| Maestro 4000 Controller (P980003/S087) | Boston Scientific Corp | 2019-01-28 |
| Model 4340 Respiratory Sensing Lead (P130008/S031) | Inspire Medical Systems | 2019-01-28 |
| Eversense Continuous Glucose Monitoring System (P160048/S008) | Senseonics, Incorporated | 2019-01-28 |
| Maestro 4000 Controller (P920047/S110) | Boston Scientific Corp | 2019-01-28 |
| Maestro 4000 Controller (P020025/S113) | Boston Scientific | 2019-01-28 |
| Zephyr Endobronchial Valve System (P180002/S004) | Pulmonx Corporation | 2019-01-28 |
| MetriQ Pump (P150005/S039) | Boston Scientific Corp | 2019-01-28 |
| Maestro Rechargeable System (P130019/S017) | Reshape Lifesciences, Inc. | 2019-01-25 |
| Obalon Balloon System (P160001/S021) | Medtimo, Inc. | 2019-01-25 |
| Maestro Rechargeable System (P130019/S018) | Reshape Lifesciences, Inc. | 2019-01-25 |
| Model 3028 Implantable Pulse Generator (P130008/S037) | Inspire Medical Systems | 2019-01-24 |
| ARCHITECT Anti-HCV Reagent Kit (P050042/S038) | Abbott Laboratories, Inc. | 2019-01-24 |
| Arista AH; Arista AH Absorbable Hemostat (P050038/S032) | Davol, Inc. | 2019-01-24 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD (P110042/S121) | Boston Scientific Corporation | 2019-01-23 |
| Cardiac Resynchronization Therapy Defibrillators (CRT-D) Origen, Inogen, Dynagen, Autogen and Momentum CRT-D (P010012/S495) | Boston Scientific Corp | 2019-01-23 |
| BOND Oracle HER2 IHC System (P090015/S006) | Leica Biosystems | 2019-01-23 |
| Implantable Cardioverter Defibrillator (ICD) Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate and Perciva (P960040/S432) | Boston Scientific | 2019-01-23 |
| Mi1210 SYNCHRONY ST Cochlear Implant (P000025/S103) | Med-El Corp. | 2019-01-22 |
| Consulta , Syncra and Viva CRT-P (P010015/S389) | Medtronic, Inc. | 2019-01-22 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S005) | Physio-Control, Inc. | 2019-01-22 |
| SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (P860004/S319) | Medtronic, Inc. | 2019-01-18 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S015) | ABBOTT MEDICAL | 2019-01-18 |
| HEMOBLAST Bellows Laparoscopic Applicator (P170012/S007) | Dilon Technologies, Inc. | 2019-01-18 |
| Vercise PC/Gevia DBS System (P150031/S002) | Boston Scientific Corp | 2019-01-18 |
| Lap-Band Adjustable Gastric Banding System (P000008/S046) | Medtimo, Inc. | 2019-01-18 |
| SUPARTZ FX; VISCO-3 (P980044/S051) | Seikagaku Corp. | 2019-01-18 |
| EGFR pharmDx (P030044/S006) | Agilent Technologies, Inc. | 2019-01-17 |
| CardioMEMS HF (Heart Failure) System (P100045/S034) | ABBOTT MEDICAL | 2019-01-17 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S058) | Boston Scientific Corp | 2019-01-17 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S161) | Boston Scientific Corp | 2019-01-17 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S005) | Celonova Biosciences, Inc. | 2019-01-17 |
| Biocor, Biocor Supra, Epic, Epic Supra Valves (P040021/S037) | ABBOTT MEDICAL | 2019-01-17 |
| PD-L1 IHC 22C3 pharmDx (P150013/S013) | Agilent Technologies, Inc. | 2019-01-17 |
| Angio Seal Vascular Closure Device (P930038/S090) | Terumo Medical Corporation | 2019-01-17 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S013) | Medtronic Vascular | 2019-01-17 |
| PD-L1 IHC 28-8 pharmDx (P150025/S010) | Agilent Technologies, Inc. | 2019-01-17 |
| Spinal Cord Stimulation (SCS) Leads, Extensions and Adapters (P010032/S146) | ABBOTT MEDICAL | 2019-01-16 |
| SynchroMed Infusion System, Ascenda Intrathecal Catheters (P860004/S323) | Medtronic, Inc. | 2019-01-16 |
| VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S104) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-01-16 |
| Synvisc One (P940015/S044) | Sanofi Genzyme Corp. | 2019-01-16 |
| LifeVest Wearable Defibrillator (P010030/S112) | Zoll Manufacturing Corporation | 2019-01-16 |
| Infinity Deep Brain Stimulation (DBS) Leads, Extensions and Adapters (P140009/S044) | ABBOTT MEDICAL | 2019-01-16 |
| AMS Ambicor Inflatable Penile Prosthesis (IPP) (N970012/S151) | Boston Scientific Corp | 2019-01-15 |
| TECNIS 3-Piece Acrylic Monofocal (P990080/S047) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| Infuse Bone Graft/Medtronic Interbody Fusion Device (P000058/S071) | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 |
| SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Exten (P980040/S097) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses (P040045/S103) | Vistakon, Division of Johnson & Johnson Vision Car | 2019-01-15 |
| TECNIS 3-Poece Multifocal (P080010/S017) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| AspireAssist (P150024/S010) | Aspire Bariatrics, Inc. | 2019-01-15 |
| SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Exten (P980040/S096) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| Infuse Bone Graft (P000054/S052) | Medtronic Sofamor Danek USA, Inc. | 2019-01-15 |
| TECNIS 3-Piece Acrylic Monofocal (P990080/S048) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| TECNIS 3-Poece Multifocal (P080010/S016) | Johnson & Johnson Surgical Vision, Inc. | 2019-01-15 |
| Eversense Continuous Glucose Monitoring System (P160048/S007) | Senseonics, Incorporated | 2019-01-15 |
| Infuse Bone Graft (P050053/S043) | Medtronic, Inc. | 2019-01-15 |
| Nevisense (P150046/S002) | Scibase AB | 2019-01-14 |
| HiResolution Bionic Ear System (P960058/S135) | Advanced Bionics | 2019-01-11 |
| AMPLATZER Piccolo Occluder (P020024/S052) | ABBOTT MEDICAL | 2019-01-11 |
| Biofinity XR Toric (comfilcon A) (P080011/S086) | CooperVision, Inc. | 2019-01-11 |
| HEMOBLAST Bellows (P170012/S013) | Dilon Technologies, Inc. | 2019-01-11 |
| Obalon Touch Dispenser (P160001/S027) | Medtimo, Inc. | 2019-01-11 |
| Synvisc and Synvisc-One (P940015/S043) | Sanofi Genzyme Corp. | 2019-01-10 |
| Fineline II Lead Family (P960004/S087) | Boston Scientific | 2019-01-10 |
| Ingevity Lead Family (passive fixation models) (P150012/S069) | Boston Scientific | 2019-01-10 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S058) | ABBOTT MEDICAL | 2019-01-10 |
| EasyTrak II Lead Family (P010012/S493) | Boston Scientific Corp | 2019-01-10 |
| Therapy Ablation Catheters (P040014/S035) | Irvine Biomedical, Inc. | 2019-01-10 |
| Innova Vascular Self-Expanding Stent System (P140028/S036) | Boston Scientific Corporation | 2019-01-10 |
| Rotapro Rotational Atherectomy System (P900056/S174) | Boston Scientific Corp | 2019-01-10 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter (P960016/S076) | St Jude Medical | 2019-01-10 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S657) | Medtronic Cardiac Rhythm Disease Management | 2019-01-10 |
| Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S041) | Irvine Biomedical,Inc.(Ibi) | 2019-01-10 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators (P060019/S044) | Irvine Biomedical, Inc. | 2019-01-10 |
| Therakos CELLEX Procedural Kit (P860003/S100) | Therakos Development Limited | 2019-01-10 |
| Vercise PC DBS System / Vercise Gevia DBS System (P150031/S001) | Boston Scientific Corp | 2019-01-10 |
| TactiCath Quartz Set (P130026/S037) | St Jude Medical | 2019-01-10 |
| AngioJet Rheolytic Thrombectomy System (P980037/S072) | Boston Scientific Corp | 2019-01-10 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S028) | ETHICON, Inc. | 2019-01-10 |
| Reliance 4-Front Lead Family (passive fixation models) (P910073/S152) | Boston Scientific | 2019-01-10 |
| Propel Family of Sinus Implants (P100044/S036) | Intersect Ent. | 2019-01-10 |
| HiResolution Bionic Ear System (P960058/S134) | Advanced Bionics | 2019-01-09 |
| Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I (P910077/S167) | Boston Scientific | 2019-01-09 |
| Stimulator, Hypoglossal Nerve, Implanted, Apnea (P130008/S038) | Inspire Medical Systems | 2019-01-09 |
| 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/S650) | Medtronic Cardiac Rhythm Disease Management | 2019-01-09 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI (P150005/S041) | Boston Scientific Corp | 2019-01-09 |
| IntellaNav ST (P920047/S112) | Boston Scientific Corp | 2019-01-09 |
| 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/S692) | Medtronic Cardiac Rhythm Disease Management | 2019-01-09 |
| Impella CP System (P140003/S028) | Abiomed, Inc. | 2019-01-09 |
| IntellaNav XP and MiFI XP (P020025/S115) | Boston Scientific | 2019-01-09 |
| Syncardia Temporary Total Artificial Heart (TAH-T) system (P030011/S066) | Syncardia Systems, LLC | 2019-01-09 |
| Access Hybritech p2PSA Reagent Pack (P090026/S023) | Beckman Coulter, Inc. | 2019-01-09 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S072) | Hologic, Inc. | 2019-01-09 |
| Amplatzer Duct Occluder/Amplatzer Duct Occluder II (P020024/S053) | ABBOTT MEDICAL | 2019-01-08 |
| Implantable System for Remodulin (P140032/S023) | Medtronic, Inc. | 2019-01-08 |
| InterStim Therapy System, Verify Evaluation System (SNS Urinary Neurostimulator Implantable InterStim) (P970004/S281) | Medtronic Neuromodulation | 2019-01-08 |
| Activa Deep Brain Stimulation Therapy System (P960009/S334) | Medtronic, Inc. | 2019-01-08 |
| SynchroMed Infusion System and Ascenda Intrathecal Catheters (P860004/S322) | Medtronic, Inc. | 2019-01-08 |
| Amplatzer PFO Occluder (P120021/S009) | ABBOTT MEDICAL | 2019-01-08 |
| InterStim Therapy System and Verify Evaluation System (SNS Bowel Neurostimulators Implantable InterStim) (P080025/S176) | Medtronic Neuromodulation | 2019-01-08 |
| HeartMate 3 Left Ventricular Assist System (P160054/S016) | ABBOTT MEDICAL | 2019-01-08 |