| K172623 — NuVasive Navigation Instruments | Nu Vasive, Incorporated Dec 21, 2017 |
| K172467 — OMNI ARC Anteverted Neck Hip Stem | Omnilife Science Dec 21, 2017 |
| K172321 — Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters | Cook Incorporated Dec 21, 2017 |
| K171109 — Praxiject 0.9% NaCl | Medxl, Inc. Dec 21, 2017 |
| K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer | Quidel Corporation Dec 21, 2017 |
| K173375 — Anterior Cervical Plate System | Evolution Spine, LLC Dec 21, 2017 |
| K172560 — PREMIUM ONE Implant Systems | Sweden & Martina S.P.A. Dec 21, 2017 |
| K172185 — Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC Dec 21, 2017 |
| K171434 — ROCCIA® MultiLIF | Silony Medical GmbH Dec 21, 2017 |
| K173332 — OMNI Surgical System | Sight Sciences, Inc. Dec 21, 2017 |
| K172926 — SeaSpine Vu cPOD, Zuma-C, Complete Cervical | SeaSpine Orthopedics Corporation Dec 21, 2017 |
| K172973 — Life Spine Foot and Ankle Plating System | Life Spine, Inc. Dec 21, 2017 |
| K171530 — Deltaven XiV Max, Deltaven XiV Max FF | Delta Med Spa Dec 21, 2017 |
| K170005 — FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | Dako Denmark A/S Dec 21, 2017 |
| K172960 — easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use | Ezisurg Medical Co., Ltd. Dec 21, 2017 |
| K171043 — Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters | Coloplast Corp. Dec 21, 2017 |
| DEN170024 — AQUABEAM System | Procept Biorobotics, Corporation Dec 21, 2017 |
| K172886 — Breakaway Screw System | Paragon 28 Dec 20, 2017 |
| K173555 — LOGIQ E10 | GE Healthcare Dec 20, 2017 |
| K171275 — Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design | Cook Incorporated Dec 20, 2017 |
| K173578 — Biograph mCT Family of PET/CT Systems | Siemens Medical Solutions USA, Inc. Dec 20, 2017 |
| K172989 — Electric Breast Pump | Joytech Healthcare Co. , Ltd. Dec 20, 2017 |
| K173685 — Peel-Away Introducer Set | Cook Incorporated Dec 20, 2017 |
| K173125 — T2 STRATOSPHERE Expandable Corpectomy System | Medtronic Sofamor Danek Dec 20, 2017 |
| K173349 — Operio | Toul Meditech AB Dec 20, 2017 |
| K172565 — Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | Boston Scientific Corporation Dec 20, 2017 |
| K173115 — COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS | Globus Medical, Inc. Dec 20, 2017 |
| K173662 — speX Support Catheter | Reflow Medical, Inc. Dec 20, 2017 |
| K170972 — Apex Tibial Nailing System | Orthoxel Dec 20, 2017 |
| K171866 — Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular, Inc. Dec 20, 2017 |
| K163550 — Pobling MIITY 2 | Habalan Med & Beauty Co.,Ltd Dec 20, 2017 |
| K170950 — Well-Root ST | Vericom Co., Ltd. Dec 20, 2017 |
| K173182 — ProLift® Expandable System | Life Spine, Inc. Dec 20, 2017 |
| K171012 — Veraview X800 | J. Morita USA, Inc. Dec 19, 2017 |
| K170862 — Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope | Solace Therapeutics, Inc. Dec 19, 2017 |
| K173646 — FS Ergo | Palodex Group OY Dec 19, 2017 |
| K172986 — Zmachine Synergy | Consolidated Research Of Richmond, Inc. Dba General Sleep CO Dec 19, 2017 |
| K173130 — Reform® Midline Cortical Screw System | Precision Spine, Inc. Dec 19, 2017 |
| K173251 — LumiCoil Platinum Fiducial Marker | Boston Scientific Corporation Dec 19, 2017 |
| DEN170075 — ContainOR | Advanced Surgical Concepts, Ltd. Dec 19, 2017 |
| K173307 — Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL | Liofilchem S.R.L. Dec 19, 2017 |
| K172677 — Advantage Plus Pass-Thru | Medivators, Inc. Dec 19, 2017 |
| K173600 — MAGNETOM Amira | Siemens Medical Solutions USA, Inc. Dec 19, 2017 |
| K172944 — VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mL | bioMerieux, Inc. Dec 19, 2017 |
| K172861 — Digital thermometer(with disposable thermometer cover) | Hangzhou Hua'An Medical&Health Instruments Co.,Ltd Dec 19, 2017 |
| K173618 — ACUSON AcuNav Volume Intracardiac Echocardiography Catheter | Siemens Medical Solutions USA, Inc. Dec 19, 2017 |
| K172982 — SuperGrow 272, Ultimate 272 | Super Grow Lasers Dec 19, 2017 |
| K171552 — Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV | Cepheid Dec 19, 2017 |
| DEN160062 — IlluminOss Bone Stabilization System | Illminoss Medical, Inc. Dec 19, 2017 |
| K171834 — G Surgical OCT Spinal System | G Surgical, LLC Dec 19, 2017 |