| DuraSheath Introducer Sheath System (K181463) | Contract Medical International, GmbH | 2018-12-13 |
| Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series (K182397) | Cardiovascular Systems, Inc. | 2018-12-13 |
| Selectra Catheters, Selectra Accessory Kit (K183265) | Biotronik, Inc. | 2018-12-13 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K183128) | Abbott | 2018-12-12 |
| BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) (K182075) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2018-12-10 |
| Route 92 Medical Delivery Catheter (K182512) | Route 92 Medical, Inc. | 2018-12-10 |
| Tractus Crossing Support Catheter (K180889) | Tractus Vascular, LLC | 2018-12-07 |
| Unity Network ID (K183116) | GE Healthcare | 2018-12-06 |
| FFRct (K182035) | HeartFlow, Inc. | 2018-12-06 |
| Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection (K181529) | Contego Medical, LLC | 2018-12-06 |
| ZOLL Propaq M (K180482) | ZOLL Medical Corporation | 2018-11-30 |
| EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System (K182245) | Edwards Lifesciences, LLC | 2018-11-30 |
| Arterial Pressure Monitoring Set/Tray (K180792) | Cook Incorporated | 2018-11-30 |
| Prizma (K173589) | G-Medical Innovations , Ltd. | 2018-11-30 |
| AS-3XX Series Fingertip Pulse Oximeter (K180685) | Xiamen Acurio Instruments Co., Ltd. | 2018-11-29 |
| FlexCath Advance Steerable Sheath and Dilator (K183174) | Medtronic Cryocath, LP | 2018-11-26 |
| Selethru PTCA Balloon Dilatation Catheter (K182699) | Kossel Medtech (Suzhou) Co., Ltd. | 2018-11-26 |
| EkoSonic Endovascular System (K182324) | Btg International, Inc. | 2018-11-26 |
| Digistat Smart Central (K180430) | Ascom Ums Srl Unipersonale | 2018-11-23 |
| Visor System (K182967) | Cerebrotech Medical Systems, Inc. | 2018-11-23 |
| Heli-FX EndoAnchor System (K182957) | Medtronic Vascular, Inc. | 2018-11-21 |
| AI-ECG Platform (K180432) | Shenzhen Carewell Electronics., Ltd. | 2018-11-19 |
| Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr (K182916) | Lemaitre Vascular | 2018-11-16 |
| PureFlex Arterial Cannulae (K180979) | Sorin Group Italia S.R.L. | 2018-11-16 |
| HemoSphere Advanced Monitor, HemoSphere Pressure Cable (K180881) | Edwards Lifesciences, LLC | 2018-11-16 |
| CardioBand ECG Event Recorder (K181998) | Samsung Strategy and Innovation Center (Ssic) | 2018-11-15 |
| Reprocessed Marinr Diagnostic EP Catheter (K181897) | Innovative Health, LLC | 2018-11-15 |
| IntelliVue Multi-Measurement Module MMX (K181831) | Philips Medizin Systeme Boeblingen GmbH | 2018-11-15 |
| Riptide Aspiration System (React 71 Catheter) (K182101) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 |
| React 71 Catheter (K182097) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2018-11-14 |
| Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (K182543) | Snap40, Ltd. | 2018-11-14 |
| Handheld Pulse Oximeter, Model SP-20 (K172792) | Shenzhen Creative Industry Co., Ltd. | 2018-11-13 |
| HEM-6410T-ZM Wrist Blood Pressure Monitor (K182481) | Omron Healthcare, Inc. | 2018-11-09 |
| Teleport Microcatheter (K182360) | Orbusneich Medical Trading, Inc. | 2018-11-09 |
| VAMP Plus Venous/Arterial Blood Management Protection System (K181684) | Edwards Lifesciences, LLC | 2018-11-08 |
| CardioInsight Cardiac Mapping System (K181918) | Medtronic, Inc. | 2018-11-08 |
| Wrist Blood Pressure Monitor Model BP4350 (K182166) | Omron Healthcare, Inc. | 2018-11-08 |
| Faros Mobile (K182030) | Bittium Biosignals , Ltd. | 2018-11-08 |
| Curbell branded Patient Monitoring Cables (K182220) | Curbell Medical Products, Inc. | 2018-11-07 |
| Günther Tulip® Vena Cava Filter Retrieval Set (K181757) | Cook Incorporated | 2018-11-06 |
| Finapres Nova Noninvasive Hemodynamic Monitor (K173916) | Finapres Medical Systems B.V. | 2018-11-06 |
| MiniGuard Arterial Safety Valve (K182442) | Quest Medical, Inc. | 2018-11-06 |
| CDI Blood Parameter Monitoring System 550 (K182110) | Terumo Cardiovascular Systems Corporation | 2018-11-02 |
| Wrist Blood Pressure Monitor Model BP6100 (K182127) | Omron Healthcare, Inc. | 2018-11-02 |
| MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT (K182273) | Bayer Medical Care, Inc. | 2018-11-01 |
| MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit (K182276) | Bayer Medical Care, Inc. | 2018-11-01 |
| MC3 Vascular Access Kit 21030 (K182914) | Mc3 Incorporated | 2018-10-29 |
| Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter (K181458) | Innovative Health, LLC | 2018-10-27 |
| Polyethylene Catheter (K180286) | Cook Incorporated | 2018-10-26 |
| TSI Transseptal Introducer (K181031) | Pressure Products Medical Device Manufacturing, LLC | 2018-10-26 |
| 074 Zenith Flex System (K181354) | Inneuroco, Inc. | 2018-10-25 |
| DyeVert PLUS EZ Contrast Reduction System (K181936) | Osprey Medical, Inc. | 2018-10-25 |
| KODEX EPD System (K180940) | Philips Medical Systems Nederland B.V. | 2018-10-24 |
| VAMP Optima closed blood sampling system (K180275) | Edwards Lifesciences, LLC | 2018-10-24 |
| Masimo Rad-97 and Accessories (K180046) | Masimo Corporation | 2018-10-23 |
| Comarch e-Care Platform (K181248) | Comarch Healthcare SA | 2018-10-22 |
| DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port (K182586) | Medtronic, Inc. | 2018-10-19 |
| EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 (K182644) | Abbott | 2018-10-19 |
| Reprocessed Torqr Diagnostic EP Catheter (K181618) | Innovative Health, LLC | 2018-10-18 |
| Quantum Ventilation Module (K181942) | Spectrum Medical , Ltd. | 2018-10-18 |
| Full Automatic(NIBP) Blood Pressure Monitor (K180240) | Health & Life Co., Ltd. | 2018-10-17 |
| FlowTriever Retrieval/Aspiration System (K182233) | Inari Medical | 2018-10-15 |
| Penumbra System (Modified 110 Aspiration Tubing) (K182522) | Penumbra, Inc. | 2018-10-12 |
| Radial Medical Compression System (K181651) | Radial Medical, Inc. | 2018-10-12 |
| Endophys Pressure Sensing Sheath Kit (K180620) | Endophys Holdings, LLC | 2018-10-12 |
| Fingertip Pulse Oximeter (K181503) | Beijing Choice Electronic Technology Co., Ltd. | 2018-10-11 |
| ClotTriever Thrombectomy System (K182531) | Inari Medical | 2018-10-10 |
| CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (K181038) | Cormatrix Cardiovascular, Inc. | 2018-10-10 |
| Sterile High-pressure Angiographic Syringes for Single-use (K182289) | Shenzhen Baoan Medical Supplies Co., Ltd. | 2018-10-10 |
| Bluetooth blood pressure monitor (K182018) | Shenzhen Kingyield Technology Co., Ltd. | 2018-10-06 |
| Royal Flush Plus High-Flow Catheter (K180054) | Cook Incorporated | 2018-10-05 |
| Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) (K181725) | Avenu Medical, Inc. | 2018-10-05 |
| GORE Tri-Lumen Catheter (K180919) | W. L. Gore and Associates, Inc. | 2018-10-05 |
| B-Laser Atherectomy System (K181642) | Eximo Medical, Ltd. | 2018-10-05 |
| HYBRID Guidewire (K182337) | Balt USA, LLC | 2018-10-04 |
| Caretaker Remote Display App and Caretaker Software Library (K181196) | Caretaker Medical, LLC | 2018-10-03 |
| MPS2 Myocardial Protection System Console (K173716) | Quest Medical, Inc. | 2018-10-01 |
| FibriCheck (K173872) | Qompium NV | 2018-09-28 |
| TSP Crosser Transseptal Access System (K181088) | Transseptal Solutions , Ltd. | 2018-09-28 |
| EmboCube Embolization Gelatin (K181021) | Biosphere Medical, S.A. | 2018-09-27 |
| The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology (K181563) | Access Scientific, LLC | 2018-09-26 |
| Magic Torque DLVR Guidewire (K182315) | Boston Scientific Corporation | 2018-09-26 |
| BB-613 Watch Oximeter (K181006) | Bio-Beat Technologies , Ltd. | 2018-09-21 |
| Medline Patient Cables and Lead Wires (K181726) | Medline Industries, Inc. | 2018-09-20 |
| The CVC WAND Safety Introducer with Valved Peelable Sheath (K182243) | Access Scientific, LLC | 2018-09-18 |
| MAC VU360 Resting ECG Analysis System (K173830) | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 |
| CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (K173871) | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| SelectFlex 072 Neurovascular Access System (K181000) | Q'Apel | 2018-09-13 |
| AirStrip RPM InvisionHeart Adapter (K182226) | Airstrip Technologies, Inc. | 2018-09-11 |
| ECG App (DEN180044) | Apple, Inc. | 2018-09-11 |
| Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth (K182196) | Imediplus, Inc. | 2018-09-11 |
| Octane Mechanical Thrombectomy System (K182232) | Vascular Solutions, Inc. | 2018-09-11 |
| Irregular Rhythm Notification Feature (DEN180042) | Apple, Inc. | 2018-09-11 |
| Philips Hemodynamic Application R1.0 (K181311) | Philips Medical Systems Nederlands B.V. | 2018-09-07 |
| Disposable SpO2 Sensors, Reusable SpO2 Sensors (K181270) | Orantech, Inc. | 2018-09-07 |
| Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) (K181128) | Contego Medical, LLC | 2018-09-06 |
| IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension (K181314) | Philips Medizin Systeme Boeblingen GmbH | 2018-09-04 |
| Surveyor Patient Monitor (K173765) | Mortara Instrument, Inc. | 2018-09-04 |
| Reusable & Disposable SpO2 Sensors (K173368) | Shenzhen Coreray Technology, Ltd. | 2018-08-31 |
| Zio AT ECG Monitoring System, ZEUS System (K181502) | iRhythm Technologies, Inc. | 2018-08-29 |