| K183102 — BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | Leica Biosystems Newcastle, Limited Dec 7, 2018 |
| K182048 — Avenir Complete Hip System | Zimmer, Inc. Dec 7, 2018 |
| K181695 — Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. Dec 7, 2018 |
| K182664 — FiXcision | Agency For Medical Innovations GmbH Dec 7, 2018 |
| K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 | Flexicare Medical Limited. Dec 7, 2018 |
| K180679 — CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) | Global Scientific Technologies, LLC Dec 7, 2018 |
| K180754 — C-Zero Pedicle Screw System, Freedom Pedicle Screw System | Signature Orthopaedics Pty, Ltd. Dec 7, 2018 |
| K183100 — Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | Leica Biosystems Newcastle, Limited Dec 7, 2018 |
| K180889 — Tractus Crossing Support Catheter | Tractus Vascular, LLC Dec 7, 2018 |
| K183111 — Contour 24 | Quality Electrodynamics, LLC Dec 7, 2018 |
| K180670 — ICONN Campbell Interference Screw | Iconn Orthopedics, LLC Dec 7, 2018 |
| K182183 — GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | Samsung Electronics Co., Ltd. Dec 7, 2018 |
| K182007 — Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies Dec 7, 2018 |
| K180657 — Resin for Temporary Crown & Bridge | Dentis Co., Ltd. Dec 7, 2018 |
| K172897 — Neck Care Therapy, Model: SYK 509B | Shenzhen Osto Technology Co., Ltd. Dec 7, 2018 |
| K183212 — Nexus DR Digital X-ray Imaging System with stitching | Varex Imaging Corporation Dec 7, 2018 |
| K182438 — Synthetic Polyisoprene Lubricated Male Condom - 5 senses | Sxwell USA, LLC Dec 6, 2018 |
| K181357 — PATRIOT® Lumbar Spacers, SUSTAIN® Spacers | Globus Medical, Inc. Dec 6, 2018 |
| K182680 — KerraContact Ag Perf Advanced Perforated Silver Wound Dressing | Exciton Technologies, Inc. Dec 6, 2018 |
| K183116 — Unity Network ID | GE Healthcare Dec 6, 2018 |
| K163601 — RII Smart IR Thermometer | Radiant Innovation, Inc. Dec 6, 2018 |
| K181529 — Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection | Contego Medical, LLC Dec 6, 2018 |
| K182373 — PowerLook Tomo Detection V2 Software | Icad, Inc. Dec 6, 2018 |
| K182125 — EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. Dec 6, 2018 |
| K173048 — No-contact Forehead Thermometer | Dongguan Simzo Electronic Technology Co., Ltd. Dec 6, 2018 |
| K182035 — FFRct | HeartFlow, Inc. Dec 6, 2018 |
| K182016 — Simplicit90Y | Mirada Medical, Ltd. Dec 6, 2018 |
| K181107 — Elevo® Kit Snoring Intervention Device | Zelegent, Inc. Dec 6, 2018 |
| K181231 — DePuy Synthes T-PAL Spacer System | Depuy Synthes Spine Dec 6, 2018 |
| K182926 — IntelliSpace Radiology | Philips Healthcare Informatics, Inc. Dec 6, 2018 |
| K183098 — Senhance Surgical System | Transenterix, Inc. Dec 6, 2018 |
| K181958 — MagnetOs Putty | Kuros Biosciences B.V Dec 6, 2018 |
| K181727 — Vivid iq | GE Medical Systems Ultrasound And Primary Care Diagnostics Dec 6, 2018 |
| K183040 — Zenition 70 | Philips Medical Systems Nederland B.V. Dec 6, 2018 |
| K182006 — Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths | Hologic, Inc. Dec 6, 2018 |
| K173749 — AMRA Profiler | Amra Medical AB Dec 6, 2018 |
| K182479 — NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus | Hycor Biomedical Dec 4, 2018 |
| K181970 — MectaLIF Posterior Extension | Medacta International S.A. Dec 4, 2018 |
| K183069 — NobelZygoma 0° | Nobel Biocare AB Dec 4, 2018 |
| K183037 — Monaco RTP System | Elekta, Inc. Dec 4, 2018 |
| K181336 — HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. Dec 4, 2018 |
| K183065 — Coolrail Linear Pen | AtriCure, Inc. Dec 4, 2018 |
| K182949 — Healix Compression Screw System | Nvision Biomedical Technologies, LLC Dec 4, 2018 |
| K180653 — Spartan eCoil System | Spartan Micro, Inc. Dec 4, 2018 |
| K180615 — AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter | Fresenius Kabi USA,Llc Dec 4, 2018 |
| K181935 — Endoform Reconstructive Template - Non Absorbable | Aroa Biosurgery , Ltd. Dec 4, 2018 |
| K182076 — Elekta Unity | Elekta Limited Dec 4, 2018 |
| K181825 — CAAS MR Solutions | Pie Medical Imaging BV Dec 4, 2018 |
| K183191 — 6420 Ultrasound System | Esaote, S.P.A. Dec 4, 2018 |
| K183034 — MOSAIQ Oncology Information System | Elekta, Inc. Dec 4, 2018 |