| PC ECG (K161302) | Edan Instruments, Inc. | 2016-07-01 |
| INDIGO Aspiration System (K161523) | Penumbra, Inc. | 2016-07-01 |
| MRI Patient Monitor TeslaDUO (K153739) | Mipm Mammendorfer Institut Fur Physik Und Medizin | 2016-06-28 |
| CareEvent inclusive of the CareEvent Mobile Application accessory (K161164) | Philips Medical Systems | 2016-06-24 |
| Digital Blood Pressure Monitor (K153033) | Suzhou Sunspiri Co., Ltd. | 2016-06-24 |
| NC Quantum Apex PTCA Dilatation Catheter (K160823) | Boston Scientific Corporation | 2016-06-23 |
| Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter (K153006) | Sterilmed, Inc. | 2016-06-23 |
| Chocolate XD PTCA Balloon Catheter (K153682) | Trireme Medical, LLC | 2016-06-23 |
| Portable ECG Monitor (K152863) | Contec Medical Systems Co.,Ltd | 2016-06-22 |
| OptiCross 18, 30 MHz Peripheral Imaging Catheter (K160514) | Boston Scientific Corporation | 2016-06-22 |
| ASAHI Fielder XT-A, ASAHI Fielder XT-R (K153106) | Asahi Intecc Co., Ltd. | 2016-06-21 |
| Masimo Root Monitoring System and Accessories (K153225) | Masimo Corporation | 2016-06-21 |
| REBOA Balloon Catheter (K160598) | NuMED, Inc. | 2016-06-20 |
| CenterCross Ultra Catheter (K160681) | Roxwood Medical, Inc. | 2016-06-17 |
| PreSep Oligon Oximetry Catheter (K160645) | Edwards Lifesciences, LLC | 2016-06-16 |
| NormaTec PCD-T and PCD-B (K161346) | NormaTec Industries, LP | 2016-06-15 |
| ASAHI Corsair Armet (K161362) | Asahi Intecc Co., Ltd. | 2016-06-14 |
| Full Automatic (NIBP) Blood Pressure Monitor (K161156) | Health & Life Co., Ltd. | 2016-06-14 |
| M3290B Philips IntelliVue Information Center iX (K153702) | Philips Medical Systems | 2016-06-13 |
| Arrow Quickflash Arterial Catheterization Device (K160018) | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-06-13 |
| Medline Singe Patient Use Blood Pressure Cuff (K161035) | Medline Industries, Inc. | 2016-06-13 |
| NR Recorder (K161062) | Norav Medical GmbH | 2016-06-13 |
| Penumbra System ACE 68 Reperfusion Catheter (K161064) | Penumbra, Inc. | 2016-06-12 |
| Reprocessed Inquiry Steerable Diagnostic EP Catheter (K160496) | Innovative Health, LLC | 2016-06-10 |
| Masimo O3 Regional Oximeter System (K160526) | Masimo Corporation | 2016-06-09 |
| Halo One Thin-Walled Guiding Sheath (K161183) | C.R. Bard, Inc. | 2016-06-03 |
| LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream (K153719) | Honeywell Hommed, LLC | 2016-06-03 |
| EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (K160552) | Edwards Lifesciences, LLC | 2016-06-01 |
| AGE Automatic Upper Arm Blood Pressure Monitor (K153552) | Ageless Health Industrial Co., Ltd. | 2016-06-01 |
| Cirona 6400 (K161209) | Devon Medical Products | 2016-05-31 |
| Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor (K151781) | Ivy Biomedical Systems, Inc. | 2016-05-27 |
| Reveal LINQ (K160809) | Medtronic, Inc. | 2016-05-26 |
| FLEX SCORING CATHETER (K152789) | Venturemed Group | 2016-05-25 |
| Penumbra System, Penumbra Pump MAX (K160449) | Penumbra, Inc. | 2016-05-25 |
| Smartdop XT6 (K153762) | Koven Technology, Inc. | 2016-05-25 |
| EMMa Electronic Monitoring Management (K153477) | Vitasystems GmbH | 2016-05-25 |
| Hypocore (K153162) | Novocor Medical Systems, Inc. | 2016-05-24 |
| Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System) (K160533) | Penumbra, Inc. | 2016-05-24 |
| CROSSER CTO Recanalization Catheter (K161208) | Bard Peripheral Vacular, Inc. | 2016-05-24 |
| BIB Stent Placement Catheter (K160889) | NuMED, Inc. | 2016-05-20 |
| Nester Embolization Coils, Tornado Embolization Coils (K153778) | Cook Incorporated | 2016-05-19 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| OptiCross X, 40 MHz Coronary Imaging Catheter (K161125) | Boston Scientific Corporation | 2016-05-19 |
| GORE DrySeal Flex Introducer Sheath (K160254) | W. L. Gore & Associates, Inc. | 2016-05-12 |
| Guiding Catheter (K153703) | Texasmedical Technologies, Inc. | 2016-05-12 |
| moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager (K152749) | Moor Instruments, Ltd. | 2016-05-12 |
| Venous Assist System (K150980) | Daesung Maref Co., Ltd. | 2016-05-12 |
| Reprocessed Livewire Steerable Diagnostic EP Catheter (K160242) | Innovative Health, LLC | 2016-05-10 |
| Reprocessed Polaris X Steerable Diagnostic EP Catheter (K160303) | Innovative Health, LLC | 2016-05-10 |
| Diagnostic Station DS20 (K152043) | Schiller AG | 2016-05-06 |
| Achieve ST Mapping Catheter, Catheter Connecting Cable (K153139) | Medtronic, Inc. | 2016-05-06 |
| Digital Blood Pressure Monitor (K152415) | Suzhou Sunspirit Co., Ltd. | 2016-05-06 |
| Cogent Hemodynamic Monitoring System (K152006) | Icu Medical, Inc. | 2016-05-05 |
| Philips Efficia CMS200 Central Monitoring System (K160951) | Philips Medical Systems | 2016-05-05 |
| PeriFlux6000 (K152930) | Perimed AB | 2016-05-05 |
| Swan Ganz Catheters (K160084) | Edwards Lifesciences, LLC | 2016-05-03 |
| Crosstella OTW (K160004) | KANEKA Corporation | 2016-04-29 |
| Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit (K160866) | C.R. Bard, Inc. | 2016-04-29 |
| Patient Monitor (K152552) | Edan Instruments, Inc. | 2016-04-29 |
| Dyna-Vision Telemonitoring System (K152973) | Techmedic Development International B.V. | 2016-04-29 |
| Crosperio OTW (K160013) | KANEKA Corporation | 2016-04-29 |
| MMS PTA Balloon Catheter (K152934) | Micro Medical Solutions, Inc. | 2016-04-25 |
| U80 Series Upper Arm Electronic Blood Pressure Monitor (K160019) | Shenzhen Urion Technology Co., Ltd. | 2016-04-22 |
| Reveal LINQ (K160689) | Medtronic, Inc. | 2016-04-22 |
| Matrix Mini ECG Monitor (K152701) | Global Instrumentation, LLC | 2016-04-22 |
| Pantheris Catheter (K160827) | Avinger, Inc. | 2016-04-21 |
| Pulse Oximeter (MD300M/MD300K2) (K152563) | Beijing Choice Electronic Technology Co., Ltd. | 2016-04-18 |
| Bullfrog Micro-Infusion Device (K153501) | Mercator Medsystems, Inc. | 2016-04-15 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff (K153251) | Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. | 2016-04-14 |
| A&D Medical TM-2657 Family of Digital Blood Pressure Monitors (K151953) | A&D Company, Ltd. | 2016-04-13 |
| Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit (K153038) | Medtronic, Inc. | 2016-04-13 |
| HealthChek Network Health Station (K152107) | Healthchek Network, LLC | 2016-04-12 |
| BioMonitor 2-AF, BioMonitor 2-S (K152995) | Biotronik, Inc. | 2016-04-11 |
| Map-it Diagnostic Mapping Catheters (K160390) | Access Point Technologies Ep, Inc. | 2016-04-11 |
| Nihon Kohden Afib Detection Program QP-039P (K152305) | Nihon Kohden Corporation | 2016-04-08 |
| Merge Hemo (K152864) | Merge Healthcare Incorporated | 2016-04-07 |
| ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) (K160659) | Asahi Intecc Co., Ltd. | 2016-04-07 |
| FIRMap Catheter (K153093) | Abbott Electrophysiology | 2016-04-07 |
| transGlide Expandable Introducer (K152194) | Transaortic Medical, Inc. | 2016-04-07 |
| Disposable Temporary Pacing Cable (K152947) | Tiger Medical Products | 2016-04-05 |
| Hydroven 12, Hydroven 12 Garments (K152228) | Huntleigh Healthcare , Ltd. | 2016-04-04 |
| SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM (K152881) | Spacelabs Healthcare, Ltd. | 2016-04-01 |
| PlasmaFlow (K160318) | Manamed, Inc. | 2016-04-01 |
| T3 Software (K152258) | Etiometry, Inc. | 2016-03-31 |
| AVIVO Mobile Patient Management (MPM) System (K153160) | Medtronic, Inc. | 2016-03-30 |
| Full Automatic (NIBP) Blood Pressure Monitor (K160336) | Health & Life Co., Ltd. | 2016-03-29 |
| DeRoyal Angiography Kits (K152978) | Deroyal Industries, Inc. | 2016-03-25 |
| Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (K153226) | Zoll Circulation, Inc. | 2016-03-24 |
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |
| CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor (K151499) | Caretaker Medical, LLC | 2016-03-18 |
| CorPath 200 System (K152999) | Corindus, Inc. | 2016-03-18 |
| LiDCOunity Monitor (K152935) | Lidco, Ltd. | 2016-03-17 |
| Axeo 3 Patient Monitor (K153079) | Axeo Medical Technologies, LLC | 2016-03-17 |
| AlertWatch: OR (K153335) | Alertwatch, LLC | 2016-03-15 |
| MODEL 621/624 BIOMAGNETOMETER (K151135) | Tristan Technologies, Inc. | 2016-03-15 |
| Reprocessed Electrophysiology Catheter (K153153) | Innovative Health, LLC | 2016-03-14 |
| Full Automatic (NIBP) Blood Pressure Monitor (K160145) | Health & Life Co., Ltd. | 2016-03-13 |
| Surefire Infusion System (K160662) | Surefire Medical, Inc. | 2016-03-11 |
| MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System (K160064) | Infobionic, Inc. | 2016-03-11 |