FDA 510(k) Applications Received During February, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K180289 02/01/2018 3D Bolus Software 3D Bolus, Inc. Peter Hickey
K180404 02/14/2018 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System 3M Health Care Lam Duong
K180352 02/08/2018 7D Surgical System 7D Surgical Inc. Daniel Ziskind
K180504 02/26/2018 Mission Lipid Panel Monitoring System ACON Laboratories, Inc. Qiyi Xie
K180407 02/14/2018 Smartinhaler Adherium (NZ) Ltd Chris Mander
K180433 02/20/2018 ENNOVATE« Aesculap Implant Systems, LLC Melanie Burkert
K180321 02/05/2018 Aesculap Optilene Nonabsorbable Suture Aesculap, Inc. Kathy A. Racosky
K180464 02/21/2018 AEVUMED PHANTOM Suture Anchors Aevumed, Inc. Saif Khalil
K180398 02/13/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal Alcon Laboratories, Inc. Sherri Lakota
K180296 02/02/2018 Afinion HbA1c Dx Alere Technologies AS Monica Vallestad
K180480 02/23/2018 ATEC Universal Spacer System Alphatec Spine, Inc Jeremy Markovich
K180305 02/02/2018 Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) Aquilabs US LLC Juan Salcedo
K180427 02/16/2018 ARK Fentanyl Assay ARK Diagnostics, Inc. Cherry Mun
K180539 02/28/2018 Deformity Analysis and Correction Software (DACS) and Instrumentation Arrowhead Medical Device Technologies, LLC Thomas J. Twardzik
K180349 02/08/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K180301 02/02/2018 AXIS 5.5 Lumbar Pedicle Screw System Axis Orthopaedics Craig Wilcox
K180319 02/05/2018 Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Bausch and Lomb Incorporated Melissa Thomas
K180438 02/20/2018 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit BD Brad Spring
K180493 02/26/2018 A3 Total Knee System Beijing AK Medical Co., Ltd. Aiguo Liu
K180417 02/15/2018 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use BERPU MEDICAL TECHNOLOGY CO., LTD Jundong Tan
K180315 02/05/2018 DISKOM Biopsybell s.r.l. Tiziana Bellini
K180344 02/08/2018 TheraCal DC Bisco, Inc. Ryan Hobson
K180530 02/28/2018 Imager II Urology Torque Catheter Boston Scientific Corporation Daniel FitzDaniel
K180375 02/12/2018 The IQoolTM Warm System Brain Cool AB Martin Waleij
K180323 02/05/2018 Vitrea Software Package; VSTP-001A Canon Medical Systems Corporation Paul Biggins
K180475 02/22/2018 CapLOX II« / TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. Jackie Ferro
K180416 02/15/2018 ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System Cardiovascular Systems Inc. Susan Wolf
K180526 02/27/2018 EIDON FA CenterVue SpA Roberto Gabriotti
K180293 02/01/2018 Retia 2 CenterVue SpA Roberto Gabriotti
K180531 02/28/2018 NovoStitch Pro Meniscal Repair System Ceterix Orthopaedics, Inc. Tarhan Kayihan
K180519 02/27/2018 HARRIER-SAÖ Lumbar Interbody System Choice Spine, LP Kim Finch
K180476 02/22/2018 Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Comfort Rubber Gloves Industries Sdn. Bhd. Chan Yew Men
K180429 02/16/2018 Advincula Delineator Uterine Manipulator CooperSurgical, Inc. Roaida Johnson
K180517 02/27/2018 CorPath GRX System Corindus, Inc. Robert Lavado
K180496 02/26/2018 TruClear Elite Hysteroscope Covidien Gail Yaeker-Daunis
K180485 02/23/2018 Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Covidien, llc Carol Ming
K180350 02/08/2018 Dornier Medilas H Solvo 35 Laser Dornier MedTech America John Hoffer
K180473 02/22/2018 ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR ECOTRON Co., Ltd Sang Bond Lee
K180408 02/14/2018 U60 Diagnostic Ultrasound System Edan Instruments, Inc. Crystal Cai
K180538 02/28/2018 gammaCore Sapphire electroCore, LLC Mike Romaniw
K180406 02/14/2018 Ellipse Ydun Ellipse A/S Ole Kofod
K180524 02/27/2018 EEG-Now EncephaloDynamics, Inc. J. Chris Sackellares
K180403 02/14/2018 ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length Ethicon Endo-Surgery, LLC Sigfrido Delgado
K180348 02/08/2018 Field Orthopaedics Micro Screw System Field Orthopaedics Pty. Ltd. Christopher Jeffery
K180513 02/27/2018 CustomizedBone Service Fin-Ceramica Faenza S.p.A Marina Monticelli
K180341 02/07/2018 FUJIFILM 600 Series Endoscope EG-600WR v2 FUJIFILM Corporation Randy Vader
K180405 02/14/2018 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Corporation Randy Vader
K180414 02/15/2018 EPX-4440FN Digital Video Processor with Light Source FUJIFILM New Development U.S.A., Inc. Stephen Mariano
K180535 02/28/2018 Voluson P6 and Voluson P8 GE Healthcare Bryan Behn
K180374 02/12/2018 Voluson S8/ Voluson S10/ Voluson S10 Expert GE Healthcare Bryan Behn
K180318 02/05/2018 PET Digital Gating GE Medical Systems, LLC Lee Bush
K180304 02/02/2018 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K180518 02/27/2018 GME LinScan Lite 808 Laser System GME German Medical Engineering GmbH Stefan Schulze
K180287 02/01/2018 GSI Corti Grason-Stadler Inc. Amy Yanta
K180360 02/09/2018 OKTAGON Implant System Hager & Meisinger GmbH Adam Tomczak
K180505 02/26/2018 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) Hartalega Sdn. Bhd. Kuan Kam Hon
K180364 02/12/2018 HD LifeSciences Cervical IBFD System HD LifeSciences LLC John Sullivan
K180385 02/12/2018 Infrared Body Thermometer HeTaiDa Technology Co., Ltd. Tom Chen
K180527 02/28/2018 IS3 Hiossen, Inc. David Kim
K180326 02/06/2018 icobrain icometrix Dirk Smeets
K180522 02/27/2018 IGTFusion IGI Technologies Will Plishker
DEN180005 02/05/2018 OsteoDetect Imagen Technologies, Inc. Alex Dresner
K180377 02/12/2018 Fracture and Correction System In2Bones USA, LLC Rebecca Wahl
K180329 02/06/2018 ClotTriever Thrombectomy System Inari Medical Eben Gordon
K180466 02/21/2018 FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K180486 02/23/2018 HemosIL Factor XII Deficient Plasma Instrumentation Laboratory Co. Carol Marble
K180351 02/08/2018 EndoWrist Mercury Bipolar Grasper Intuitive Surgical, Inc. Vishal Kanani
K180515 02/27/2018 GammaTile Isoray Medical Inc. Bill Joy
K180536 02/28/2018 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K180299 02/02/2018 ACUVUE OASYS (senofilcon A) with Photochromic Additive Johnson & Johnson Vision Care, Inc. Victoria Brennand
K180376 02/12/2018 K2M Patient Specific Rods K2M, Inc. Nancy Giezen
K180401 02/14/2018 TiWAVE-CÖ Porous Titanium Cervical Cage Kalitec Direct, LLC Scott Winn
K180320 02/05/2018 dpl IIa Panel LED Technologies, Inc. Lloyd Nelson
K180447 02/20/2018 reVive Light Therapy LED Cleansing System LED Technologies, Inc. Lloyd Nelson
K180445 02/20/2018 reVive Light Therapy LED Ultrasonic Wrinkle System LED Technologies, Inc. Lloyd Nelson
K180332 02/06/2018 17HK700G-W LG Electronics Jinhwan Jun
K180339 02/07/2018 Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K180330 02/06/2018 Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL Liofilchem s. r. l. Fabio Brocco
K180313 02/05/2018 Apollo TMS Therapy System Mag & More GmbH Kerstin Haringer
K180307 02/02/2018 Mazor X Mazor Robotics Ltd. Shiran Conforti
K180308 02/02/2018 Prelude MedCom GmbH Johannes Messow
K180453 02/20/2018 Bio-Medicus Adult Cannulae and Introducer Medtronic Inc Huda Yusuf
K180456 02/20/2018 Bio-Medicus Adult Cannulae Kit Medtronic Inc. Huda Yusuf
K180450 02/20/2018 Corvocet Biopsy System Merit Medical Systems, Inc. Angela Brady
K180325 02/05/2018 Single Use MultiClip Device Micro-Tech (Nanjing) CO., Ltd Becky Li
K180317 02/05/2018 EVOLUTION« Knee Systems û MR Labeling, EVOLUTION« BIOFOAM« Tibial System, EVOLUTION« Revision Tibial System, EVOLUTION« Revision CCK System MicroPort Orthopedics, Inc. Grace Johnson-Bann
K180396 02/13/2018 miraDry System Miramar Labs, Inc. Cynthia Kada
K180393 02/13/2018 AIRO Computed Tomography (CT) X-ray System Mobius Imaging, LLC Norma LeMay
DEN180008 02/16/2018 MolecuLight i:X MolecuLight Inc. Jeffrey K. Shapiro
K180290 02/01/2018 Natus Brain Monitor Amplifier Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta
K180421 02/16/2018 Natus NeuroWorks Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Shane Sawall
K180455 02/20/2018 NeuralBot Neural Analytics, Inc. Javad Seyedzadeh
K180431 02/16/2018 Cortina [MAX] Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K180306 02/02/2018 Nexy Next Sight srl Arianna Dalla Ba
K180428 02/16/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180503 02/26/2018 PRECICE STRYDE System NuVasive Specialized Orthopedics, Inc. Lance Justice
K180458 02/20/2018 FOCUS Pedicle Screw System Nvision Biomedical Technologies, LLC Diana Langham
K180449 02/20/2018 Single Use Aspiration Needle NA-U200H Olympus Medical Systems Corp. Toshiyuki Nakajima
K180378 02/12/2018 Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module Optomed Oy Jyri Leskela
K180459 02/20/2018 VERASENSE for Zimmer Biomet Persona OrthoSensor, Inc. Deborah Johnson
K180412 02/15/2018 Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K180534 02/28/2018 Philips IntelliVue GuardianSoftware Philips Medizin Systeme Boeblingen GmbH Michael Asmalsky
K180426 02/16/2018 Empower H35 Quanta System Spa Francesco Dell'Antonio
K180423 02/16/2018 Empower H65 quanta system spa Francesco Dell'Antonio
K180288 02/01/2018 QuickVue Influenza A+B Quidel Corporation Jennifer S. Rial
K180379 02/12/2018 RayStation 7 RaySearch Laboratories AB (publ) David Hedfors
K180372 02/12/2018 Aurora Evacuator Rebound Therapeutics Jeffrey J. Valko
K180502 02/26/2018 S128 Anterior Lumbar Interbody Fusion (ALIF) System Renovis Surgical Technologies Inc. Anthony DeBenedictis
K180497 02/26/2018 Scone Mask ResMed Ltd Kim Kuan LEE
K180452 02/20/2018 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim Riverstone Resources SDN BHD Suresh Kumar
K180481 02/23/2018 Servator B SALF Solution S.A.L.F. spa Carmelo Gagliano
K180409 02/14/2018 HS40 Diagnostic Ultrasound System Samsung Medison Co, Ltd. Ji Yea Lee
K180356 02/08/2018 inui In-Home Urine Analysis Test System Scanadu, Inc. Daya Ranamukhaarachchi
K180508 02/26/2018 JOULE SYSTEM Sciton, Inc. Jay M/ Patel
K180367 02/12/2018 Ureterorenoscope System Shanghai AnQing Medical Instrument CO., Ltd. Lina FEI
K180335 02/06/2018 Accutension Smartphone Auscultatory Blood Shanghai Hulu Devices Co., Ltd Junfeng Zhao
K180331 02/06/2018 Wireless Pain Relieve Device Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K180383 02/12/2018 Light based hair removal device Shenzhen GSD Tech Co., Ltd Ziyi Gui
K180419 02/15/2018 Ultrasonic Doppler (Model YM-2T8) Shenzhen IMDK Medical Technology Co., Ltd. Yuan Xia
K180461 02/20/2018 Navi e/Navi s/Navi X Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K180454 02/20/2018 Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. Plessy Paul
K180336 02/07/2018 syngo.MR Applications Siemens Medical Solutions USA, Inc. Cordell L Fields
K180334 02/06/2018 LEGION Knee System Smith & Nephew, Inc. Michael Scott
K180361 02/09/2018 MICRORAPTOR REGENESORB Suture Anchor Smith and Nephew, Inc Katherine Marcaccio
K180443 02/20/2018 Tumark Vision SOMATEX Medical Technologies GmbH Burkhard Jakob
K180448 02/13/2018 INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter Sorin Group Italia S.r.l Luigi Vecchi
K180411 02/15/2018 MEMO 4D Sorin Group Italia S.r.l. Mauro Ercolani
K180472 02/22/2018 ViSi Mobile Monitoring System Sotera Wireless, Inc. Lan Herrington
K180514 02/27/2018 VERITON NM Spectrum Dynamics Medical Ltd. Igor Naroditsky
K180437 02/20/2018 Hexanium« TLIF SpineVision, SAS Anaella Gallego
K180342 02/07/2018 SYSTEM 1E Liquid Chemical Sterilant Processing System Steris Corporations Jennifer Nalepka
K180327 02/06/2018 Stryker iVAS 13g Bone Biopsy Kit Stryker Corporation Kristi Ashton
K180500 02/26/2018 VariAx 2 System Stryker GmbH Paul Nelson
K180451 02/20/2018 Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider Stryker Sustainability Solutions Scott English
K180499 02/26/2018 Reprocessed LigaSure Maryland Jaw Sealer/Divider Stryker Sustainability Solutions Scott English
K180436 02/20/2018 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma GmbH Heike Gustke
K180389 02/13/2018 Venera 508 Deep Vein Thrombosis (DVT) Prevention System Suzhou Minhua Medical Apparatus Supplies Co. Ltd. Michael Ying
K180394 02/13/2018 BrightMatter Plan 1.6.0 Synaptive Medical Inc. Maham Ansari
K180460 02/20/2018 Theradome LH40 Theradome, Inc. Tamim Hamid
K180402 02/14/2018 PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar Topcon Medical Laser Systems, Inc. Sweta Srivastava
K180324 02/05/2018 Patriot Spinal Fixation System Valorus Spine Leah Fero
K180322 02/05/2018 Si-Hy (olifilcon B) color silicone hydrogel soft contact lens Visco Vision Inc. Evan Huang
K180386 02/12/2018 Meron Plus QM Voco GmbH M. Th. Plaumann
K180373 02/12/2018 CancelleX Porous Titanium Lumbar Interbody Device Xenco Medical, LLC. Gustavo R. Prado
K180314 02/05/2018 Infrared Thermometer Xuzhou Yongkang Electronic Science Technology Co., Ltd Xuecheng Zhao
K180537 02/28/2018 Zavation Buttress Plate System Zavation Medical Products LLC Matt Jones
K180353 02/08/2018 Diode laser hair removal device Zhengzhou PZ Laser Slim Technology Co., Ltd Zhou Hongwei


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