| Therapy Cool Path Duo Ablation Catheter (P110016/S066) | ABBOTT MEDICAL | 2020-03-04 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S075) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter (P040014/S038) | Irvine Biomedical, Inc. | 2020-03-04 |
| M6-C Artificial Cervical Disc (P170036/S005) | Spinal Kinetics, LLC | 2020-03-04 |
| cobas HPV Test (P100020/S049) | Roche Molecular Systems, Inc. | 2020-03-04 |
| Surgicel Powder Absorbable Hemostatic Powder (N12159/S068) | ETHICON, Inc. | 2020-03-04 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S078) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Gore Excluder AAA Endoprosthesis (P020004/S173) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| T-SPOT. TB Test (P070006/S012) | Oxford Immunotec, Ltd. | 2020-03-03 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera (P980035/S617) | Medtronic, Inc. | 2020-03-03 |
| HeartWare Ventricular Assist System (P100047/S153) | Medtronic | 2020-03-03 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S066) | Boston Scientific Corp | 2020-03-02 |
| Inspire II Upper Airway Stimulator (P130008/S051) | Inspire Medical Systems | 2020-03-02 |
| PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS Premier Everolimus-Eluting Platinum Chro (P110010/S175) | Boston Scientific Corp | 2020-03-02 |
| Adapta, Versa, Sensia, IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S614) | Medtronic, Inc. | 2020-03-02 |
| Freezor Cardiac Cryoablation Catheter (P020045/S092) | Medtronic Cryocath, LP | 2020-03-02 |
| RADIESSE Injectable Implant (P050037/S100) | Merz North America, Inc. | 2020-03-02 |
| 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/S689) | Medtronic Cardiac Rhythm Disease Management | 2020-03-02 |
| Express SD Premounted Renal Stent System (P060006/S099) | Boston Scientific Corp | 2020-03-02 |
| Express LD Premounted Iliac Stent System (P090003/S049) | Boston Scientific Corporation | 2020-03-02 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S426) | Medtronic, Inc. | 2020-03-02 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S033) | Lutonix | 2020-03-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera VR ICD, Intrinsic 30 ICD, Marq (P980016/S728) | Medtronic Cardiac Rhythm Disease Management | 2020-03-02 |
| Synergyst II Pulse Generator (P890003/S425) | Medtronic, Inc. | 2020-03-02 |
| Micra TPS (P150033/S065) | Medtronic, Inc. | 2020-03-02 |
| RADIESSE Injectable Implant and RADIESSE (+) Lidocaine Dermal Filler (P050052/S117) | Merz North America, Inc. | 2020-03-02 |
| NovaSure Impedance Controlled Endometrial Ablation System (P010013/S075) | Hologic, Inc. | 2020-03-02 |
| Powerheart G3 Pro Automated External Defibrillator (P160034/S002) | ZOLL Medical Corporation | 2020-03-01 |
| Restore, Itrel, Synergy, and Intellis Spinal Cord Stimulation System and Pisces, Specify, and Vectris Spinal Cord Stimul (P840001/S455) | Medtronic Neuromodulation | 2020-03-01 |
| Fortify, Fortify Assura, and Ellipse (P910023/S425) | ABBOTT MEDICAL | 2020-02-28 |
| Axonics Sacral Neuromodulation (SNM) System (P190006/S005) | Boston Scientific Corporation | 2020-02-28 |
| Impella CP with SmartAssist (P140003/S069) | Abiomed, Inc. | 2020-02-28 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S312) | ABBOTT MEDICAL | 2020-02-28 |
| GORE VIATORR TIPSEndoprosthesis product family (P040027/S074) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| Medtronic CoreValve Evolut R, Medtronic CoreValve Evolut PRO, and Medtronic Evolut PRO+ transcatheter aortic valves (TAV (P130021/S071) | Medtronic, Inc. | 2020-02-28 |
| Tecnis Multifocal Toric II Intraocular Lenses (IOL) (P980040/S107) | Johnson & Johnson Surgical Vision, Inc. | 2020-02-28 |
| OPTIMIZER Smart IPG (P180036/S004) | Impulse Dynamics (Usa), Inc. | 2020-02-28 |
| Apollo Onyx Delivery Micro Catheter (P030004/S023) | Ev3 Neurovascular | 2020-02-28 |
| GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P130006/S073) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S024) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P040037/S134) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S012) | Euclid Vision Corporation | 2020-02-28 |
| Propel (P100044/S043) | Intersect Ent. | 2020-02-28 |
| Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI (P140033/S055) | ABBOTT MEDICAL | 2020-02-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet (P030054/S376) | ABBOTT MEDICAL | 2020-02-28 |
| AED 3 defibrillator (P160015/S001) | ZOLL Medical Corporation | 2020-02-28 |
| Microny (P970013/S083) | ABBOTT MEDICAL | 2020-02-28 |
| Sculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid) (P030050/S031) | Q-Med AB | 2020-02-28 |
| Axonics Sacral Neuromodulation (SNM) System (P180046/S005) | Boston Scientific Corporation | 2020-02-28 |
| Allure, Allure Quadra, and Quadra Allure MP (P030035/S180) | ABBOTT MEDICAL | 2020-02-28 |
| Gelfoam (absorbable gelatin) Sterile Sponge (N18286/S034) | Pfizer, Inc. | 2020-02-27 |
| PD-L1 IHC 22C3 PharmDx (P150013/S018) | Agilent Technologies, Inc. | 2020-02-27 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System (P130013/S036) | Boston Scientific Corp | 2020-02-27 |
| DEFLUX Injectable Gel (P000029/S088) | Palette Life Sciences | 2020-02-27 |
| Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II (P160019/S010) | Roche Diagnostics, Inc. | 2020-02-27 |
| Restylane Injectable Gels (P040024/S118) | Q-Med AB | 2020-02-27 |
| Solesta Injectable Gel (P100014/S025) | Palette Life Sciences | 2020-02-27 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S027) | Boston Scientific Corp | 2020-02-27 |
| Sculptra (injectable poly-L Lactic acid) and Sculptra Aesthetic (injectable poly-L Lactic acid) (P030050/S030) | Q-Med AB | 2020-02-27 |
| Navistar DS Electrophysiology Catheter (P010068/S058) | Biosense Webster, Inc. | 2020-02-26 |
| Navistar Electrophysiology Catheter (P990025/S058) | Biosense Webster, Inc. | 2020-02-26 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S037) | ABBOTT MEDICAL | 2020-02-26 |
| Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog (P950005/S073) | Biosense Webster, Inc. | 2020-02-26 |
| EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter, (P030031/S101) | Biosense Webster, Inc. | 2020-02-26 |
| THxID-BRAF assay kit (P120014/S010) | bioMerieux, Inc. | 2020-02-26 |
| AcrySof IQ Vivity Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A (P930014/S126) | Alcon Laboratories, Inc. | 2020-02-26 |
| Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology (P040036/S069) | Biosense Webster, Inc. | 2020-02-26 |
| WOLVERINE Coronary Cutting Balloon (Over-The-Wire and Monorail) (P950020/S102) | Boston Scientific Corp | 2020-02-24 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S103) | Medtronic Cryocath, LP | 2020-02-24 |
| Durata and Optisure (P950022/S129) | ABBOTT MEDICAL | 2020-02-24 |
| Esteem (P090018/S039) | Envoy Medical Corporation | 2020-02-24 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S028) | Cardiovascular Systems, Inc. | 2020-02-24 |
| LIFEPAK 15 monitor/defibrillator (P160026/S012) | Physio-Control, Inc. | 2020-02-21 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S174) | Boston Scientific Corp | 2020-02-21 |
| Nucleus Hybrid L24 Cochlear Implant System (P130016/S043) | Cochlear Americas | 2020-02-21 |
| LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers (P180039) | DiaSorin, Inc. | 2020-02-21 |
| Nucleus Cochlear Implant System (C124RE and C1500) (P970051/S195) | Cochlear Americas | 2020-02-21 |
| C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens and RayOne Aspheric (P060011/S019) | Rayner Intraocular Lenses , Ltd. | 2020-02-21 |
| Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify and Vectris Spinal Cord Stimulation Lead (P840001/S454) | Medtronic Neuromodulation | 2020-02-20 |
| Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 (P050028/S081) | Roche Molecular Systems, Inc. | 2020-02-20 |
| Epic Vascular Self-Expanding Stent System (P110035/S055) | Boston Scientific Corp | 2020-02-20 |
| Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 (P060030/S082) | Roche Molecular Systems, Inc. | 2020-02-20 |
| In.Pact AV Paclitaxel-Coated PTA Balloon Catheter (P190008/S002) | Medtronic Vascular, Inc. | 2020-02-20 |
| HeartLight System (P150026/S010) | Cardiofocus, Inc. | 2020-02-20 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S026) | Boston Scientific Corp | 2020-02-20 |
| WOLVERINE Coronary Cutting Balloon (P950020/S101) | Boston Scientific Corp | 2020-02-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S054) | Boston Scientific Corporation | 2020-02-20 |
| In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S049) | Medtronic, Inc. | 2020-02-20 |
| EXCOR IKUS Driver (P160035/S008) | Berlin Heart, Inc. | 2020-02-20 |
| NeuroPace RNS System (P100026/S069) | NeuroPace, Inc. | 2020-02-20 |
| Cobas AmpliPrep/Cobas TaqMan CMV Test (P110037/S052) | Roche Molecular Systems, Inc. | 2020-02-20 |
| Restylane Refyne and Restylane Defyne Injectable Gels (P140029/S023) | Q-Med AB | 2020-02-20 |
| IntellaNav ST Temperature Ablation Catheter (P920047/S121) | Boston Scientific Corp | 2020-02-19 |
| IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters (P020025/S125) | Boston Scientific | 2020-02-19 |
| InterStim Therapy System and Verify Evaluation System (SNS Urinary) (P970004/S292) | Medtronic Neuromodulation | 2020-02-19 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Open-Irrigated Ablation Catheters (P150005/S052) | Boston Scientific Corp | 2020-02-19 |
| Mobi-C Cervical Disc Prosthesis (P110009/S023) | Highridge Medical, LLC | 2020-02-18 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD Systems (P140003/S059) | Abiomed, Inc. | 2020-02-18 |
| PyloPlus UBT System (P170022) | Arj Medical, Inc. | 2020-02-18 |
| HeartWare Ventricular Assist System (P100047/S152) | Medtronic | 2020-02-18 |