| K171183 — OmniTom | Neurologica Corporation Aug 18, 2017 |
| K171407 — ExsoMed ArcPhix and ExsoMed ArrowPhix | Exsomed Holding Company, LLC Aug 18, 2017 |
| K163418 — Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories Aug 18, 2017 |
| K171227 — StarWalker | Fotona D.O.O. Aug 18, 2017 |
| K170667 — QEVO System with KINEVO 900 | Carl Zeiss Meditec, AG Aug 18, 2017 |
| K172194 — Connector System | Orthofix, Inc. Aug 18, 2017 |
| K171660 — Duo Lumbar Interbody Fusion Device | Spineology, Inc. Aug 18, 2017 |
| K172139 — Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) Aug 18, 2017 |
| K171738 — Supria True64 | Hitachi Healthcare Americas Corporation Aug 18, 2017 |
| DEN160025 — ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit | Id-Fish Technology, Inc. Aug 18, 2017 |
| K163359 — ARK Methotrexate Assay | Ark Diagnostics, Inc. Aug 18, 2017 |
| K171900 — Acclarix AX4 Diagnostic Ultrasound System | Edan Instruments, Inc. Aug 18, 2017 |
| K172359 — UroLift System (UL500) | Neotract, Inc. Aug 18, 2017 |
| K170003 — Zip 4 Skin Closure Device | Zipline Medical, Inc. Aug 18, 2017 |
| K171261 — ScannerSide DoseCheck | Right Dose, Inc. Aug 18, 2017 |
| K170825 — SnoreRx | Apnea Sciences Corporation Aug 18, 2017 |
| K161679 — s LDL-EX SEIKEN | Denka Seiken Co., Ltd. Aug 18, 2017 |
| K171898 — Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs | Better Care Plastic Technology Co., Ltd. Aug 18, 2017 |
| K170782 — Medline UNITE® Snap-Off Screws | Medline Industries, Inc. Aug 18, 2017 |
| K171845 — EMBA Hourglass Peripheral Embolization Device | Emba Medical Limited Aug 18, 2017 |
| K171143 — Relievant Medsystems RF Generator | Relievant Medsystems Aug 18, 2017 |
| K170431 — 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 | Coeur, Inc. Aug 18, 2017 |
| K171406 — Optum TeleHealth Application | United Health Group, Inc. Aug 18, 2017 |
| K170800 — NuVasive LessRay with Enhanced Tracking | Nu Vasive, Incorporated Aug 18, 2017 |
| K171993 — Zimmon Needle Knife Papillotome | Wilson-Cook Medical Inc./Cook Endoscopy Aug 17, 2017 |
| K162917 — Allerhope Allergy Skin Tester | Procare Industrial Co., Limited Aug 17, 2017 |
| K171028 — CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories | GE Healthcare Finland Oy Aug 17, 2017 |
| K170384 — Dentium NR Line CAD/CAM Abutments | Dentium Co., Ltd. Aug 17, 2017 |
| K171475 — DeRoyal Laprador Specimen Retrieval System | Deroyal Industries, Inc. Aug 17, 2017 |
| K171156 — OMNI Anseris Hip Stem | Omnilife Science Aug 17, 2017 |
| K172204 — BD Intima II PLUS Closed IV Catheter System | Becton, Dickinson And Company Aug 17, 2017 |
| K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit | Rocket Medical Plc Aug 17, 2017 |
| K172220 — Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation Aug 17, 2017 |
| K172165 — Q-Fix Suture Anchor | ArthroCare Corporation Aug 17, 2017 |
| K171793 — Sequential Circulator SC-2004FC-OC | Bio Compression Systems, Inc. Aug 17, 2017 |
| K170979 — ARIX Ankle Fibula Hook Plate System | Jeil Medical Corporation Aug 17, 2017 |
| K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) | Ion Beam Applications S.A. Aug 17, 2017 |
| K171983 — Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. Aug 17, 2017 |
| K170555 — U Deliver Bolink ENFit Enteral Feeding Sets | U Deliver Medical, LLC Aug 17, 2017 |
| K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. Aug 17, 2017 |
| K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0 | Spectralmd, Inc. Aug 17, 2017 |
| K170064 — GLUCOCARD W Blood Glucose Monitoring System | Arkray Factory, Inc. Aug 16, 2017 |
| K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare Aug 16, 2017 |
| K172175 — CapSure® PS System | Spine Wave, Inc. Aug 16, 2017 |
| K170910 — Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. Aug 16, 2017 |
| K172426 — Clear Blue Digi LED Curing Light | Promident, LLC Aug 16, 2017 |
| K171950 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) | Visionary Optics, LLC Aug 16, 2017 |
| K171651 — EXCELSIUS GPS | Globus Medical, Inc. Aug 16, 2017 |
| K170968 — PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc Aug 16, 2017 |
| K162768 — 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 | Integral Process Sas Aug 16, 2017 |