| K171124 — Nihon Kohden Wireless Input Unit WEE-1200 | Nihon Kohden Corporation Aug 25, 2017 |
| K171853 — Liver Access and Biopsy Sets | Cook Incorporated Aug 24, 2017 |
| K170750 — RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | Brainlab AG Aug 24, 2017 |
| K171299 — Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. Aug 24, 2017 |
| K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System | Volcano Atheromed, Inc. Aug 24, 2017 |
| K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | Smiths Medical Ads, Inc. Aug 24, 2017 |
| K172061 — PRECICE UNYTE System | Nuvasive Specialized Orthopedics, Inc. Aug 24, 2017 |
| K171048 — RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Aug 24, 2017 |
| K171563 — MagnetOs Putty | Kuros Biosciences B.V Aug 24, 2017 |
| K171921 — VenaCure EVLT NeverTouch Procedure Kit | AngioDynamics, Inc. Aug 24, 2017 |
| K171173 — OrthoPediatrics Titanium PediPlates® System | OrthoPediatrics Corp. Aug 24, 2017 |
| K171249 — Entrada hip stem | Ortho Development Corporation Aug 24, 2017 |
| K170367 — Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | Fisher And Paykel Healthcare Limited Aug 24, 2017 |
| K171865 — F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring | Farus, LLC Aug 24, 2017 |
| K171331 — NxStage System One | Nxstage Medical, Inc. Aug 24, 2017 |
| K171465 — Stryker Self-Punching ICONIX | Stryker Aug 24, 2017 |
| K170876 — Passport Series Patient Monitors(Passport 12m, Passport 17m) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Aug 23, 2017 |
| K172262 — EVOS Small Fragment Plating System | Smith & Nephew, Inc. Aug 23, 2017 |
| K170984 — LG BEAUTY LED MASK | Lg Electronics Aug 23, 2017 |
| K171244 — Physiotrace | Nimbleheart, Inc. Aug 23, 2017 |
| K172214 — Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. Aug 23, 2017 |
| K172227 — Endoscopic Injection Needle | Carbon Medical Technologies, Inc. Aug 23, 2017 |
| K172104 — Ozark(tm) Cervical Plate System | K2M, Inc. Aug 23, 2017 |
| K171587 — VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation Aug 22, 2017 |
| K171523 — Monopolar Single Use Laparoscopic Instrument | Getsch+Hiller Medizintechnik GmbH Aug 22, 2017 |
| K170911 — NEOCERA Advanced Barrier Cream | Exeltis USA Dermatology, LLC Aug 22, 2017 |
| K171041 — SilverSeal | Alliqua Biomedical, Inc. Aug 22, 2017 |
| K171895 — Grivamax Hair Growth System | Leana Orders, Inc. Aug 22, 2017 |
| K170642 — GRAVITY Soft Tissue Repair System | Wrightmedicaltechnologyinc Aug 22, 2017 |
| K171504 — VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation Aug 22, 2017 |
| K171617 — OKI Surgical Planning Software | Ortho Kinematics, Inc. Aug 22, 2017 |
| K172364 — EzDent-i / E2 / Prora View | Ewoosoft Co., Ltd. Aug 22, 2017 |
| K172367 — Stryker Integrated Bipolar Cord and Tubing Sets | Stryker Instruments Aug 22, 2017 |
| K163342 — i-STAT Hematocrit test with i-STAT Alinity System | Abbott Laboratories Aug 22, 2017 |
| K171140 — Matrixx System | Nexxt Spine, LLC Aug 22, 2017 |
| K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls | Siemens Healthcare Diagnostics Prodcts GmbH Aug 22, 2017 |
| K163695 — Borrelia B31 ViraChip IgM Test Kit | Viramed Biotech AG Aug 22, 2017 |
| K172107 — Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System | Spineology, Inc. Aug 21, 2017 |
| K171526 — Zenius, lliad and Kora Spinal Fixation Systems | Medyssey USA, Inc. Aug 21, 2017 |
| K171897 — Approach CTO Microwire Guide | Cook Incorporated Aug 21, 2017 |
| K171276 — Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | Tg Medical Sdn. Bhd. Aug 21, 2017 |
| K171511 — RIDA GENE Norovirus GI/GII | R-Biopharm AG Aug 21, 2017 |
| K171452 — MAMBA and MAMBA FLEX Microcatheters | Boston Scientific Corporation Aug 21, 2017 |
| K163375 — INFINITY OCT System | Medtronic Sofamor Danek USA, Inc. Aug 21, 2017 |
| K171225 — Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB Aug 21, 2017 |
| K171024 — ShockPulse-SE Lithotripsy System | Cybersonics, Inc. Aug 21, 2017 |
| K171459 — Ceribell Instant EEG Headband | Ceribell, Inc. Aug 21, 2017 |
| K170149 — 3DMetal Tibial Cones | Medacta International S.A. Aug 18, 2017 |
| K172216 — ACIST RXi Mini System | Acist Medical Systems, Inc. Aug 18, 2017 |
| K172182 — QUANTIEN Measurement System | St. Jude Medical (Now Part Of The Abbott Medical) Aug 18, 2017 |