| ER-REBOA Catheter (K172790) | Prytime Medical Devices, Inc. | 2017-11-08 |
| Rooti Rx ECG Event Recorder, Rooti Link APP Software (K163694) | Rooti Labs , Ltd. | 2017-11-07 |
| Fixed Patient Leads ECG Cable (Model 3153) (K172591) | Boston Scientific Corporation | 2017-11-03 |
| Reprocessed Halo XP Diagnostic Electrophysiology Catheter (K171788) | Innovative Health, LLC | 2017-11-03 |
| Fingertip Pulse Oximeter (K170965) | Shenzhen Jumper Medical Equipment Co., Ltd. | 2017-11-03 |
| Phlebo Press DVT Model (K172277) | Mego Afek AC , Ltd. | 2017-11-03 |
| VitalPatch® VitalConnect Platform (K163453) | Vitalconnect, Inc. | 2017-11-02 |
| myMerlin(TM) Mobile Application Model APP1001 (K173232) | St Jude Medical | 2017-11-02 |
| Monitor B125, Monitor B105 (K171580) | Ge Medical Systems (China) Co., Ltd. | 2017-11-01 |
| Stethee Pro (K172296) | M3Dicine Pty , Ltd. | 2017-10-30 |
| Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (K172236) | Avinger, Inc. | 2017-10-30 |
| Automatic Blood Pressure Monitor Model LD-518 & LD-537 (K170466) | Honsun (Nantong) Co., Ltd. | 2017-10-27 |
| Tubing Pack (K171979) | Medtronic, Inc. | 2017-10-27 |
| Gel-Bead (K171946) | Vascular Solutions, Inc. | 2017-10-25 |
| Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir (K172626) | Medtronic, Inc. | 2017-10-25 |
| 3880 MRI Patient Monitoring System (K172200) | Iradimed Corporation | 2017-10-25 |
| Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U (K170454) | Honsun (Nantong) Co., Ltd. | 2017-10-25 |
| SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (K171751) | Capsule Technologie Sas | 2017-10-24 |
| ClearLumen II Peripheral Thrombectomy System (K172000) | Walk Vascular, LLC | 2017-10-24 |
| Reprocessed Inquiry Steerable Diagnostic EP Catheter (K171277) | Innovative Health, LLC | 2017-10-23 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K173063) | Acist Medical Systems, Inc. | 2017-10-23 |
| TruWave Disposable Pressure Transducer (K171996) | Edwards Lifesciences, LLC | 2017-10-23 |
| Heraeus TMW Guidewire (K173052) | Heraeus Medical Components, LLC | 2017-10-20 |
| SafeSept Transseptal Guidewire (K170671) | Pressure Products Medical Device Manufacturing, LLC | 2017-10-20 |
| GuideLiner V3 Catheter (K172090) | Vascular Solutions, Inc. | 2017-10-20 |
| D'Vill Introducer (K171206) | NuMED, Inc. | 2017-10-20 |
| 065 Zenith, 074 Zenith (K171672) | Inneuroco, Inc. | 2017-10-19 |
| ECG SENTINEL System (K172801) | Cardiomedix, Inc. | 2017-10-18 |
| Liberator Beacon Tip Locking Stylet (K170298) | Cook Incorporated | 2017-10-18 |
| NovaCross Microcatheter (K172297) | Nitiloop , Ltd. | 2017-10-18 |
| RVS-100 Vital Signs Monitor (K170538) | Rudolf Riester GmbH | 2017-10-17 |
| EnsoETM (K172493) | Attune Medical | 2017-10-17 |
| AcQMap High Resolution Imaging and Mapping System (K170948) | Acutus Medical, Inc. | 2017-10-16 |
| Coaxial Dilator Set (Micro-Introducer) (K172487) | Galt Medical Corp. | 2017-10-16 |
| AcQMap 3D Imaging and Mapping Catheter (K170819) | Acutus Medical, Inc. | 2017-10-16 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y (K172498) | Microlife Intellectual Property GmbH | 2017-10-13 |
| Electronic Blood Pressure Monitor (K170151) | Shenzhen Pango Electronic Co., Ltd. | 2017-10-13 |
| CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305) | Datascope Corp. | 2017-10-12 |
| Creavo Vitalscan Magnetocardiograph (K170154) | Creavo Medical Technologies, Ltd. | 2017-10-12 |
| higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing) (K172739) | Higi Sh, LLC | 2017-10-10 |
| 3M Bair Hugger Model 675 Total Temperature Management System (K171373) | 3M Company | 2017-10-10 |
| IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable (K171801) | Philips Medizin Systeme Boeblingen GmbH | 2017-10-06 |
| R2P Destination Slender Guiding Sheath (K171491) | Terumo Medical Corporation | 2017-10-05 |
| Shoocin Introducer Kit (K172099) | Lepu Medical Technology (Beijing) Co., Ltd. | 2017-10-05 |
| Reprocessed CristaCath Diagnostic Electrophysiology Catheter (K171503) | Innovative Health, LLC | 2017-10-05 |
| ECG Check - Universal, ECG Check - Universal Plus (K170506) | Cardiac Designs, Inc. | 2017-10-02 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| Peel-Away Introducer Set (K170020) | Cook Incorporated | 2017-09-28 |
| Peerbridge Cor(TM) System (K171936) | Peerbridge Health, Inc. | 2017-09-27 |
| Electrocardiograph (K171943) | Edan Instruments, Inc. | 2017-09-25 |
| ULTRASCORE Focused Force PTA Balloon (K172571) | C. R. Bard | 2017-09-22 |
| NOWCARDIO SYSTEM (K162956) | Contex International Technologies (Canada), Inc. | 2017-09-22 |
| Finger Pulse Oximeter (K163135) | Shenzhen Fitfaith Technology Co.,Ltd | 2017-09-19 |
| ECOM™ Cardiac Output Monitoring System (K172196) | Ecom Medical, Inc. | 2017-09-19 |
| Glidewire GT (K170417) | Terumo Corporation | 2017-09-15 |
| M-CATH Microcatheter (K171176) | Acrostak (Schweiz) AG | 2017-09-15 |
| Masimo Rad-97 and Accessories (K170168) | Masimo Corporation | 2017-09-14 |
| Prelude Pursuit Splittable Sheath Introducer (K172117) | Merit Medical Systems, Inc. | 2017-09-11 |
| All-in-One Health Monitor, PC-303 (K170047) | Shenzhen Creative Industry Co., Ltd. | 2017-09-09 |
| 014 Hydrophilic Coated PTA Balloon Dilatation Catheter (K171251) | Creagh Medical | 2017-09-08 |
| Medline Hemo-Force DVT Compression Sleeve (K170415) | Medline Industries, Inc. | 2017-09-08 |
| QMAPP Amplifier; QMAPP Hemodynamic Monitoring System; QMAPP PCM; QMAPP GO; QMAPP EP (K170032) | Fysicon BV | 2017-09-08 |
| ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook (K163699) | Aln Implants Chirurgicaux | 2017-09-08 |
| XableCath Support Catheter (K170041) | Xablecath, Inc. | 2017-09-07 |
| QuadraSphere Microspheres (K172372) | Biosphere Medical, S.A. | 2017-09-06 |
| Steerable Guide Catheter (K172394) | Abbott Vascular | 2017-09-06 |
| Prizma (K170181) | G-Medical Innovations , Ltd. | 2017-09-01 |
| RhythmView Workstation (K171583) | Abbott Electrophysiology | 2017-09-01 |
| Pirouette High Pressure (HP) (K172033) | Arravasc, Ltd. | 2017-08-31 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor (K170467) | Microlife Intellectual Property GmbH | 2017-08-30 |
| ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm (K170958) | Tricol Biomedical, Inc. | 2017-08-29 |
| Captus Vascular Retrieval System (K170987) | Avantec Vascular Corporation | 2017-08-28 |
| Hi-Torque Command 18 Guide Wire (K172073) | Abbott Vascular | 2017-08-25 |
| Liver Access and Biopsy Sets (K171853) | Cook Incorporated | 2017-08-24 |
| 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System (K172386) | Volcano Atheromed, Inc. | 2017-08-24 |
| Passport Series Patient Monitors(Passport 12m, Passport 17m) (K170876) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2017-08-23 |
| Physiotrace (K171244) | Nimbleheart, Inc. | 2017-08-23 |
| MAMBA and MAMBA FLEX Microcatheters (K171452) | Boston Scientific Corporation | 2017-08-21 |
| Approach CTO Microwire Guide (K171897) | Cook Incorporated | 2017-08-21 |
| QUANTIEN Measurement System (K172182) | St. Jude Medical (Now Part of the Abbott Medical) | 2017-08-18 |
| Optum TeleHealth Application (K171406) | United Health Group, Inc. | 2017-08-18 |
| EMBA Hourglass Peripheral Embolization Device (K171845) | Emba Medical Limited | 2017-08-18 |
| CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip (K170431) | Coeur, Inc. | 2017-08-18 |
| ACIST RXi Mini System (K172216) | Acist Medical Systems, Inc. | 2017-08-18 |
| Sequential Circulator SC-2004FC-OC (K171793) | Bio Compression Systems, Inc. | 2017-08-17 |
| Rocket Indwelling Pleural Catheter (IPC) Insertion Kit (K163321) | Rocket Medical Plc | 2017-08-17 |
| SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 (K163339) | Spectralmd, Inc. | 2017-08-17 |
| Advanced Perfusion System 1 (K172220) | Terumo Cardiovascular Systems Corporation | 2017-08-17 |
| ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables (K162768) | Integral Process Sas | 2017-08-16 |
| SOZO (K172122) | ImpediMed Limited | 2017-08-11 |
| Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr (K170488) | Surge Cardiovascular | 2017-08-10 |
| MegaVac Mechanical Thrombectomy System (K171493) | Capture Vascular, Inc. | 2017-08-10 |
| HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm (K171431) | Biostable Science & Engineering, Inc. | 2017-08-10 |
| Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K171712) | William Cook Europe Aps | 2017-08-07 |
| Maestro Microcatheter (K172081) | Merit Medical Systems, Inc. | 2017-08-04 |
| CADence System (K170928) | Aum Cardiovascular, Inc. | 2017-08-03 |
| eCareManager 4.1 (K171322) | Visicu, Inc. | 2017-08-03 |
| Accutorr 7/VS-900 Vital Signs Monitor (K170712) | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2017-08-02 |
| BP5S Wireless Blood Pressure Monitor (K171062) | Andon Health Co, Ltd. | 2017-08-01 |
| LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L (K170565) | Lifewatch Services, Inc. | 2017-08-01 |