FDA 510(k) Applications Received During March, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K190581 03/06/2019 Amplatzer Trevisio Intravascular Delivery System Abbott Medical Mary Johnson
K190525 03/04/2019 RELIEVA ULTIRRA Sinus Balloon Catheter Acclarent, Inc. Leena Sorathia
K190532 03/04/2019 TruDi NAV Wire Acclarent, Inc. Leena Sorathia
K190674 03/15/2019 REFRESH RELIEVA For CONTACTS Allergan, Inc Emily Huang
K190594 03/07/2019 AngioVac C20, AngioVac C180 AngioDynamics, Inc. Kasey Newcomb
K190585 03/06/2019 Biocode Gastrointestinal Pathogen Panel (GPP) Applied Biocode, Inc. Robert Di Tullio
K190599 03/08/2019 Aptis Medical Distal Radio Ulnar Joint Implant Aptis Medical, LLC Bryan Babb
K190645 03/13/2019 Arthrex NanoScope System Arthrex Inc. Heli F. Chambi Infantas
K190728 03/21/2019 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K190524 03/04/2019 MRopen 0.5 T ASG Superconductors S.p.A. Luisella De Benedetti
K190587 03/07/2019 Coolrail Linear Pen AtriCure, Inc Jake Lawson
K190499 03/01/2019 Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance Inc. Julie Carlston
K190688 03/18/2019 VersaCross Steerable Sheath, VersaCross Transseptal Dilator Baylis Medical Company Inc. May Tsai
K190567 03/06/2019 KeYi Spinal Fixation System Beijing KeYi Medical Device Technology Co., Ltd. Jenny Jiang
K190792 03/27/2019 BB-613WP BioBeat Technologies Ltd. Johanan May
K190616 03/11/2019 VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 ?g/mL) bioMerieux, Inc. Cherece L. Jones
K190576 03/06/2019 WalterLorenz Surgical Assist Arm Scope Holder Biomet Microfixation Lauren Jasper
K190564 03/05/2019 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB Bionime Corporation Shane Chou
K190548 03/05/2019 BIOMONITOR III, Remote Assistant III Biotronik, Inc. Jon Brumbaugh
K190603 03/08/2019 Tria Firm Ureteral Stent Boston Scientific Corporation Justin Kapitan
K190664 03/15/2019 RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG Rainer Birkenbach
K190815 03/29/2019 BrainScope TBI BrainScope Company, Inc. Michael Singer
K190550 03/05/2019 IKON 40 Manual Wheelchair Broda Seating (Broda LP) Jeremy Ballard
K190784 03/27/2019 BUHLMANN fCAL turbo BUHLMANN Laboratories AG Laura Zurbrugg
K190505 03/01/2019 Low Dose Lung Screening Option Canon Medical Systems Corporation Paul Biggins
K190526 03/04/2019 High V+ Bone Cement, CarboClear« Fenestrated Pedicle Screws CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K190634 03/12/2019 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System Cardiovascular Systems Inc. Kris Miller
K190771 03/26/2019 Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System Cepheid Yi-Ping Lin
K190613 03/11/2019 BD MAX Check-Points CPO Check-Points Health B.V. Pieter Vos
K190802 03/29/2019 Envision ultrasound pad and cover CIVCO Medical Solutions Jim Leong
K190589 03/07/2019 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments Cochlear Americas Laura Blair
K190620 03/11/2019 SpeediCath Flex Coude Pro Coloplast Delaney McDougal
K190597 03/07/2019 BRILLIANT EverGlow Flow Coltene/Whaledent AG Wolfgang Dorner
K190562 03/05/2019 iTotal Identity Cruciate Retaining Knee Replacement System Conformis, Inc. Paul Smolenski
K190516 03/04/2019 MicroLink All-Suture Button Fixation System (Radiolucent) CONMED Corporation Diana L. Nader-Martone
K190582 03/06/2019 MicroLink All-Suture Button Fixation System (Radiopaque) CONMED Corporation Diana L. Nader-Martone
K190639 03/13/2019 Endosee System CooperSurgical, Inc. Christine Kupchick
K190813 03/29/2019 CrossBay Cervical Dilator Catheter System CrossBay Medical Piush Vidyarthi
K190722 03/20/2019 TriMAX Implant System CrossRoads Extemity Systems, LLC Chad Hollis
K190658 03/14/2019 MIS Bunion Plating System CrossRoads Extremity Systems, LLC Chad Hollis
K190678 03/18/2019 TempSure Cynosure, Inc Michael King
K190777 03/26/2019 DemeTECH DemeFORCE Nonabsorbable Surgical Suture DemeTECH Corporation Tracy Chadwrick
K190758 03/25/2019 Opus Bulk Fill APS, Opus Bulk Fill Flow APS DentsCare LTDA Roberta Uyara
K190750 03/25/2019 DePuy Synthes Plates and Screws Portfolio DePuy Synthes Quinn McCarthy
K190569 03/06/2019 Shaders ZR Digital Age Dental Lab Tim McKimson
K190789 03/27/2019 IntelliCartTM System Dornoch Medical Systems Larry Smith
K190629 03/12/2019 DBSWIN and VISTAEASY Imaging Software Durr Dental SE Oliver Lange
K190583 03/06/2019 DynaFlex DynaFlex Matthew Malabey
K190565 03/05/2019 Cervical Plate EiserTech, LLC Lukas Eisermann
K190786 03/27/2019 Eye Prime Ellex Medical Pty Ltd. Andrew Pfeiffer
K190572 03/06/2019 Erchonia FX-635 Erchonia Corporation Steven Shanks
K190791 03/27/2019 Ez3D-i/E3 EwooSoft Co., Ltd. Young Seok Kim
K190713 03/19/2019 F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) Fisher & Paykel Healthcare Ltd. Masar Mohammad
K190628 03/12/2019 FlexSeal Introducer Sheath with Hydrophilic Coating Freudenberg Medical MIS, Inc Larry Bender
K190649 03/13/2019 FUJIFILM Endoscope Model EC-760S-V/L FUJIFILM Corporation Randy Vader
K190702 03/18/2019 Lumipulse G whole PTH Fujirebio Diagnostics, Inc. Stacey Dolan
K190762 03/25/2019 The JASPER Spinal Fixation System II GBS Commonwealth Co., Ltd. Jimmy Kim
K190809 03/29/2019 Sample Imaging for Senographe Pristina GE Healthcare Nicole Landreville
K190754 03/25/2019 Orthoss(R) Geistlich Pharma AG Marco Steiner
K190506 03/01/2019 NeoForm Annuloplasty Ring Genesee BioMedical, Inc Woodrow Mathison
K190598 03/07/2019 CROSSWAY Spinal Access System Globus Medical Inc. Kelly J. Baker
K190653 03/14/2019 ExcelsiusGPS Globus Medical Inc. Kelly J. Baker
K190553 03/05/2019 HardyCHROM CRE Hardy Diagnostics Rianna Malherbe
K190507 03/01/2019 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co. ltd. J.S. Hsu
K190766 03/25/2019 PALACOS fast R+G Heraeus Medical GmbH Ute Greiner
K190617 03/11/2019 Wrap accessory electrodes Hi-Dow International Inc. Eric Chen
K190735 03/21/2019 EQ Balance Highmark Innovations Inc. DBA Highmark Interactive Dave Crane
K190515 03/01/2019 Aptima Combo 2 Assay (Panther System) Hologic, Inc. Jeffrey Hergesheimer
K190694 03/18/2019 Unifi Workspace v1.0.0 Hologic, Inc. Meghan Wakeford
K190804 03/29/2019 HydroCision TenJet Device HydroCision, Inc. Mark J. Lewis
K190545 03/04/2019 VADER« one Pedicle System MIS and LightMore« Pedicle System 6.0 icotec ag Marina Hess
K190684 03/18/2019 LxHA PEEK Lateral IBF System Innovasis, Inc. Marshall McCarty
K190785 03/27/2019 Reprocessed PentaRay Nav eco High-Density Mapping Catheter Innovative Health, LLC. Amanda Babcock
K190654 03/14/2019 Straumann CI RD Ceramic Healing Caps Institut Straumann AG Pierre-Yves Calinon
K190593 03/07/2019 Zio XT ECG Monitoring System, Zio AT ECG Monitoring System iRhythm Technologies, Inc. Gabrielle Logan
K190502 03/01/2019 ENFit Oral / Enteral Syringe Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K190534 03/04/2019 Manual Wheelchair SIVFH2A102 Jiangsu Horizon Medical Science & Technology Co., Ltd. Cheng Gong
K190718 03/20/2019 Zygomatic Implants JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K190584 03/06/2019 CAYMAN LP Plate System K2m, Inc. Casey Hinckley
K190528 03/04/2019 MariGen Wound Extra Kerecis Limited Gudmundur Fertram Sigurjonsson
K190606 03/08/2019 Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile Kossan International Sdn. Bhd. Cho Sow Fong
K190573 03/06/2019 KOWA DR-1a Kowa Company, Ltd. Nariaki Morita
K190708 03/19/2019 AccelFix Lumbar Interbody Fusion Cage System L&K Biomed Co., Ltd. Jihyeon Seo
K190782 03/27/2019 FlexGard Cut-Resistant Glove Liners LDI Corporation Lou LaMarca
K190631 03/12/2019 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA Stefano Baj
K190601 03/08/2019 MasteRad MX30 MedicaTech USA George Makar
K190536 03/04/2019 Mediracer NCS Mediracer Oy Lassi Laitinen
K190764 03/25/2019 SurgicalAR MEDIVIS, Inc. Amy Lynn
K190643 03/13/2019 Medline Electrocautery Pencil Medline Industries, Inc. Matt Clausen
K190774 03/26/2019 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant Medos International SARL LeeAnn Walosin
K190623 03/11/2019 Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device Medtronic Rahul Shah
K190716 03/19/2019 Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead Medtronic Joven Almazan
K190672 03/15/2019 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 Medtronic Navigation Inc Elizabeth Waite
K190574 03/06/2019 Patient Assistant Model PA97000 Medtronic, Inc Cheryl Swanson
K190557 03/05/2019 Bio-Medicus Insertion Kit Medtronic, Inc. Huda Yusuf
K190753 03/25/2019 EverCrossTM 0.035 OTW PTA Dilatation Catheter Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) Breanna Fautsch
K190619 03/11/2019 Aspiron(TM) Aspiration Catheter Meril Life Sciences Private Limited Utpal Thakor
K190724 03/20/2019 MD-Temp Plus Meta Biomed Co., Ltd Suk Song Oh
K190503 03/01/2019 CeraSeal Meta Biomed Co., Ltd. Suk Song Oh
K190510 03/01/2019 GuttaSil Meta Biomed Co., Ltd. Suk Song Oh
K190666 03/15/2019 CYGNUSÖ Anterior Cervical Plate System MiRus, LLC Jordan Bauman
K190618 03/11/2019 RIGEL PEEK Anterior Cervical Interbody Fusion System MiRus, LLC Jordan Bauman
K190568 03/06/2019 ComPAS2 (Computerized Pulmonary Analysis System) Morgan Scientific, Inc. Deborah Cornish
K190546 03/05/2019 NEXXT MATRIXX Stand Alone Cervical System Nexxt Spine LLC Andy Elsbury
K190560 03/05/2019 SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface Nonin Medical, Inc. Nancy DeAngelo
K190729 03/21/2019 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies ULC. (now a part of Stryker) Agatha Szeliga
K190636 03/12/2019 NuVasive« Reline« 4.5-5.0 System NuVasive, Incorporated Ivanna Lopez
K190772 03/26/2019 SURGICAL MICROSCOPE SYSTEM ORBEYE with IR OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K190744 03/22/2019 ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K190693 03/18/2019 HEM-6410T-ZL Wrist Blood Pressure Monitor Omron Healthcare, Inc. Renee Thornborough
K190732 03/21/2019 P200TxE Optos Plc Rachel Reay
K190520 03/04/2019 VITROS XT Chemistry Products GLU-Ca Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K190807 03/29/2019 VITROS XT Chemistry Products TBIL-ALKP Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K190751 03/25/2019 Connector System Orthofix Inc. Jacki Koch
K190595 03/07/2019 Signature ONE System Orthosoft Inc. (d/b/a Zimmer CAS) Paul Hardy
K190523 03/04/2019 Cranial PSI Accessory û Anatomical Model Original, Cranial PSI Accessory û Anatomical Model Modified, Cranial PSI Accessory û Plastic Drawing Guide, Cranial PSI Accessory û Cranial Implant Trial OssDsign AB Ulrik Birgersson
K190540 03/04/2019 Ponto 4 Oticon Medical AB Lise Terkelsen
K190663 03/15/2019 Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 Pajunk GmbH Medizintechnologie Christian G. H. Quass
K190586 03/06/2019 Monster« Screw System Paragon 28, Inc. Eric Lintula
K190667 03/15/2019 Sonopet iQ Sterilization Tray Paragon Medical Rebecca Walker
K190719 03/20/2019 Artemis Eye System Penumbra, Inc. Aditi Kolla
K190691 03/18/2019 Pixx2430 Digital Diagnostic X-Ray Receptor Panel Pixxgen Corporation John Ross
K190749 03/25/2019 087 Balloon Guide Catheter System Q'Apel Ken Peartree
K190668 03/15/2019 Encompass 15 Channel Head Coil, 3T Qfix Alexandra Low Smythe
K190646 03/13/2019 QT Scanner 2000 Model A QT Ultrasound, LLC Rajni Natesan
K190812 03/29/2019 RAYSCAN a-Expert3D RAY Co., Ltd Changhwan Lee
K190504 03/01/2019 Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator Relievant Medsystems Alex DiNello
K190801 03/29/2019 PressOn Electrode Headset Rhythmlink International, LLC Gabriel Orsinger
K190773 03/26/2019 Elecsys TSH Roche Diagnostics Edie Eads
K190699 03/18/2019 Rowheels Revolution 1.0 Rowheels Inc. Matthew Doeppers
K190591 03/07/2019 Safergel Sterile Ultrasound Gel Safersonic US, Inc. David L. Seitelman
K190655 03/14/2019 SeaSpine« ShorelineÖ ACS- Anterior Cervical Standalone System SeaSpine Orthopedics Corporation Alicia McArthur
K190630 03/12/2019 SolidAIRity III Airway Stabilization System Securisyn Medical, LLC Arthur Kanowitz
K190795 03/28/2019 Tetragraph Neuromuscular Transmission Monitor Senzime AB Johanna Faris
K190700 03/18/2019 ELECTRODES PAD Shenzhen Bestpad Technology Development Co., Ltd Junwei Xu
K190675 03/15/2019 Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K190757 03/25/2019 MAGNETOM Avanto Fit Siemens Medical Solution USA, Inc. Cordell L. Fields
K190780 03/27/2019 syngo Application Software Siemens Medical Solution USA, Inc. Patricia D. Jones
K190578 03/06/2019 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence Siemens Medical Solutions USA Inc. Kimberly Mangum
K190768 03/26/2019 ARTIS icono Siemens Medical Solutions USA, Inc. Patricia D. Jones
K190704 03/18/2019 Signature Ceramic Femoral Head Signature Orthopaedics Pty Ltd. Declan Brazil
K190680 03/18/2019 FAVO S-TLIF Silony Medical GmbH Melanie Lubjuhn
K190533 03/04/2019 Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented Sleepnet Corporation Jennifer Kennedy
K190563 03/05/2019 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage Solco Biomedical Co., Ltd. Il Kim
K190542 03/04/2019 Soliton Acoustic Wave Device Soliton Inc. Leslie Honda
K190555 03/05/2019 PowerX Lipo System Solta Medical Manal Morcos
K190551 03/05/2019 VASERlipo System Solta Medical Manal Morcos
K190690 03/18/2019 INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir SORIN GROUP ITALIA S.R.L. Luigi Vecchi
K190650 03/13/2019 Revolution Centrifugal Blood Pump SORIN GROUP ITALIA S.R.L. Luigi Vecchi
K190788 03/27/2019 Disposable Standard Clamp Standard Bariatrics Alison Sathe
K190687 03/18/2019 Twilite Appliance Stephen J Harkins, DDS, PC Stephen Harkins
K190610 03/11/2019 Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology Sterilmed, Inc. Jan Flegeau
K190662 03/15/2019 MRI Compatibility for Existing Straumann Dental Implant Systems Straumann USA LLC Loretta Kushner-Mooney
K190696 03/18/2019 Stryker Surgeon iD Mandible Recon Plate Stryker Zainab Amini
K190779 03/27/2019 Trevo XP ProVue Retriever Stryker Rhoda M. Santos
K190621 03/11/2019 SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long Sumitomo Bakelite Co., Ltd Shiro Agehama
K190592 03/07/2019 YelloPort Elite Port Access System Surgical Innovations Limited Shazia Chaudhry
K190644 03/13/2019 Guide Sheath Surmodics, Inc. Peggy Ju
K190769 03/26/2019 Bladder Scanner (Models: M2, M2-W, M1, M1-W) Suzhou Lischka Medtech Co., Ltd. Shi Jing
K190579 03/06/2019 TD-4183 Blood Glucose Monitoring System TaiDoc Technology Corporation Sophia Wu
K190686 03/18/2019 Optilite IgM CSF Kit The Binding Site Group Ltd. Kanika Darbar
K190521 03/04/2019 Aequalis Ascend Flex Shoulder System Tornier SAS Lamia Askri
K190575 03/06/2019 iBreastExam UE LifeSciences Inc. Mihir Shah
K190627 03/12/2019 VALO Grand Corded Ultradent Products, Inc. Karen Kakunes
K190810 03/29/2019 OPERA, OPERA eco Unimom Co. Sang-Hyun Hong
K190683 03/18/2019 External Counterpulsation System Vamed Medical Instrument Co., Ltd Ji Mia
K190604 03/08/2019 PIVO Velano Vascular Tiffini Wittwer
K190743 03/22/2019 Venus Bliss Venus Concept USA Inc. Yoni Iger
K190689 03/18/2019 SignalMark Breast Marker View Point Medical, Inc. Thomas Kane
K190611 03/11/2019 VIVIX-S 1751S Vieworks Co., Ltd. Jordin Kim
K190543 03/04/2019 Cannulated Hemi Implant Vilex in Tennessee, Inc. Sylvia Southard
K190626 03/11/2019 SyncVision System Volcano Corporation Rand Daoud
K190538 03/04/2019 NIO-I WaisMed Ltd Maya Shuvi
K190535 03/04/2019 BiMobile Dual Mobility System - E-Dur Inserts Waldemar Link GmbH & Co. KG Stefanie Fuchs
K190705 03/19/2019 WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream Wholepower Biotech Co., Ltd. William Gao
K190670 03/15/2019 ORTHOLOCÖ 2 Lapidus with Rotation System Wright Medical Technology, Inc. Alayne Melancon
K190685 03/18/2019 Hair Growth System Xuzhou Kernel Medical Equipment Co., Ltd. Wang Jing
K190648 03/13/2019 Pusen Eview Medical Video Endoscope Image Processor Zhuhai Pusen Medical Technology Co., Ltd. Wang ChangShen
K190814 03/29/2019 AccuFill Bone Substitute Material Zimmer Knee Creations David l. Nichols


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