| Guardian Connect system (P160007/S023) | Medtronic Minimed | 2019-07-18 |
| MiniMed 670G System (P160017/S067) | Medtronic Minimed, Inc. | 2019-07-18 |
| ETI-MAK-2 Plus Assay (P990038/S029) | DiaSorin, Inc. | 2019-07-18 |
| ETI-AB-EBK Plus Assay (P990041/S028) | DiaSorin, Inc. | 2019-07-18 |
| MINIMED 630G SYSTEM WITH SMARTGUARD(TM) (P150001/S071) | Medtronic Minimed | 2019-07-18 |
| ETI-CORE-IGMK Plus Assay (P990044/S026) | DiaSorin, Inc. | 2019-07-18 |
| IPRO2 CGM SYSTEM WITH ENLITE SENSOR (P150029/S029) | Medtronic Minimed | 2019-07-18 |
| MINIMED 530G SYSTEM (P120010/S131) | Medtronic, Inc. | 2019-07-18 |
| PSW 1901.U (P070008/S101) | Biotronik, Inc. | 2019-07-18 |
| Senza Spinal Cord Stimulation (SCS) System (P130022/S023) | Nevro Corporation | 2019-07-18 |
| MiniMed 670G System (P160017/S062) | Medtronic Minimed, Inc. | 2019-07-18 |
| Momentum, Resonate, Autogen, and Dynagen (CRT-D) (P010012/S507) | Boston Scientific Corp | 2019-07-18 |
| SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System (P030011/S071) | Syncardia Systems, LLC | 2019-07-18 |
| MiniMed 630G System with SmartGuard (P150001/S066) | Medtronic Minimed | 2019-07-18 |
| Visionist and Valitude (CRT-P) (P030005/S187) | Guidant Corp. | 2019-07-18 |
| Amplia MRI and MRI Quad CRT-D, Brava CRT-D and Quad CRT-D, Claria MRI and MRI Quad CRT-D, Compia MRI and MRI Quad CRT-D, (P010031/S673) | Medtronic Cardiac Rhythm Disease Management | 2019-07-18 |
| Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, To (P980040/S104) | Johnson & Johnson Surgical Vision, Inc. | 2019-07-18 |
| MitraClip NT, NTR, and XTR Clip Delivery System (P100009/S032) | ABBOTT MEDICAL | 2019-07-18 |
| ETI-AB-COREK Plus Assay (P990045/S026) | DiaSorin, Inc. | 2019-07-18 |
| PARADIGM REAL-TIME REVEL SYSTEM (P150019/S056) | Medtronic Minimed | 2019-07-18 |
| HiResolution Bionic Ear System (P960058/S139) | Advanced Bionics | 2019-07-18 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S119) | Zoll Manufacturing Corporation | 2019-07-18 |
| GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS (P010032/S152) | ABBOTT MEDICAL | 2019-07-17 |
| Freestyle Bioprosthesis (P970031/S066) | Medtronic, Inc. | 2019-07-17 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S033) | Medinol, Ltd. | 2019-07-17 |
| Zephyr Endobronchial Valve (EBV) System (P180002/S008) | Pulmonx Corporation | 2019-07-17 |
| Mosaic Bioprosthesis (P990064/S079) | Medtronic, Inc. | 2019-07-17 |
| Avalus Bioprosthesis (P170006/S015) | Medtronic, Inc. | 2019-07-17 |
| Melody Transcatheter Pulmonary Valve (TPV) System (P140017/S015) | Medtronic, Inc. | 2019-07-17 |
| Hancock Valved Conduit (P870078/S046) | Medtronic, Inc. | 2019-07-17 |
| SURGIFOAM Absorbable Gelatin Sponge (P990004/S035) | Ferrosan Meidcal Devices A/S | 2019-07-17 |
| Hancock II Bioprosthesis (P980043/S071) | Medtronic, Inc. | 2019-07-17 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S018) | Medinol, Ltd. | 2019-07-17 |
| Hancock Valved Conduit (P790007/S061) | Medtronic Heart Valves | 2019-07-17 |
| LIFEPAK 1000 defibrillator (P160026/S007) | Physio-Control, Inc. | 2019-07-16 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S007) | Great Batch Medical | 2019-07-15 |
| Macroplastique Implants (P040050/S012) | Uroplasty, LLC | 2019-07-15 |
| Integra Meshed Dermal Regeneration Template (P900033/S081) | Integra Lifesciences Corp. | 2019-07-15 |
| Pipeline Flex Embolization Device (P100018/S021) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2019-07-15 |
| Genesis Neurostimulation System (P010032/S150) | ABBOTT MEDICAL | 2019-07-15 |
| LINX Reflux Mnagement System (P100049/S026) | Torax Medical | 2019-07-15 |
| Brio Neurostimulation System (P140009/S047) | ABBOTT MEDICAL | 2019-07-15 |
| MemoryGel Silicone Gel-Filled Breast Implants (P030053/S052) | Mentor Corp. | 2019-07-12 |
| Prestige LP Cervical Disc Two Level (P090029/S012) | Medtronic Sofamor Danek USA, Inc. | 2019-07-12 |
| MiniMed 630G System (P150001/S070) | Medtronic Minimed | 2019-07-12 |
| MiniMed 670G System (P160017/S066) | Medtronic Minimed, Inc. | 2019-07-12 |
| Cartiva Synthetic Cartilage Implant (P150017/S011) | Cartiva, Inc. | 2019-07-12 |
| XIENCE PRIME SV/LL Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIEN (P110019/S105) | Abbott Vascular | 2019-07-12 |
| XIENCE V Everolimus Eluting Coronary Stent Systemand XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S145) | Abbott Vascular, Inc. | 2019-07-12 |
| Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint (P050031/S005) | CooperVision, Inc. | 2019-07-11 |
| Lotus Edge Valve System (P180029/S005) | Boston Scientific Corporation | 2019-07-11 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S165) | Boston Scientific Corp | 2019-07-11 |
| 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, (P980016/S711) | Medtronic Cardiac Rhythm Disease Management | 2019-07-11 |
| Cartiva Synthetic Cartilage Implant (Cartiva SCI) (P150017/S010) | Cartiva, Inc. | 2019-07-11 |
| GORE CARDIOFORM ASD Occluder (P050006/S078) | W. L. Gore & Associates, Inc. | 2019-07-11 |
| Bard E-Luminexx Vascular Stent (P080007/S022) | Bard Peripheral Vascular, Inc. | 2019-07-11 |
| SURGICEL Powder Absorbable Hemostatic Powder (N12159/S058) | ETHICON, Inc. | 2019-07-11 |
| DuraSeal Dural Sealant System (P040034/S029) | Integra LifeSciences Corporation | 2019-07-11 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S598) | Medtronic, Inc. | 2019-07-11 |
| IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA (P930027/S021) | Siemens Healthcare Diagnostics, Inc. | 2019-07-11 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S410) | Medtronic, Inc. | 2019-07-11 |
| 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/S671) | Medtronic Cardiac Rhythm Disease Management | 2019-07-11 |
| DuraSeal Exact Spine Sealant System (P080013/S017) | Integra LifeSciences Corporation | 2019-07-11 |
| Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu (P870024/S051) | CooperVision, Inc. | 2019-07-11 |
| ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER (P020012/S030) | Tiger Aesthetics Medical, LLC | 2019-07-11 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S126) | Boston Scientific Corporation | 2019-07-11 |
| Implantable System for Remodulin (P140032/S032) | Medtronic, Inc. | 2019-07-10 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S009) | Physio-Control, Inc. | 2019-07-10 |
| Cordis Incraft AAA Stent Graft System (P150002/S005) | Cordis US Corporation | 2019-07-10 |
| MitraClip G4 System (P100009/S029) | ABBOTT MEDICAL | 2019-07-09 |
| MiniMed 670G (MMT-1780) System (P160017/S061) | Medtronic Minimed, Inc. | 2019-07-09 |
| HeartWare HVAD System (P100047/S138) | Medtronic | 2019-07-09 |
| MiniMed 630G System with SmartGuard (P150001/S065) | Medtronic Minimed | 2019-07-09 |
| Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S032) | Boston Scientific Corp | 2019-07-09 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE and PROPONENT Pacemaker Devices (N970003/S239) | Boston Scientific Corp | 2019-07-08 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT and PERCIVA CRT-D Res (P010012/S502) | Boston Scientific Corp | 2019-07-08 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST and VALITUDE (P030005/S182) | Guidant Corp. | 2019-07-08 |
| LATITUDE Programming System (P910077/S172) | Boston Scientific | 2019-07-08 |
| LATITUDE Programming System (P910077/S169) | Boston Scientific | 2019-07-08 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S498) | Boston Scientific Corp | 2019-07-08 |
| Pacemaker Devices: ADVANTIO, INEGNIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S236) | Boston Scientific Corp | 2019-07-08 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI PROPONENT MRI and ACCOLADE MRI (P150012/S076) | Boston Scientific | 2019-07-08 |
| Pacemaker Devices: INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S073) | Boston Scientific | 2019-07-08 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERCIVA ICD Devic (P960040/S437) | Boston Scientific | 2019-07-08 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S434) | Boston Scientific | 2019-07-08 |
| INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization Devices (P030005/S184) | Guidant Corp. | 2019-07-08 |
| Bellafill Dermal Filler (P020012/S031) | Tiger Aesthetics Medical, LLC | 2019-07-08 |
| Obalon Balloon System with Navigation and Touch (P160001/S031) | Medtimo, Inc. | 2019-07-05 |
| Activa Deep Brain Stimulation Therapy System (P960009/S352) | Medtronic, Inc. | 2019-07-05 |
| Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimu (P840001/S437) | Medtronic Neuromodulation | 2019-07-05 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S333) | Medtronic, Inc. | 2019-07-05 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel) (P080025/S186) | Medtronic Neuromodulation | 2019-07-05 |
| HeartWare Ventricular Assist System (P100047/S141) | Medtronic | 2019-07-05 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S291) | Medtronic Neuromodulation | 2019-07-05 |
| Implantable System for Remodulin (P140032/S035) | Medtronic, Inc. | 2019-07-05 |
| SpinalStim (P850007/S042) | Orthofix, Inc. | 2019-07-03 |
| Obalon Touch Dispenser (P160001/S040) | Medtimo, Inc. | 2019-07-03 |
| Prometra Programmable Infusion Pump System (P080012/S058) | Infusyn Therapeutics, LLC | 2019-07-03 |
| HiResolution Bionic Ear System (P960058/S140) | Advanced Bionics | 2019-07-03 |
| Juvederm Injectable Gel Implants (P110033/S044) | Allergan | 2019-07-03 |