FDA 510(k) Applications Received During January, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K180087 01/12/2018 A.M. Surgical Intramedullary Fixation Device A.M. Surgical, Inc Gavriel Feuer
K180040 01/05/2018 NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI Abbott Vascular Emily Zhao
K180196 01/24/2018 On Call Express Mobile Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K180096 01/16/2018 GDT-1000 System AcuVu Inc. Sam Mostafavi
K180239 01/29/2018 Additive Orthopaedics Patient Specific 3D Printed Bone Segments Additive Orthopaedics, LLC Gregory Kowalczyk
K180244 01/29/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K180006 01/02/2018 AmCAD-UT Detection 2.2 AmCad BioMed Corporation Jack Yang
K180185 01/23/2018 BIO-C REPAIR Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveria
K180026 01/03/2018 Bowel Management Device, Bowel Management Irrigation Set Applied Medical Technology, Inc. Michelle Scott
K180191 01/23/2018 SuperBall Meniscal Repair System Arcuro Medical Ltd. Lee Ranon
K180118 01/16/2018 Arthrex NanoSuture Anchor Arthrex Inc. Rebecca R. Homan
K180010 01/02/2018 AtriClip FLEX-V AtriCure, Inc. Brittany Lowe
K180138 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO2) AtriCure, Inc. Melissa Smallwood
K180137 01/17/2018 AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) AtriCure, Inc. Melissa Smallwood
K180155 01/19/2018 Arm Type Blood Pressure Monitor Avita Corporation Steven Jhou
K180061 01/08/2018 UltraCor Twirl Breast Tissue Marker Bard Peripheral Vascular, Inc. Meghan McKelvey
K180174 01/22/2018 Belun Ring Belun Technology Company Limited Leung Lap Wai Lydia
K180248 01/29/2018 VascuEase IC-1200-WH Bio Compression Systems, Inc. Barbara Whitman
K180238 01/29/2018 CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT Biosense Webster, Inc. Phuong Chau
K180271 01/31/2018 NAVIOÖ Surgical System (NAVIO system) Blue Belt Technologies, Inc. Corrine Herlinger
K180107 01/16/2018 Blue Sky Bio Aligner Blue Sky Bio LLC Albert Zickmann
K180102 01/16/2018 Embozene Color-Advanced Microspheres Boston Scientific Heidi Shearer
K180211 01/25/2018 Freezpoint Bovie Medical Corp. Sam Niedbala
K180069 01/09/2018 HDR MRI Lumen Marker C4 Imaging LLC Andrew Bright
K180269 01/31/2018 Cadwell Apollo System Cadwell Industries, Inc. Alison Hull
K180162 01/19/2018 VivaScope System Caliber Imaging & Diagnostics, Inc. Joel Radford
K180003 01/02/2018 FORE-SIGHT ELITE Module Tissue Oximeter CAS Medical Systems, Inc. Ron Jeffrey
K180274 01/31/2018 Ventix Link Knotless Anchor with Inserter Cayenne Medical, Inc Shima Hashemian
K180121 01/16/2018 Rafugen DBM Cellumed Co., Ltd. JooWoong (Albert) Jang
K180218 01/25/2018 Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV Cepheid Yi-Ping Lin
K180104 01/16/2018 Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant Church & Dwight Co., Inc Joelle Reinson
K180150 01/19/2018 PL8 Wrist Reconstruction Plate CITIEFFE S.r.l. Stefano Pullega
K180070 01/09/2018 SpeediCath Flex Coude Pro Coloplast Troy Thome
K180057 01/08/2018 VORTEK URETERAL DOUBLE LOOP STENT Coloplast Corp Cori Ragan
K180028 01/03/2018 Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated Carly Powell
K180034 01/04/2018 Weinmann Tracheostomy Exchange Set Cook Incorporated Paul Meyer
K180052 01/08/2018 UriSwab-Urine Collection, Transport and Preservation System Copan Italia S.p.A. Elisabetta Zanella
K180081 01/11/2018 RAILWAY Sheathless Access System Cordis Corporation Michelle Ragozzino Rodgers
K180037 01/05/2018 Beacon EUS Access System Covidien llc Rachel Silva
K180192 01/24/2018 Emprint Ablation Visualization Application Covidien, LLC Patti L. Arndt
K180149 01/19/2018 Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide Covidien, llc Nancy Sauer
K180007 01/02/2018 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter Creagh Medical, Ltd. Shane Costello
K180252 01/30/2018 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Crown Porcelain Dental Technology Co., Ltd. Chu Lien Fan
K180044 01/08/2018 SIROLaser Blue Dentsply Sirona Karl J Nittinger
K180074 01/10/2018 Diazyme Lipoprotein (a) Assay Diazyme Laboratories, Inc. Abhijit Datta
K180106 01/16/2018 ThinkQA DOSIsoft Marc Uszynski
K180193 01/24/2018 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) El.En Electronic Engineering S.p.A. Paolo Peruzzi
K180224 01/26/2018 ELEMENT-TL Elemenic Co., Ltd. Jo Won Ju
K180165 01/22/2018 Habib EndoHPB EMcision Ltd. Francois Poulin
K180197 01/24/2018 Erchonia FX-635 Erchonia Corporation Steven Shanks
K180031 01/04/2018 Endopath Electrosurgery Probe Plus II Ethicon Endo-Surgery, LLC Carmen Ortiz
K180208 01/24/2018 Disposable Endoscopic Trocar Fengh Medical Co., Ltd. Jun Zhou
K180082 01/11/2018 geko T-2 and geko Plus R-2 Firstkind Ltd Neil Buckley
K180023 01/03/2018 WIRION Gardia Medical Ltd. Vardit Segal
K180092 01/12/2018 Intellitorq Gauthier Biomedical, Inc. Austin Braganza
K180225 01/26/2018 GSI Viewer with GSI Fat Option GE Medical Systems SCS Peter Uhlir
K180152 01/19/2018 gel-e Flex gel-e, Inc. Elsa Abruzzo
K180188 01/23/2018 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K180056 01/08/2018 Genesys Spine AIS-C Cervical Anchored Interbody System Genesys Spine Benjamin V. Keller
K180171 01/22/2018 PillCam Patency System Given Imaging Ltd. Hilla Debby
K180210 01/24/2018 CREO« Stabilization System Globus Medical Inc. Kelly J. Baker
K180156 01/19/2018 SP-Fix« Spinous Process Fixation Plate, RELIEVE« Laminoplasty Fixation System Globus Medical Inc. Lori Burns
K180264 01/30/2018 Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K180136 01/17/2018 BioNude Lubricant Good Clean Love, Inc. Wendy Strgar
K180086 01/12/2018 Gyrus ACMI û EZDilate 3-Stage Balloon Dilatation Catheter Gyrus ACMI, Inc. Mary Anne Patella
K180255 01/30/2018 CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K180079 01/10/2018 Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation Hill-Rom Inc. Sarah Marie Fitzgerald
K180233 01/29/2018 Eviva Stereotactic Guided Breast Biopsy System Hologic, Inc Brenda M Geary
K180279 01/31/2018 Silk'n MODEL H5003 device Home Skinovations Ltd. Amit Goren
K180125 01/16/2018 PowerLook Density Assessment Software iCAD, Inc John DeLucia
K180036 01/05/2018 SMAXEL CO2 Surgical Laser System IDS, LTD. Kwang Yeong Ahn
DEN180001 01/12/2018 IDx-DR IDx, LLC Michael D. Abramoff
K180129 01/17/2018 Imbio Segmentation Editing Tool software Imbio, LLC Vipul Goel
K180126 01/16/2018 SOZO ImpediMed Limited Catherine Kingsford
K180169 01/22/2018 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, Imperative Care Inc. Jake Wolenberg
K180263 01/30/2018 EcoFit Vit E Acetabular System implantcast Gmbh Juliane Hoeppner
K180189 01/23/2018 InMode System with Fractora3D/3D-90 Applicators Inmode MD Ltd. Amit Goren
K180140 01/18/2018 ProFlex Laser Fibers InnovaQuartz LLC Stephen E Griffin
K180078 01/10/2018 Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System Innovasis, Inc. Marshall McCarty
K180045 01/08/2018 Omnipod DASH Insulin Management System Insulet Corporation Matthew King
K180033 01/04/2018 8mm Monopolar Curved Scissors Intuitive Surgical, Inc Gayle Perry
K180259 01/30/2018 Sterile Hypodermic Needle for Single Use Jiangsu Shenli Medical Production Co., Ltd Tina Cai
K180146 01/18/2018 KARL STORZ ICG Imaging System KARL STORZ Endoscopy America, Inc. Winkie Wong
K180131 01/17/2018 Vicks RapidRead Digital Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K180084 01/11/2018 Ultrasound System SONIMAGE MX1 Konica Minolta, Inc. Tsutomu Fukui
K180071 01/09/2018 STYLO Interbody Fusion Device Legend Spine Technologies Gwendolyn DeBoer
K180114 01/16/2018 AEON Retrieval Bag Lexington Medical Inc. Donna Gasper
K180166 01/22/2018 Life Spine Lumbar Fixation System (SENTRY) Life Spine, Inc. Randy Lewis
K180270 01/31/2018 Cellvizio 100 Series Systems with Confocal Miniprobes Mauna Kea Technologies Veronique Dentan
K180151 01/19/2018 MC3 Jugular Dual Lumen Catheter MC3 Incorporated Adam Viitala
K180089 01/12/2018 Medacta Shoulder System Short Humeral Diaphysis Medacta International SA Stefano Baj
K180242 01/29/2018 HeRO Symphony, HeRO ES, HeRO solo/duet Medical Predictive Science Corporation Will King
K180091 01/12/2018 UNiD Spine Analyzer Medicrea International David Ryan
K180090 01/12/2018 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K180101 01/16/2018 HEALIX ADVANCE KNOTLESS BR Anchor Medos International SARL Ashley Goncalo
K180222 01/25/2018 Reaxon Plus Medovent GmbH Peter Meier
K180021 01/03/2018 Proton Positioing and Immobilization Devices MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radi Alena Newgren
K180030 01/03/2018 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K180122 01/16/2018 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K180022 01/03/2018 Athena Cervical Plate System Medyssey USA, Inc. Shawn Kim
K180004 01/02/2018 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
K180018 01/02/2018 Disposable Hot Biopsy Forceps Micro-Tech (Nanjing) CO., Ltd. Becky Li
K180282 01/31/2018 MIS Internal Hex Dental Implant System MIS Implants Technologies Ltd. Arbel Shezaf
K180100 01/16/2018 MRIaudio PREM System MRIaudio Joe Caruso
K180181 01/23/2018 Natus Quantum Natus Medical Incorporated DBA Excel_tech Ltd. (XLTEK) Sanjay Mehta
K180257 01/30/2018 InCore« Lapidus System Nextremity Solutions, Inc. Greg Denham
K180123 01/16/2018 Breast BI 7 MR Coil 1.5T Mammavention Noras MRI products GmbH Jens Heidenmann
K180186 01/23/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180038 01/05/2018 NuVasive Pulse System NuVasive, Incorporated Olga Lewis
K180198 01/24/2018 NuVasive« VuePoint« II OCT System NuVasive, Incorporated Michelle Cheung
K180237 01/29/2018 Rezum System NxThera, Inc. Kathy Simpson
K180200 01/24/2018 ESG-300, APU-300, Pressure Reducer, MAPC Probes Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K180130 01/17/2018 ELEOSÖ Bipolar Acetabular System Onkos Surgical, Inc. Jan Triani
K180025 01/03/2018 Centurion POCT System Orthofix Inc. Jacki Koch
K180179 01/23/2018 Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw Orthofix Inc. Jacki Koch
K180109 01/16/2018 STARband, STARlight, St. Louis Band Orthomerica Products, Inc David C. Kerr
K180064 01/09/2018 OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc. M. Beth Pashko
K180173 01/22/2018 Freespira Palo Alto Health Sciences, Inc. Simon Thomas
K180226 01/26/2018 TREND II Spinal Fixation System- STEP Series Paonan Biotech Co., Ltd. Vivi Tsai
K180172 01/22/2018 FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroP Paragon Vision Sciences Rich Jefferies
K180194 01/24/2018 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System Paragonix Technologies, Inc. Leo Basta
K180105 01/16/2018 Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister Penumbra, Inc. Richard Kimura
K180008 01/02/2018 Penumbra System Penumbra, Inc. Richard Kimura
K180195 01/24/2018 Frigitronics adapter Phakos Olivier Aumaitre
K180015 01/02/2018 Philips Incisive CT Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K180017 01/02/2018 MX40 Release C.01 Philips Medical Systems Theresa Poole
K180234 01/29/2018 physiQ Heart Rhythm Module physiQ Inc. George Allen Hides
K180019 01/02/2018 CAAS Workstation Pie Medical Imaging BV Annemiek Bouts
K180167 01/22/2018 Playtex Stella Tampons Playtex Manufacturing, Inc. Ludjane Fiorillo
K180080 01/10/2018 FIBERGRAFT BG Matrix Bone Graft Substitute Prosidyan, Inc Charanpreet S Bagga
K180011 01/02/2018 Pulmonx Chartis Tablet Console Pulmonx Corporation Sherry Kim
K180111 01/16/2018 ClearGuard HD Antimicrobial Barrier Cap Pursuit Vascular, Inc. Douglas Killion
K180157 01/19/2018 QT ECG QT Medical, Inc. Ruey-Kang Chang
K180154 01/19/2018 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K180158 01/19/2018 Surgical Laser fibers Quanta System SPA Francesco Dell'Antonio
K180265 01/31/2018 COMPACT TOUCH Ophthalmic Ultrasound System Quantel Medical Maureen O'Connell
K180027 01/03/2018 ACCUSYTE 3D Fiducial Marker Radiation Products LLC John D Corbitt
K180206 01/24/2018 neuromate Gen III Renishaw Mayfield Sarl Stephane Vinot
K180051 01/08/2018 XSTAT 30, 1-Pack RevMedx, Inc. Amy K. Pointer
K180272 01/31/2018 Saniclave 250 REVOLUTIONARY SCIENCE Isaac Erickson
K180201 01/24/2018 Route 92 Medical Access System Route 92 Medical, Inc. Kirsten Valley
K180176 01/22/2018 SeaSpine NewPort Spinal System SeaSpine Orthopedics Corporation Gina Flores
K180148 01/19/2018 ATS Thermal Imaging Probe, ATS Patient Interface Unit Securus Medical Group, Inc. William J. Gorman
K180260 01/30/2018 Powder Free Vinyl Patient Examination Gloves (Yellow, White) Shanxi Hongjin Plastic Technology Co., Ltd Wu Zhigang
K180016 01/02/2018 Home Use IPL Beauty Device Shenzhen Mismon Technology Co., Ltd Vicky Yang
K180073 01/09/2018 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set Shenzhen Vitavitro Bio-tech Co., Ltd Jenny Lin
K180262 01/30/2018 SICAT Endo SICAT GmbH & Co. KG Manfred Breuer
K180039 01/05/2018 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180067 01/09/2018 ACUSON X800 Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Sulgue Choi
K180134 01/17/2018 Ensizor Monopolar Endoscopic Scissors Slater Endoscopy, LLC John Starkey
K180124 01/16/2018 ZQuiet Sleeping Well,LLC Daniel Webster
K180221 01/25/2018 Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd Foo Khon Pu
K180277 01/31/2018 Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter Smith & Nephew, Inc. Allison Chan
K180220 01/25/2018 SAGICO OSI Spinal System by Osimplant Spinal Analytics & Geometrical Implant Co, LLC James J Gibson Jr.
K180002 01/02/2018 Rampart One Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K180141 01/18/2018 SPIWay Endonasal Access Guide SPIWay, LLC Eugene Chen
K180077 01/10/2018 NeuroQ 3.8 Syntermed Kenneth Van Train
K180115 01/16/2018 TWBM Pump Taiwan Biomaterial Co., Ltd. Monoj Mon Kalita
K180135 01/17/2018 THD Anopress with THD SensyProbe THD SpA Maurizio Pantaleoni
K180063 01/09/2018 OCM-G1 Attachment The Anspach Effort, Inc. Tamara J West
K180159 01/19/2018 Klassic« Knee System Total Joint Orthopedics, Inc. Chris Weaber
K180163 01/19/2018 TransEnterix Senhance Surgical System TransEnterix, Inc. Stephanie Fitts
K180075 01/10/2018 MINUET LCD, MINUET LCD eco Unimom Co. Hong Sang-Hyun
K180219 01/25/2018 JO H2O Flavored Personal Lubricants United Consortium Stephanie Morris
K180083 01/11/2018 Silicone Personal Lubricant, ALL-IN-ONE United Consortium Stephanie Morris
K180214 01/25/2018 Repris Bladder Injection System URO-1, Inc. Thomas Lawson
K180128 01/17/2018 Warrior 14 guidewire Vascular Solutions, Inc Becky Astrup
K180088 01/12/2018 TrapLiner catheter Vascular Solutions, Inc. Beka Vite
K180217 01/25/2018 VESTEX Apparel Vestagen Protective Technologies, Inc. Scott Pease
K180161 01/19/2018 Viz CTP Viz.ai, Inc. Gregory Ramina
K180024 01/03/2018 SALVATION Midfoot Nail Wright Medical Technology, Inc. Alayne Melancon
K180153 01/19/2018 X-spine Cortical Bone Screw System X-spine Systems, Inc. Charlene Brumbaugh
K180243 01/29/2018 Infinity-Lock Button System Xiros Ltd Stephen Seed
K180076 01/10/2018 Ti 3Z Interbody System Zavation Medical Products, LLc Katie Motley
K180227 01/26/2018 Polaris Spinal Growth System Zimmer Biomet Spine, Inc. Anthony Michael Maahs


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