FDA 510(k) Applications Received During November, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K193085 11/05/2019 PuraDERM Gel 3-D Matrix, Inc. Lisa Spirio
K193055 11/01/2019 Purzir Dental Zirconia 3DBioCAD Gyu D. Cho
K193254 11/26/2019 3M Attest Steam Chemical Integrator 3M Company Mary Fretland
K193154 11/14/2019 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 3M Company Mary Fretland
K193110 11/12/2019 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E 3M Health Care Andrew Wingen
K193293 11/27/2019 XV Lung Ventilation Analysis Software 4Dx Limited Terrence Thiel
K193310 11/29/2019 myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) Abbott (St. Jude Medical) Vanessa Powell
K193126 11/12/2019 HI-TORQUE InfilTrac Guide Wire Family Abbott Vascular Aniket Khakhadiya
K193183 11/18/2019 ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter ACIST Medical Systems, Inc. Angela Johnson
K193262 11/26/2019 DR 600 with Tomosynthesis Agfa N.V. Wim Govaerts
K193298 11/27/2019 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
K193069 11/04/2019 AIROS 6 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K193068 11/04/2019 AIROS 8 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K193095 11/07/2019 Ambu aScope 4 Cysto Ambu A/S Anita Fjaestad
K193256 11/26/2019 Anjon Bremer Halo System Anjon Holdings LLC Kenneth A Collins
K193292 11/27/2019 Voyant 5mm Fusion Device, Voyant Maryland Fusion Device Applied Medical Resources Corp. Blake Stacy
K193268 11/26/2019 APrioCore Plus AprioMed AB Katrin Svensson
K193157 11/14/2019 Arthrex 3.9mm Corkscrew Suture Anchor Arthrex Inc. Jessica L. Singelais
K193156 11/14/2019 Arthrex Mini Comprehensive Fixation System - 1.0mm Screws Arthrex Inc. Rebecca R. Homan
K193116 11/12/2019 MRopen EVO ASG Superconductors S.p.A. DeBenedetti Luisella
K193162 11/15/2019 EPi-Sense Guided Coagulation System with VisiTrax AtriCure, Inc. Caitlin Wunderlin
K193066 11/04/2019 Steripack cases and Tray Systems Avalign Technologies, Inc. Hiren Patel
K193101 11/08/2019 Omnifix Low Dead Space Luer Lock Syringe B. Braun Medical Inc. Tracy Larish
K193137 11/13/2019 EASYGRIP FLO-41 Precision MIS Delivery System Baxter Healthcare Corportation Jeanette Licata
K193124 11/12/2019 Unicel DxH 800 Coulter Cellular Analysis System Beckman Coulter Samy Puccio
K193185 11/18/2019 Anscare SIMO Negative Pressure Wound Therapy (NPWT) System BenQ Materials Corporation Miranda Chang
K193172 11/15/2019 Luna XD Ti Interbody Fusion System Benvenue Medical, Inc. Laurent Schaller
K193122 11/12/2019 Biocore9 Humeral Resurfacing System Biocore9, LLC. Stan Matlak
K193168 11/15/2019 Agilon Moldable Biogennix, LLC. Timothy Bumbalough
K193092 11/06/2019 TunneLoc Tibial Fixation Device Biomet Inc. Haley Pioch
K193237 11/25/2019 Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. Richard Lauhead
K193120 11/12/2019 Real Intelligence Cori Blue Belt Technologies, Inc. Corrine Herlinger
K193279 11/27/2019 Comet II Pressure Guidewire Boston Scientific Corporation Kimberly Berg
K193202 11/20/2019 EXALT Model D Single-Use Duodenoscope, EXALT Controller Boston Scientific Corporation Carter Navarro
K193307 11/29/2019 HIP7 Brainlab AG Cherita James
K193201 11/20/2019 BTL-785F BTL David Chmel
K193181 11/18/2019 Serranator PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K193153 11/13/2019 SPIRA-C Integrated Fixation System Camber Spine Technologies Daniel Pontecorvo
K193097 11/07/2019 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Paul Biggins
K193270 11/26/2019 CapLOX II«/TowerLOX« MIS Pedicle Screw System Captiva Spine, Inc. George Chaux
K193177 11/18/2019 CER-S CardioCalm Fabio Badilini
K193173 11/18/2019 CareView 1800Le CareRay Digital Medical System Co., Ltd. Leilei Li
K193317 11/29/2019 CoreLite X-Ray Specimen Cabinet Cirdan Imaging Limited Jenna McGarry
K193105 11/08/2019 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System Conformis, Inc. Nancy Giezen
K193220 11/21/2019 AVIEW LCS Coreline Soft Co., Ltd Hyeyi Park
K193077 11/05/2019 Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Covidien Stacy Barton
K193232 11/25/2019 Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology Covidien LLC Hilla Debby
K193144 11/13/2019 T-Line Hernia Mesh Deep Blue Medical Advances, Inc. William Perry
K193078 11/05/2019 MIS CONNECT Conical Connection System Dentsply Sirona Karl Nittinger
K193064 11/04/2019 Atlantis suprastructures Dentsply Sirona Inc. Karl Nittinger
K193057 11/01/2019 ATTUNE All-Polyethylene Tibia DePuy Ireland UC Kathy Harris Brocato
K193051 11/01/2019 LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set DiaSorin Inc. John C. Walter
K193212 11/21/2019 DSM Biomedical Dental Bone Graft Plus DSM Biomedical Susan Pileggi
K193245 11/25/2019 Dunamis PunchTac Suture Anchors Dunamis LLC Prithviraj Chavan
K193139 11/13/2019 ProVecta 3D Prime Ceph Durr Dental SE Oliver Lange
K193149 11/13/2019 True 3D Viewer Software EchoPixel Inc. Michael Gabler
K193121 11/12/2019 GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims ECO Medi Glove SDN BHD Suresh Kumar
K193179 11/18/2019 EV1000 Clinical Platform Edwards Lifesciences, LLC Jamie Byun
K193226 11/22/2019 AltiVate Anatomic Canal-Sparing (CS) Shoulder Encore Medical, L.P Teffany Hutto
K193115 11/12/2019 EUROIMMUN Anti-BP230-CF ELISA (IgG) Euroimmun US, Inc. Kruti Shah
K193098 11/07/2019 Exactech« Equinoxe« Reverse Shoulder Glenospheres Exactech, Inc Zach Sharrah
K193045 11/01/2019 gekoÖ W-2 Firstkind Limited Neil Buckley
K193255 11/26/2019 Largo PEEK Interbody System FloSpine, LLC Peter Harris
K193209 11/21/2019 Wego-Stainless Steel Foosin Medical Supplies Inc., Ltd. Zhipeng Yang
K193123 11/12/2019 FUJIFILM Distal Cap Models 33-40 FUJIFILM Corporation Randy Vader
K193219 11/21/2019 G Surgical Marksman System G Surgical LLC Donald Grafton
K193061 11/01/2019 G3 40 Radiopaque Bone Cement G21 S.r.l Flilippo Foroni
K193059 11/01/2019 G1 40 Radiopaque Bone Cement G21 S.r.l. Filippo Foroni
K193113 11/12/2019 GC Temp Print GC America Inc. Mark Heiss
K193282 11/27/2019 SIGNA Premier GE Healthcare (GE Medical Systems, LLC) Glen Sabin
K193170 11/15/2019 Deep Learning Image Reconstruction GE Healthcare Japan Corporation Tomohiro Ito
K193261 11/26/2019 FlightPlan for Embolization GE Medical Systems SCS Ning Wen
K193281 11/27/2019 Hepatic VCAR GE Medical Systems SCS Lifeng Wang
K193303 11/29/2019 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K193272 11/26/2019 GTK Trocars Guangzhou TK Medical Instrument Co., Ltd. Tracy Weng
K193228 11/22/2019 Hamilton-G5 Hamilton Medical AG Simone Haller
K193132 11/12/2019 CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream Hangzhou Clongene Biotech Co.,Ltd. Zheng Shujian
K193189 11/19/2019 RFID Localization System Health Beacons, Inc. Nancy Confrey
K193152 11/13/2019 Affinity Hermes Medical Solutions AB Joakim Arwidson
K193148 11/13/2019 VaPro Plus Pocket, VaPro Plus Hollister Incorporated Michelle Schiltz-Taing
K193233 11/25/2019 Restoration« Modular Hip System Howmedica Osteonics Corp. (aka Stryker Orthopaedics) Nora O'Connor
K193263 11/26/2019 Reprocessed Achieve Catheter Connecting Cable Innovative Health, LLC. Rick Ferreira
K193218 11/21/2019 Innovision Audio Innovere Medical Inc. Lynsie Thomason
K193046 11/01/2019 Straumann« Retentive System û Novaloc TiN Abutments Institut Straumann AG Ana C.M. Vianna
K193192 11/19/2019 Tamper Evident Cap International Medical Industries Inc. David Meily
K193087 11/06/2019 Rapid ICH iSchemaView Incorporated James Rosa
K193234 11/25/2019 NUVO IF Implant System JJGC Industria e Comercio de Materiais Dentarios S.A. Luiza Vaccari Toppel
K193203 11/20/2019 MOJAVE Expandable Interbody System K2M, Inc. Oonagh Lahiff
K193129 11/12/2019 Yukon OCT Spinal System K2M, Inc. Oonagh Lahiff
K193235 11/25/2019 Telepack + Karl Storz Endoscopy America, Inc. Winkie Wong
K193213 11/21/2019 Vicks VNT200 No Touch Forehead Thermometer Kaz USA, Inc., a Helen of Troy Company Matt J. Baun
K193174 11/18/2019 Keos Lumbar IBFD Keos Scott Peterson
K193250 11/25/2019 Irrigation Tubing with CO2 or Air KeyMed (Medical and Industrial Equipment) Ltd. Andy Hollingsworth
K193311 11/29/2019 Aluna Knox Medical Diagnostics, Inc. Charvi Shetty
K193225 11/22/2019 KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography Konica Minolta Healthcare Americas, Inc Jan Maniscalco
K193288 11/27/2019 Koya Ripple Koya, Inc. Andy Doraiswamy
K193060 11/01/2019 Noritake Super Porcelain EX-3 Kuraray Noritake Dental Inc. Yasujiro Ohara
K193258 11/26/2019 ProLift Expandable System Life Spine Inc. Angela Batker
K193284 11/27/2019 Physica LMC Knee System Limacorporate S.p.A Michela Zanotto
K193259 11/26/2019 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Little Doctor Electronic (Nantong)Co.,Ltd Iris Du
K193167 11/15/2019 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software Luminex Molecular Diagnostics, Inc. Jennifer Grimes
K193072 11/04/2019 Lucent : IPL LUVO Medical Technologies, Inc. Gregory Berzak
K193128 11/12/2019 Mako Total Hip Application Mako Surgical Corp. Liza Gordillo
K193242 11/25/2019 Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories Masimo Corporation Sindura Penubarthi
K193175 11/18/2019 Lateralized Glenosphere Medacta Inernational SA Stefano Baj
K193083 11/05/2019 M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System Medacta International SA Stefano Baj
K193165 11/15/2019 MectaFix CL Fixation Button with Continuous Loop Medacta International SA Stefano Baj
K193104 11/08/2019 Unified Arrhythmia Diagnostic System PocketECG IV Medicalgorithmics S.A. Marek Dziubinski
K193188 11/18/2019 MiiS Horus Eye Anterior Camera Medimaging Integrated Solution Inc. (MiiS) Yi-Ying Chen
K193217 11/21/2019 SensiCare PI and SensiCare PI Micro Surgical Gloves Medline Industries, Inc. Jennifer Mason
K193305 11/29/2019 DynaClip Bone Staple MedShape, Inc. Jack Griffis
K193278 11/27/2019 MedSource CathMED IV Catheter MedSource Labs Emilie Andrews
K193145 11/13/2019 Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch Megadyne Medical Products, Inc. Sharon Sussex
K193082 11/05/2019 Fountain ValveTip Infusion Catheter Merit Medical Systems, Inc Spriha Pandey
K193252 11/25/2019 Contour ProtegeAI MIM Software Inc. Lynn Hanigan
K193239 11/25/2019 MPowRx Snoring Solution (also known as Good Morning Snore Solution) MPowRx Health and Wellness Products 2012 Inc Nancy Markley
K193102 11/08/2019 MRIaudio PREM System with MRIview MRIaudio, Inc. Joseph Caruso
K193130 11/12/2019 MVP Aligner System MVP Aligners, LLC Daniel Michaeli
K193211 11/21/2019 Nano FortiFix« System Nanovis Spine LLC Matthew Hedrick
K193094 11/07/2019 Naviswiss Hip Navigation System Naviswiss AG Jan Stifter
K193269 11/26/2019 UroLift System (UL400) Neotract, Inc. Brian Gall
K193063 11/04/2019 EMBOTRAP III Revascularization Device Neuravi, Ltd. Niall Fox
K193264 11/26/2019 Disposable High Speed Air Turbine Handpiece Ningbo HPDOVE Dental Instruments Co., Ltd. Liyue Huang
K193246 11/25/2019 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K193074 11/04/2019 Bevel Up Holder NSP Tech Pte Ltd HC TAN
K193182 11/18/2019 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp. Toshiyuki Nakajima
K193052 11/01/2019 HBP6 Settable, Resorbable Hemostatic Bone Paste Orthocon, Inc. Howard Schrayer
K193100 11/08/2019 RESPONSEÖ Spine System, RESPONSEÖ 4.5/5.0 Spine System, RESPONSEÖ 5.5/6.0 Spine System OrthoPediatrics, Corp Jackie Jaskula
K193207 11/20/2019 TaiChiA Our United Corporation Qi Liu
K193295 11/27/2019 Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor Parcus Medical, LLC Paul Vagts
K193244 11/25/2019 Indigo Aspiration System û Lightning Aspiration Tubing Penumbra, Inc. Micaela Victoria
K193103 11/08/2019 NeoBase 2 Non-derivatized MSMS Kit PerkinElmer Inc. Eva Nalian
K193109 11/08/2019 MRCAT brain Philips Medical Systems MR Finland Janne Marvola
K193215 11/21/2019 Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems Philips Medical Systems Nederland BV Jan Van de Kerkhof
K193204 11/20/2019 Cryocheck Chromogenic Factor VIII Precision BioLogic Karen Black
K193161 11/15/2019 Pristine Scope Pristine Surgical Stewart B. Davis
K193243 11/25/2019 Alta Multipurpose Device Qfix Alexandra Low Smythe
K193140 11/13/2019 Flex Body SPEEDER Quality Electrodynamics, LLC Eric Yeh
K193300 11/27/2019 AIMI-Triage CXR PTX RADLogics, Inc. Moshe Becker
K193313 11/29/2019 Elecsys Anti-TSHR Roche Diagnostics Reanna Toney
K193053 11/01/2019 Tina-quant Hemoglobin A1cDx Gen.3 Roche Diagnostics Operations (RDO) Leslie Patterson
K193274 11/26/2019 Rodo Abutment System RODO Medical, Inc. James Park
K193096 11/07/2019 S.I.N. Dental Implant System S.I.N. -Sistema de Implante Nacional S.A. Denise Domiciano
K193194 11/19/2019 CrossTorq 14 Guidewire Scientia Cardio Access LLC Amy McManus
K193229 11/22/2019 Transpara ScreenPoint Medical B.V. Umar Waqas
K193224 11/22/2019 Daytona« Small Stature Growth Rod Conversion Set SeaSpine Orthopedics Corporation Jesse Albright
K193054 11/01/2019 Sectra Digital Pathology Module Sectra AB Edoardo Mastrovito
K193241 11/25/2019 Emission Computed Tomography System Shanghai United Imaging Healthcare Co., Ltd Shumei Wang
K193176 11/18/2019 uMR 780 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K193073 11/04/2019 Deep Recon Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K193210 11/21/2019 HYPER DLR Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K193200 11/20/2019 uMR Omega Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K193253 11/18/2019 Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 Shenzhen Changkun Technology Co., Ltd. Steve Li
K193275 11/26/2019 Nerve and Muscle Stimulator Shenzhen XFT Medical Limited Cindy Peng
K193178 11/18/2019 Biograph Horizon Siemens Medical Solution USA, Inc. Alaine Medio
K193283 11/27/2019 AI-Rad Companion Prostate MR Siemens Medical Solutions USA Inc. Lauren Bentley
K193257 11/26/2019 ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc Sulgue Choi
K193248 11/25/2019 Biograph Vision, Biograph mCT Family of PET/CTs Siemens Medical Solutions USA, Inc Tabitha Estes
K193290 11/27/2019 AI-Rad Companion Brain MR Siemens Medical Solutions USA, Inc. Lauren Bentley
K193294 11/27/2019 AI-Rad Companion Engine Siemens Medical Solutions USA, Inc. Lauren Bentley
K193267 11/26/2019 Al-Rad Companion (Musculoskeletal) Siemens Medical Solutions USA, Inc. Alaine Medio
K193166 11/15/2019 MAMMOMAT Revelation Siemens Medical Solutions USA, Inc. Martin Rajchel
K193089 11/06/2019 MULTIX Impact Siemens Medical Solutions USA, Inc. Martin Rajchel
K193277 11/27/2019 SOMATOM On.site and On.scene Siemens Medical Solutions USA, Inc. Alaine Medio
K193216 11/21/2019 syngo.CT Lung CAD Siemens Medical Solutions, Inc Abhineet Johri
K193075 11/04/2019 Osteo3 ZP Putty Sirakoss Ltd. Jordan Conway
K193058 11/01/2019 SonarMed AirWave Airway Monitoring System SonarMed, Inc. Laura Lyons
K193106 11/08/2019 SpineFrontier Lumbar Interbody Fusion Device System SpineFrontier, Inc. Vito Lore
K193147 11/13/2019 Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System Stereotaxis, Inc. Kenneth H. Lock
K193136 11/13/2019 Stryker Customized Mandible Recon Plate Kit Stryker Zainab Amini
K193143 11/13/2019 Stryker Facial iD Plating System Stryker Zainab Amini
K193118 11/12/2019 TGS Guidewire and updated Scopis Software Stryker ENT Bruce Backlund
K193308 11/29/2019 T2 Alpha Tibia Nailing System, IMN Screws System Stryker Trauma GmbH Sanja Jahr
K193160 11/15/2019 Glidesheath Slender Tibial Pedal Kit Terumo Medical Coporation Liang Lu
K193125 11/12/2019 R2P Destination Slender Guiding Sheath Terumo Medical Corporation Liang Lu
K193135 11/12/2019 TSolution One Total Knee Application Think Surgical, Inc. Meliha Mulalic
K193071 11/04/2019 Bashir Plus Endovascular Catheter Thrombolex, Inc. Amy Katsikis
K193150 11/13/2019 Latex Examination Powder Free Glove, Aloe Vera Top Glove SDN BHD Noor Akilah BT Saidin
K193247 11/25/2019 LATITUDE EVÖ Total Elbow Arthroplasty Tornier Inc. Renee Stoffel
K193107 11/08/2019 TriSalus Infusion System TriSalus Life Sciences Patrick McCain
K193222 11/22/2019 Tyber Medical Anatomical Plating System Tyber Medical LLC Mark Schenk
K193312 11/29/2019 UNIKO PointCloudÖ Knee Instruments Unik Orthopedics, Inc. Charlie Chi
K193108 11/08/2019 Bonecam Suture Anchor Valeris Medical Inc. Brendan Thies
K193238 11/25/2019 Nexus DR Digital X-Ray Imaging System (with vSharp) Varex Imaging Corporation Michael Van Ryn
K193240 11/25/2019 Universal Cylinder Applicator Family Varian Medical Systems, Inc. Peter J. Coronado
K193119 11/12/2019 Twin-Pass Dual Access Catheter Vascular Solutions LLC Iroquois Ledbeter
K193260 11/26/2019 U-Cem Premium & MAZIC Cem Vericom Co., Ltd. Yun Ki Kim
K193197 11/20/2019 QuickClear Mechanical Thrombectomy System 6F- Straight, QuickClear Mechanical Thrombectomy System 8F- Straight, QuickClear Mechanical Thrombectomy System 8F- Shaped, QuickClear Mechanical Thrombectomy System 10F- Shaped, QuickClear Aspiration Pump Volcano AtheroMed Inc. Anna Gloria Stephen
K193067 11/04/2019 The INBONEÖ Total Ankle System, the INFINITYÖ Total Ankle System and the INVISIONÖ Total Ankle Revision System Wright Medical Technology, Inc. Antonio Ayala
K193315 11/29/2019 Xenocor Articulating Xenoscope Laparoscope Xenocor, Inc Evan Kelso
K193230 11/25/2019 Ziehm Vision FD Ziehm Imaging GmbH Steve Seeman
K193050 11/01/2019 Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem Zimmer GmbH Roberto Tommasini
K193099 11/07/2019 Anatomical Shoulder System Zimmer GmbH Roberto Tommasini
K193180 11/18/2019 Alliance Augmented Glenoid Zimmer Inc. Patricia Sandborn Beres
K193223 11/22/2019 Persona Personalized Knee System Zimmer, Inc Gregory Foster


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