| Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device (K161886) | Guangdong Transtek Medical Electronics Co., Ltd. | 2016-10-14 |
| HawkOne Directional Atherectomy System (K161361) | Medtronic Vascular, Inc. | 2016-10-14 |
| R2P SlenGuide (K161546) | Ashitaka Factory of Terumo Corporation | 2016-10-14 |
| VascuCel (K162579) | Admedus Regen Pty, Ltd. | 2016-10-14 |
| ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip (K161912) | Asahi Intecc Co., Ltd. | 2016-10-14 |
| Bioflux Software (K162571) | Biotricity, Inc. | 2016-10-13 |
| Sunmed Haemostatic Valves (K153685) | Sunny Medical Device (Shenzhen) Co., Ltd. | 2016-10-13 |
| FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band (K161815) | Genesee Biomedical, Inc. | 2016-10-12 |
| Navien Intracranial Support Catheter (K161152) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-10-12 |
| Medtronic Model 5392 External Pulse Generator (EPG) (K162550) | Medtronic, Inc. | 2016-10-12 |
| EnSite Velocity Surface Electrode Kit (K160186) | St Jude Medical | 2016-10-07 |
| Pantera Pro (K160985) | Biotronik, Inc. | 2016-10-07 |
| Sapphire NC Plus (K162209) | Orbusneich Medical, Inc. | 2016-10-06 |
| ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 (K161584) | Asahi Intecc Co., Ltd. | 2016-10-06 |
| MR Syringe Dual Pack for Solaris Injectors (K161471) | Coeur, Inc. | 2016-10-06 |
| Fingertip Pulse Oximeter MD300CN310 (K161560) | Beijing Choice Electronic Technology Co., Ltd. | 2016-10-05 |
| Traxcess .007 Mini Guidewire (K161803) | MicroVention, Inc. | 2016-09-30 |
| Electronic Stethoscope DS301 (K160023) | Imediplus, Inc. | 2016-09-30 |
| Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters (K161464) | Innovative Health, LLC | 2016-09-30 |
| eCareManager 4.0.1 (K153156) | Visicu, Inc. | 2016-09-30 |
| Penumbra Aspiration System (K161506) | Penumbra, Inc. | 2016-09-26 |
| Endophys Blood Pressure Monitor (K160945) | Endophys Holdings, LLC | 2016-09-26 |
| BIB Stent Placement Catheter (K161451) | NuMED, Inc. | 2016-09-22 |
| TrailBlazer Angled Support Catheter (K162384) | Medtronic Vascular, Inc.(Formerly Ev3 Inc.) | 2016-09-22 |
| Surefire Guiding Catheter (K162359) | Surefire Medical, Inc. | 2016-09-21 |
| Full Automatic (NIBP) Blood Pressure Monitor (K162338) | Health & Life Co., Ltd. | 2016-09-21 |
| Solitaire Platinum Revascularization Device (K161879) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2016-09-21 |
| Affinity NT Oxygenator with Cortiva BioActive Surface (K162016) | Medtronic, Inc. | 2016-09-21 |
| Hansen Medical Magellan Robotic Catheter 9Fr (K160919) | Hansen Medical, Inc. | 2016-09-20 |
| Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip (K161887) | Volcano Corporation | 2016-09-20 |
| AirStrip RPM (K160862) | Airstrip Technologies, Inc. | 2016-09-19 |
| Super Distal Access (SDA) (K161262) | Inneuroco, Inc. | 2016-09-19 |
| Sentry WEB SmartInterp (K153654) | Carefusion Germany 234 GmbH | 2016-09-16 |
| TEMPEDY (K152946) | Seiratherm GmbH | 2016-09-15 |
| CARESCAPE Central Station V2 (K162012) | GE Healthcare | 2016-09-15 |
| Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable (K161384) | Shockwave Medical, Inc. | 2016-09-14 |
| Flexitouch System (K153311) | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016-09-14 |
| TXM Guiding Sheath (K153771) | Texasmedical Technologies, Inc. | 2016-09-13 |
| OptoMonitor II (K161263) | Opsens, Inc. | 2016-09-13 |
| TorqVue Low Profile Delivery Catheter (K162228) | Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor | 2016-09-09 |
| AMC Health VitalCaregiving System (K151839) | Amc Health | 2016-09-09 |
| CardioConfirm (K161465) | Mortara Instrument, Inc. | 2016-09-03 |
| Edwards eSheath Introducer Set (K162184) | Edward Lifesciences | 2016-09-02 |
| Nihon Kohden Vital Sign Telemeter (K153707) | Nihon Kohden Corporation | 2016-09-02 |
| Arctic Sun Temperature Management System (K161602) | Medivance, Inc. | 2016-09-02 |
| WiCap (K160582) | Athena Gtx | 2016-09-02 |
| Indy OTW Vascular Retriever (K160593) | Cook Incorporated | 2016-09-02 |
| ASAHI Corsair Pro (K161126) | Asahi Intecc Co., Ltd. | 2016-08-25 |
| HQS Introducer (Model 2064-HQS) (K153494) | Alseal | 2016-08-25 |
| V10 (K152659) | Mediana Co., Ltd. | 2016-08-25 |
| FFRct (K161772) | HeartFlow, Inc. | 2016-08-24 |
| DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak (K161287) | Medtronic Vascular | 2016-08-19 |
| Streamline 6495 Bipolar Temporary Myocardial Pacing Lead (K161249) | Medtronic | 2016-08-19 |
| Fingertip Pulse Oximeter (K152091) | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-18 |
| Medke Oximetry Finger Sensor (K152390) | Shenzhen Medke Technology Co., Ltd. | 2016-08-18 |
| S-Wire Guidewire System (K153397) | Concert Medical, LLC | 2016-08-18 |
| Reprocessed Compression Garments (K161105) | Covidien | 2016-08-18 |
| Vein Clamps, Artery Clamps (K161315) | Aros Surgical Instruments Corporation | 2016-08-18 |
| Bullfrog Micro-Infusion Device (K161402) | Mercator Medsystems, Inc. | 2016-08-18 |
| Wrist Pulse Oximeter (K152089) | Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd. | 2016-08-17 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| ECG100+, ECG200+ (K160840) | Cardioline S.P.A | 2016-08-12 |
| VSI StraitSet micro-introducer kit (K161336) | Vascular Solutions, Inc. | 2016-08-11 |
| Rhythm View Workstation (non-streaming) (K161240) | Abbott Electrophysiology | 2016-08-10 |
| Fully Automatic Electronic Blood Pressure Monitor (K160565) | Andon Health Co, Ltd. | 2016-08-10 |
| Quantitative Electrocardiographic Detector (QED 2000) (K152135) | Acme Portable Machines, Inc. | 2016-08-09 |
| Apollo Balloon Dilatation Catheter (K153742) | Brosmed Medical Co., Ltd. | 2016-08-08 |
| Steerable Guide Catheter (K161985) | Abbott Vascular | 2016-08-07 |
| EP-TRACER System (K161245) | Cardio Tek, BV | 2016-08-05 |
| Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso (K160865) | Nonin Medical, Inc. | 2016-08-05 |
| SIDEKICK and USHER Support Catheters (K161986) | Bard Peripheral Vascular, Inc. | 2016-08-04 |
| Surveyor S4 Mobile Monitor (K160685) | Mortara Instrument, Inc. | 2016-08-04 |
| Fully Automatic Electronic Blood Pressure Monitor (K160563) | Andon Health Co, Ltd. | 2016-08-04 |
| Hilal Embolization MicroCoils (K160219) | Cook Incorporated | 2016-08-03 |
| DyeVert NG Contrast Modulation System (K161505) | Osprey Medical, Inc. | 2016-08-03 |
| Pirouette 035 (K161427) | Arravasc Limited | 2016-07-30 |
| Mozec NC-Rx PTCA Baloon Dilatation Catheter (K160961) | Meril Life Sciences Private Limited | 2016-07-30 |
| CrossCath Support Catheter (K161801) | Cook Incorporated | 2016-07-29 |
| Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (K160256) | Brosmed Medical Co., Ltd. | 2016-07-29 |
| DiamondTOUCH Inflation Device and Fluid Dispensing Syringe (K160107) | Merit Medical Systems, Inc. | 2016-07-29 |
| Angel Catheter (K160747) | Bio2 Medical, Inc. | 2016-07-28 |
| Permaseal (DEN150029) | Micro Interventional Devices,Inc. | 2016-07-27 |
| Sheath Introducer (K150932) | Bioteque Corp. | 2016-07-22 |
| Gianturco-Roehm Bird’s Nest Vena Cava Filter (K161218) | Cook Incorporated | 2016-07-22 |
| Braemar Telemetry Patch System (K153473) | Braemar Manufacturing, LLC | 2016-07-22 |
| GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle (K152913) | Creganna Medical Aslo Business AS Cregganna Tactx Medical | 2016-07-21 |
| ABPM 7100, Hypertension Management Software (K153557) | I.E.M. GmbH | 2016-07-19 |
| myPatch-s (K160704) | Dms-Service, LLC | 2016-07-15 |
| Steth IO (K160016) | Stratoscientific, Inc. | 2016-07-15 |
| FlexSeal Introducer Sheath with Hydrophilic Coating (K161659) | Libramedical, Inc. | 2016-07-15 |
| Wingman 18 Crossing Catheter (K160848) | Reflow Medical, Inc. | 2016-07-14 |
| ActiveCare Home (K160431) | Medical Compression Systems (Dbn) , Ltd. | 2016-07-13 |
| Penumbra System ACE 68 Reperfusion Catheter (K161640) | Penumbra, Inc. | 2016-07-12 |
| ARTLINE (K160448) | Health Line International Corporation | 2016-07-12 |
| TightRail Sub-C Rotating Dilator Sheath (K161333) | Spectranetics, Inc. | 2016-07-08 |
| SunTech CT40 Spot-check Vital Signs Device (K160439) | Suntech Medical | 2016-07-06 |
| Full Automatic (NIBP) Blood Pressure Monitor (K160557) | Health & Life Co., Ltd. | 2016-07-06 |
| LD-Oxi system (K160956) | Ld Technology, LLC | 2016-07-06 |
| Tearaway Introducer Sheath, MicroSlide Tearaway Introducer (K153533) | Galt Medical Corp. | 2016-07-05 |
| IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 (K161531) | Philips Medizin Systeme Boeblingen GmbH | 2016-07-01 |