| Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire (K151840) | Boston Scientific Corporation | 2015-12-16 |
| XM-01 Electronic Automatic Blood Pressure Monitor (K150908) | Sky Innovation Technology ( Shanghai) Limited | 2015-12-16 |
| Advanced Perfusion System 1 (K153376) | Terumo Cardiovascular Systems Corporation | 2015-12-16 |
| Monitor B40 (K151063) | Ge Medical Systems China Co., Ltd. | 2015-12-15 |
| Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm (K152202) | Tni Manufacturing, Inc. | 2015-12-14 |
| ViSi Mobile Monitoring System (K152341) | Sotera Wireless, Inc. | 2015-12-14 |
| AbStats Gateway (K150782) | Gi Logic, Inc. | 2015-12-14 |
| LC Bead LUMI (K152157) | Biocompatibles UK , Ltd. | 2015-12-11 |
| ALP VasQcare Take Home System (K151158) | Currie Medical Specialties, Inc. | 2015-12-10 |
| Checkme Pro Health Monitor (K150869) | Viatom Technology Co., Ltd. | 2015-12-10 |
| MIVI Mi-AXUS Guide Catheter (K151396) | Mivi Neuroscience, Inc. | 2015-12-09 |
| higi Station (K151127) | Higi Sh, LLC | 2015-12-08 |
| Houdini Catheter (K151896) | Cruzar Medsystems, Inc. | 2015-12-07 |
| Vital Connect Platform, HealthPatch MD, VitalPatch (K152139) | Vitalconnect, Inc. | 2015-12-06 |
| Stingray LP Catheter (K152401) | Boston Scientific Corporation | 2015-12-04 |
| Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle (K151936) | Synaptic Medical Limited | 2015-12-04 |
| Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir (K153213) | Terumo Cardiovascular Systems Corporation | 2015-12-03 |
| CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (K152582) | Volcano Corporation | 2015-12-03 |
| Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating (K153140) | Terumo Cardiovascular Systems Corp. | 2015-12-02 |
| Capiox Advance Hardshell Reservoir (K153143) | Terumo Cardiovascular Systems Corporation | 2015-12-02 |
| Attachable Cath Lab Hemostasis Valve (K152528) | Galt Medical Corp. | 2015-12-02 |
| Lantern Delivery Microcatheter (K152840) | Penumbra, Inc. | 2015-12-02 |
| Glidesheath (K152173) | Terumo Medical Corporation | 2015-12-01 |
| Edwards eSheath Introducer Set (K152225) | Edwards Lifesciences | 2015-11-24 |
| QuadraSphere Microspheres (K153102) | Biosphere Medical, S.A. | 2015-11-23 |
| Fogarty Occlusion Catheter (K152762) | Edwards Lifesciences, LLC | 2015-11-23 |
| RX ACCUNET Embolic Protection System (K153086) | Abbott Vascular | 2015-11-20 |
| Visions PV.014P RX Digital IVUS Catheter (K152829) | Volcano Corporation | 2015-11-19 |
| MoisturemeterD (K143310) | Delfin Technologies, Ltd. | 2015-11-19 |
| Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir (K151791) | Terumo Cardiovascular Systems Corporation | 2015-11-19 |
| R350 guidewire (K151234) | Vascular Solutions, Inc. | 2015-11-18 |
| Viradius Neurowire (K151825) | Mivi Neuroscience, Inc. | 2015-11-16 |
| Radifocus Glidewire (K152740) | Ashitaka Factory of Terumo Corp. | 2015-11-16 |
| Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter (K151638) | Cathera, Inc. | 2015-11-13 |
| AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (K151667) | Stryker | 2015-11-13 |
| Turbo-Power Laser Atherectomy Catheter (K152181) | Spectranetics, Inc. | 2015-11-12 |
| TR BAND Radial Compression Device (K152525) | Terumo Medical Corporation | 2015-11-10 |
| Wrist - Type Fully Automatic Digital Blood Pressure Monitor (K152426) | Sejoy Electronics & Instruments Co., Ltd. | 2015-11-09 |
| LILLIPUP PMP, LILLIPUT PMP INTEGRATED (K151713) | Sorin Group Italia S.R.L. | 2015-11-06 |
| CerOX (K150268) | Or-Nim Medical , Ltd. | 2015-11-06 |
| Nihon Kohden CSM 1901 Bedside Monitor (K151080) | Nihon Kohden | 2015-11-05 |
| elance Vital Signs Monitor, Central Monitor Software (K150329) | Spacelabs Healthcare | 2015-11-05 |
| Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter (K150046) | Zoll Circulation, Inc. | 2015-10-30 |
| Philips CS770 IntelliSpace Critical Care and Anesthesia (K151366) | Philips Medical Systems | 2015-10-30 |
| Prelude SNAP Splittable Hydrophilic Sheath Introducer (K152381) | Merit Medical Systems, Inc. | 2015-10-30 |
| Impulse Angiographic Catheter, Expo Angiographic Catheter (K152605) | Boston Scientific Corporation | 2015-10-29 |
| Disposable Blood Pressure Cuff (K152465) | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 |
| T3 Software (K151715) | Etiometry, Inc. | 2015-10-29 |
| Reusable Blood Pressure Cuff (K152468) | Shenzhen Vistar Medical Supplies Co., Ltd. | 2015-10-29 |
| Tempus IC2 (K152124) | Remote Diagnostics Technologies, Ltd. | 2015-10-28 |
| ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT (K152801) | Statcorp Medical | 2015-10-27 |
| Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M (K152363) | Philips Medical Systems | 2015-10-27 |
| PremiPatch PTFE Pledget (K151865) | Aesculap, Inc. | 2015-10-27 |
| PolarCath Peripheral Dilatation System (K152665) | Nucyro Vascular, LLC | 2015-10-26 |
| Bard Snare Retrieval Kit (K152560) | Neometrics, Inc. | 2015-10-23 |
| ER-REBOA Catheter (K151821) | Pryor Medical Devices, Inc. | 2015-10-23 |
| Masimo MightySat Rx Fingertip Pulse Oximeter (K150314) | Masimo Corporation | 2015-10-22 |
| Pacel Bipolar Pacing Catheters (K152784) | St Jude Medical | 2015-10-22 |
| WorkMate Claris System, WorkMate Claris System Display Plus (K151911) | St Jude Medical | 2015-10-22 |
| 330psi Extension Y-Line with Dual Check Valve (K150902) | Coeur, Inc. | 2015-10-22 |
| Philips IntelliVue GuardianSoftware (K151736) | Philips Medizin Systeme Boblingen GmbH | 2015-10-21 |
| Diamondback 360 Peripheral Orbital Atherectomy System (K152694) | Cardiovascular Systems, Inc. | 2015-10-21 |
| CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels (K152693) | Boston Scientific Corporation | 2015-10-21 |
| HI-TORQUE BALANCE (K152709) | Abbott Vascular | 2015-10-21 |
| ProBP 2400 Digital Blood Pressure Device (K152770) | Microlife Intellectual Property GmbH | 2015-10-21 |
| Oregon Scientific (K151415) | Idt Technology Limited | 2015-10-21 |
| Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir (K151389) | Terumo Cardiovascular Systems Corporation | 2015-10-20 |
| Radifocus Optitorque Angiographic Catheter (K150232) | Ashitaka Factory of Terumo Corp. | 2015-10-19 |
| Arm-Type Fully Automatic Digital Blood Pressure Monitor (K152687) | Sejoy Electronics & Instruments Co., Ltd. | 2015-10-16 |
| AVERT Contrast Modulation System (K151300) | Osprey Medical, Inc. | 2015-10-15 |
| Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe (K152633) | Edwards Lifesciences, LLC | 2015-10-15 |
| AngioDynamics Mariner Angiographic Catheters (K151724) | AngioDynamics, Inc. | 2015-10-14 |
| Pantheris System (K152275) | Avinger, Inc. | 2015-10-14 |
| Dyevert Contrast Modulation System (K151746) | Osprey Medical, Inc. | 2015-10-09 |
| Passeo-18 Peripheral Dilation Catheter (K151744) | Biotronik, Inc. | 2015-10-08 |
| Passeo-14 Peripheral Dilatation Catheter (K152240) | Biotronik, Inc. | 2015-10-08 |
| MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM (K152550) | Medicalgorithmics S.A. | 2015-10-08 |
| Comet Pressure Guidewire (K151610) | Boston Scientific Corporation | 2015-10-06 |
| iLab Polaris Multi-Modality Guidance System (K151613) | Boston Scientific Corporation | 2015-10-06 |
| CorPath 200 System (K150892) | Corindus, Inc. | 2015-10-02 |
| zensor system (K151027) | Intelesens Limited | 2015-10-02 |
| SonoStik IV Guide Wire Introducer (K152177) | Sonostik, LLC | 2015-10-01 |
| SureSigns VS3, SureSigns VS4 (K151761) | Phillips Medical Systems | 2015-09-29 |
| Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series (K152483) | Grandway Technology (Shenzhen) Limited | 2015-09-29 |
| Endoluminal Occlusion System-EOS (K150402) | Artventive Medical Group, Inc. | 2015-09-25 |
| AZUR CX Detachable 35 Coils (K151358) | MicroVention, Inc. | 2015-09-25 |
| iHealth BP3L Wireless Blood Pressure Monitor (K152003) | Andon Health Co, Ltd. | 2015-09-24 |
| Metacross OTW PTA Balloon Dilatation Catheter (K152080) | KANEKA Corporation | 2015-09-24 |
| Infinity Delta, Infinity Delta XL, Infinity Kappa (K152407) | Draeger Medical Sytems, Inc. | 2015-09-23 |
| iHealth View BP7S Wireless Blood Pressure Wrist Monitor (K152379) | Andon Health Co, Ltd. | 2015-09-23 |
| Destino Reach (K151951) | Oscor, Inc. | 2015-09-22 |
| ZelanteDVT Thrombectomy Set (K151313) | Boston Scientific Corporation | 2015-09-21 |
| Chameleon PTA Balloon Catheter (K151678) | Av Medical Technologies, Ltd. | 2015-09-21 |
| Hi-Torque Command 18 Guide Wire (K152404) | Abbott Vascular | 2015-09-21 |
| AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System (K152218) | Osprey Medical | 2015-09-21 |
| TM eCloud ECG Analysis System (K142349) | Telemed Solutions, Inc. | 2015-09-21 |
| Thoratec CentriMag Drainage (Venous) Cannula Kit (K152190) | Thoratec Corporation | 2015-09-18 |
| Thoratec CentriMag Return (Arterial) Cannula Kit (K152161) | Thoratec Corporation | 2015-09-18 |
| Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System (K151189) | Devon Medical Products | 2015-09-18 |
| Export Advance Aspiration Catheter (K152335) | Medtronic, Inc. | 2015-09-18 |