| Performer Introducer (K171999) | Cook Incorporated | 2017-07-31 |
| Electronic Blood Pressure Monitor (K161845) | Shenzhen Pango Electronic Co., Ltd. | 2017-07-31 |
| AXS Offset Delivery Assist Catheter (K163259) | Stryker Neurovascular | 2017-07-28 |
| Fully Automatic Blood Pressure Monitor (K171282) | Andon Health Co, Ltd. | 2017-07-27 |
| Nasal Alar SpO2 Sensor (K171423) | Xhale, Inc. | 2017-07-27 |
| Bunegin-Albin Air Aspiration Set (K163031) | Cook Incorporated | 2017-07-27 |
| CARTO 3 EP Navigation System, Version 6.0 and Accessories (K170600) | Biosense Webster, Inc. | 2017-07-25 |
| Rubicon 14, 18 and 35 Support Catheters (K171913) | Boston Scientific Corporation | 2017-07-25 |
| CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (K170997) | Biosense Webster, Inc. | 2017-07-25 |
| True Form Reshapable Guide Wire (K170532) | Merit Medical Systems, Inc. | 2017-07-21 |
| Progreat (K170223) | Ashitaka Factory of Terumo Corporation | 2017-07-21 |
| CARDIOVIT FT-1 (K170182) | Schiller AG | 2017-07-19 |
| Mini Stick ENVI Non-Vascular Introducer Kit (K170775) | AngioDynamics, Inc. | 2017-07-19 |
| Vela RX PTA Balloon Dilatation Catheter (K171290) | Curatia Medical | 2017-07-19 |
| Altrix Temperature Management Wraps (K171149) | Stryker Medical | 2017-07-18 |
| eCareCoordinator (K171029) | Visicu, Inc. | 2017-07-14 |
| Dictum Health (K170798) | Dictum Health, Inc. | 2017-07-14 |
| Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) | Vascutek, Ltd. | 2017-07-14 |
| Reprocessed AcuNav Diagnostic Ultrasound Catheter (K163560) | Innovative Health, LLC | 2017-07-12 |
| Devon 24 (K170814) | Devon Medical Products (Jiangsu), Ltd. | 2017-07-11 |
| Needle's Eye Snare Retrieval Set - 54cm (K163353) | Cook Incorporated | 2017-07-11 |
| Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series (K163648) | Grandway Technology (Shenzhen) Limited | 2017-07-07 |
| M3290B Philips IntelliVue Information Center iX (K163584) | Philips Medical Systems | 2017-07-07 |
| Smart Syringe (K171698) | Osprey Medical, Inc. | 2017-07-07 |
| RX NC Takeru PTCA Balloon Dilatation Catheter (K170941) | KANEKA Corporation | 2017-07-07 |
| PSA Cable (K170815) | Boston Scientific Corporation | 2017-07-06 |
| Tempus Pro Patient Monitor (K170567) | Remote Diagnostic Technologies , Ltd. | 2017-07-06 |
| YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up (K171653) | Codman & Shurtleff, Inc. | 2017-07-03 |
| ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip (K171613) | Asahi Intecc Co., Ltd. | 2017-07-01 |
| ACUITY Pro Lead Delivery System (K171612) | Boston Scientific Corporation | 2017-06-30 |
| Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor (K171621) | Welch Allyn, Inc. | 2017-06-30 |
| Gelweave Vascular Grafts (K162794) | Vascutek, Ltd. | 2017-06-30 |
| BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set (K171514) | Biotronik, Inc. | 2017-06-29 |
| Vessel Dilator (K163524) | Fetzer Medical GmbH & Co. KG | 2017-06-29 |
| Firebow Wire Torque Assist Device (K170684) | Vesatek, LLC | 2017-06-29 |
| CardioLogs ECG Analysis Platform (K170568) | Cardiologs Technologies | 2017-06-26 |
| Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga. (K171146) | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | 2017-06-23 |
| Ossler Exam Scope (K171188) | Lr Med, Inc. | 2017-06-23 |
| CoVa Monitoring System 2 (K160899) | Tosense, Inc. | 2017-06-22 |
| Merit Hydrophilic Guide Wire (K170933) | Merit Medical Systems, Inc. | 2017-06-22 |
| Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System (K163316) | Carefusion 303, Inc. | 2017-06-22 |
| Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K170922) | Innovative Health, LLC | 2017-06-22 |
| TVC Imaging System, TVC Catheter (K163345) | Infraredx, Inc. | 2017-06-21 |
| Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae (K162215) | Sorin Group Italia S.R.L. | 2017-06-16 |
| Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter (K170474) | Innovative Health, LLC | 2017-06-16 |
| SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System (K170191) | Medtronic Vascular, Inc. | 2017-06-16 |
| AcuNav V 10F Ultrasound Catheter (K170992) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| Merit Coronary Control Syringe (K163084) | Merit Medical Systems, Inc. | 2017-06-15 |
| AcuNav Diagnostic Ultrasound Catheter 8F,10F (K170263) | Siemens Medical Solutions USA, Inc. | 2017-06-15 |
| UltraScore Focused Force PTA Balloon (K163420) | Bard Peripheral Vascular, Inc. | 2017-06-14 |
| TONOPORT VI (K170966) | Par Medizintechnik GmbH & Co. KG | 2017-06-14 |
| Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette (K171427) | Medtronic Vascular, Inc. | 2017-06-13 |
| SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters (K162625) | B. Braun Interventional Systems, Inc. | 2017-06-12 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K170792) | Cardiovascular Systems, Inc. | 2017-06-09 |
| Wingman 14C Crossing Catheter (K170996) | Reflow Medical, Inc. | 2017-06-09 |
| Sorin Connect (K170460) | Sorin Group Deutschland GmbH | 2017-06-08 |
| Venture 038 catheter (K171335) | Vascular Solutions, Inc. | 2017-06-07 |
| Digital Automatic Blood Pressure Monitor MD3600 (K163679) | Grandway Technology (Shenzhen) Limited | 2017-06-07 |
| Advanced Perfusion System 1 (K163531) | Terumo Cardiovascular Systems Corporation | 2017-06-07 |
| EK12 Algorithm (K170155) | Ge Medical Systems Information Technologies, Inc. | 2017-06-06 |
| LiDCOunity v2 Hemodynamic Monitor (K163334) | Lidco, Ltd. | 2017-06-05 |
| Reprocessed Agilis NxT Steerable Introducer (K170311) | Innovative Health, LLC | 2017-06-02 |
| Zio AT ECG Monitoring System (K163512) | iRhythm Technologies, Inc. | 2017-06-02 |
| VitalWatch Software User Interface (K170973) | Vitalconnect, Inc. | 2017-06-02 |
| Tubing Pack (K171308) | Medtronic, Inc. | 2017-06-02 |
| Electrocardiograph (K170995) | Edan Instruments, Inc. | 2017-06-02 |
| Biopsy Forceps (K170726) | Fehling Instruments GmbH & Co. KG | 2017-06-02 |
| Sentinel Cerebral Protection System (DEN160043) | Claret Medical, Inc. | 2017-06-01 |
| Medcomp Vessel Dilator (K162389) | Medcomp ( Medical Components) | 2017-06-01 |
| Reverse 021 Micro Catheter, Reverse 027 Micro Catheter (K171268) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2017-05-31 |
| Lympha Press Optimal Plus (K170658) | Mego Afek AC , Ltd. | 2017-05-31 |
| Portable ECG Monitor (K170954) | Contec Medical Systems Co.,Ltd | 2017-05-30 |
| VenaCure EVLT NeverTouch Direct Introducer Sheath (K170695) | AngioDynamics, Inc. | 2017-05-30 |
| Pulse* Spray Infusion System, Uni*Fuse Infusion System (K163356) | AngioDynamics, Inc. | 2017-05-30 |
| T3 Software (K163065) | Etiometry, Inc. | 2017-05-26 |
| Flexitouch System (K170216) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017-05-26 |
| DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (K171217) | Osprey Medical, Inc. | 2017-05-26 |
| Masimo O3 Regional Oximeter System (K162603) | Masimo Corporation | 2017-05-26 |
| White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter (K162448) | Cook Incorporated | 2017-05-26 |
| Mistral-Air Warming Unit (K171234) | The Surgical Company International BV (As the 37company) | 2017-05-26 |
| Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead (K171253) | Medtronic | 2017-05-25 |
| RA-308 Excimer Laser System, Excimer Laser Catheter (K170349) | Ra Medical Systems,Inc | 2017-05-24 |
| INDIGO Aspiration System (K163618) | Penumbra, Inc. | 2017-05-24 |
| HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit (K163172) | Smiths Medical Asd, Inc. | 2017-05-24 |
| Central Monitoring System (K170514) | Guangdong Biolight Meditech Co., Ltd. | 2017-05-24 |
| Matrix Data Management System (K162463) | Global Instrumentation, LLC | 2017-05-24 |
| Eko Model E5 System (EME5), Eko DUO (K170874) | Eko Devices, Inc. | 2017-05-19 |
| Supreme and Response Electrophysiology Catheters (K161272) | Surgical Instrument Service and Savings, Inc. | 2017-05-18 |
| A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor (K170196) | A&D Company, Ltd. | 2017-05-17 |
| Surefire Precision Infusion System (K171355) | Surefire Medical, Inc. | 2017-05-17 |
| Cardiac Trigger Monitor (K170828) | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| Direxion and Direxion HI-FLO Torqueable Microcatheters (K163701) | Boston Scientific Corporation | 2017-05-16 |
| Unity Network ID (K170199) | GE Healthcare | 2017-05-12 |
| Fully Automatic Electronic Blood Pressure Monitor (K163276) | Andon Health Co, Ltd. | 2017-05-11 |
| Anybattery C2 Rechargeable Battery (K160667) | Anybattery, Inc. | 2017-05-11 |
| EpiAccess System (K170831) | Epiep, Inc. | 2017-05-09 |
| Guider Catheter Introducer (K171081) | Rhythm Xience, Inc. (Rxi) | 2017-05-09 |
| Oxitone 1000 (K163382) | Oxitone Medical , Ltd. | 2017-05-09 |
| Digital Blood Pressure Monitor-Automatic Upper Arm Style (K163606) | Shenzhen Combei Technology Co., Ltd. | 2017-05-09 |
| Fingertip Pulse Oximeter (K161938) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2017-05-08 |