FDA 510(k) Applications Received During July, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K181796 07/05/2018 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc. Sherri Lakota
K181853 07/11/2018 Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. Angela Drysdale
K182054 07/31/2018 Natrelle 133S Tissue Expander Allergan Melissa Pathmajeyan
K182024 07/30/2018 Dissecting Balloon System Applied Medical Resources Corp. Corinne Yestrepsky
K181768 07/03/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K181804 07/06/2018 Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181834 07/10/2018 Ultimax-i, DREX-UI80 (V1.60) Canon Medical Systems Corporation Paul Biggins
K181736 07/02/2018 CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, Centers for Disease Control and Prevention (CDC) Yon Yu
K181772 07/03/2018 NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) Ceterix Orthopaedics, Inc. Tarhan Kayihan
K181836 07/10/2018 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters Cordis, a Cardinal Health Company Vidya Venkataeaghavan
K181799 07/05/2018 ResCUBEÖ Ligament Fixation System Cousin Biotech S.A.S. Mathilde Collet
K181866 07/12/2018 MotoCLIP/HiMAX Step Staple Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181962 07/23/2018 CubeVue CurveBeam, LLC Stuti Singh
K181891 07/13/2018 Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., LTD. Youngbae Kwon
K181997 07/26/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K182057 07/31/2018 EasyMax BT Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K181849 07/11/2018 iStim S2 OTC Pain Relief TENS Everyway Medical Instruments CO., LDT. Paul Hung
K181763 07/03/2018 FUJIFILM Ultrasonic Endoscope FUJIFILM Corporation Randy Vader
K181741 07/02/2018 IceSphere 1.5 CX Cryoablation Needle Galil Medical Ltd. Stacey Backlund
K181791 07/05/2018 SIMPLYSTRONG, SIMPLYEZEE Genicon, Inc Katlyn Kachman
K181943 07/20/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd. Jeff Hwang
K181855 07/11/2018 RadialSeal Introducer Kit Greatbatch Medical Phyllis Piet-Hughes
K181790 07/05/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K181974 07/24/2018 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc Rachelle D. Fitzgerald
K181982 07/25/2018 MIDAScope and Introducer Kit, and MIDASystem IntraVu, Inc. Plamena Entcheva-Dimitrov
K181749 07/02/2018 SuperCable« Iso-ElasticÖ Cerclage System Kinamed, Incorporated Heather Neely
K181809 07/06/2018 GRYPHON« Anchors with DYNACORDÖ Suture Medos International SARL Tatyana Korsunsky
K181954 07/23/2018 autoLog IQ Autotransfusion System MEDTRONIC PERFUSION SYSTEMS Sue Fidler
K181973 07/24/2018 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K181978 07/24/2018 ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems Medyssey USA, Inc. Shawn Kim
K181977 07/24/2018 WiScope Digital Endoscope System OTU Medical Inc. Doris Dong
K182004 07/27/2018 PENTAX Medical Endoscopic Ultrasound System PENTAX of America, Inc. William Goeller
K181830 07/09/2018 Azurion R2.0 Philips Medical Systems Nederland BV Owen Callaghan
K181966 07/23/2018 SmartPerfusion Philips Medical Systems Nederlands B.V. Chandrika Srinivasan
K181797 07/05/2018 Philips CT Big Bore Sliding Gantry Configuration Phillips Medical Systems (Cleveland) Inc. Michael Chilbert
K181983 07/25/2018 PreXion 3D Excelsior PreXion Corporation Katsumi Hayashi
K181968 07/24/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K181828 07/09/2018 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile Scientia Vascular LLC David Sabodski
K181767 07/03/2018 Cios Select Siemens Medical Solutions USA, Inc. Patricia D. Jones
K181923 07/18/2018 Quantum Workstation 12.1 Spectrum Medical Ltd Colleen Powell
K181792 07/05/2018 DuoÖ Lumbar Interbody Fusion Device Spineology Inc. Karen Roche
K181946 07/20/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific Cynthia Knapp
K181909 07/17/2018 Luminelle DTx Hysteroscopy System UVision360 Inc. Allison London Brown
K181940 07/19/2018 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. Michael J. Titus
K181740 07/02/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Ewald Riechert


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