| K180801 — Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. Nov 5, 2018 |
| K182095 — Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) Nov 5, 2018 |
| K180601 — Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) | Villa Sistemi Medicali S.P.A. Nov 2, 2018 |
| K181208 — Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter | Vygon USA Nov 2, 2018 |
| K182270 — Cellene CO2 Laser System | Bio-Med USA, Inc. Nov 2, 2018 |
| K182596 — Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | Canon Medical Systems Corporation Nov 2, 2018 |
| K180786 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff | Hartalega Sdn Bhd Nov 2, 2018 |
| K182427 — Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Canon Medical Systems Corporation Nov 2, 2018 |
| DEN170056 — Parathyroid Detection (Model PTeye) System | Aibiomed, Corp. Nov 2, 2018 |
| DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System | Fluoptics Nov 2, 2018 |
| K182077 — Mazor X System (Mazor X Stealth Edition) | Mazor Robotics , Ltd. Nov 2, 2018 |
| K182823 — PRODENSE Bone Graft Substitute | Wrightmedicaltechnologyinc Nov 2, 2018 |
| K181403 — Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | GE Healthcare Nov 2, 2018 |
| K182121 — CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition | Medtronic Sofamor Danek USA, Inc. Nov 2, 2018 |
| K180415 — Invia White Foam NPWT | Medela AG Nov 2, 2018 |
| K182405 — Dexcom Pro Q Continuous Glucose Monitoring System | Dexcom, Inc. Nov 2, 2018 |
| K182557 — MTS Eravacycline 0.002 - 32 µg/mL | Liofilchem S.R.L. Nov 2, 2018 |
| K181195 — ClearPoint System | Mri Interventions, Inc. Nov 2, 2018 |
| K180180 — HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) | M.I.Tech Co., Ltd. Nov 2, 2018 |
| K182096 — Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs | Owens & Minor Halyard, Inc. Nov 2, 2018 |
| K182127 — Wrist Blood Pressure Monitor Model BP6100 | Omron Healthcare, Inc. Nov 2, 2018 |
| K182104 — NavLock Trackers, Robotic Reference Frame | Medtronic Navigation Nov 2, 2018 |
| K180253 — Sheridan Endobronchial Tubes | Teleflex Medical Nov 2, 2018 |
| K181837 — Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. Nov 2, 2018 |
| K181639 — Panta 2 Arthrodesis Nail System | Integra LifeSciences Corporation Nov 2, 2018 |
| K181911 — Interlude 100% Cotton Tampon | Albaad Fem Nov 2, 2018 |
| K181501 — Afina | Neurovision Imaging, LLC Nov 2, 2018 |
| K182110 — CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation Nov 2, 2018 |
| K182616 — NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System | Ninepoint Medical, Inc. Nov 2, 2018 |
| K181820 — Medline Unite Mini Plates and Screws | Medline Industries, Inc. Nov 1, 2018 |
| K181266 — Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA Nov 1, 2018 |
| K180363 — Clear-Tip EUS-FNA | Finemedix Co., Ltd. Nov 1, 2018 |
| K182523 — Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. Nov 1, 2018 |
| K180310 — DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. Nov 1, 2018 |
| K182276 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | Bayer Medical Care, Inc. Nov 1, 2018 |
| K181049 — Spectra Optia Apheresis System | Terumobct, Inc. Nov 1, 2018 |
| K182273 — MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | Bayer Medical Care, Inc. Nov 1, 2018 |
| K182098 — N Latex FLC kappa assay, N Latex FLC lambda assay | Siemens Healthcare Diagnostics Products GmbH Nov 1, 2018 |
| K181273 — GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | I-Sens, Inc. Nov 1, 2018 |
| K180247 — DAEHAN Adhesive Surface Electrodes | Daehan Medical Systems Co., Ltd. Nov 1, 2018 |
| K173351 — Panpac Flexi Shelf Pessary | Panpac Medical Corporation Oct 31, 2018 |
| K171585 — LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. Oct 31, 2018 |
| K182679 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | Canon Medical Systems Corporation Oct 31, 2018 |
| K182087 — DynaMesh-POSTERIOR | Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft Oct 31, 2018 |
| K182082 — Tumark for Eviva, Tumark for Brevera | Somatex Medical Technologies GmbH Oct 31, 2018 |
| K181994 — Single Use Aspiration Needle NA-U201H | Olympus Medical Systems Corp. Oct 31, 2018 |
| K182880 — Halifax Imaging Kit | Halifax Biomedical, Inc. Oct 31, 2018 |
| K180899 — Universal Base Abutment | Nobel Biocare AB Oct 31, 2018 |
| K182088 — XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro | Fotona D.O.O. Oct 31, 2018 |
| K182085 — Balanced Knee Revision System Trabecular Tibial Cone Augments | Ortho Development Corporation Oct 31, 2018 |