inc. | 2021-04-13 |
| Intera 3000 Hepatic Artery Infusion Pump accessories (P890055/S077) | Intera Oncology | 2021-04-13 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S779) | Medtronic Cardiac Rhythm Disease Management | 2021-04-12 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D (P980035/S679) | Medtronic, Inc. | 2021-04-12 |
| 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/S741) | Medtronic Cardiac Rhythm Disease Management | 2021-04-12 |
| Mara Water Vapor Ablation System (P160047/S022) | CooperSurgical, Inc. | 2021-04-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biplar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S472) | Medtronic, Inc. | 2021-04-12 |
| Cologuard (P130017/S046) | Exact Sciences Corporation | 2021-04-12 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S053) | Allergan | 2021-04-10 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) (P910023/S436) | ABBOTT MEDICAL | 2021-04-09 |
| Microny (P970013/S086) | ABBOTT MEDICAL | 2021-04-09 |
| Propel and Propel Mini Sinus Implants (P100044/S048) | Intersect Ent. | 2021-04-09 |
| Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional) (P960013/S117) | ABBOTT MEDICAL | 2021-04-09 |
| Inspire Upper Airway Stimulation System (P130008/S064) | Inspire Medical Systems | 2021-04-09 |
| InterStim Therapy System, Verify Evaluation System (P080025/S223) | Medtronic Neuromodulation | 2021-04-09 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems) (P970004/S332) | Medtronic Neuromodulation | 2021-04-09 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S001) | Shockwave Medical, Inc. | 2021-04-09 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL (P880086/S318) | ABBOTT MEDICAL | 2021-04-09 |
| Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional) (P950022/S138) | ABBOTT MEDICAL | 2021-04-09 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S535) | Boston Scientific Corp | 2021-04-09 |
| Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional) (P030035/S185) | ABBOTT MEDICAL | 2021-04-09 |
| InterStim Therapy System and Veify Evaluation System (SNS Bowel Programming Systems) (P080025/S227) | Medtronic Neuromodulation | 2021-04-09 |
| Assurity MRI, Endurity MRI and Tendril MRI (P140033/S066) | ABBOTT MEDICAL | 2021-04-09 |
| IsoFlex Optim (P960030/S074) | ABBOTT MEDICAL | 2021-04-09 |
| InterStim Therapy System, Verify Evaluation System (P970004/S328) | Medtronic Neuromodulation | 2021-04-09 |
| Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S391) | ABBOTT MEDICAL | 2021-04-09 |
| IntellaTip MiFi Filter Module and IntellaTip MiFi Reference Cable (P020025/S130) | Boston Scientific | 2021-04-08 |
| AFX Endovascular AAA System (AFX System) (P040002/S067) | Endologix, LLC | 2021-04-08 |
| Bausch + Lomb Ultra (samfilcon A) Contact Lenses Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S012) | Bausch and Lomb, Inc., | 2021-04-08 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S740) | Medtronic Cardiac Rhythm Disease Management | 2021-04-08 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S125) | W. L. Gore & Associates, Inc. | 2021-04-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S778) | Medtronic Cardiac Rhythm Disease Management | 2021-04-08 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S041) | Bausch & Lomb, Inc. | 2021-04-07 |
| Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S114) | Biosense Webster, Inc. | 2021-04-07 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S034) | Medinol, Ltd. | 2021-04-07 |
| Celsius Thermocool, EZ Steer Thermocool Non-Nav Bi-Directional, Celsius RMT Thermocool, Thermocool SF Bi-directional non (P030031/S115) | Biosense Webster, Inc. | 2021-04-07 |
| Celsius, Celsius RMT, EZ Steer Bi-directional non nav (P950005/S077) | Biosense Webster, Inc. | 2021-04-07 |
| Navistar Thermocool, EZ Steer Thermocool Nav Bi- Directional, Navistar RMT Thermocool, Thermocool SF Nav Bi-directional, (P040036/S079) | Biosense Webster, Inc. | 2021-04-07 |
| Navistar DS, Celsius DS, EZ Steer DS Bi-directional non nav, EZ Steer Nav DS Bi-directional, Celsius FLTR Uni-directiona (P010068/S062) | Biosense Webster, Inc. | 2021-04-07 |
| Epic Self-Expanding Nitinol Vascular Stent with Delivery System (P110035/S066) | Boston Scientific Corp | 2021-04-07 |
| Navistar, Navistar RMT, EZ Steer Nav Bi-directional (P990025/S062) | Biosense Webster, Inc. | 2021-04-07 |
| HeartLight X3 Endoscopic Ablation System (P150026/S012) | Cardiofocus, Inc. | 2021-04-06 |
| Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear (P080011/S124) | CooperVision, Inc. | 2021-04-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S331) | Medtronic Neuromodulation | 2021-04-06 |
| Harmony TPV System (P200046/S001) | Medtronic, Inc. | 2021-04-06 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris, Spinal Cord Stimu (P840001/S485) | Medtronic Neuromodulation | 2021-04-06 |
| INFUSE Bone Graft (P050053/S056) | Medtronic, Inc. | 2021-04-06 |
| HeartStart FRx Defibrillator (P180028/S005) | Philips Medical Systems | 2021-04-06 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S226) | Medtronic Neuromodulation | 2021-04-06 |
| Cardiomems HF System (P100045/S050) | ABBOTT MEDICAL | 2021-04-06 |
| Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense (P960009/S399) | Medtronic, Inc. | 2021-04-06 |
| HeartStart OnSite and Home Defibrillator (P160029/S008) | Philips Medical Systems, Inc. | 2021-04-06 |
| INFUSE Bone Graft (P000054/S065) | Medtronic Sofamor Danek USA, Inc. | 2021-04-05 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S084) | Medtronic Sofamor Danek USA, Inc. | 2021-04-05 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-Tech Programmer and Related Accessories (P110042/S153) | Boston Scientific Corporation | 2021-04-02 |
| COSMOS System (P830026/S083) | Boston Scientific | 2021-04-02 |
| ACUITY Steerable Lead System (P050046/S031) | Guidant Corp. | 2021-04-02 |
| SELUTE Lead System (P950001/S029) | Boston Scientific | 2021-04-02 |
| INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S107) | Boston Scientific | 2021-04-02 |
| ENDOTAK Lead System (P910073/S160) | Boston Scientific | 2021-04-02 |
| Pulsar, Pulsar Max, Discovery, Nexus, Intelis, Insignia, Altrua, Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent (N970003/S261) | Boston Scientific Corp | 2021-04-02 |
| Micra AV TPS, Micra TPS (P150033/S103) | Medtronic, Inc. | 2021-04-02 |
| VIGOR DR/SR, DISCOVERY, and MERIDIAN (P940031/S079) | Boston Scientific | 2021-04-02 |
| VENTAK (P830060/S085) | Boston Scientific | 2021-04-02 |
| VENTAK P (P890061/S024) | Boston Scientific | 2021-04-02 |
| INGEVITY MRI Pace/Sense Leads (P150012/S108) | Boston Scientific | 2021-04-02 |
| DELTA/VISTA (P840068/S055) | Boston Scientific | 2021-04-02 |
| VENTAK PRx and VENTAK MINI (P910077/S183) | Boston Scientific | 2021-04-02 |
| Contak CD, Contak Renewal, Livian, Cognis, Energen CRT-D, Punctua CRT-D, Incepta CRT-D, Origen CRT-D, Inogen CRT-D, Dyna (P010012/S533) | Boston Scientific Corp | 2021-04-02 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S155) | Boston Scientific Corporation | 2021-04-02 |
| VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I (P960040/S462) | Boston Scientific | 2021-04-02 |
| VENTAK P2 System (P930035/S031) | Boston Scientific | 2021-04-02 |
| Contak Renewal TR, Valitude, Invive, and Intua (P030005/S207) | Guidant Corp. | 2021-04-02 |
| SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND (P960006/S051) | Boston Scientific | 2021-04-02 |
| THINLINE/FINELINE Family of Endocardial Pacing Leads (P960004/S093) | Boston Scientific | 2021-04-02 |
| Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S019) | Rxsight, Inc. | 2021-04-01 |
| Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S728) | Medtronic Cardiac Rhythm Disease Management | 2021-04-01 |