| K180289 — 3D Bolus Software | 3D Bolus, Inc. Jul 10, 2018 |
| K181522 — PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | Pentax Of America, Inc. Jul 9, 2018 |
| K181261 — Curiteva Cervical Interbody Fusion System | Curiteva, LLC Jul 9, 2018 |
| K181547 — FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Echosens Jul 9, 2018 |
| K180923 — Personal Lubricating Jelly | Perrigo New York, Inc. Jul 9, 2018 |
| K180798 — Prime Acetabular Cup System | Microport Orthopedics, Inc. Jul 9, 2018 |
| K180930 — EMPOWR VVC TIBIAL INSERT | Encore Medical L.P. Jul 9, 2018 |
| K173562 — Straumann Jason Membrane | Institut Straumann AG Jul 9, 2018 |
| K173766 — PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs | Shen Wei USA, Inc. Jul 8, 2018 |
| K172971 — BMLS16-1 | Biomedical Life Systems, Inc. Jul 8, 2018 |
| K180590 — Tyber Medical PT Interbody Spacer System | Tyber Medical, LLC Jul 6, 2018 |
| K181350 — ASTRA-OCT Spine System | Spinecraft, LLC Jul 6, 2018 |
| K181509 — Endorate Valve Sets | Smartdata Suzhou Co., Ltd. Jul 6, 2018 |
| K173776 — BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. Jul 6, 2018 |
| K173927 — Elecsys BRAHMS PCT | Roche Diagnostics Jul 6, 2018 |
| K180868 — Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set | Cook Ireland Jul 6, 2018 |
| K180515 — GammaTile | Isoray Medical, Inc. Jul 6, 2018 |
| K181139 — OLYMPIC Posterior Spinal Fixation System | Astura Medical, LLC Jul 6, 2018 |
| K181092 — CHROMID CARBA agar (CARB) | Biomerieux S.A. Jul 6, 2018 |
| K173970 — Materialise PKA Guide System | Materialise NV Jul 6, 2018 |
| K173019 — GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar | ETHICON, Inc. Jul 6, 2018 |
| K180755 — Vail ALIF Buttress Plate System | Evolution Spine, LLC Jul 6, 2018 |
| K181499 — DRI Cocaine Metabolite Assay | Microgenics Corporation Jul 6, 2018 |
| K181327 — InPen Dose Calculator | Companion Medical, Inc. Jul 6, 2018 |
| K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. Jul 6, 2018 |
| K172694 — Sterile Disposable Syringes | Shenyang Mastech Medical Device Co., Ltd. Jul 6, 2018 |
| K181493 — FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC Jul 5, 2018 |
| K181175 — 12F Tri-Flow Triple Lumen Catheter | Medical Components, Inc. (Dba MedComp) Jul 5, 2018 |
| K173277 — ASAHI PTCA Guide Wire ASAHI SION black | Asahi Intecc Co., Ltd. Jul 5, 2018 |
| K173359 — Fractional CO2 Surgical Laser System | Ami, Inc. Jul 5, 2018 |
| K161085 — Nitrile Patient Examination Powder Free Glove, Textured, Black | Multisafe Sdn. Bhd. Jul 5, 2018 |
| K180018 — Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. Jul 5, 2018 |
| K172778 — CheckMyHeart Plus | Dailycare Biomedical, Inc. Jul 5, 2018 |
| K173721 — SureForm 60 and SureForm 60 Reloads | Intuitive Surgical Jul 5, 2018 |
| K181044 — 400um Perforator and Accessory Vein Ablation Kit | AngioDynamics, Inc. Jul 5, 2018 |
| K180705 — Riptide Aspiration System React 68 Catheter | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 4, 2018 |
| K180715 — React 68 Catheter | Micro Therapeutics, Inc. D/B/A Ev3 Neurovascular Jul 4, 2018 |
| K181193 — PeriView FLEX | Olympus Surgical Technologies America Jul 3, 2018 |
| K181526 — XRpad2 4343 HWC-M Flat Panel Detector | Varex Imaging Corporation Jul 3, 2018 |
| K172952 — Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. Jul 3, 2018 |
| K180367 — Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. Jul 3, 2018 |
| K173679 — PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Pentax Of America, Inc. Jul 3, 2018 |
| K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL) | Biomerieux S.A. Jul 3, 2018 |
| K173276 — Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP | Medline Industries, Inc. Jul 2, 2018 |
| K180910 — ULTRAPRO Mesh and ULTRAPRO ADVANCED | ETHICON, Inc. Jul 2, 2018 |
| K173864 — Peekplus® Interbody Fusion Device | Vallum Corporation Jul 2, 2018 |
| K173868 — Serenity Body Position Sensor, Serenity RIP Sensors | Neurotronics, Inc. Jul 2, 2018 |
| K171414 — qEEG-Pro | Brainmaster Technologies, Inc. Jul 1, 2018 |
| K171197 — Zuga Dental Implant System | Zuga Medical, Inc. Jun 30, 2018 |
| K173815 — Allergan Botox Needle Electrode | Natus Manufacturing Limited Jun 29, 2018 |