FDA 510(k) Applications Received During March, 2018

FDA 510(k) Number Submission Date Device Name Applicant Contact
K180629 03/09/2018 DentiqGuide 3D Industrial Imaging Co., Ltd Jin Sa Kim
K180582 03/05/2018 Sternal Cable System A & E Medical Corporation Hollie Johnson
K180776 03/23/2018 Cytal Wound Particulate ACell, Inc. Andrea Artman
K180771 03/23/2018 Acro HCG Pregnancy Rapid Test ACRO Biotech, Inc. Joseph Fan
K180742 03/22/2018 EnsoETM Advanced Cooling Therapy, Inc. d/b/a Attune Medical Erik Kulstad
K180634 03/12/2018 Surgical Silver Post Operative Dressing Advanced Medical Solutions Ltd. Rose Guang
K180589 03/06/2018 DR 800 with MUSICA Dynamic Agfa HealthCare N.V. Wim Govaerts
K180647 03/12/2018 BriefCase Aidoc Medical, Ltd. Anna Kuperberg
K180669 03/14/2018 Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal Alcon Laboratories, Inc. Sherri Lakota
K180699 03/16/2018 Voyant Open Fusion Device Applied Medical Resources Corporation Patricia Villarreal
K180662 03/14/2018 Arthrex FastThread Interference Screw Arthrex Inc. Jessica L. Singelais
K180594 03/06/2018 Knotless SutureTak Anchors Arthrex, Inc. Ivette Galmez
K180784 03/26/2018 ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K180566 03/05/2018 Unite Connect for Clinical Systems Ascom Sweden AB Ivan Liljegren
K180725 03/20/2018 Aspire Introducer Needle Aspire Bariatrics, Inc. Monica Ferrante
K180675 03/15/2018 Atlas Spine Expandable Cervical Interbody System Atlas Spine, Inc. Thomas Smith
K180577 03/05/2018 BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories Arlene Carillo
K180805 03/28/2018 Pure EP BioSig Technologies Tiffini Wittwer
K180737 03/22/2018 Ultrasound Scanner System bk2300 BK Medical ApS Susana Mogensen
K180542 03/01/2018 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe Boston Endo Surgical Tech, James Rogers
K180795 03/27/2018 JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire Boston Scientific Nikki M. Ibis
K180785 03/26/2018 iSLEEVE Introducer Set Boston Scientific Corporation Toni Guidarelli
K180726 03/20/2018 Savion DLVR Guidewire, Savion FLX Guidewire Boston Scientific Inc. Jake Baldauf
K180813 03/29/2018 BTL 799-2 BTL Industries, Inc. David Chmel
K180548 03/01/2018 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology C.R. Bard, Inc (Bard has joined BD) Bryan Stone
K180560 03/01/2018 Sherlock 3CG+ T ip Confirmation System C.R. Bard, Inc. Christopher M. Phillips
K180724 03/20/2018 SPIRA Open Matrix LLIF Camber Spine Technologies LLC Sean S. Bishop
K180734 03/20/2018 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie Maylin Truesdell
K180809 03/28/2018 Eclipse II Carestream Health, Inc Diane Koetter
K180667 03/14/2018 SmartGrid Carestream Health, Inc. Diane Koetter
K180839 03/30/2018 AT 030 Carl Zeiss Meditec AG Christian Muenster
K180764 03/23/2018 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Church & Dwight Co., Inc Joelle Reinson
K180799 03/27/2018 Clarius Ultrasound Scanner Clarius Mobile Health Corp. Brendan Seward
K180800 03/27/2018 Colonic Plus Regular, Small, and Straight Shape Hydrokit Colonic Plus Rosa Alvarez
K180738 03/22/2018 COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter Compactcath, Inc. Naama S. Breckler
K180763 03/23/2018 CuffLink Implant System Biocomposite CONMED Corporation Diana L. Nader-Martone
K180616 03/08/2018 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens Contamac Ltd. Rob McGregor
K180552 03/01/2018 Modified Novy Cornual Cannulation Set Cook Incorporated Naomi Funkhouser
K180756 03/22/2018 Safety Wire Guide Introducer COOK Incorporated Carly Powell
K180556 03/01/2018 Corelink Foundation 3D Anterior Lumbar System Corelink, LLC Steven D. Mounts
K180814 03/29/2018 CoreLink« M3Ö Stand-Alone Anterior Lumbar System CoreLink, LLC Steve Mounts
K180752 03/22/2018 Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole Corinth MedTech, Inc. Sandeep Saboo
K180727 03/20/2018 LineUp CurveBeam, LLC Stuti Singh
K180709 03/19/2018 truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc. Brad Renton
K180674 03/15/2018 EVOL« ha-C Cervical Interbody Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K180561 03/05/2018 MobileX Portable X-ray System Denterprise International, Inc. Claude Berthoin
K180627 03/09/2018 Macroduct Advanced Model 3710 ELITechGroup Inc. Stacey Pahulu
K180766 03/23/2018 Endiscope, Endiscope Cervical Elliquence, LLC Paul D. Buhrke
K180640 03/12/2018 SmartClip Soft Tissue Marker Elucent Medical, Inc. Debra Kridner
K180592 03/06/2018 G-scan Brio Esaote S.p.A Massimo Polignano
K180829 03/30/2018 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh Ethicon, Inc Stephanie Saati
K180755 03/22/2018 Vail ALIF Buttress Plate System Evolution Spine, LLC Douglas Davis
K180636 03/12/2018 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Inc. Randy AuCoin
K180632 03/12/2018 Exactech Equinoxe Small Reverse Shoulder System Exactech Inc. Zach Sharrah
K180808 03/28/2018 Omni Foot Plating System Extremity Medical, LLC Brian Smekal
K180695 03/16/2018 FBC 921 (ALIF) FBC Device ApS Finn Bjarke Christensen
K180581 03/01/2018 UV Lamps for Sunlamp Products Feilo Sylvania Germany GmbH Achim Tonat
K180711 03/19/2018 FUJIFILM Endoscopic CO2 Regulator GW-100 FUJIFILM Corporation Randy Vader
K180704 03/19/2018 SonoSite iViz Ultrasound System FUJIFILM SonoSite, Inc. Sudipta Chakrabarti
K180641 03/12/2018 Invenia ABUS Viewer GE Healthcare Bryan Behn
K180666 03/14/2018 48CH Head Coil GE Healthcare Coils (USA Instruments, Inc.) Veronica A. Meridith
K180782 03/26/2018 Aria GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC Nicole Landreville
K180599 03/07/2018 Venue GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K180610 03/08/2018 Geister retractor for neuro - and spine surgery Geister Medizintechnik GmbH Christian Grotzinger
K180579 03/05/2018 Ezee Retrieval Genicon, Inc Katlyn Kachman
K180836 03/30/2018 Genistrong Genicon, Inc Katlyn Kachman
K180817 03/29/2018 AERIALÖ Interspinous Fixation Globus Medical Inc. Kelly J. Baker
K180690 03/16/2018 Navigation Instruments Globus Medical Inc. Lori Burns
K180545 03/01/2018 VACUETTE SAFELINK Holder with male luer lock Greiner Bio-One NA Inc. Manfred Abel
K180646 03/12/2018 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Halyard Health Christine L. Macauley
K180644 03/12/2018 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Hartalega Sdn Bhd Mr. Kuan Kam Hon
K180824 03/30/2018 VaPro 2 Intermittent Catheter Hollister Incorporated Michelle Schiltz-Taing
K180681 03/15/2018 Aptima Combo 2 Assay (Panther System) Hologic, Inc. Jeffrey Hergesheimer
K180825 03/30/2018 Fluent Fluid Management System Hologic, Inc. Christine Cameron
K180612 03/08/2018 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts Howmedica Osteonics Corp aka Stryker Orthopaedics Emily DiMambro
K180729 03/20/2018 FaSet Fixation System Huvexel Co., Ltd Sung Hee-Lee
K180719 03/19/2018 InMode Diolaze System InMode MD Ltd. Amit Goren
K180619 03/09/2018 Bongo InnoMed Healthscience, Inc. Javier Collazo
K180710 03/19/2018 Reprocessed DecaNav Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K180791 03/27/2018 Straumann BLX Surgical Cassette Institut Straumann AG Anna Vianna
K180769 03/23/2018 SecurAcath Interrad Medical Inc Denise Lenz
K180775 03/23/2018 Watch-PAT300 Itamar Medical, Ltd. Koby Sheffy
K180574 03/05/2018 Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor J & J Solutions, Inc. d/b/a/ Corvida Medical Dana Schramm
K180777 03/26/2018 K2M Expandable Interbody System K2M, Inc. Nancy Giezen
K180722 03/19/2018 CAPERE Thrombectomy System KP Medcure, Inc. Samuel Shaolian
K180749 03/22/2018 Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine Inc. Randy Lewis
K180642 03/12/2018 Pro-Link« Ti Stand-Alone Cervical Spacer System Life Spine Inc. Randy Lewis
K180663 03/14/2018 LaVid FMTS DIAGNOSTIC X-RAY SYSTEM LIVERMORETECH Inc. Jae Hong Kim
K180576 03/05/2018 Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) LPI, Inc. Christopher Steadman
K180597 03/06/2018 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO Lumenis Ltd. Amaya De Levie
K180720 03/19/2018 Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel Medibio Usa LLC. Jatin Rajani
K180567 03/05/2018 C3 Wave System Medical Components, Inc. (dba Medcomp) Courtney Nix
K180696 03/16/2018 Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) Medline Industries, Inc. Pauline Maralit
K180816 03/29/2018 Ziehm RFD 3D Tracker Medtronic Navigation Nicole Zimmerman
K180700 03/16/2018 KYPHON HV-R Bone Cement Medtronic Sofamor Danek USA, Inc. Laveeda Leflore
K180819 03/29/2018 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens Menicon Co., Ltd. Kenichi Tanaka
K180723 03/19/2018 PreludeSYNC DISTAL Radial Compression System Merit Medical Systems, Inc Susan Christensen
K180802 03/28/2018 Meta P&Bond META BIOMED, CO., LTD. Suk Song Oh
K180715 03/19/2018 React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K180705 03/19/2018 Riptide Aspiration System React 68 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K180761 03/23/2018 SD LTM STIM Cortical Stimulator micromed S.p.A. Monica Camillo
K180798 03/27/2018 Prime Acetabular Cup System MicroPort Orthopedics Inc. Sarah Evonne Stroupe
K180815 03/29/2018 MIM - SPECTRA Quant MIM Software Inc. Lynn Hanigan
K180565 03/05/2018 PEAK NS033CF, PEAK NS017CF Neosil Co., Ltd Woo-ryong Ryou
K180608 03/07/2018 Lunoa System NightBalance BV Sophia Lam
K180575 03/05/2018 THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X Olympus Medical Systems Corp. Toshiyuki Nakajima
K180630 03/09/2018 PTFE SURGICAL SUTURE OMNIA SPA Roberto Cerioli
K180660 03/14/2018 Avanti Optovue, Inc. Indu Lakshman
K180740 03/22/2018 VitriGuard ORIGIO a/s Roaida Johnson
K180743 03/22/2018 Balanced Knee Revision System - Offset Junction Box Ortho Development Corporation Dan Petersen
K180624 03/09/2018 Guided Growth Plate System Plus Orthofix Srl Gianluca Ricadona
K180651 03/13/2018 Uroview FD II Pausch Medical GmbH Christian Stoian
K180655 03/13/2018 Viking Lumbar Polyaxial Screw System Presidio Surgical Meredith Lee May
K180595 03/06/2018 SciMoCa Radialogica LLC Debra Vigil
K180770 03/23/2018 Propeller Sensor for Neohaler Reciprocal Labs Corporation David Hubanks
K180687 03/15/2018 Reliance Lumber IBF System Reliance Medical Systems Bret M Berry
K180637 03/12/2018 leva Pelvic Floor Trainer Renovia Inc. Gina Prochillo-Cawston
K180583 03/05/2018 LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD Richard Wolf Medical Instruments Corporation Michael Loiterman
K180625 03/09/2018 Rondek PGA Suture (Beige or Violet) RK Manufacturing Corporation Joshua Hubbard
K180684 03/15/2018 CoaguChek XS Plus System Roche Diagnostics Bin Sun
K180693 03/16/2018 CoaguChek XS Pro System Roche Diagnostics Angie Clements
K180609 03/08/2018 Rodo Smilekey Rodo Medical, Inc. Michael Parsons
K180654 03/13/2018 PINXEL-RF system Rohrer Aesthetics, LLC Mark Rohrer
K180697 03/16/2018 Pseudo-Patient RTsafe, Inc. Dimitris Makris
K180701 03/16/2018 SafePath Suturing System SafePath Medical, Inc. Howard L. Schrayer
K180753 03/22/2018 SafetyFix EasyOut System SafetyFix Medical Technologies, Inc. Michael Horwitz
K180543 03/01/2018 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 Samsung Electronics Co.,Ltd. Jaesang Noh
K180686 03/15/2018 SeaSpine Daytona Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K180773 03/23/2018 Reusable and Self-Adhesive Electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU
K180649 03/13/2018 BeautiCem Veneer Kit Shofu Dental Corporation Mauro Malzyner
K180563 03/05/2018 syngo.plaza Siemens Healthcare GmbH Vijay Ramadas
K180811 03/29/2018 Biograph Vision Siemens Medical Solutions USA, Inc. Alaine Medio
K180661 03/14/2018 SIGMA Sterilization Pouch and Roll Sigma Medical Supplies Corp. Mason Huang
K180672 03/14/2018 Sterilization Pouch/Roll Made with Tyvek Sigma Medical Supplies Corporation Mason Huang
K180750 03/22/2018 World Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
K180744 03/22/2018 Stablyx CMC Arthroplasty Implant System Skeletal Dynamics, LLC Ana M. Escagedo
K180698 03/16/2018 PICO 7 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K180614 03/08/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K180618 03/09/2018 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K180606 03/07/2018 SOMAVAC Device SOMAVAC Medical Solutions, Inc. Esra Roan
K180621 03/09/2018 EchoMark, EchoMark LP Sonavex, Inc. David Narrow
K180694 03/16/2018 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Travis Pittman
K180796 03/27/2018 Spineology Navigation Instruments Spineology Inc. Jacqueline A. Hauge
K180807 03/28/2018 Celling Aspiration Needle SpineSmith Holdings, LLC Clifton (Chris) Naivar
K180558 03/01/2018 PressureWire X St. Jude Medical (now part of Abbott Medical) Josh Johnson
K180689 03/15/2018 Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device STERIS Corporation Tony Piotrkowski
K180553 03/01/2018 VERIFY Spore Test Strip for S40 Sterilant Steris Corporation Marcia L. Benedict
K180834 03/30/2018 Altrix Precision Temperature Management System Stryker Medical Brian Orwat
K180572 03/05/2018 AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 Supersonic Imagine Laurence Hermitte
K180677 03/15/2018 Surefire Spark Infusion System Surefire Medical, Inc. Lynne Aronson
K180580 03/05/2018 Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K180593 03/06/2018 Vbeam Prima Laser System Syneron-Candela Sharon Timberlake
K180544 03/01/2018 DePuy Synthes Static Staples Synthes (USA) Products, LLC Suchitra Basu
K180585 03/05/2018 Collagentex Rx-6 Tanses Technologies inc. Kirk Kiremitci
K180588 03/06/2018 FAST1Ö Intraosseous Infusion System; FASTResponderÖ Sternal Intraosseous Device Teleflex Medical Ying Zhao
K180765 03/23/2018 Televere Podiatry X-Ray System HF Televere Systems, Inc. Randell Quaal
K180818 03/29/2018 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) Tenon Medical, Inc. Kal Mentak
K180613 03/08/2018 Estelite Universal Flow Tokuyama Dental Corporation Keith A. Barritt
K180590 03/06/2018 Tyber Medical PT Interbody Spacer System Tyber Medical, LLC Mark F Schenk
K180759 03/22/2018 SECULOKÖ Suture Anchor U & I Corporation Bo-Ram Kang
K180623 03/09/2018 Ulthera System Ulthera, Inc Jessica Newhard
K180598 03/07/2018 UNIQA Dental Implants System UNIQA DENTAL LTD Dima Goberman
K180712 03/19/2018 Coconut Infused Hybrid Personal Lubricant United Consortium Stephanie Morris
K180731 03/20/2018 Ultramatrix EUS Balloon United States Endoscopy Group, Inc. (US Endoscopy) Coletta Cohara
K180586 03/05/2018 Varian Head Frame Varian Medical Systems, Inc. Peter J. Coronado
K180703 03/19/2018 VITA YZ ST and VITA YZ XT VITA Zahnfabrik H.Rauter GmbH Co. Bernd Walker
K180584 03/05/2018 Viveve RF System, Secure Viveve Inc. Suzon Lommel
K180730 03/20/2018 INVISION Total Ankle Revision System Wright Medical Technology, Inc. Alayne Melancon
K180832 03/30/2018 SALVATION External Fixation System Wright Medical Technology, Inc. Rachel Roberts
K180571 03/05/2018 GammaPod Xcision Medical Systems, LLC Daniel R. Plonski
K180617 03/08/2018 Hair Up Y&J BIO Co, Ltd., Kwang Sic Kim
K180673 03/14/2018 Normandy VBR System Zavation Medical Products LLC Frankie Cummins
K180549 03/01/2018 ZED Link Zed Technologies Ronald Li
K180562 03/05/2018 TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT Zirkonzahn Gmbh Julian Steger


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