| K182549 — StatStrip Xpress 2 Glucose Hospital Meter System | Nova Biomedical Corporation Dec 13, 2018 |
| K182359 — HipCheck | Stryker Corp. Dec 13, 2018 |
| K182178 — neoBLUE blanket LED Phototherapy System | Natus Medical Incorporated Dec 13, 2018 |
| K182552 — StatStrip Xpress Glucose Hospital Meter System | Nova Biomedical Corporation Dec 13, 2018 |
| K181372 — Argos | Retia Medical, LLC Dec 13, 2018 |
| K183265 — Selectra Catheters, Selectra Accessory Kit | Biotronik, Inc. Dec 13, 2018 |
| K182812 — Medline Cautery Electrode (SILICONE) | Medline Industries, Inc. Dec 12, 2018 |
| K182339 — LEUCADIA AUTOLOK Pedicle Screw System | Clearview Orthopedic Development, LLC Dec 12, 2018 |
| K183383 — ANAX OCT Spinal System | U&I Corporation Dec 12, 2018 |
| DEN170055 — Retrograde Intubation Set | Cook Incorporated Dec 12, 2018 |
| K181869 — On1 Universal Abutment | Nobel Biocare AB Dec 12, 2018 |
| K182997 — enlighten III Laser System | Cutera, Inc. Dec 12, 2018 |
| K182473 — PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems | K2M, Inc. Dec 12, 2018 |
| K182954 — Salvo Spine System | Spine Wave, Inc. Dec 12, 2018 |
| K183128 — EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 | Abbott Dec 12, 2018 |
| K180578 — Harvest Dental Polymer Blocks | Harvest Dental Products, LLC Dec 12, 2018 |
| K181744 — BI-MENTUM dual mobility system | Serf Dec 11, 2018 |
| K180999 — Mygen V-1000 RF System | RF Medical Co., Ltd. Dec 11, 2018 |
| K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | CooperVision, Inc. Dec 11, 2018 |
| K181625 — Life Spine Resolute Threaded Cage System | Life Spine, Inc. Dec 11, 2018 |
| K181174 — Cardinal Health Sterilization Wrap | Cardinal Health200, LLC Dec 11, 2018 |
| K183107 — Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. Dec 11, 2018 |
| K182946 — Invacare TDX SP2-HD with Captain's Seat | Invacare Corporation Dec 11, 2018 |
| K183307 — Magma Spark Pro (Magma Spark Plus, Alpha) | Formatk Systems , Ltd. Dec 11, 2018 |
| K182902 — Precision1 | Alcon Laboratories, Inc. Dec 11, 2018 |
| K183168 — OpenLoc-L Spinal Fixation System | L&K BIOMED Co., Ltd. Dec 11, 2018 |
| K180533 — Procellera Composite Antibacterial Wound Dressing | Vomaris Wound Care, Inc. Dec 10, 2018 |
| K182831 — SabreLine and SabreGuard Laser Fibers | Coloplast Corp. Dec 10, 2018 |
| K182038 — URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation Dec 10, 2018 |
| K181967 — Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. Dec 10, 2018 |
| K181826 — Glenoid Polyaxial Non-locking Screws | Medacta International S.A. Dec 10, 2018 |
| K182810 — Distal Radius Plating System | Miami Device Solutions, LLC Dec 10, 2018 |
| K182506 — LipiScan Dynamic Meibomian Imager | Tearscience, Inc. Dec 10, 2018 |
| K173681 — reSET-O | Pear Therapeutics, Inc. Dec 10, 2018 |
| K181498 — X-ray Imaging System for the McLaren Proton Treatment System | Ehmetdx, LLC Dec 10, 2018 |
| K182280 — ARK Tramadol Assay | Ark Diagnostics, Inc. Dec 10, 2018 |
| K180831 — CATSmart | Fresenius Kabi AG Dec 10, 2018 |
| K182512 — Route 92 Medical Delivery Catheter | Route 92 Medical, Inc. Dec 10, 2018 |
| K182075 — BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Dec 10, 2018 |
| K181675 — FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System | Taidoc Technology Corporation Dec 10, 2018 |
| K182491 — Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. Dec 10, 2018 |
| K181766 — VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance | bioMerieux, Inc. Dec 10, 2018 |
| K180945 — LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation Dec 10, 2018 |
| K181405 — Hailie Sensor | Adherium (Nz), Ltd. Dec 10, 2018 |
| K183080 — Mega Plus Spine System | Bk Meditech, Co., Ltd. Dec 10, 2018 |
| K182584 — Lucent® XP | Spinal Elements, Inc. Dec 10, 2018 |
| K182724 — CelerityTM 10 STEAM Chemical Indicator | STERIS Corporation Dec 10, 2018 |
| K183286 — 17HK701G-W | Lg Electronics.Inc Dec 7, 2018 |
| K182809 — CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation Dec 7, 2018 |
| K180175 — SignalMark Lung Biopsy Site Marker | View Point Medical, Inc. Dec 7, 2018 |