| K173726 — ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut | Phadia AB Apr 16, 2018 |
| K173935 — Mediant Anterior Cervical Plating System | Intelligent Implant Systems, LLC Apr 16, 2018 |
| K172727 — Hemoclip | Hangzhou AGS MedTech Co., Ltd. Apr 16, 2018 |
| K173226 — CardiMax Electrocardiograph | Fukuda Denshi USA, Inc. Apr 16, 2018 |
| K180096 — GDT-1000 System | Acuvu, Inc. Apr 16, 2018 |
| K180126 — SOZO | ImpediMed Limited Apr 16, 2018 |
| K171603 — Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set | Cook Incorporated Apr 16, 2018 |
| K170463 — KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System | I-Sens, Inc. Apr 13, 2018 |
| K172143 — uMI 780 PET/CT System | Shanghai United Imaging Healthcare Co., Ltd. Apr 13, 2018 |
| K171562 — Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH Apr 13, 2018 |
| K170761 — LIGHTSonic BUBM | Lightmed USA, Inc. Apr 13, 2018 |
| K180704 — SonoSite iViz Ultrasound System | FUJIFILM Sonosite, Inc. Apr 13, 2018 |
| K173692 — D-Actor 200 Vibration Massage System | Storz Medical AG Apr 13, 2018 |
| K173632 — SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. Apr 13, 2018 |
| K180699 — Voyant Open Fusion Device | Applied Medical Resources Corporation Apr 13, 2018 |
| K173103 — Pivet and Soft-Pass Embryo Transfer Catheter Sets | Cook Incorporated Apr 13, 2018 |
| K180305 — Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) | Aquilabs Us, LLC Apr 13, 2018 |
| K173371 — VisuMax Femtosecond Laser | Carl Zeiss Meditec, Inc. Apr 13, 2018 |
| K180408 — U60 Diagnostic Ultrasound System | Edan Instruments, Inc. Apr 13, 2018 |
| K172930 — mCare Powder-free Blue Nitrile Examination Gloves | Mercator Medical (Thailand), Ltd. Apr 13, 2018 |
| K170901 — ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 | Biosystems S.A. Apr 13, 2018 |
| K180667 — SmartGrid | Carestream Health, Inc. Apr 13, 2018 |
| K173934 — Reza Band, Reflux Band | Somna Therapeutics, LLC Apr 13, 2018 |
| K173606 — SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation Apr 13, 2018 |
| K162499 — Best Instruminal Applicator | Best Medical International, Inc. Apr 13, 2018 |
| K171326 — Piezosurgery White | Mectron S.P.A. Apr 13, 2018 |
| K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire | Boston Scientific Apr 12, 2018 |
| K180651 — Uroview FD II | Pausch Medical GmbH Apr 12, 2018 |
| K172201 — Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. Apr 12, 2018 |
| K173515 — Admiral Xtreme | Medtronic Vascular Apr 12, 2018 |
| K172315 — Straub Endovascular System | Straub Medical AG Apr 12, 2018 |
| K180567 — C3 Wave System | Medical Components, Inc. (Dba MedComp) Apr 12, 2018 |
| K180689 — Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device | STERIS Corporation Apr 12, 2018 |
| K172155 — StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC Apr 12, 2018 |
| K180549 — ZED Link | Zed Technologies Apr 12, 2018 |
| K180666 — 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) Apr 12, 2018 |
| K180318 — PET Digital Gating | Ge Medical Systems, LLC Apr 11, 2018 |
| K180744 — Stablyx CMC Arthroplasty Implant System | Skeletal Dynamics, LLC Apr 11, 2018 |
| K172047 — Riva Star | Sdi Limited Apr 11, 2018 |
| DEN180001 — IDx-DR | Idx, LLC Apr 11, 2018 |
| K173880 — Corin TriFit CF Hip Stem | Corin U.S.A. Limited Apr 11, 2018 |
| K172495 — Reform® POCT System | Precision Spine, Inc. Apr 11, 2018 |
| K172187 — Inno-Hydrowire | Suzhou Innomed Medical Device Co., Ltd. Apr 11, 2018 |
| K173859 — HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL Apr 11, 2018 |
| K173860 — s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | Volcano Corporation Apr 11, 2018 |
| K180121 — Rafugen DBM | Cellumed Co., Ltd. Apr 11, 2018 |
| K173686 — Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter | Cook Incorporated Apr 11, 2018 |
| K171379 — Digital Automatic Wrist Blood Pressure Monitor MD4300 | Grandway Technology (Shenzhen) Limited Apr 10, 2018 |
| K172206 — NAJA Ligament Correction System | Cousin Biotech Sas Apr 10, 2018 |
| K172967 — Mercury® Spinal System | Spinal Elements, Inc. Apr 10, 2018 |