| K183097 — Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream | Weihai Kangzhou Biotechnology Engineering Co., Ltd. Jan 10, 2019 |
| K181180 — OSSIO Pin Product Family | OSSIO , Ltd. Jan 10, 2019 |
| K181204 — RENASYS Y-Connector; RENASYS TOUCH | Smith & Nephew Medical Limited Jan 10, 2019 |
| K183071 — VLIFT-s Vertebral Body Replacement System | Stryker Spine Jan 10, 2019 |
| K180355 — Advocate Non-Contact Infrared Thermometer | Broadmaster Biotech, Corp. Jan 10, 2019 |
| K182635 — Signal Catheter | Safe Medical Design Jan 10, 2019 |
| K181444 — CLARUS | Carl Zeiss Meditec, Inc. Jan 10, 2019 |
| K183713 — Wireless Digital Flat Detector | Iray Technology Taicang , Ltd. Jan 9, 2019 |
| K182869 — Fit SA | Shofu Dental Corporation Jan 9, 2019 |
| K183422 — Wireless Digital Flat Panel Detector | Iray Technology Taicang , Ltd. Jan 9, 2019 |
| K181282 — G3A 40 Bone Cement | G21, S.R.L. Jan 9, 2019 |
| K182846 — PENTAX Medical EPK-3000 Video Imaging System | Pentax Of America, Inc. Jan 9, 2019 |
| K181637 — DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 9, 2019 |
| K181118 — Reliance Lumbar IBF System | Reliance Medical Systems Jan 9, 2019 |
| K181047 — Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs | Smart Glove Corporation Sdn. Bhd. Jan 9, 2019 |
| K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | C&E GP Specialist, Inc. Jan 9, 2019 |
| K183133 — MRCP+ v1.0 | Perspectum Diagnostics, Ltd. Jan 9, 2019 |
| K181086 — Cortical Fixation Systems | Cousin Biotech Sas Jan 9, 2019 |
| K182439 — TruShot with Y-Knot Shallow All-Suture Anchor | Conmed Corporation Jan 8, 2019 |
| K180648 — Park Dental Research Aligners | Park Dental Research Corporation Jan 8, 2019 |
| K182692 — BD MAX CTGCTV2, BD MAX System | Becton, Dickinson And Company Jan 8, 2019 |
| K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation Jan 8, 2019 |
| K182632 — HS30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Jan 8, 2019 |
| K182721 — Choice Spine Navigation System | Choicespine, LP Jan 8, 2019 |
| K182868 — INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor | Covidien, LLC Jan 8, 2019 |
| K182210 — TiWAVE-L Porous Titanium Lumbar Cage | Kalitec Medical, LLC Jan 7, 2019 |
| K180564 — Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | Medentika GmbH Jan 7, 2019 |
| K182305 — Stryker Facial iD Plating System | Stryker Jan 7, 2019 |
| K182114 — FlareHawk Interbody Fusion System | Integrity Implants, Inc. Jan 7, 2019 |
| K183470 — Precision Ideal Eyes Arthroscopes | Stryker Jan 7, 2019 |
| K180199 — BIO-C TEMP | Angelus Industria DE Produtos Odontologicos S/A Jan 4, 2019 |
| K182675 — Polygon Resection Device | Polygon Medical, Inc. Jan 4, 2019 |
| K183392 — PicoLO Nd:YAG Picosecond Laser System | Laseroptek Co., Ltd. Jan 4, 2019 |
| K182621 — CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver | Conmed Corporation Jan 4, 2019 |
| K183293 — VERIFY VH202 Indicator Tape | STERIS Corporation Jan 4, 2019 |
| K183033 — Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml | Thermo Fisher Scientific Jan 4, 2019 |
| K183295 — Celerity HP Chemical Indicator (CI) | Steris Corporations Jan 4, 2019 |
| K183256 — GlideScope BFlex Single-Use Bronchoscope System | Verathon Medical (Canada) Ulc Jan 4, 2019 |
| K182982 — BridalVeil Navigated Instruments | Astura Medical Jan 4, 2019 |
| K183175 — BostonSight Scleral | Bostonsight Jan 4, 2019 |
| K181053 — Care Orchestrator | Respironics, Inc. Jan 4, 2019 |
| K181461 — Rapid-i Kit | Vitrolife Sweden AB Jan 4, 2019 |
| K180477 — Straumann PURE Ceramic Implant System | Institut Straumann AG Jan 4, 2019 |
| K180435 — Arm Blood Pressure Monitor | Alicn Medical (Shenzhen), Inc. Jan 3, 2019 |
| K183301 — PRO-LITE Sterilization Tray | STERIS Corporation Jan 3, 2019 |
| K183297 — Vis-U-All Low Temperature Sterilization Pouch/Tubing | STERIS Corporation Jan 3, 2019 |
| K180983 — Maxcon Two Gallon Chemotherapy Container | Ningbo Maxcon Medical Technology Co., Ltd. Jan 3, 2019 |
| K182766 — Cufitec Surgical Mask | Nbc Meshtec, Inc. Jan 3, 2019 |
| K182741 — SculpSure | Cynosure Jan 3, 2019 |
| K180951 — Responsive Arthroscopy Suture Anchor System | Responsive Arthroscopy, LLC Jan 3, 2019 |