| Simplify Cervical Artificial Disc (P200022/S007) | Nuvasive, Inc. | 2021-07-21 |
| Activa® Deep Brain Stimulation Therapy System (P960009/S402) | Medtronic, Inc. | 2021-07-21 |
| Juvéderm Hyaluronate Gel Implants (P050047/S082) | Allergan | 2021-07-21 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S158) | Biotronik, Inc. | 2021-07-21 |
| Master Restore, Itrel®, Synergy®, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify®, and Vectri (P840001/S492) | Medtronic Neuromodulation | 2021-07-21 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, Intica Neo 5 DR-T (P000009/S093) | Biotronik, Inc. | 2021-07-21 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S376) | Medtronic, Inc. | 2021-07-21 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S013) | Foundation Medicine, Inc. | 2021-07-21 |
| InterStim® Therapy System, Verify® Evaluation System (P970004/S335) | Medtronic Neuromodulation | 2021-07-21 |
| InterStim® Therapy System, Verify® Evaluation System (P080025/S230) | Medtronic Neuromodulation | 2021-07-21 |
| Juvederm Gel Implants (P050047/S080) | Allergan | 2021-07-21 |
| FoundationOne CDx, FoundationOne Liquid CDx (P170019/S022) | Foundation Medicine, Inc. | 2021-07-21 |
| Implantable System for Remodulin (P140032/S073) | Medtronic, Inc. | 2021-07-21 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S016) | Medtronic Vascular, Inc. | 2021-07-21 |
| Evia SR-T, Evia SR, Evia DR-T, Evia DR, Entovis SR-T, Entovis DR-T, Entovis DR, Estella SR-T, Estella DR-T, Estella DR, (P950037/S226) | Biotronik, Inc. | 2021-07-21 |
| Juvéderm Voluma XC, Juvéderm Vollure XC, and Juvéderm Volbella XC (P110033/S061) | Allergan | 2021-07-21 |
| Juvederm injectable Gel (P110033/S058) | Allergan | 2021-07-21 |
| enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S046) | Bausch & Lomb, Inc. | 2021-07-21 |
| Mentor Saline-Filled and Spectrum Breast Implants (P990075/S052) | Mentor Worldwide, LLC | 2021-07-21 |
| MetriQ Irrigation Tubing Set (P150005/S065) | Boston Scientific Corp | 2021-07-21 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S106) | Biotronik, Inc. | 2021-07-21 |
| 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/S127) | Biotronik, Inc. | 2021-07-21 |
| NATRELLE Saline-Filled Breast Implants (P990074/S047) | Allergan | 2021-07-20 |
| IntellaNav MiFi Open-Irrigated Ablation Catheters, IntellaTip MiFi Open-Irrigated Ablation Catheters, IntellaNav Open-Ir (P150005/S064) | Boston Scientific Corp | 2021-07-20 |
| CERAMAX Ceramic Total Hip System (P070026/S083) | DePuy Orthopaedics, Inc. | 2021-07-20 |
| NATRELLE Silicone-Filled Breast Implants (P020056/S056) | Allergan | 2021-07-20 |
| NexGen LPS-Flex/LPS Mobile Bearing Knee System (P060037/S072) | Zimmer, Inc. | 2021-07-19 |
| Collamer Intraocular Lens (CIOL) (P990013/S041) | Starr Surgical Co. | 2021-07-19 |
| Pipeline Flex Embolization Device with Shield Technology (P100018/S032) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-07-19 |
| Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System (P130021/S101) | Medtronic, Inc. | 2021-07-19 |
| Visian Implantable Collamer Lens (ICL) (P030016/S041) | STAAR Surgical Company | 2021-07-19 |
| Harmony Transcatheter Pulmonary Valve System (P200046/S005) | Medtronic, Inc. | 2021-07-19 |
| Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. (P170013/S006) | MicroVention, Inc. | 2021-07-16 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S039) | Nevro Corporation | 2021-07-16 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S196) | Medtronic Cardiac Rhythm Disease Management | 2021-07-16 |
| Woven EndoBridge Aneurysm Embolization (WEB) System (P170032/S007) | MicroVention, Inc. | 2021-07-16 |
| Micra AV TPS, Micra TPS (P150033/S116) | Medtronic, Inc. | 2021-07-16 |
| Prismaflex TPE2000 Set (P830063/S018) | Vantive US Healthcare, LLC | 2021-07-16 |
| Flow Re-Direction Endoluminal Device (FRED®) System (P180027/S003) | MicroVention, Inc. | 2021-07-16 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary) (P970004/S336) | Medtronic Neuromodulation | 2021-07-15 |
| St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant (P150004/S048) | ABBOTT MEDICAL | 2021-07-15 |
| St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, St. Jude Medical In (P140009/S070) | ABBOTT MEDICAL | 2021-07-15 |
| Coseal Surgical Sealant (P030039/S026) | Baxter Bio Science | 2021-07-15 |
| FoundationOne Liquid CDx (F1 Liquid CDx) (P190032/S001) | Foundation Medicine, Inc. | 2021-07-15 |
| InterStim Therapy System, Verify Evaluation System (SNS Bowel) (P080025/S231) | Medtronic Neuromodulation | 2021-07-15 |
| Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord (P840001/S495) | Medtronic Neuromodulation | 2021-07-15 |
| St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim XR 5 Implan (P010032/S177) | ABBOTT MEDICAL | 2021-07-15 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S478) | Medtronic, Inc. | 2021-07-14 |
| AcrySof Posterior Chamber Intraocular Lens (P930014/S137) | Alcon Laboratories, Inc. | 2021-07-14 |
| 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/S687) | Medtronic, Inc. | 2021-07-14 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S063) | Boston Scientific Corp | 2021-07-14 |
| ADVIA Centaur Anti-HBe2 (aHBe2) assay (P200017) | Siemens Healthcare Diagnostics, Inc. | 2021-07-14 |
| INGEVITY Passive Fixation leads (P150012/S113) | Boston Scientific | 2021-07-14 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S787) | Medtronic Cardiac Rhythm Disease Management | 2021-07-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S751) | Medtronic Cardiac Rhythm Disease Management | 2021-07-14 |
| Micra AV TPS, Micra TPS (P150033/S115) | Medtronic, Inc. | 2021-07-14 |
| AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S099) | Alcon Research, Ltd. | 2021-07-14 |
| Impella Left Ventricular Support Systems (P140003/S082) | Abiomed, Inc. | 2021-07-13 |
| Duett Sealing Device (P990037/S035) | Vascular Solutions, Inc. | 2021-07-13 |
| Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual (P810031/S072) | Johnson & Johnson Surgical Vision, Inc. | 2021-07-13 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S017) | Biotronik AG | 2021-07-13 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S014) | Biotronik AG | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S083) | Abiomed, Inc. | 2021-07-13 |
| Impella Ventricular Support Systems (P140003/S081) | Abiomed, Inc. | 2021-07-13 |
| Surpass Evolve Flow Diverter System (P170024/S009) | Stryker Neurovascular | 2021-07-12 |
| Impella RP System (P170011/S033) | Abiomed, Inc. | 2021-07-12 |
| Evolut PRO+ Delivery Catheter System (P130021/S100) | Medtronic, Inc. | 2021-07-12 |
| Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi Spinal Cord Stimulator (SCS) System, Precision Mon (P030017/S344) | Boston Scientific Corp | 2021-07-12 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S004) | CooperVision, Inc. | 2021-07-12 |
| EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool, (P040036/S083) | Biosense Webster, Inc. | 2021-07-09 |
| Integra Dermal Regeneration Template and Intergra Meshed Dermal Regeneration Template (P900033/S096) | Integra Lifesciences Corp. | 2021-07-09 |
| Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T (P030031/S121) | Biosense Webster, Inc. | 2021-07-09 |
| Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D (P950005/S081) | Biosense Webster, Inc. | 2021-07-09 |
| Smartablate System Interface Cables (P990071/S050) | Biosense Webster, Inc. | 2021-07-09 |
| Impella RP System (P170011/S031) | Abiomed, Inc. | 2021-07-09 |
| Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl (P010068/S066) | Biosense Webster, Inc. | 2021-07-09 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S003) | Cook Medical Incorporated | 2021-07-09 |
| Abre Venous Self-expanding Stent System (P200026/S002) | Medtronic Vascular, Inc. | 2021-07-09 |
| Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar (P990025/S066) | Biosense Webster, Inc. | 2021-07-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist System (P140003/S078) | Abiomed, Inc. | 2021-07-09 |
| Micra AV TPS and Micra TPS (P150033/S114) | Medtronic, Inc. | 2021-07-09 |
| WaveLight EX500 Laser System (P030008/S034) | Alcon Laboratories, Inc. | 2021-07-08 |
| Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S042) | Bausch & Lomb, Inc. | 2021-07-08 |
| CT LUCIA Intraocular lens (Model 611P) (P100016/S008) | Carl Zeiss Meditec Production, LLC | 2021-07-08 |
| Restore, Itrel, Synergy, Intellis, Vanta, Sequentia LT, Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris (P840001/S491) | Medtronic Neuromodulation | 2021-07-08 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S188) | Boston Scientific Corp | 2021-07-08 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S015) | Physio-Control, Inc. | 2021-07-08 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S039) | Pfizer, Inc. | 2021-07-08 |
| Micra AV TPS and Micra TPS (P150033/S113) | Medtronic, Inc. | 2021-07-08 |
| WaveLight EX500 Laser System (P020050/S038) | Alcon Laboratories, Inc. | 2021-07-08 |
| Infant/Child Reduced Energy Defibrillation Electrodes (P160012/S003) | Physio-Control, Inc. | 2021-07-08 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment (P000053/S121) | Boston Scientific Corp | 2021-07-08 |
| LCS Total Knee System (P830055/S268) | Depuy, Inc. | 2021-07-07 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Entrant, Gallant, Ellipse (MR Conditional) (P910023/S438) | ABBOTT MEDICAL | 2021-07-07 |
| 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/S686) | Medtronic, Inc. | 2021-07-07 |
| CERAMAX Ceramic Total Hip System (P070026/S082) | DePuy Orthopaedics, Inc. | 2021-07-07 |
| MiniMed 670G System, MiniMed 770G System (P160017/S092) | Medtronic Minimed, Inc. | 2021-07-07 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S320) | ABBOTT MEDICAL | 2021-07-07 |
| MiniMed 630G System (P150001/S091) | Medtronic Minimed | 2021-07-07 |
| Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S139) | ABBOTT MEDICAL | 2021-07-07 |