| K182352 — SP-LINK System | Medical Designs, LLC Nov 21, 2018 |
| K181454 — DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. Nov 21, 2018 |
| K181996 — MATRx Plus | Zephyr Sleep Technologies Nov 21, 2018 |
| K182265 — CodMan Certas Plus Programmable Valve | Integra Lifesciences Corp. Nov 20, 2018 |
| K182931 — VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag | Steris Corporations Nov 20, 2018 |
| K182715 — Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. Nov 20, 2018 |
| K181731 — MR Compatible Aspiration Kit | Mri Interventions, Inc. Nov 20, 2018 |
| K182274 — Orbit Subretinal Delivery System | Orbit Biomedical, Inc. Nov 20, 2018 |
| K182652 — COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 | Kangfu Medical Equipment Factory Nov 20, 2018 |
| K181247 — Vitrea CT Brain Perfusion | Vital Images, Inc. Nov 20, 2018 |
| K181857 — Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Kossan International Sdn Bhd Nov 20, 2018 |
| K182291 — 6MP Color LCD Monitor (C61W+) | Shenzhen Beacon Display Technology Co., Ltd. Nov 20, 2018 |
| K182133 — Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. Nov 20, 2018 |
| K182288 — TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona Nov 20, 2018 |
| K180550 — NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated Nov 20, 2018 |
| K180917 — GC Acrylic Primer | GC America, Inc. Nov 20, 2018 |
| K181806 — ARIX Sternal System | Jeil Medical Corporation Nov 20, 2018 |
| K182696 — Telepack X LED | KARL STORZ Endoscopy-America, Inc. Nov 20, 2018 |
| K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. Nov 19, 2018 |
| K180432 — AI-ECG Platform | Shenzhen Carewell Electronics., Ltd. Nov 19, 2018 |
| K182772 — Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil | Covidien Nov 19, 2018 |
| DEN180030 — QMS Plazomicin Immunoassay | Microgenics Corporation Nov 19, 2018 |
| K182535 — R3 Anteverted Liners | Smith & Nephew, Inc. Nov 19, 2018 |
| K181646 — Celesteion, PCA-9000A/3, V6.5 | Canon Medical Systems Corporation Nov 16, 2018 |
| K182958 — 1.5T 16ch Breast Coil | Neocoil, LLC Nov 16, 2018 |
| K182179 — AdvantageRib Anterior System | Sig Medical Corp. Nov 16, 2018 |
| K182916 — Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr | Lemaitre Vascular Nov 16, 2018 |
| K182109 — REDAPT Modular Acetabular Shell | Smith & Nephew, Inc. Nov 16, 2018 |
| K180979 — PureFlex Arterial Cannulae | Sorin Group Italia S.R.L. Nov 16, 2018 |
| K180184 — Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG Nov 16, 2018 |
| K181137 — IT-III active System | Neobiotech Co., Ltd. Nov 16, 2018 |
| K181948 — 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Rapid Biomedical GmbH Nov 16, 2018 |
| K181709 — Serenity Piezo Sensor, Serenity Thermocouple Sensor | Neurotronics, Inc. Nov 16, 2018 |
| K180343 — LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | Bonraybio Co., Ltd. Nov 16, 2018 |
| K180881 — HemoSphere Advanced Monitor, HemoSphere Pressure Cable | Edwards Lifesciences, LLC Nov 16, 2018 |
| K181140 — Axis Chena Cervical PEEK Spacer System | Axis Orthopaedics Nov 16, 2018 |
| K181643 — SmartBag (SmartPouch) | 11 Health Technologies Limited Nov 16, 2018 |
| K180528 — InstruSafe(R) Sterilization Container | Summit Medical, Inc. Nov 16, 2018 |
| K182201 — Stratum Foot Plating System | Nextremity Solutions, Inc. Nov 16, 2018 |
| K182562 — Hair Boom 69 | Wontech Nov 16, 2018 |
| K182090 — AposTherapy System | Apos Medical Assets , Ltd. Nov 16, 2018 |
| K182980 — Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. Nov 16, 2018 |
| K181921 — Solidity Vertebral Body Replacement | Ulrich Medical USA Nov 16, 2018 |
| K180645 — Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | Hartalega Sdn Bhd Nov 16, 2018 |
| K182626 — OEC One | Ge Hualun Medical Systems Co. , Ltd. Nov 16, 2018 |
| K173373 — SafeT T-Piece Resuscitator | Ventlab, LLC Nov 16, 2018 |
| K181396 — Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited Nov 16, 2018 |
| K182298 — hemochroma PLUS System | Immunostics Inc., Nov 16, 2018 |
| K182182 — YUKON OCT Spinal System | K2M Nov 15, 2018 |
| K180668 — Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. Nov 15, 2018 |