| Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (K192318) | Bard Peripheral Vascular, Inc. | 2019-10-03 |
| Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (K191444) | Medtronic, Inc. | 2019-09-27 |
| Sterile Dilator (K192195) | Galt Medical Corp. | 2019-09-26 |
| LifeWindow LW8 Lite (K183687) | Digicare Biomedical Technology, Inc. | 2019-09-25 |
| Patient Assistant Model PA97000 (K190574) | Medtronic, Inc. | 2019-09-24 |
| T-Stat 2.0 Microvascular Tissue Oximeter (K192322) | Spectros Corporation | 2019-09-23 |
| ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath (K192332) | Inari Medical | 2019-09-20 |
| Medtronic 6F Taiga Guiding Catheter (K192296) | Medtronic Vascular | 2019-09-20 |
| Sapphire NC Plus Coronary Dilatation Catheter (K192344) | Orbusneich Medical Trading, Inc. | 2019-09-19 |
| Advisor VL Circular Mapping Catheter, Sensor Enabled (K192037) | ABBOTT MEDICAL | 2019-09-17 |
| Reusable NIBP Cuff (K191253) | Shenzhen Changke Connect Electronics Co., Ltd. | 2019-09-17 |
| Full Automatic (NIBP) Blood Pressure Monitor (K190507) | Health & Life Co., Ltd. | 2019-09-16 |
| Intra.Ox 2.0 Handheld Tissue Oximeter (K191676) | Vioptix, Inc. | 2019-09-16 |
| ACIST RXi System and Navvus II Catheter (K190473) | Acist Medical Systems, Inc. | 2019-09-13 |
| Multi-Link X2 ECG and SpO2 Adapter (K191273) | Vyaire Medical, Inc. | 2019-09-13 |
| Pulse Oximeter (K190869) | Shenzhen Aeon Technology Co., Ltd. | 2019-09-13 |
| Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire (K191419) | Rex Medical, L.P. | 2019-09-12 |
| PeraMobile and PeraWatch (K183370) | Perahealth, Inc. | 2019-09-11 |
| CNAP Monitor (K183521) | Cnsystems Medizintechnik GmbH | 2019-09-11 |
| External Counterpulsation System (K190683) | Vamed Medical Instrument Co., Ltd. | 2019-09-10 |
| SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes (K183574) | Huntleigh Healthcare , Ltd. | 2019-09-06 |
| Steerable catheter control system (K183027) | Stereotaxis, Inc. | 2019-09-06 |
| AcQMap High Resolution Imaging and Mapping System (K191392) | Acutus Medical, Inc. | 2019-09-06 |
| FlowTriever Retrieval/Aspiration System (K191710) | Inari Medical | 2019-09-05 |
| AcQRef Introducer Sheath (K192106) | Acutus Medical, Inc. | 2019-09-03 |
| Geomed Vascular Dilators (K183438) | Geomed Medizin-Technik GmbH & Co. | 2019-09-03 |
| EV1000 Clinical Platform NI, EV1000 Clinical Platform (K192058) | Edwards Lifesciences, LLC | 2019-08-30 |
| SelectFlex 072 Neurovascular Access System (K191664) | Q'Apel Medical | 2019-08-30 |
| Carnation Ambulatory Monitor (K191471) | Bardy Diagnostics, Inc. | 2019-08-30 |
| HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (K190205) | Edwards Lifesciences, LLC | 2019-08-29 |
| ClotTriever Thrombectomy System (K192036) | Inari Medical | 2019-08-29 |
| B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter (K182401) | Amzetta Technologies Private Limited | 2019-08-28 |
| Delta 3300 (K190437) | Netech Corporation | 2019-08-28 |
| Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor (K191077) | Medtronic, Inc. | 2019-08-27 |
| Plexus (K191107) | Alleva Medical (D.G), Ltd. | 2019-08-27 |
| EkoSonic Endovascular Device (K191119) | Btg International, Inc. | 2019-08-23 |
| Zio XT ECG Monitoring System, Zio AT ECG Monitoring System (K190593) | iRhythm Technologies, Inc. | 2019-08-23 |
| Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter (K190127) | Innovative Health, LLC | 2019-08-23 |
| Electronic Blood Pressure Monitor (K191180) | Shenzhen AOJ Medical Technology Co., Ltd. | 2019-08-23 |
| BB-613WP (K190792) | Biobeat Technologies , Ltd. | 2019-08-22 |
| Bendit2.7 Steerable Microcatheter (K190126) | Bend IT Technologies, Ltd. | 2019-08-22 |
| Blood Pressure Monitor (K190207) | Shenzhen Viatom Technology Co., Ltd. | 2019-08-19 |
| Biovitals Analytics Engine (K183282) | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| HeartFlow FFRct Analysis (K190925) | HeartFlow, Inc. | 2019-08-15 |
| Zurich Pressure Guidewire System Model 100 (K190852) | Zurich Medical, Inc. | 2019-08-14 |
| Instylla Microcatheter (K191731) | Instylla, Inc. | 2019-08-13 |
| Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP Catheter (K191560) | Vascular Solutions, LLC | 2019-08-09 |
| Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle (K191114) | Avenu Medical | 2019-08-09 |
| Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead (K190716) | Medtronic | 2019-08-08 |
| Non-invasive Hemodynamic Blood Pressure Monitor (K190893) | Vita-Course Technologies Co., Ltd. | 2019-08-07 |
| RenovoCath (K191606) | Renovorx, Inc. | 2019-08-07 |
| Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (K191840) | Shockwave Medical, Inc. | 2019-08-07 |
| 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set (K191871) | Boston Scientific Corporation | 2019-08-07 |
| Revolution Centrifugal Blood Pump (K190650) | Sorin Group Italia S.R.L. | 2019-08-07 |
| M3290B Patient Information Center iX (K183387) | Philips Medical Systems | 2019-08-06 |
| EmboCube Embolization Gelatin (K183120) | Biosphere Medical, S.A. | 2019-08-06 |
| Beddr 200 System (K190399) | Hancock Medical, Inc. | 2019-08-05 |
| Crossing Support Catheter (K183305) | Tractus Vascular, LLC | 2019-08-05 |
| Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor (K181154) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2019-08-02 |
| DynoSense Vital Sign Measuring System (K190090) | Dynosense Corp. | 2019-08-02 |
| 046 Zenith Flex (K190338) | Inneuroco, Inc. | 2019-08-02 |
| Epicardial Access System (K191546) | Baylis Medical Company, Inc. | 2019-08-02 |
| MINAMO (K190176) | Asahi Intecc Co., Ltd. | 2019-08-01 |
| Steerable Introducer (K191190) | Freudenberg Medical, LLC | 2019-08-01 |
| Biotronik Stylets (K191469) | Biotronik, Inc. | 2019-08-01 |
| Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K183547) | Medtronic | 2019-07-30 |
| Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter (K190132) | Medtronic | 2019-07-30 |
| AXS Vecta Aspiration System (K191768) | Stryker Neurovascular | 2019-07-30 |
| Non-invasive blood pressure measurement systems (K190886) | Joytech Healthcare Co. , Ltd. | 2019-07-29 |
| ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (K191714) | Asahi Intecc Co., Ltd. | 2019-07-26 |
| Passio Pump Drainage System (K190292) | Bearpac Medical | 2019-07-25 |
| The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model (K183066) | Access Scientific, LLC | 2019-07-25 |
| Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (K191173) | Abbott Vascular | 2019-07-25 |
| Roadrunner PC Wire Guide, Olcott Torque Device (K182985) | Cook Incorporated | 2019-07-22 |
| Digital Automatic Blood Pressure Monitor MD36 Series (K191593) | Grandway Technology (Shenzhen) Limited | 2019-07-22 |
| Plexus SCD110 Sequential Compression Device Sleeve (K190975) | Midway Medical, LLC | 2019-07-22 |
| CerusEndo Microcatheter (K182487) | Cerus Endovascular, Inc. | 2019-07-20 |
| CARTO 3 EP Navigation System, Version 7.1 and Accessories (K191660) | Biosense Webster, Inc. | 2019-07-20 |
| AeroDVx System (K183349) | Sun Scientific, Inc. | 2019-07-19 |
| ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (K191060) | Acist Medical Systems, Inc. | 2019-07-18 |
| Impress Angiographic Catheter (K191608) | Merit Medical Systems, Inc. | 2019-07-16 |
| 087 Balloon Guide Catheter System (K190749) | Q'Apel | 2019-07-15 |
| Radial Medical Compression System (K190976) | Radial Medical, Inc. | 2019-07-12 |
| Wearable Device, Wearable Package (K191272) | Current Health , Ltd. | 2019-07-12 |
| Scepter Mini Occlusion Balloon Catheter (K182829) | MicroVention, Inc. | 2019-07-10 |
| CentriMag Acute Circulatory Support System (K191557) | Thoratec Corporation (Now Part of Abbott) | 2019-07-10 |
| physIQ Heart Rhythm and Respiratory Module (K183322) | Physiq, Inc. | 2019-07-10 |
| Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) (K190011) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2019-07-10 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K190818) | Microlife Intellectual Property GmbH | 2019-07-10 |
| LifeSPARC Pump, LifeSPARC Controller (K183623) | Cardiacassist, Inc. | 2019-07-09 |
| AngioVac C20, AngioVac C180 (K190594) | AngioDynamics, Inc. | 2019-07-05 |
| BIOMONITOR III, Remote Assistant III (K190548) | Biotronik, Inc. | 2019-07-05 |
| Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors (K191018) | Surgical Instrument Service and Savings, Inc. | 2019-07-03 |
| Arm-type Electronic Blood Pressure Monitor (K183058) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019-07-03 |
| iLab Polaris Multi-Modality Guidance System (K191008) | Boston Scientific Corporation | 2019-07-02 |
| Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (K190634) | Cardiovascular Systems, Inc. | 2019-07-02 |
| Site Seal SV (K190351) | Ensite Vascular | 2019-07-02 |
| Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K190980) | Innovative Health, LLC | 2019-07-01 |
| ASAHI Silverway (K183062) | Asahi Intecc Co., Ltd. | 2019-07-01 |
| Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (K190475) | Centerpoint Systems | 2019-06-28 |