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
K180629 03/09/2018 DentiqGuide 3D Industrial Imaging Co., Ltd Jin Sa Kim
K180941 03/28/2018 Ortho System 3Shape A/S Kristian Worziger Nielsen
K180582 03/05/2018 Sternal Cable System A & E Medical Corporation Hollie Johnson
K180582 03/05/2018 Sternal Cable System A & E Medical Corporation Hollie Johnson
K180776 03/23/2018 Cytal Wound Particulate ACell, Inc. Andrea Artman
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
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
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
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
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
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
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
K180826 03/30/2018 Natrelle 133 Plus MICROCELL Tissue Expander Allergan Melissa Pathmajeyan
K180650 03/13/2018 Amsel Endo Occluder Amsel Medical Corporation Yoram Levy
K180699 03/16/2018 Voyant Open Fusion Device Applied Medical Resources Corporation Patricia Villarreal
K180699 03/16/2018 Voyant Open Fusion Device Applied Medical Resources Corporation Patricia Villarreal
K180570 03/05/2018 Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) Argentum Medical, LLC Paul Boentges
K180662 03/14/2018 Arthrex FastThread Interference Screw Arthrex Inc. Jessica L. Singelais
K180662 03/14/2018 Arthrex FastThread Interference Screw Arthrex Inc. Jessica L. Singelais
K180768 03/23/2018 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K180594 03/06/2018 Knotless SutureTak Anchors Arthrex, Inc. Ivette Galmez
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
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
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
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
K180675 03/15/2018 Atlas Spine Expandable Cervical Interbody System Atlas Spine, Inc. Thomas Smith
K180801 03/28/2018 Actreen Hi-Lite Cath, Actreen Hi-Lite Set B. Braun Medical Inc. Anita J. Nemeth
K180688 03/15/2018 SLENDERTONE CoreFit Abs 8, Type 734 Bio-Medical Research Ltd Eoin Keating
K180577 03/05/2018 BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories Arlene Carillo
K180577 03/05/2018 BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories Arlene Carillo
K180605 03/07/2018 GastroFlush Bionix Development Corporation James Huttner
K180805 03/28/2018 Pure EP BioSig Technologies Tiffini Wittwer
K180805 03/28/2018 Pure EP BioSig Technologies Tiffini Wittwer
K180737 03/22/2018 Ultrasound Scanner System bk2300 BK Medical ApS Susana Mogensen
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
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
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
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
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
K180813 03/29/2018 BTL 799-2 BTL Industries, Inc. David Chmel
K180781 03/26/2018 Bard Vertus Foley Catheter C. R. Bard, Inc. Sharon Lambert
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
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
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
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
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
K180809 03/28/2018 Eclipse II Carestream Health, Inc Diane Koetter
K180667 03/14/2018 SmartGrid 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
K180839 03/30/2018 AT 030 Carl Zeiss Meditec AG Christian Muenster
K180683 03/15/2018 Certa Dose Pediatric Midazolam 5mg/mL IM Syringe Certa Dose, Inc. Caleb Hernandez
K180764 03/23/2018 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Church & Dwight Co., Inc Joelle Reinson
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
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
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
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
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
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
K180837 03/30/2018 CONTEC Oxygen Concentrator Contec Medical System Co., Ltd. Xueyong Li
K180792 03/27/2018 Arterial Pressure Monitoring Set/Tray Cook Incorporated Johnathan Liu
K180557 03/01/2018 Greene Renal Transplant Stent Set Cook Incorporated Yuan Zhou
K180552 03/01/2018 Modified Novy Cornual Cannulation Set Cook Incorporated Naomi Funkhouser
K180552 03/01/2018 Modified Novy Cornual Cannulation Set Cook Incorporated Naomi Funkhouser
K180830 03/30/2018 Reuter Tip Deflecting Wire Guide Cook Incorporated Jennifer L. Allman
K180756 03/22/2018 Safety Wire Guide Introducer COOK Incorporated Carly Powell
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
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
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
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
K180622 03/09/2018 Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port Covidien Alexis Erazo
K180820 03/29/2018 Tono Vue Non-Contact Tonometer Crystalvue Medical Corporation Oliver Lin
K180797 03/27/2018 Xcess Guiding Catheter Curatia Medical Co. Jessica Chiu
K180727 03/20/2018 LineUp CurveBeam, LLC Stuti Singh
K180727 03/20/2018 LineUp CurveBeam, LLC Stuti Singh
K180709 03/19/2018 truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc. Brad Renton
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
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
K180561 03/05/2018 MobileX Portable X-ray System Denterprise International, Inc. Claude Berthoin
K180657 03/13/2018 Resin for Temporary Crown & Bridge Dentis Co., Ltd. Dong-Hun Jang
K180779 03/26/2018 Savina 300 Dragerwerk AG & CO. KGaA Dr. Bettina Mobius
K180568 03/05/2018 KidCap Eastern Cranial Affiliates, LLC Joseph Terpenning
K180559 03/01/2018 HSV 1 & 2 ELITe MGB Kit; ELITe InGenius ELITechGroup Terry Trimingham
K180627 03/09/2018 Macroduct Advanced Model 3710 ELITechGroup Inc. Stacey Pahulu
K180627 03/09/2018 Macroduct Advanced Model 3710 ELITechGroup Inc. Stacey Pahulu
K180766 03/23/2018 Endiscope, Endiscope Cervical Elliquence, LLC Paul D. Buhrke
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
K180640 03/12/2018 SmartClip Soft Tissue Marker Elucent Medical, Inc. Debra Kridner
K180620 03/09/2018 Endophys Pressure Sensing Sheath Kit Endophys Holdings, LLC Phillip Purdy
K180592 03/06/2018 G-scan Brio Esaote S.p.A Massimo Polignano
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
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
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
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
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
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
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
K180581 03/01/2018 UV Lamps for Sunlamp Products Feilo Sylvania Germany GmbH Achim Tonat
K180831 03/30/2018 CATSmart Fresenius Kabi AG Barry G. Hicks
K180615 03/08/2018 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter Fresenius Kabi USA LLC Kim Forch
K180711 03/19/2018 FUJIFILM Endoscopic CO2 Regulator GW-100 FUJIFILM Corporation Randy Vader
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
K180704 03/19/2018 SonoSite iViz Ultrasound System FUJIFILM SonoSite, Inc. Sudipta Chakrabarti
K180641 03/12/2018 Invenia ABUS Viewer GE Healthcare Bryan Behn
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
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
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
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
K180610 03/08/2018 Geister retractor for neuro - and spine surgery Geister Medizintechnik GmbH Christian Grotzinger
K180840 03/30/2018 UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. Andrew Goh
K180579 03/05/2018 Ezee Retrieval Genicon, Inc Katlyn Kachman
K180579 03/05/2018 Ezee Retrieval Genicon, Inc Katlyn Kachman
K180836 03/30/2018 Genistrong Genicon, Inc Katlyn Kachman
K180836 03/30/2018 Genistrong Genicon, Inc Katlyn Kachman
K180679 03/15/2018 CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Conc Global Scientific Technologies, LLC William J. Griswold, Jr.
K180817 03/29/2018 AERIALÖ Interspinous Fixation Globus Medical Inc. Kelly J. Baker
K180817 03/29/2018 AERIALÖ Interspinous Fixation Globus Medical Inc. Kelly J. Baker
K180554 03/01/2018 ANTHEM Fracture System Globus Medical Inc. Kelly J. Baker
K180690 03/16/2018 Navigation Instruments Globus Medical Inc. Lori Burns
K180690 03/16/2018 Navigation Instruments Globus Medical Inc. Lori Burns
K180626 03/09/2018 Pedimax II - Pedicular Screw Spinal System Gm Dos Reis Industria E Comerico Ltda Paula Oliveira
K180545 03/01/2018 VACUETTE SAFELINK Holder with male luer lock Greiner Bio-One NA Inc. Manfred Abel
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
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
K180644 03/12/2018 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Hartalega Sdn Bhd Mr. Kuan Kam Hon
K180645 03/12/2018 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Hartalega Sdn Bhd Mr. Kuan Kam Hon
K180786 03/26/2018 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff HARTALEGA SDN. BHD. Kuan Kam Hon
K180578 03/05/2018 Harvest Dental Polymer Blocks Harvest Dental Products, LLC Sasha Der Avanessian
K180824 03/30/2018 VaPro 2 Intermittent Catheter Hollister Incorporated Michelle Schiltz-Taing
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
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
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
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
K180729 03/20/2018 FaSet Fixation System Huvexel Co., Ltd Sung Hee-Lee
K180670 03/14/2018 ICONN Campbell Interference Screw ICONN Orthopedics, LLC Whitt Israel
K180780 03/26/2018 microINR System iLine Microsystems S.L. Alberto Molinero
K180719 03/19/2018 InMode Diolaze System InMode MD Ltd. Amit Goren
K180719 03/19/2018 InMode Diolaze System InMode MD Ltd. Amit Goren
K180619 03/09/2018 Bongo InnoMed Healthscience, Inc. Javier Collazo
K180619 03/09/2018 Bongo InnoMed Healthscience, Inc. Javier Collazo
K180710 03/19/2018 Reprocessed DecaNav Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
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
K180791 03/27/2018 Straumann BLX Surgical Cassette Institut Straumann AG Anna Vianna
K180769 03/23/2018 SecurAcath Interrad Medical Inc Denise Lenz
K180769 03/23/2018 SecurAcath Interrad Medical Inc Denise Lenz
K180732 03/20/2018 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K180775 03/23/2018 Watch-PAT300 Itamar Medical, Ltd. Koby Sheffy
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
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
K180546 03/01/2018 Jet Power Injectable PICC Jet Medical, Inc. Courtney Nix
K180555 03/01/2018 Ergoline Prestige 1600 Hybrid Performance JK Holding GmbH Juergen Gerstenmeier
K180714 03/19/2018 Probe Covers for Thermometers K-jump Health Co., Ltd. JM Lin
K180777 03/26/2018 K2M Expandable Interbody System K2M, Inc. Nancy Giezen
K180777 03/26/2018 K2M Expandable Interbody System K2M, Inc. Nancy Giezen
K180665 03/14/2018 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2M, LLC. Nancy Giezen
K180735 03/22/2018 Endomat Select Karl Storz SE & Co. KG Serkan Sezer
K180722 03/19/2018 CAPERE Thrombectomy System KP Medcure, Inc. Samuel Shaolian
K180722 03/19/2018 CAPERE Thrombectomy System KP Medcure, Inc. Samuel Shaolian
K180607 03/07/2018 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit KRONUS, Inc. Brian Deis
K180680 03/15/2018 Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray Laclede, Inc. Michael Pellico
K180767 03/23/2018 FEMON Banana Thermometer Life Science Technology Inc. Jaewoo Jun
K180749 03/22/2018 Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine Inc. Randy Lewis
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
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
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
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
K180597 03/06/2018 AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO Lumenis Ltd. Amaya De Levie
K180643 03/12/2018 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) MedCu Technologies, Ltd. Gadi Borkow
K180564 03/05/2018 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases Medentika GmbH Gerhard Polzer
K180720 03/19/2018 Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel Medibio Usa LLC. Jatin Rajani
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
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
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
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
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
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
K180723 03/19/2018 PreludeSYNC DISTAL Radial Compression System Merit Medical Systems, Inc Susan Christensen
K180772 03/23/2018 Met One Czar Anterior Cervical Plate System Met One Technologies Evan Carbonell
K180802 03/28/2018 Meta P&Bond META BIOMED, CO., LTD. Suk Song Oh
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
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
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
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
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
K180815 03/29/2018 MIM - SPECTRA Quant MIM Software Inc. Lynn Hanigan
K180778 03/26/2018 Exceed Microneedling Device MT.DERM GmbH Anderas Pachten
K180828 03/30/2018 Natureplex Warm Touch Warming Jelly Natureplex, LLC Pamela Hopkins
K180565 03/05/2018 PEAK NS033CF, PEAK NS017CF Neosil Co., Ltd Woo-ryong Ryou
K180565 03/05/2018 PEAK NS033CF, PEAK NS017CF Neosil Co., Ltd Woo-ryong Ryou
K180608 03/07/2018 Lunoa System NightBalance BV Sophia Lam
K180608 03/07/2018 Lunoa System NightBalance BV Sophia Lam
K180550 03/01/2018 NuVasive Monolith Cervical Corpectomy System NuVasive, Incorporated Martin Yahiro
K180668 03/14/2018 Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N Olympus Medical Systems Corp. Toshiyuki Nakajima
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
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
K180630 03/09/2018 PTFE SURGICAL SUTURE OMNIA SPA Roberto Cerioli
K180660 03/14/2018 Avanti Optovue, Inc. Indu Lakshman
K180660 03/14/2018 Avanti Optovue, Inc. Indu Lakshman
K180740 03/22/2018 VitriGuard ORIGIO a/s Roaida Johnson
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
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
K180624 03/09/2018 Guided Growth Plate System Plus Orthofix Srl Gianluca Ricadona
K180648 03/13/2018 Park Dental Research Aligners Park Dental Research Corporation Ronald A. Bulard
K180651 03/13/2018 Uroview FD II Pausch Medical GmbH Christian Stoian
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
K180655 03/13/2018 Viking Lumbar Polyaxial Screw System Presidio Surgical Meredith Lee May
K180595 03/06/2018 SciMoCa Radialogica LLC Debra Vigil
K180595 03/06/2018 SciMoCa Radialogica LLC Debra Vigil
K180770 03/23/2018 Propeller Sensor for Neohaler Reciprocal Labs Corporation David Hubanks
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
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
K180637 03/12/2018 leva Pelvic Floor Trainer Renovia Inc. Gina Prochillo-Cawston
K180573 03/05/2018 Responsive Arthroscopy Interference Screw System Responsive Arthroscopy LLC Doug Kohrs
K180583 03/05/2018 LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD Richard Wolf Medical Instruments Corporation Michael Loiterman
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
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
K180684 03/15/2018 CoaguChek XS Plus System Roche Diagnostics Bin Sun
K180693 03/16/2018 CoaguChek XS Pro System Roche Diagnostics Angie Clements
K180693 03/16/2018 CoaguChek XS Pro System Roche Diagnostics Angie Clements
K180609 03/08/2018 Rodo Smilekey Rodo Medical, Inc. Michael Parsons
K180609 03/08/2018 Rodo Smilekey Rodo Medical, Inc. Michael Parsons
K180654 03/13/2018 PINXEL-RF system Rohrer Aesthetics, LLC Mark Rohrer
K180654 03/13/2018 PINXEL-RF system Rohrer Aesthetics, LLC Mark Rohrer
K180697 03/16/2018 Pseudo-Patient RTsafe, Inc. Dimitris Makris
K180697 03/16/2018 Pseudo-Patient RTsafe, Inc. Dimitris Makris
K180701 03/16/2018 SafePath Suturing System SafePath Medical, Inc. Howard L. Schrayer
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
K180753 03/22/2018 SafetyFix EasyOut System SafetyFix Medical Technologies, Inc. Michael Horwitz
K180838 03/30/2018 SaliPen Saliwell Ltd. Ben Z. Beiski
K180543 03/01/2018 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 Samsung Electronics Co.,Ltd. Jaesang Noh
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
K180686 03/15/2018 SeaSpine Daytona Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K180762 03/23/2018 CAPI 3 HEMOGLOBIN(E) SEBIA Karen Anderson
K180773 03/23/2018 Reusable and Self-Adhesive Electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU
K180773 03/23/2018 Reusable and Self-Adhesive Electrodes Shaoxing DongZhi Electrical Technology Co., Ltd. Haze XU
K180788 03/26/2018 Gas Module 3 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Yanhong Bai
K180803 03/28/2018 BeautiBond Universal Shofu Dental Corporation Mauro Malzyner
K180649 03/13/2018 BeautiCem Veneer Kit Shofu Dental Corporation Mauro Malzyner
K180649 03/13/2018 BeautiCem Veneer Kit Shofu Dental Corporation Mauro Malzyner
K180563 03/05/2018 syngo.plaza Siemens Healthcare GmbH Vijay Ramadas
K180563 03/05/2018 syngo.plaza Siemens Healthcare GmbH Vijay Ramadas
K180811 03/29/2018 Biograph Vision Siemens Medical Solutions USA, Inc. Alaine Medio
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
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
K180672 03/14/2018 Sterilization Pouch/Roll Made with Tyvek Sigma Medical Supplies Corporation Mason Huang
K180754 03/22/2018 C-Zero Pedicle Screw System, Freedom Pedicle Screw System Signature Orthopaedics Pty Ltd. Declan Brazil
K180750 03/22/2018 World Knee System Signature Orthopaedics Pty Ltd. Declan Brazil
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
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
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
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
K180631 03/09/2018 Silk Voice Sofregen Medical, Inc. Anh Hoang
K180606 03/07/2018 SOMAVAC Device SOMAVAC Medical Solutions, Inc. Esra Roan
K180606 03/07/2018 SOMAVAC Device SOMAVAC Medical Solutions, Inc. Esra Roan
K180621 03/09/2018 EchoMark, EchoMark LP Sonavex, Inc. David Narrow
K180621 03/09/2018 EchoMark, EchoMark LP Sonavex, Inc. David Narrow
K180653 03/13/2018 Spartan eCoil System Spartan Micro, Inc Mark Dias
K180694 03/16/2018 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Travis Pittman
K180694 03/16/2018 Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics, Inc. Travis Pittman
K180728 03/20/2018 Spinal Elements Cerclage System Spinal Elements Inc Julie Lamothe
K180796 03/27/2018 Spineology Navigation Instruments Spineology Inc. Jacqueline A. Hauge
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
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
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
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
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
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
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
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
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
K180593 03/06/2018 Vbeam Prima Laser System Syneron-Candela Sharon Timberlake
K180821 03/30/2018 TruMatch Graft Cage - Long Bone Synthes (USA) LLC Christopher J. Medberry
K180544 03/01/2018 DePuy Synthes Static Staples Synthes (USA) Products, LLC Suchitra Basu
K180544 03/01/2018 DePuy Synthes Static Staples Synthes (USA) Products, LLC Suchitra Basu
K180541 03/01/2018 DePuy Synthes 2.0 mm Quick Insertion Screws Synthes USA Products, LLC Nicholas Fountoulakis
K180585 03/05/2018 Collagentex Rx-6 Tanses Technologies inc. Kirk Kiremitci
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
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
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
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
K180613 03/08/2018 Estelite Universal Flow Tokuyama Dental Corporation Keith A. Barritt
K180718 03/19/2018 ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES TOMY, Inc. Jinichi Watanabe
K180590 03/06/2018 Tyber Medical PT Interbody Spacer System Tyber Medical, LLC Mark F Schenk
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
K180759 03/22/2018 SECULOKÖ Suture Anchor U & I Corporation Bo-Ram Kang
K180623 03/09/2018 Ulthera System Ulthera, Inc Jessica Newhard
K180623 03/09/2018 Ulthera System Ulthera, Inc Jessica Newhard
K180598 03/07/2018 UNIQA Dental Implants System UNIQA DENTAL LTD Dima Goberman
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
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
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
K180586 03/05/2018 Varian Head Frame Varian Medical Systems, Inc. Peter J. Coronado
K180601 03/07/2018 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) Villa Sistemi Medicali S.p.A. Paolo Casagrande Santin
K180703 03/19/2018 VITA YZ ST and VITA YZ XT VITA Zahnfabrik H.Rauter GmbH Co. Bernd Walker
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
K180584 03/05/2018 Viveve RF System, Secure Viveve Inc. Suzon Lommel
K180822 03/30/2018 VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System Wenzel Spine, Inc. Beckinam Nowatzke
K180758 03/22/2018 Osteocera Resorbable Bone Substitute Wiltrom Corporation Limited Yi-Chun Su
K180736 03/22/2018 WishBone Medical Plate and Screw System WishBone Medical, Inc. Gary Barnett
K180730 03/20/2018 INVISION Total Ankle Revision System Wright Medical Technology, Inc. Alayne Melancon
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
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
K180571 03/05/2018 GammaPod Xcision Medical Systems, LLC Daniel R. Plonski
K180708 03/19/2018 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profi Xeridiem Medical Devices, A Spectrum Plastics Group Company Steve Murray
K180685 03/15/2018 AS-3XX Series Fingertip Pulse Oximeter Xiamen Acurio Instruments Co., Ltd Angel Liu
K180617 03/08/2018 Hair Up Y&J BIO Co, Ltd., Kwang Sic Kim
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
K180673 03/14/2018 Normandy VBR System Zavation Medical Products LLC Frankie Cummins
K180549 03/01/2018 ZED Link Zed Technologies Ronald Li
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
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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