| Quantum Pump Console (K173834) | Spectrum Medical , Ltd. | 2018-05-25 |
| Route 92 Medical Access System (K180201) | Route 92 Medical, Inc. | 2018-05-23 |
| Pantheris System (K173862) | Avinger, Inc. | 2018-05-22 |
| The IQoolTM Warm System (K180375) | Braincool AB | 2018-05-18 |
| Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (K181023) | Meril Life Sciences Private Limited | 2018-05-17 |
| EnsoETM (K180742) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-05-17 |
| FlowTriever Retrieval/Aspiration System (K180466) | Inari Medical, Inc. | 2018-05-17 |
| Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter (K181042) | Boston Scientific Corporation | 2018-05-17 |
| Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister (K180412) | Penumbra, Inc. | 2018-05-15 |
| XableCath Support Catheter Product Family (K180986) | Xablecath, Inc. | 2018-05-15 |
| Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (K172625) | Nonin Medical, Inc. | 2018-05-11 |
| µCor Heart Failure and Arrhythmia Management System (K172510) | Zoll Manufacturing Corporation | 2018-05-11 |
| FORE-SIGHT ELITE Module Tissue Oximeter (K180003) | Cas Medical Systems, Inc. | 2018-05-10 |
| ANGIO-PRESS LITE DVT Compression Device (K173012) | Pegasus Medical Supply, Inc. | 2018-05-10 |
| VSI Micro-Introducer Kit (K180913) | Vascular Solutions, Inc. | 2018-05-09 |
| EmboTrap ll Revascularization Device (K173452) | Neuravi, Ltd. | 2018-05-09 |
| Glidesheath Slender (K173831) | Terumo Medical Corporation | 2018-05-08 |
| BioStamp nPoint (K173510) | Mc10, Inc. | 2018-05-08 |
| QT ECG (K180157) | QT Medical, Inc. | 2018-05-04 |
| Medtronic Confida Brecker Guidewire (K181001) | Medtronic Core Valve, LLC | 2018-05-03 |
| Indigo Aspiration System - Modified 110 Aspiration Tubing (K180939) | Penumbra, Inc. | 2018-05-03 |
| Micropuncture Pedal Access Set (K172980) | Cook Incorporated | 2018-05-03 |
| PeraServer and PeraTrend (K172959) | Perahealth, Inc. | 2018-05-01 |
| Novasight Hybrid System (K172258) | Conavi Medical, Inc. | 2018-04-27 |
| EnSite Velocity Cardiac Mapping System v5.2 (K172396) | St Jude Medical | 2018-04-23 |
| Patient Status Engine (K172329) | Isansys Lifecare, Ltd. | 2018-04-23 |
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| Medtronic Model 53401 External Pulse Generator (EPG) (K180873) | Medtronic, Inc. | 2018-04-19 |
| 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (K180007) | Creagh Medical, Ltd. | 2018-04-19 |
| Zenith Flex System (K172167) | Inneuroco, Inc. | 2018-04-19 |
| RAILWAY Sheathless Access System (K180081) | Cordis Corporation | 2018-04-18 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K172880) | Microlife Intellectual Property GmbH | 2018-04-18 |
| Wingman 35 Crossing Catheter (K173661) | Reflow Medical, Inc. | 2018-04-18 |
| ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System (K180416) | Cardiovascular Systems, Inc. | 2018-04-17 |
| PreludeSYNC DISTAL Radial Compression System (K180723) | Merit Medical Systems, Inc. | 2018-04-17 |
| CardiMax Electrocardiograph (K173226) | Fukuda Denshi USA, Inc. | 2018-04-16 |
| SOZO (K180126) | ImpediMed Limited | 2018-04-16 |
| JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire (K180795) | Boston Scientific | 2018-04-12 |
| Admiral Xtreme (K173515) | Medtronic Vascular | 2018-04-12 |
| Straub Endovascular System (K172315) | Straub Medical AG | 2018-04-12 |
| Inno-Hydrowire (K172187) | Suzhou Innomed Medical Device Co., Ltd. | 2018-04-11 |
| Digital Automatic Wrist Blood Pressure Monitor MD4300 (K171379) | Grandway Technology (Shenzhen) Limited | 2018-04-10 |
| ClotTriever Thrombectomy System (K180329) | Inari Medical, Inc. | 2018-04-09 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K180694) | Spectranetics, Inc. | 2018-04-05 |
| VAMP Venous/Arterial Blood Management Protection System (K173586) | Edwards Lifesciences, LLC | 2018-04-05 |
| Wedge Microcatheter (K172014) | MicroVention, Inc. | 2018-04-05 |
| TrapLiner catheter (K180088) | Vascular Solutions, Inc. | 2018-04-04 |
| Pulse Oximeter (K172141) | Shanghai Berry Electronic Tech Co., Ltd. | 2018-04-04 |
| High-Flo Silver Polyethylene Catheter (K172635) | Cook Incorporated | 2018-04-03 |
| Unite Connect for Clinical Systems (K180566) | Ascom Sweden AB | 2018-04-03 |
| Surefire Spark Infusion System (K180677) | Surefire Medical, Inc. | 2018-04-03 |
| Merit Pursue Microcatheter (K173548) | Merit Medical Systems, Inc. | 2018-03-30 |
| Performer Guiding Sheath (K171988) | Cook Incorporated | 2018-03-30 |
| Mandril Wire Guide (K171997) | Cook Incorporated | 2018-03-30 |
| NaviCross 0.018 (K173799) | Terumo Corporation | 2018-03-29 |
| Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) (K172071) | Terumo Cardiovascular Systems Corporation | 2018-03-29 |
| CorPath GRX System (K180517) | Corindus, Inc. | 2018-03-29 |
| Bloom2 Programmable Electrophysiology Stimulator (K173439) | Fischer Medical | 2018-03-29 |
| Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (K173591) | Spectrum Medical , Ltd. | 2018-03-28 |
| PressureWire X (K180558) | St. Jude Medical (Now Part of Abbott Medical) | 2018-03-28 |
| Pulse Oximeter (K171241) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2018-03-27 |
| Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D (K170605) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2018-03-27 |
| CPRmeter 2 CPR Feedback Device (K173886) | Laerdal Medical AS | 2018-03-23 |
| Bio-Medicus Adult Cannulae and Introducer (K180453) | Medtronic, Inc. | 2018-03-22 |
| Bio-Medicus Adult Cannulae Kit (K180456) | Medtronic, Inc. | 2018-03-22 |
| WIRION (K180023) | Gardia Medical , Ltd. | 2018-03-21 |
| Double Flexible Tip Wire Guides (K171912) | Cook Incorporated | 2018-03-19 |
| OTW Takeru PTCA Balloon Dilatation Catheter (K172264) | KANEKA Corporation | 2018-03-19 |
| AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm (K173841) | Stryker | 2018-03-18 |
| Acumen Hypotension Prediction Index (HPI) Feature Software (DEN160044) | Edwards Lifesciences, LLC | 2018-03-16 |
| Wrist Pulse Oximeter (K172366) | Beijing Choice Electronic Technology Co., Ltd. | 2018-03-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K171937) | Microlife Intellectual Property GmbH | 2018-03-16 |
| MEMO 4D (K180411) | Sorin Group Italia S.R.L. | 2018-03-16 |
| INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter (K180448) | Sorin Group Italia S.R.L. | 2018-03-15 |
| Cardiovascular Analzyer (K172431) | Physiowave, Inc. | 2018-03-14 |
| Athena GTX Device Management Suite (ADMS) Software (K173203) | Athena Gtx | 2018-03-14 |
| Transjugular Liver Access Sets (K171820) | Cook Incorporated | 2018-03-09 |
| Wrist Type Blood Pressure Monitor (K162616) | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018-03-09 |
| Fixed Core Wire Guides (K171764) | Cook Incorporated | 2018-03-09 |
| Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister (K180105) | Penumbra, Inc. | 2018-03-08 |
| Accutension Smartphone Auscultatory Blood (K180335) | Shanghai Hulu Devices Co., Ltd. | 2018-03-08 |
| Neuro Assessment System NAS-1000 (K172892) | Headsense Medical, Inc. | 2018-03-08 |
| Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter (K173262) | Innovative Health, LLC | 2018-03-06 |
| Wrist Type Automatic Blood Pressure Monitor (K172972) | Shenzhen Jiacom Technology CO ., Ltd. | 2018-03-02 |
| Type I, Type II, Type III, Type IV (K172331) | Lepu Medical Technology (Beijing) Co., Ltd. | 2018-03-02 |
| Flowtron DVT5 Small Calf Garment (K172103) | Getinge (Suzhou) Co., Ltd. | 2018-03-02 |
| Sapphire II PRO (K173680) | Orbusneich Medical Trading, Inc. | 2018-03-01 |
| CorPath GRX System (K173806) | Corindus, Inc. | 2018-03-01 |
| EnsoETM (K180244) | Advanced Cooling Therapy, Inc. D/B/A Attune Medical | 2018-02-28 |
| HeRO Symphony, HeRO ES, HeRO solo/duet (K180242) | Medical Predictive Science Corporation | 2018-02-28 |
| ECG Cable/Leadwires (K172797) | Shenzhen Coreray Technology, Ltd. | 2018-02-28 |
| Bluetooth blood pressure monitor (K171668) | Visiomed Group SA | 2018-02-26 |
| Nexxis OR (K173381) | Barco N.V. | 2018-02-22 |
| Sentry IVC Filter (K173236) | Novate Medical , Ltd. | 2018-02-22 |
| Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 (K170866) | Honsun (Nantong) Co., Ltd. | 2018-02-21 |
| TSN Transseptal Needle (K172950) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-21 |
| PiCCO Catheter (K171620) | Pulsion Medical Systems SE | 2018-02-21 |
| PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (K172423) | Edwards Lifescience, LLC | 2018-02-20 |
| ACISTCVi® Contrast Delivery System (K171646) | Acist Medical Systems, Inc. | 2018-02-16 |
| Needle Free Transseptal Cannula (K172934) | Pressure Products Medical Device Manufacturing, LLC | 2018-02-16 |