FDA 510(k) Applications Received During May, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K191355 05/21/2019 3MÖ High Fluid-Resistant Surgical Mask and 3MÖ High Fluid-Resistant Procedure Mask 3M Health Care Angie Draper
K191345 05/20/2019 Pegasus System A.M. Surgical, Inc. Vincent Pascale
K191173 05/01/2019 Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires Abbott Vascular Namratha Manthani
K191175 05/01/2019 ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System ACIST Medical Systems, Inc. Angela Johnson
K191392 05/24/2019 AcQMap High Resolution Imaging and Mapping System Acutus Medical, Inc. Karla Schaffner
K191431 05/29/2019 Interlude Rolled Tampons in Plastic Applicator ALBAAD fem Shlomo Helvits
K191185 05/03/2019 Solanas« Posterior OCT Fixation System Alphatec Spine Ruby Zheng
K191311 05/15/2019 ATEC Lateral Interbody System Alphatec Spine, Inc. Cynthia Adams
K191439 05/30/2019 OverStitch 2-0 Polypropylene Suture Apollo Endosurgery Maritza Ward
K191294 05/14/2019 Transvaginal Access Platform Applied Medical Resources Corp. Corinne Yestrepsky
K191326 05/16/2019 Arthrex Mini Comprehensive Fixation System û 1.4mm & 1.6mm Module Arthrex Inc. Rebecca R. Homan
K191344 05/20/2019 Arthrex Mini Comprehensive Fixation System û 2.0mm & 2.4mm Module Arthrex Inc. Rebecca R. Homan R. Homan
K191226 05/07/2019 Arthrex SwiveLock Suture Anchor Arthrex Inc. David L. Rogers
K191167 05/01/2019 Fungitell STAT Associates of Cape Cod, Inc Alison Skinner
K191413 05/28/2019 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip AtriCure, Inc Jim Taufen
K191340 05/20/2019 CORTRAK* 2 Equilateral Enteral Access System Avanos Medical, Inc. Monica King
K191252 05/09/2019 Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance Inc. Julie Carlston
K191417 05/28/2019 Belun Ring Belun Technology Company Limited Leung Lap Wai Lydia
K191352 05/20/2019 binx health io CT/NG Assay binx health, Inc. Sarah Kalil
K191223 05/07/2019 NAVIO Blue Belt Technologies, Inc. Amy Winegarden
K191150 05/01/2019 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. Guy Sevigny
K191274 05/13/2019 BonAlive Granules BonAlive Biomaterials Ltd. Jimmy Lucchesi
K191285 05/13/2019 Spine & Trauma Navigation Brainlab AG Julia Mehltretter
K191331 05/16/2019 Life Sensor Cardiac Monitor BraveHeart Wireless, Inc. Balaji Sudabattula
K191232 05/08/2019 AccuCath Ace Intravascular Catheter C.R. Bard, Inc Mona Shahrebani
K191194 05/03/2019 CLARUS Carl Zeiss Meditec, Inc Saurabh Jamkhindikar
K191301 05/14/2019 Ceribell Pocket EEG Device Ceribell, Inc. Josef Parvizi
K191174 05/01/2019 Mercy babyTAPE Children's Mercy Hospital Susan Abdel-Rahman
K191367 05/22/2019 Harrier-SA Lumbar Interbody System ChoiceSpine LLC Kim Finch
K191324 05/16/2019 CivaDerm CivaTech Oncology Inc. Suzanne Babcock
K191263 05/10/2019 Idys ALIF TiVac Clariance SAS Fadwa Bahr
K191204 05/06/2019 Infinity Fixation System ConMed Corporation Orjada Dervishleri
K191291 05/14/2019 Wallace Dual Lumen Oocyte Recovery System CooperSurgical, Inc. Christine Kupchick
K191374 05/23/2019 Revival Modular Hip Stem Corin USA Limited Rachel King
K191335 05/17/2019 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags Corinth MedTech, Inc. Sandeep Saboo
K191341 05/20/2019 Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags Corinth MedTech, Inc. Sandeep Saboo
K191394 05/24/2019 ILLUMISITE Platform Covidien llc Kristi Fox
K191342 05/20/2019 CrossRoads Screw System CrossRoads Extemity Systems, LLC Chad Hollis
K191272 05/13/2019 Wearable Device, Wearable Package Current Health Ltd. Edwin Lindsay
K191287 05/13/2019 OptiFix AT Absorbable Fixation System with Articulating Technology û 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology û 15 Fasteners Davol Inc., Subsidiary of C.R. Bard Angelica Hutchison
K191427 05/29/2019 Halley resin system Dentsply Sirona Karl Nittinger
K191450 05/31/2019 Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc. Emily Chung
K191166 05/01/2019 DigniCap Delta Dignitana Inc. William Cronin
K191209 05/06/2019 Aneroid Type Blood Pressure Kit Dongguan Mars Medical Products Co., Ltd Lily Liao
K191187 05/03/2019 Dornier MINNOW Ureteral Catheter Dornier MedTech America Inc John Hoffer
K191370 05/22/2019 DreaMed Advisor Pro DreaMed Diabetes Ltd Eran Atlas
K191319 05/15/2019 Dunamis Fixation Button System Dunamis LLC Prithviraj Chavan
K191325 05/16/2019 EMPOWR Partial Knee Encore Medical, L.P. Teffany Hutto
K191387 05/24/2019 ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube Envizion Medical Ltd. Doron Besser
K191438 05/30/2019 ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector Erbe USA, Inc. John Tartal
K191257 05/10/2019 Erchonia EVRL Erchonia Corporation Steven Shanks
K191262 05/10/2019 aBSI EXINI Diagnostics AB Aseem Anand
K191388 05/24/2019 FloPatch (FP110) Flosonics Medical (r/a 1929803 Ontario Corp.) Joe Eibl
K191190 05/03/2019 Steerable Introducer Freudenberg Medical LLC Mary Prunty
K191243 05/09/2019 HEDRON Cervical Spacers Globus Medical Inc. Kelly Baker
K191391 05/24/2019 HEDRON Lumbar Spacers Globus Medical Inc. Kelly Baker
K191216 05/06/2019 Voxel DosimetryÖ v1.0 Hermes Medical Solutions AB Joakim Arwidson
K191321 05/15/2019 Primelase Excellence High Technology Products SLU Sergi Lozano
K191233 05/08/2019 ARIETTA 750 Hitachi Healthcare Americas Aaron Pierce
K191281 05/13/2019 Omni Hysteroscope, Omni Lok cervical seal Hologic, Inc. Rachelle D. Fitzgerald
K191245 05/09/2019 Yumizen C1200 ALP, Yumizen C1200 Albumin HORIBA ABX SAS Caroline Ferrer
K191396 05/24/2019 Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe Horiba ABX SAS Caroline Ferrer
K191310 05/15/2019 Insight Essentials DRF Digital Imaging System Imaging Engineering, LLC George Jachode
K191217 05/06/2019 JAZZ PF Implanet, S.A. Fabienne Larquey Cadiere
K191458 05/31/2019 Legacy SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K191368 05/22/2019 FlowTriever Retrieval/Aspiration System Inari Medical Eben Gordon
K191372 05/22/2019 Lyra Interacoustics A/S Erik Nielsen
K191159 05/01/2019 Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra Invacare Corporation Elijah Wreh
K191448 05/31/2019 Barrier Sleeves Ivoclar Vivadent, AG Sandra Cakebread
K191382 05/23/2019 IPS e.max CAD Abutment Solutions- extra systems Ivoclar Vivadent, AG Sandra Cakebread
K191151 05/01/2019 JKH Stimulator Plus JKH USA, LLC Bill Quanqin Dai
K191357 05/21/2019 Flexible HD Cysto-Urethroscope System KARL STORZ Endoscopy-America, Inc. Irina Fedorov
K191188 05/03/2019 ASHK100G LG Electronics Jinhwan Jun
K191457 05/31/2019 BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) MED-EL Elektromedizinische Geraete GmbH Ines Roman Santiago
K191300 05/14/2019 MectaLock Ti Suture Anchor Medacta International SA Stefano Baj
K191378 05/23/2019 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe Medline Industries, Inc. Stephanie Augsburg
K191212 05/06/2019 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, Medos International SARL Sergio M. Cordeiro
K191242 05/09/2019 HEALIX ADVANCE SP BIOCOMPOSITE Anchor Medos International SARL Elizabeth Messana
K191267 05/10/2019 ImagingRing System on Rails MedPhoton GmbH Daniel Schaffarzick
K191444 05/31/2019 Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir Medtronic, Inc. Harsh Dharamshi
K191328 05/16/2019 Megadyne Foot Switch Megadyne Medical Products, Inc. Sharon Sussex
K191307 05/14/2019 Palm Bladder Scanner - PBSV5.1 Mianyang Meike Electronic Equipment Co., Ltd. Wenjun Zhao
K191172 05/01/2019 Cepheid Xpert MRSA NxG Control Panel Microbiologics, Inc. Tina Sobania
K191168 05/01/2019 Cepheid Xpert SA Nasal Complete Control Panel Microbiologics, Inc. Tina Sobania
K191451 05/31/2019 CMDR 2CW (Multiple models) MinXray, Inc Keith Kretchmer
K191376 05/23/2019 Modular Power Standing System Motion Concepts Dona Bhamra
K191220 05/07/2019 Pure Vu System Motus GI Medical Technologies Ltd. Ravit Peled
K191400 05/24/2019 Voyager Trajectory Array Guide (V-TAG) MRI Interventions, Inc. Pete Piferi
K191435 05/30/2019 IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 Nalu Medical, Inc. Michele Chin-Purcell
K191363 05/22/2019 Neocis Planning Software Application (NPSA) for 3rd Party PCs Neocis Inc. Thomas ("Ted") E. Claiborne
K191424 05/29/2019 Interphalangeal Joint Fusion Device Range Neosteo Anne-Cecile Grandremy
K191415 05/28/2019 Pathfinder Endoscope Overtube Neptune Medical, Inc. Alex Tilson
K191181 05/02/2019 NXPRO Neuromuscular Electrical Stimulation Device NeuX Technologies, Inc. Scot Minniear
K191408 05/28/2019 Nexxt Matrixx System Nexxt Spine LLC Andy Elsbury
K191359 05/21/2019 Nipro Syringe Nipro Medical Corporation Jessica Oswald-McLeod
K191365 05/22/2019 Stat Profile Prime ES Comp Plus Analyzer System Nova Biomedical Corporation Cesidio Tempesta
K191336 05/17/2019 PRECICE System NuVasive Specialized Orthopedics, Inc. Aditya Sharma
K191169 05/01/2019 NuVasive« Camber Laminoplasty System NuVasive, Incorporated Thao Huynh
K191183 05/02/2019 EyeBOX Oculogica, Inc. Rosina Samadani
DEN190025 05/13/2019 OraQuick Ebola Rapid Antigen Test OraSure Technologies, Inc. Tiffany Miller
K191158 05/01/2019 The AIO Solution Orfit Industries NV Eddy Marivoet
K191317 05/15/2019 StitchKit Origami Surgical John Gillespie
K191316 05/15/2019 VITROS XT Chemistry Products ALB-TP Slides Ortho-Clinical Diagnostics, Inc. Darlene Phillips
K191241 05/08/2019 AutoStrut OrthoSpin Oren Cohen
K191179 05/02/2019 Myo Plus Otto Bock Healthcare Products GmbH Rene Urtz
K191222 05/07/2019 Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV Prismatik Dentalcraft, Inc. Herbert Schoenhoefer
K191200 05/06/2019 TULSA-PRO System PROFOUND MEDICAL INC. Goldy Singh
K191295 05/14/2019 Percutaneous Introducer Needle Progressive Medical, Inc. Roland D. Sullivan
K191384 05/23/2019 RayCare 2.3 RaySearch Laboratories AB (publ) David Hedfors
K191315 05/15/2019 Remington Medical, Inc. Automatic Cutting Needle (NAC) Remington Medical, Inc. Caitlin Senter
K191419 05/28/2019 Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire Rex Medical, L.P. Colin Valentis
K191225 05/07/2019 EEG Electrode Template Rhythmlink International, LLC Gabriel Orsinger
K191162 05/01/2019 EpiLaze Multi-wavelength Laser Rohrer Aesthetics, LLC Mark Rohrer
K191436 05/30/2019 Saalio Saalmann medical GmbH & Co. KG Rolf Eilers
K191349 05/20/2019 980nm Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K191157 05/01/2019 uMR 780, uMR 790 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K191180 05/02/2019 Electronic Blood Pressure Monitor Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K191251 05/09/2019 Infared Thermometer Shenzhen Calibeur Industries Co., Ltd. Weibin He
K191253 05/09/2019 Reusable NIBP Cuff Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K191420 05/28/2019 Reusable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K191430 05/29/2019 Pulse Oximeter Shenzhen Yimi Life-Technology Co.,Ltd. Shande Peng
K191454 05/31/2019 Atellica CH Amylase_2 (AMY_2) Siemens Healthcare Diagnostics Inc. Catherine Daigle
K191418 05/28/2019 Multix Fusion Max Siemens Medical Solutions USA, Inc. Martin Rajchel
K191309 05/14/2019 syngo.via MI Workflows VB40A, Scenium Siemens Medical Soultions USA, Inc. Veronica Padharia
K191299 05/14/2019 Silhouette Featherlift / Silhouette Lift Silhouette Lift Inc. Anthony DiBernardo
K191231 05/08/2019 Andorate Auxiliary Water Connector, Andorate Valves Set Smartdata Suzhou Co., Ltd Cindy Ye
K191366 05/22/2019 Vacutore Air/Water Bottle Tubing Smartdata Suzhou Co., Ltd Cindy Ye
K191211 05/06/2019 JOURNEY II Unicompartmental Knee System Smith & Nephew, Inc. Meenakshi Gupta
K191177 05/02/2019 LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head Smith and Nephew, Inc. Kathleen Solomon
K191421 05/28/2019 Sofacia System Sofwave Medical Ltd. Ruthie Amir
K191343 05/20/2019 SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 STERIS Corporation Jennifer Nalepka
K191259 05/10/2019 Stryker CrossFlow Integrated Arthroscopy Pump Stryker Corp. Justin Florence
K191412 05/28/2019 VariAx 2 System, VariAx 2 Mini Fragment System Stryker GmbH Sanja Jahr
K191414 05/28/2019 EXETER Centralizer, EXETER 2.5mm Plug Stryker Orthopaedics Denise Daugert
K191271 05/13/2019 T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma Gmbh Heike Gustke
K191192 05/03/2019 SurgTech GENOLL Total Knee System SurgTech, Inc. Xuegong Yu
K191283 05/13/2019 Infrared Thermometer, Breeze model Suzhou Melodicare Medical Technology Co.,Ltd. Xiaoqian Zou
K191207 05/06/2019 Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System Taiwan Aulisa Medical Devices Technologies, Inc. Paul Liu
K191456 05/31/2019 Campylobacter Quik Chek Techlab, Inc Donna Link
K191442 05/30/2019 Campylobacter Chek Techlab, Inc. Donna Link
K191268 05/13/2019 Force Fiber Suture Teleflex Medical Incorporated Andrea Curria
K191297 05/14/2019 iNSitu Bipolar Hip System Theken Companies, LLC Garrett Spurgeon
K191369 05/22/2019 TSolution One Total Knee Application THINK Surgical, Inc. Meliha Mulalic
K191318 05/15/2019 AEQUALIS FLEX REVIVE Shoulder System Tornier, Inc. Katie Molland
K191399 05/24/2019 BIOLOX CONTOURA Ceramic Femoral Head Total Joint Othopedics, Inc. Chris Weaber
K191214 05/06/2019 JO Premium Jelly Original Personal Lubricant United Consortium Stephanie Morris
K191208 05/06/2019 Spectra Cashmere Uzinmedicare Co. Nathan Ahn
K191289 05/13/2019 Bone Screw Line Addition Vilex in Tennessee, Inc Victor Lavi
K191397 05/24/2019 OxySoft (olifilcon C) silicone hydrogel soft contact lens Visco Vision Inc. Evan Huang
K191273 05/13/2019 Multi-Link X2 ECG and SpO2 Adapter Vyaire Medical, Inc. Suzanne Moreno
K191154 05/01/2019 Hair Boom 69 Wontech Gyuri (Erin) Park
K191393 05/24/2019 INFINITY Total Ankle System, INBONE Total Ankle System Wright Medical Technology, Inc. Rachel Roberts
K191332 05/16/2019 XACT Robotic System XACT Robotics Ltd. Chen Levin
K191423 05/29/2019 Normandy VBR System Zavation Medical Products LLC Frankie Cummins
K191354 05/21/2019 Ti3Z Cervical Interbody System Zavation Medical Products, LLC Katie Motley
K191339 05/20/2019 Zavation eZspand Interbody System Zavation Medical Products, LLC Matt Jones
K191398 05/24/2019 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System ZEUS Scientific Inc. Mark J. Kopnitsky
K191240 05/08/2019 ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System ZEUS Scientific Inc. Mark J. Kopnitsky
K191238 05/08/2019 Zimmer Guide Wire Devices Zimmer, Inc Annette Minthorn


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