| K180004 — Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Menicon Co, Ltd. Feb 22, 2018 |
| K172294 — Osteotomy Truss System (OTS) | 4Web, Inc. Feb 22, 2018 |
| K173967 — Remedy Acetabular Cup | Osteoremedies, LLC Feb 22, 2018 |
| K171649 — Straumann CARES M-Series CAD/CAM System | Institut Straumann AG Feb 22, 2018 |
| K173402 — Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. Feb 22, 2018 |
| K171171 — KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) | Koon Seng Sdn Bhd Feb 22, 2018 |
| K171568 — SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty | Hans Biomed Corporation Feb 22, 2018 |
| K180181 — Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) Feb 22, 2018 |
| K173629 — CELERITY 20 Steam Process Challenge Device for Gravity Cycles | STERIS Corporation Feb 21, 2018 |
| K172338 — Catasyn Advanced Technology Wound Hydrogel | Synedgen, Inc. Feb 21, 2018 |
| K172950 — TSN Transseptal Needle | Pressure Products Medical Device Manufacturing, LLC Feb 21, 2018 |
| K173963 — DRI Benzodiazepine Assay | Microgenics Corporation Feb 21, 2018 |
| K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 | Honsun (Nantong) Co., Ltd. Feb 21, 2018 |
| K173626 — Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles | STERIS Corporation Feb 21, 2018 |
| K171620 — PiCCO Catheter | Pulsion Medical Systems SE Feb 21, 2018 |
| K163377 — Captura Disposable Bronchoscope Biopsy Forceps | Wilson-Cook Medical, Inc. Feb 21, 2018 |
| K172647 — Reprocessed ArthroCare ENT Coblator | Renovo, Inc. Feb 21, 2018 |
| K180193 — DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | El.En Electronic Engineering Spa Feb 21, 2018 |
| K173270 — Tri-Staple 2.0 Reinforced Reload | Covidien Feb 20, 2018 |
| K170683 — Aesculap Video Assisted Thoracic Surgery (VATS) INstruments | Aesculap, Inc. Feb 20, 2018 |
| K171605 — Elecsys CA 15-3 II | Roche Diagnostics Feb 20, 2018 |
| K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC Feb 20, 2018 |
| K172885 — HydroPICC | Access Vascular, Inc. Feb 20, 2018 |
| K173513 — WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Feb 20, 2018 |
| K173228 — U-MED Powder Free Polyethylene Examination Gloves,Blue Color | Jiangsu U-Med Rubber & Plastic Products Co., Ltd. Feb 20, 2018 |
| K180176 — SeaSpine NewPort Spinal System | SeaSpine Orthopedics Corporation Feb 20, 2018 |
| K172390 — Optima Coil System | Blockade Medical, LLC (D.B.A. Balt Usa) Feb 18, 2018 |
| K172361 — EEA Circular Stapler with Tri-Staple Technology | Covidien Feb 16, 2018 |
| K172934 — Needle Free Transseptal Cannula | Pressure Products Medical Device Manufacturing, LLC Feb 16, 2018 |
| K180128 — Warrior 14 guidewire | Vascular Solutions, Inc. Feb 16, 2018 |
| K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG Feb 16, 2018 |
| K173587 — Magseed Magnetic Marker Systtem | Endomagnetics Ltd., Feb 16, 2018 |
| K173460 — NeuroEEG | Memory MD, Inc. Feb 16, 2018 |
| K180123 — Breast BI 7 MR Coil 1.5T Mammavention | Noras Mri Products GmbH Feb 16, 2018 |
| K180141 — SPIWay Endonasal Access Guide | Spiway, LLC Feb 16, 2018 |
| K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated Feb 16, 2018 |
| K173409 — Wireless Audio System | Neocoil, LLC Feb 16, 2018 |
| K171521 — DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. Feb 16, 2018 |
| K172208 — NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet | Nevap, Inc. Feb 16, 2018 |
| K171646 — ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. Feb 16, 2018 |
| K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) | Concentric Medical, Inc. Feb 15, 2018 |
| K173644 — Gazelle Polypropylene Suture and Delivery Device | Dura Tap, LLC Feb 15, 2018 |
| K173580 — Vinyl Patient Examination Glove (Yellow) | Nature Medical Products Co., Ltd. Feb 15, 2018 |
| K173288 — CorPath GRX System | Corindus, Inc. Feb 15, 2018 |
| K173877 — BOWA Neutral Electrodes | Bowa-Electronics GmbH & Co. KG Feb 15, 2018 |
| K171535 — SURGICAL ISOLATION GOWN | Jingzhou Haixin Green Cross Medical Products Co., Ltd. Feb 15, 2018 |
| K171604 — Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip | Cook Incorporated Feb 15, 2018 |
| K172613 — Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | The Binding Site Group , Ltd. Feb 15, 2018 |
| K180137 — AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) | AtriCure, Inc. Feb 15, 2018 |
| K180138 — AtriCure cryoICE cryo-ablation probe (CRYO2) | AtriCure, Inc. Feb 15, 2018 |