510(k) Clearances in 2018 — Page 60
Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.
| 510(k) clearances | Details |
|---|---|
| K173054 — Navigo Workstation Version 2.0 | UC-CARE , Ltd. Jan 16, 2018 |
| K173240 — Arthrex PushLock | Arthrex, Inc. Jan 16, 2018 |
| K172384 — Quickie(r) Q700-UP M | Sunrise Medical (Us), LLC Jan 16, 2018 |
| K173622 — CS Imaging | Trophy Jan 16, 2018 |
| K171799 — Elos Accurate Customized Abutment, Elos Prosthetic Screw | Elos Medtech Pinol A/S Jan 15, 2018 |
| K171354 — MR4 Laser | Multi Radiance Medical Jan 13, 2018 |
| K173504 — K-Y Silicone | Reckitt Benckiser, LLC Jan 12, 2018 |
| K173828 — GU60A & GU60A-65 | Samsung Electronics Co., Ltd. Jan 12, 2018 |
| K173291 — 6440 Ultrasound System | Esaote, S.P.A. Jan 12, 2018 |
| K172438 — ARBOR External Fixation System | Globus Medical, Inc. Jan 12, 2018 |
| K172287 — ipsogen JAK2 RGQ PCR Kit | Qiagen, Inc. Jan 12, 2018 |
| K171213 — One Touch Condom with Benzocaine | Thai Nippon Rubber Industry Public Company Limited. Jan 12, 2018 |
| K172548 — Wiltrom Spinal Fixation System | Wiltrom Corporation Limited Jan 12, 2018 |
| K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. Jan 12, 2018 |
| K171292 — A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 12, 2018 |
| K173635 — syngo.via RT Image Suite | Siemens Medical Solutions USA, Inc. Jan 12, 2018 |
| K173547 — ImagenUniversal | Cardiovascular Imaging Technologies Jan 12, 2018 |
| K163451 — Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | Action Manufacturing, Inc. Jan 12, 2018 |
| K171311 — A5 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jan 12, 2018 |
| K171148 — Aleo BME Liquid Bandage | Aleo Bme, Inc. Jan 12, 2018 |
| K171628 — HBS2 Headless Bone Screw | Stuckenbrock Medizintechnik GmbH Jan 12, 2018 |
| K172774 — T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | Stryker Trauma GmbH Jan 12, 2018 |
| K172913 — cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. Jan 12, 2018 |
| K171625 — Single Lumen Ovum Aspiration Needles | Willian A. Cook Australia Pty, Ltd. Jan 12, 2018 |
| K173588 — Illumeo System | Philips Medical Systems Technologies , Ltd. Jan 12, 2018 |
| K173795 — HI-TORQUE TurnTrac Guide Wire Family | Abbott Vascular Jan 12, 2018 |
| K173602 — Optima XR240amx, AutoGrid | Ge Medical Systems, LLC Jan 12, 2018 |
| K171411 — IRRIS (Infra-Red-Red Intubation System) | A.R Guide IN Medical , Ltd. Jan 12, 2018 |
| K171498 — MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC Jan 12, 2018 |
| K173560 — Microcatheter | Surmodics,Inc. Jan 12, 2018 |
| K171122 — CEREC Ortho Software | Dentsply Sirona Jan 11, 2018 |
| K170748 — GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC Jan 11, 2018 |
| K173090 — Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Toshibamedical Systems Corporation Jan 11, 2018 |
| K171622 — Dentium Ti-Base | Dentium Co., Ltd. Jan 11, 2018 |
| K172110 — ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation Jan 11, 2018 |
| K170421 — ET Hybrid Abutment | Hiossen, Inc. Jan 11, 2018 |
| K172205 — ExoToe Staple | Exotoe, LLC Jan 11, 2018 |
| K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia Jan 11, 2018 |
| K171207 — FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M | Fujifilm Medical Systems U.S.A, Inc. Jan 11, 2018 |
| K172655 — Automated ankle brachial pressure index measuring device | Mesi D.O.O.; Mesi, Development Of Medical Devices, Ltd. Jan 11, 2018 |
| K172452 — Bruxor | Sleep Specialties, LLC Jan 11, 2018 |
| K171665 — Microcatheter and guide-wire system | Suzhou Hengrui Disheng Medical Co., Ltd. Jan 11, 2018 |
| K172992 — Diazyme EZ Vitamin D Assay | Diazyme Laboratories Jan 11, 2018 |
| K172804 — Besmed Peak Flow Meter | Besmed Health Business Corp Jan 11, 2018 |
| K172224 — DTX Studio diagnose | Nobel Biocare AB Jan 11, 2018 |
| K171517 — Digital Electrocardiograph | Biocare Bio-Medical Equipment Co., Ltd. Jan 11, 2018 |
| K171833 — Digital Blood Pressure Monitor-Wrist Style | Shenzhen Combei Technology Co., Ltd. Jan 10, 2018 |
| K171445 — Amplatz Support Wire Guide with Apex Curve | Cook Incorporated Jan 10, 2018 |
| K173234 — Swiss LithoClast Trilogy | E.M.S Electro Medical Systems S.A Jan 10, 2018 |
| K172358 — Instalief | Privi Medical Pte, Ltd. Jan 10, 2018 |