| LifePearl Microshperes (K150958) | MicroVention, Inc. | 2015-09-17 |
| BodyGuardian Remote Monitoring System (K151188) | Preventice | 2015-09-17 |
| SmartLinx Vitals Plus Patient Monitoring System (K151071) | Capsule Technologie Sas | 2015-09-17 |
| Rhythm View Workstation (non-streaming, steaming option) (K151245) | Topera, Inc. | 2015-09-15 |
| Occlusion Perfusion Catheter (K151554) | Advanced Catheter Therapies, Inc. | 2015-09-15 |
| CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (K143359) | Lifewatch Technologies , Ltd. | 2015-09-11 |
| Fully Automatic Electronic Blood Pressure Monitor (K151460) | Andon Health Co, Ltd. | 2015-09-08 |
| Volcano Visions PV .018 Digital IVUS Catheter (K150442) | Volcano Corporation | 2015-09-04 |
| Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer (K151040) | Biometrix , Ltd. | 2015-09-04 |
| Ebony PTA .014 RX Pheripheral Dilatation Catheter (K152230) | Natec Medical | 2015-09-03 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K151869) | Microlife Intellectual Property GmbH, Switzerland | 2015-09-02 |
| Infinity CentralStation Wide (K151860) | Draeger Medical Systems, Inc. | 2015-09-02 |
| Panorama Patient Monitoring Network (K150082) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 |
| V Series Monitoring System (including V12 and V21 Monitors) (K150352) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-09-02 |
| EarlySense Central Display Station (CDS) (K151006) | Earlysense, Ltd. | 2015-08-31 |
| Eko Electronic Stethoscope System (K151319) | Eko Devices, Inc. | 2015-08-28 |
| Fingertip Pulse Oximeter (K151206) | Beijing Choice Electronic Technololgy Co., Ltd. | 2015-08-28 |
| VIA 21 Microcatheter (K150894) | Sequent Medical, Inc. | 2015-08-28 |
| Reprocessed Electrophysiology Diagnostic Catheters (K150357) | Sterilmed, Inc. | 2015-08-27 |
| Advanced Perfusion System 1 (K151349) | Terumo Cardiovascular Systems Corporation | 2015-08-27 |
| CARDIOLINE HD+ (K150289) | Cardioline S.P.A | 2015-08-27 |
| SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg) (K151305) | Nonin Medical, Inc. | 2015-08-27 |
| 5.5 F Worley Advanced LVI Lateral Vein Introducer (K152116) | Merit Medical Systems, Inc. | 2015-08-27 |
| Pruitt F3-S Carotid Shunt (K143454) | LeMaitre Vascular, Inc. | 2015-08-27 |
| EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM (K143701) | Volcano Corporation | 2015-08-26 |
| Retraction Aspirator (K152097) | Inari Medical | 2015-08-25 |
| Pirouette 018 (K151153) | Arravasc Limited | 2015-08-20 |
| Full Automatic (NIBP)Blood Pressure Monitor (K150311) | Health & Life Co., Ltd. | 2015-08-18 |
| Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components (K151463) | Hansen Medical, Inc. | 2015-08-18 |
| Flexor Radial Hydrophilic Introducer Access Set (K152044) | Cook Incorporated | 2015-08-14 |
| MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit (K143538) | Bayer Medical Care, Inc. | 2015-08-14 |
| PaxWire Occlusion Balloon System (K143613) | Accessclosure, Inc. | 2015-08-14 |
| Reusable Full Silicone Cover (K151702) | Laerdal Medical AS | 2015-08-13 |
| ComboCath OTW PTA Dilatation Catheter (K150452) | Summa Therapeutics, LLC | 2015-08-13 |
| Turnpike catheter (K151981) | Vascular Solution, Inc. | 2015-08-13 |
| Spaulding Electrocardiograph 2100iQ (K150564) | Spaulding Clinical Research, LLC | 2015-08-12 |
| Central Venous Pressure System (K151776) | Mespere Lifesciences, Inc. | 2015-08-12 |
| Digital Automatic Wrist Blood Pressure Monitor MD3200 (K151587) | Grandway Technology (Shenzhen) Limited | 2015-08-07 |
| Selectra Catheters and Selectra Accessory Kit (K151409) | Biotronik, Inc. | 2015-08-07 |
| MicroTract Access System (K151877) | Arstasis, Inc. | 2015-08-07 |
| Wingman Crossing Catheter (K151880) | Reflow Medical | 2015-08-07 |
| Digital Automatic Wrist Blood Pressure Monitor MD3900 (K151583) | Grandway Technology (Shenzhen) Limited | 2015-08-07 |
| Confida Adaptive Sheath (K152054) | Medtronic, Inc. | 2015-08-07 |
| ReDs Wearable System (K150095) | Sensible Medical Innovations , Ltd. | 2015-08-06 |
| Reveal LINQ (K150614) | Medtronic, Inc. | 2015-08-06 |
| Penumbra System 110 Aspiration Tubing (K151623) | Penumbra, Inc. | 2015-08-06 |
| Medtronic Confida Brecker Guidewire (K150465) | Medtronic Core Valve, LLC | 2015-08-03 |
| Metacross RX PTA Balloon Dilitation Catheter (K150865) | KANEKA Corporation | 2015-08-03 |
| NIRO-200NX (K143219) | Hamamatsu Photonics K.K. | 2015-07-31 |
| B40i Patient Monitor (K143676) | GE Healthcare Finland Oy | 2015-07-31 |
| Zephyr Vascular Compression Device (K151363) | Advanced Vascular Dynamics | 2015-07-31 |
| Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter (K150107) | Micro Therapeutics Inc Dba Ev3 Neurovascular | 2015-07-29 |
| Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Contralateral Design; Flexor Up and Over Balkin Contralateral Introducer; Flexor Check-Flo Introducer, Raabe Modification; Flexor Check-Flo Performer Introducer (K142829) | Cook Incorporated | 2015-07-28 |
| QuadraSphere Microspheres (K151187) | Biosphere Medical, S.A. | 2015-07-27 |
| Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set (K142819) | Cook Incorporated | 2015-07-24 |
| Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters (K143193) | Boston Scientific | 2015-07-24 |
| Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (K150347) | Deltex Medical Limited | 2015-07-24 |
| Magellan Robotic System (K151730) | Hansen Medical, Inc. | 2015-07-23 |
| TRANSONIC TISSUE PERFUSION MONITOR (K140740) | Transonic Systems, Inc. | 2015-07-23 |
| Digital Automatic Blood Pressure Monitor MD2300 (K143735) | Grandway Technology (Shenzhen) Limited | 2015-07-23 |
| TM-ABI system (K143152) | Ld Technology, LLC | 2015-07-22 |
| Retracta Detachable Embolization Coil (K151676) | Cook Incorporated | 2015-07-22 |
| Visi Mobile Monitoring System, Visi Mobile Chest Sensor (K142827) | Sotera Wireless, Inc. | 2015-07-20 |
| IntelliVue Patient Monitor (K151681) | Philips Medizin Systeme Boeblingen GmbH | 2015-07-17 |
| Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC (K150953) | Bio Compression Systems, Inc. | 2015-07-16 |
| ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare (K151377) | Medical Compression System (Dbn) , Ltd. | 2015-07-16 |
| Uncoated Tubing and Connector Components (K151523) | Medtronic, Inc. | 2015-07-16 |
| St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (K151622) | St Jude Medical | 2015-07-15 |
| Microlife Wrist Watch Blood Pressure Monitor (K151330) | Microlife Intellectual Property GmbH, Switzerland | 2015-07-14 |
| Rapid Hair Removal Pads (K150349) | Full Power Aed | 2015-07-14 |
| Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System (K142468) | Cardiac Insight, Inc. | 2015-07-11 |
| ANGIO-PRESS DVT Compression Device Model Name: IPCS (K143202) | Pegasus Medical Supply, Inc. | 2015-07-07 |
| Hypervisor IX Monitoring System (K150632) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-07-06 |
| Armada 18 PTA Catheter (K151317) | Abbott Vascular | 2015-07-06 |
| ECVUE Mapping System (K150990) | Cardioinsight Technologies, Inc. | 2015-07-02 |
| AUTOMATIC BLOOD PRESSURE MONITOR (K140762) | Jawon Medical Co., Ltd. | 2015-07-02 |
| CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254) | Datascope Corp. | 2015-07-02 |
| PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT (K141965) | Care Fusion | 2015-07-02 |
| EN Snare Endovascular Snare System (K151497) | Merit Medical Systems, Inc. | 2015-07-01 |
| Magellan Robotic System, Magellan Robotic Catheter 10Fr (K143227) | Hansen Medical, Inc. | 2015-07-01 |
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |
| Aneroid Sphygmomanometer (K151246) | Jiaxing Zhongfa Medical Products Co., Ltd. | 2015-06-30 |
| Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff (K151290) | Xuzhou Maicuff Technology Co., Ltd. | 2015-06-30 |
| AGE Automatic Wrist Blood Pressure Monitor (K151281) | Dongguan Ageless Health Industrial Co., Ltd. | 2015-06-30 |
| ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (K150445) | Asahi Intecc Co., Ltd. | 2015-06-30 |
| FILAO NC RX PTCA DILATATION CATHETER (K141933) | Natec Medical , Ltd. | 2015-06-28 |
| Plato MICROCATH 27B Microcatheter (K143398) | Scientia Vascular, LLC | 2015-06-26 |
| ADH 200 Analyzer Software (K143449) | Adams Meditech, LLC | 2015-06-26 |
| Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors (K150975) | Philips Medizin Systeme Boeblingen GmbH | 2015-06-25 |
| Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters (K143604) | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | 2015-06-25 |
| DuraSheath Introducer Sheath System (K142357) | Contract Medical International, GmbH | 2015-06-25 |
| 0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) (K143093) | Hotspur Technologies, Inc., | 2015-06-24 |
| ASAHI Corsair Microcatheter (K151103) | Asahi Intecc Co., Ltd. | 2015-06-23 |
| ESOPHAGEAL COOLING DEVICE (DEN140018) | Advanced Cooling Therapy, LLC | 2015-06-23 |
| Flowtron ACS900 (K143438) | Getinge (Suzhou) Co., Ltd. | 2015-06-23 |
| PreludeEASE Hydrophilic Sheath Introducer (K150257) | Merit Medical Systems, Inc. | 2015-06-19 |
| ZIO SR ECG Monitoring Service (K143513) | iRhythm Technologies, Inc. | 2015-06-19 |
| STAR 90 (K150512) | Skanray Technologies Pvt, Ltd. | 2015-06-17 |
| ProTrack RF Anchor Wire (K150709) | Baylis Medical Company, Inc. | 2015-06-17 |
| True Dilatation Balloon Valvuloplasty Catheter (K150667) | C.R. Bard, Inc. | 2015-06-17 |