FDA 510(k) Applications Received During April, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K191122 04/29/2019 3M RelyX Pediatric Resin Modified Glass Ionomer Cement 3M ESPE Dental Products Lin Ma
K190870 04/03/2019 Cervical Spinal Truss System-Stand Alone (CSTS-SA) 4Web, Inc. Jessee Hunt
K190926 04/09/2019 Hammertoe Truss System (HTS) 4Web, Inc. Jessee Hunt
K191060 04/22/2019 ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit ACIST Medical Systems, Inc. Matthew D. Stepanek
K191038 04/18/2019 On Call Express Voice Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K190924 04/09/2019 Revitive Medic Plus, Revitive Advanced 2 Actegy, Ltd. Lawrence Brookfield
K190819 04/01/2019 Silicone PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Adam Gregory
K190896 04/05/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K190949 04/11/2019 ScanX Barrier Envelopes Air Techniques Inc. Samir Ghevariya
K191138 04/30/2019 AeroForm Tissue Expander, Smooth AirXpanders, Inc. Belinda Pinedo
K190844 04/01/2019 Akesis Galaxy Akesis Inc Christopher Brown
K191107 04/26/2019 Plexus Alleva Medical (D.G.) Ltd Max Choi
K190972 04/15/2019 Ambu aScope 4 RhinoLaryngo Intervention Ambu A/S Gurpreet Kaur Rehal
K191080 04/24/2019 Ambu aScope 4 RhinoLaryngo Slim Ambu A/S Gurpreet Kaur Rehal
K191092 04/24/2019 Powder-Free Vinyl Patient Examination Gloves, Yellow Color Anhui Intco Medical Products Co. Ltd Jacken Cai
K190953 04/11/2019 Arthrex Minimally Invasive Ankle Fusion Plate Arthrex, Inc. Caroline Bloemker
K191099 04/25/2019 Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel Atlas Medical Amani AL-Habahbeh
K191114 04/26/2019 Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle Avenu Medical Dave Campbell
K191000 04/16/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Brit Baird
K191078 04/23/2019 BAROnova Access Sheath Kit BAROnova, Inc. Lian Cunningham
K190985 04/15/2019 BAROnova Insufflation System, BAROnova Accessory Kit BAROnova, Inc. Lian Cunningham
K190910 04/08/2019 PrisMax System Version 2 Baxter Healthcare Corp Chris Scavotto
K190905 04/08/2019 BD Phoenix Automated Microbiology System û GN Ceftaroline (0.0156-4 ?g/mL) Becton, Dickinson and Company Laura Stewart
K190941 04/10/2019 BioCardia 8.5 F Avance Steerable lntroducer BioCardia, Inc. Kevin DeMartini
K191067 04/22/2019 Arc Endocuff Glide AEG110 & AEG120 Boddingtons Plastics Ltd Shimaa Elsawy
K190996 04/16/2019 Bonus Therapeutics Mixing and Delivery System Bonus Therapeutics Ltd. Nir Shtayer
K191008 04/16/2019 iLab Polaris Multi-Modality Guidance System Boston Scientific Corporation Mugdha Dongre
K191006 04/16/2019 EasiSlush Bridge to Life Ltd. Tom Keller
K191004 04/16/2019 Advocate Non-Contact Infrared Thermometer BroadMaster Biotech, Corp. Jen Ke-Min
K191119 04/26/2019 EkoSonic Endovascular Device BTG International, Inc. Joshua Kim
K191143 04/30/2019 PowerFlow Implantable Apheresis IV Port C.R. Bard, Inc. Kristen Soodak
K191128 04/29/2019 Vantage Titan 3T, MRT-3010, V2.5 Canon Medical Systems Corporation Paul Biggins
K191025 04/18/2019 DRX-Revolution Mobile X-ray System Carestream Health Inc. Gina Maiolo
K191024 04/18/2019 xPORT Lens Fragmentation System Carl Zeiss Meditec Cataract Technology Inc. Gary Mocnik
K191083 04/24/2019 COMPLETE CONTROL System Gen2 Coapt, LLC Blair A Lock
K190904 04/08/2019 Conformis BeneFIT Hip System ConforMIS, Inc. Emmanuel Nyakako
K191015 04/17/2019 Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) Cook Incorporated Ian Herrman
K190965 04/12/2019 MyDay CooperVision, Inc. Marie Dutton
K190834 04/01/2019 Corin Optimized Position System Functional Hip Analysis (OPS FHA) Corin USA Lucinda Gerber
K191070 04/22/2019 Signia Small Diameter Reloads Covidien Frank Gianelli
K190875 04/04/2019 EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) D.O.R.C. Dutch Ophthalmic Research Center (International) Linda Van Leeuwen
K191079 04/23/2019 Piezon Built-in Kit, Piezon Built-in Kit LED E.M.S Electro Medical Systems S.A Suzanne Fassio-Hardy
K191089 04/24/2019 Edwards Pressure Cable Edwards LifeSciences, LLC Anne Lo
K190887 04/04/2019 Leksell Vantage Stereotactic System Elekta Instrument AB Helena Skar
K190885 04/04/2019 Elevation Spine Saber-C System Elevation Spine Charlie Gilbride
K191124 04/29/2019 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Timothee Deblock
K190856 04/02/2019 SeeFactorCT3 Epica International Inc. Daniel Naimey
K190823 04/01/2019 Erbe ESU Model VIO 3 with Accessories Erbe Elektromedizin GmbH Julia Weller
K191072 04/22/2019 7410 Ultrasound System (MyLabSigma) Esaote S.p.A. Piet De Jong
K190989 04/15/2019 6400 Ultrasound System (MyLabX6, MyLabX7) Esaote, S.p.A. Piet de Jong
K190894 04/05/2019 TOTIM Patient Cushion Immobilization System Essebi Medical SRL Pietro Sordina
K190937 04/10/2019 Echelon Endopath Staple Line Reinforcement Ethicon Endo-Surgery LLC Emily Nesbitt
K190995 04/16/2019 ExactVu High Resolution Micro-Ultrasound System Exact Imaging, Inc. Randy AuCoin
K191113 04/26/2019 geko T-2 and geko T-3 Neuromuscular Stimulators Firstkind Limited Neil Buckley
K190891 04/05/2019 Fluobeam LX Fluoptics Odile Allard
K191112 04/26/2019 GEHC DXA Bone Densitometers with enCORE version 18 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Martha Kamrow
K190988 04/15/2019 GIM-STIM OTC TENS/EMS System Gemore Technology Co Ltd Boden S.P. Lai
K191100 04/25/2019 ExcelsiusGPS Spine 1.1 Interbody Module Globus Medical Inc. Kelly J. Baker
K190932 04/10/2019 RFID Localization System Health Beacons, Inc. Nancy Confrey
K190925 04/09/2019 HeartFlow FFRct Analysis HeartFlow, Inc. Windi Hary
K190841 04/01/2019 SCENARIA View Hitachi Healthcare Americas Aaron Pierce
K190991 04/15/2019 Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment Howmedica Osteonics Corp. (aka Stryker Orthopaedics) Dipan Lad
K191034 04/18/2019 VPS Impression Material Hygedent Inc. Peng Wang
K191130 04/29/2019 Customized Contour Implant Implantech Associates Inc. Craig Arthur
K190980 04/15/2019 Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K191043 04/19/2019 da Vinci Handheld Camera Intuitive Surgical, Inc. Manjunath Bisalehalli
K190999 04/16/2019 SureForm 45 Curved Tip, SureForm 45 Gray Reload Intuitive Surgical, Inc. Nadine Nasr
K191012 04/16/2019 Navigated Pedicle Access Kit IZI Medical Products LLC Qiang Cao
K190886 04/04/2019 Non-invasive blood pressure measurement systems Joytech Healthcare Co., Ltd Ren Yunhua
K190873 04/03/2019 Infrared Ear/Forehead Thermometer Joytech Healthcare Co., Ltd. Ren Yunhua
K191137 04/29/2019 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 JVC Kenwood Corporation Hideki Tengeiji
K190820 04/01/2019 Aimanfun Lumea Comfort Kam Yuen Plastic Products Ltd Anna Dan
K191133 04/29/2019 KATANA Cleaner, KATANA Cleaner (Trial) Kuraray Noritake Dental Inc. Yasujiro Ohara
K191121 04/26/2019 Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apio Lentechs, LLC Robin Sears
K191005 04/16/2019 ProLift« Expandable System Life Spine Inc. Angela Batker
K190914 04/08/2019 MTS Doxycycline 0.016 - 256 ?g/mL Liofilchem s. r. l. Fabio Brocco
K190899 04/08/2019 bili-hut Little Sparrows Technologies, Inc. Erica Konston
K190874 04/04/2019 Materialise Mimics Enlight Materialise N.V. Mieke Janssen
K191033 04/18/2019 LunaGuard Nighttime Dental Protector McKeon Products Devin Benner
K191145 04/30/2019 MasterLoc Extension Medacta International SA Stefano Baj
K190892 04/05/2019 MectaScrew PEEK Interference Screw Medacta International SA Stefano Baj
K191011 04/16/2019 Scope ProTech Meditech Endoscopy Ltd Peter Ramsey
K190950 04/11/2019 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown Medline Industries, Inc. Pauline Maralit
K190895 04/05/2019 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System Medos International Sarl Sheree Geller
K191077 04/23/2019 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor Medtronic Inc Harsh Dharamshi
K190959 04/12/2019 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc Emmarie Halteman
K190840 04/01/2019 Medtronic Transportation / Sterilization Cassettes Medtronic Sofamor Danek USA, INC. Elizabeth Hamilton
K191039 04/19/2019 Navigated T2 STRATOSPHERE Inserters and Navigated Templates Medtronic Sofamor Danek, USA Inc Elizabeth Hamilton
K191066 04/22/2019 CD HorizonÖ AstuteÖ Spinal System Medtronic Sofamor Danek, USA Inc. Bhavya Vendra
K191148 04/30/2019 Medtronic HV-RÖ Bone Cement, KyphonÖ XpedeÖ Bone Cement, CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek, USA Inc. Shweta Sharma
K191029 04/18/2019 Affinity NTTM Oxygenator (Model 511), Affinity« NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity« NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity« NT Int Medtronic, Inc. Sammie C Joseph-Fredericks
K190825 04/01/2019 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Alexandra Theisen
K191127 04/29/2019 Advanced Intermezzo Implant System MegaGen Implant Co., Ltd. JiYoung Son
K190818 04/01/2019 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K190975 04/15/2019 Plexus SCD110 Sequential Compression Device Sleeve Midway Medical, LLC. Jim Tobin
K190960 04/12/2019 Nalu Lead Blank (50cm) Nalu Medical, Inc. Sunny Gill
K190831 04/01/2019 E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K190848 04/01/2019 JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Zilong Liang
K190849 04/01/2019 IS-III active System_S-narrow Type Neobiotech Co., Ltd. Young-Ku Heo
K191064 04/22/2019 Argon Handset New Deantronics Taiwan Ltd Jane Liu
K191117 04/26/2019 NvisionVLE Low-profile Optical Probe NinePoint Medical, Inc Eman Namati
K190974 04/15/2019 D'Vill Introducer NuMED, Inc. Nichelle LaFlesh
K190969 04/12/2019 ENDOSCOPE REPROCESSOR OER-Elite Olympus Medical Systems Corp. Toshiyuki Nakajima
K191140 04/30/2019 MONTAGE-QS Settable, Resorbable Hemostatic Bone Orthocon, Inc. Howard L. Schrayer
K190992 04/15/2019 OrthoPediatrics PediFoot Deformity Corrections System OrthoPediatrics, Corp Jen Gregory
K190915 04/09/2019 OsteoFab Suture Anchors Oxford Performance Materials, Inc. Andrus Maandi
K190930 04/10/2019 SmarTemp X1 Parkell, Inc. David Mott
K190913 04/08/2019 QLAB Advanced Quantification Software 13 Philips Healthcare Arti Arvind
K191136 04/29/2019 Access CT Philips Healthcare (Suzhou) Co., Ltd. Ray Sun
K190976 04/15/2019 Radial Medical Compression System Radial Medical, Inc. Eric Johnson
K190866 04/03/2019 XmaruView V1 (Xmaru Chiroview, Xmaru Podview) Rayence Co., Ltd Kevin Kim
K190889 04/05/2019 Republic Spine Restore Cervical Interbody Fusion System Republic Spine, L.L.C. James Doulgeris
K190817 04/01/2019 HS Fiber Riverpoint Medical Edwin Anderson
K190927 04/09/2019 Oscillometric Blood Pressure Monitor Rudolf Riester GmbH Vivi Ding
K191115 04/26/2019 RS85 Diagnostic Ultrasound System Samsung Medison Co., Ltd Ji Yea Lee
K191055 04/19/2019 HS40 Diagnostic Ultrasound System Samsung Medison Co., Ltd. Scully Kim
K191051 04/19/2019 ARGOS SANTEC CORPORATION Changho Chong
K190851 04/02/2019 HYDRASHIFT 2/4 daratumumab Sebia Karen Anderson
K190938 04/10/2019 Photodynamic Therapy System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K190936 04/10/2019 Q-Switched Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K190869 04/03/2019 Pulse Oximeter Shenzhen Aeon Technology Co., Ltd. Xie Hua
K191063 04/22/2019 1-Step Culture Medium Shenzhen VitaVitro Biotech Co., Ltd. Donghai Pan
K190879 04/04/2019 N Latex FLC kappa, N Latex FLC lambda Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K191040 04/19/2019 syngo.via (Version VB40A) Siemens Healthcare GmbH Elango Alampalayam Rangappan
K190900 04/08/2019 Biograph Vision Siemens Medical Solutions USA, Inc. Alaine Medio
K191050 04/19/2019 MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow Siemens Medical Solutions, USA Inc. Milind Dhamankar
K191045 04/19/2019 SalvoÖ Spine System Spine Wave, Inc. Amy Noccioli
K190877 04/04/2019 Juliet« Ti LL Lumbar Interbody Device SPINEART Franck Pennesi
K191091 04/24/2019 Rampart One Lumbar Interbody Fusion System Spineology, Inc. Andrew Adams
K190917 04/09/2019 V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems STERIS Corporation Anthony Piotrkowski
K191046 04/19/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM Stryker Agatha Szeliga
K191102 04/25/2019 Precision S 4K Sinuscope Stryker Jessie Duong
K190843 04/01/2019 Synchro2 Support Guidewire Stryker Lorraine Mazzeo
K191049 04/19/2019 Stryker MIS and Footed Attachments Stryker Corporation Paminder Khurmi
K191018 04/17/2019 Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K190963 04/12/2019 DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional Synthes (USA) Products LLC Jeffrey Krawiec
K191036 04/18/2019 SyMRI SyntheticMR AB Maria Almesaker
K190830 04/01/2019 TDM Screw Systems TDM Co. Ltd. Youngdae Kim
K191021 04/17/2019 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye Terragene SA Maria Victoria Rocha
K190940 04/10/2019 Tokuyama Rebase III Tokuyama Dental Corporation Keith A. Barritt
K191009 04/16/2019 Arsenal Plating System Trilliant Surgical Christopher Radzicki
K190858 04/02/2019 Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant United Consortium Stephanie Morris
K190827 04/01/2019 Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid UVision360 Inc. Allison London Brown
K191010 04/16/2019 Palladium High Flow Therapy System Vapotherm, Inc. Richelle Helman
K191023 04/17/2019 Dolphin/IQ, Dolphin/4D and Dolphin/MAX Viasonix Ltd. Shlomi Deler
K190893 04/05/2019 Non-invasive Hemodynamic Blood Pressure Monitor Vita-Course Technologies Co., Ltd. Kezheng Ma
K190916 04/09/2019 VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 VitalConnect, Inc. Cynthia Merrell
K190948 04/11/2019 Magic Clear Aligners Voodoo Manufacturing, Inc. Max Friefeld
K190853 04/02/2019 Vyntus BODY Vyaire Medical Inc. Colleen Watson
K191013 04/17/2019 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option Welch Allyn, Inc. Megan Pellenz
K190902 04/08/2019 RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope Wenzhou Renhua Instruments Co., Ltd Wang Saijie
K191048 04/19/2019 AcuSnare Polypectomy Snare - Duckbill Wilson-Cook Medical, Inc. Doris A. Hawks
K190970 04/12/2019 PROSTEPÖ TBIÖ (Tailors Bunion Implant) System Wright Medical Technology, Inc. Michael Mullins
K191068 04/22/2019 Powersculp laser lipolysis system Wuhan Lotuxs Technology Co., Ltd. Na Wu
K191074 04/23/2019 Sorrento Bone Graft Substitute Xenco Medical, LLC Jason Haider
K191053 04/19/2019 Xtreme-Loop Xiros Ltd Stephen Seed
K190854 04/02/2019 Therm-X Zenith Technical Innovations Greg Binversie
K190907 04/08/2019 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System ZEUS Scientific, Inc. Mark J. Kopnitsky
K190852 04/02/2019 Zurich Pressure Guidewire System Model 100 Zurich Medical Inc. Kin-Joe Sham


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