FDA 510(k) Applications Received During January, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K200078 01/14/2020 VARO Plan 3D Industrial Imaging Co., Ltd. Myungsuk Park
K200214 01/28/2020 3D Predict 3D Smile USA, Inc Marina Domracheva
K200092 01/16/2020 3MTM AttestTM Mini Auto-reader 490M 3M Andrew Wingen
K200002 01/02/2020 Anterior Spine Truss System û Stand Alone (ASTS-SA) Interbody Fusion Device 4Web, Inc. Jessee Hunt
K200144 01/22/2020 HI-TORQUE Steelcore Bare Guide Wire Abbott Vascular Shilpa Satishchandra
K200009 01/02/2020 Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation Megan Duncan
K200050 01/10/2020 Akesis Galaxy RTx Akesis Inc Christopher Brown
K200035 01/08/2020 Ultravision Visual Field Clearing System Alesi Surgical Ltd. David Broderick
K200218 01/28/2020 Digiscan FDX Allengers Medical Systems Limited Sanjeev K. Marjara
K200248 01/31/2020 Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators Allwin Medical Devices, Inc. Digish Mehta
K200056 01/13/2020 Catalys Precision Laser System AMO Manufacturng USA, LLC Laarni Ricafort
K200093 01/16/2020 Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug Anhui lntco Medical Products Co., Ltd. Jacken Cai
K200197 01/27/2020 ARK Fentanyl II Assay ARK Diagnostics, Inc. Thomas Houts
K200068 01/13/2020 Arthrex DynaNite K-Wire Arthrex Inc. Rebecca R Homan
K200057 01/13/2020 bioli lOL Delivery System AST Products, Inc. William Lee
K200154 01/22/2020 B&J DVT Compression Devices MHH800/MHH800SQ B & J Manufacturing Ltd. Billy Yu
K200030 01/07/2020 Optima Coil System Balt USA, LLC Michael Peters
K200042 01/08/2020 CO2 Laser System Beijing Superlaser Technology Co., Ltd. Shi Shuang
K200198 01/27/2020 WIRION Cardiovascular Systems, Inc Erika Huffman
K200208 01/28/2020 Agape Warming Personal Lubricant CC Wellness LLC Marlent Perez
K200228 01/30/2020 ClearCam System ClearCam, LLC Chris Idelson
K200142 01/22/2020 SpeediCath Soft Coloplast Delaney McDougal
K200181 01/24/2020 Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Comfort Rubber Gloves Industries Sdn. Bhd. Ng Kok Howe
K200028 01/06/2020 Coronet Soft Tissue Fixation System CoNextions Medical Matthew Swift
K200238 01/31/2020 ControlRad Sterile Cover ControlRad, Inc Chris Fair
K200038 01/08/2020 Endosee System CooperSurgical, Inc. Christine Kupchick
K200087 01/15/2020 F3D Cervical Stand-Alone Interbody Fusion System CoreLink, LLC Steven Mounts
K200146 01/22/2020 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor Covidien, llc Shani Frenkel
K200184 01/24/2020 SmoothSkin Pure CyDen Limited Adam Stephens
K200241 01/31/2020 TempSure System Cynosure LLC Kevin O'Connell
K200053 01/10/2020 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) DANNIK Olga Haberlad
K200039 01/08/2020 P pro Crown & Bridge DeltaMed GmbH Michael Zimmerman
K200099 01/16/2020 s-Clean SQ-SL Implant System Mini Dentis Co., Ltd. Gyu Ri Kim
K200102 01/17/2020 MIS Dental Implant System Dentsply Sirona Karl Nittinger
K200191 01/27/2020 Sirona Dental CAD/CAM System with InLab Software Dentsply Sirona Karl J. Nittinger
K200101 01/17/2020 WOLF Thrombectomy V System DeVoro Medical, Inc. Michael P. Wallace
K200232 01/30/2020 LVivo Software Application DiA Imaging Analysis Ltd Michal Yaacobi
K200174 01/23/2020 DIA-ROOT BIO MTA Diadent Group International Kab Sun Lee
K200175 01/23/2020 DIA-ROOT BIO Sealer Diadent Group International Kab Sun Lee
K200188 01/24/2020 DSI Dental Implant System DSI Dental Solutions Ltd Shlomi Krasner
K200083 01/15/2020 EMBA Hourglass Peripheral Embolization Device (PED) Embolic Acceleration, LLC Veronica McDougall
K200107 01/17/2020 epoc Blood Analysis System Epocal Inc. Amanda Barriage
K200044 01/08/2020 SkinStylus SteriLock MicroSystem Esthetic Education LLC Marc C. Sanchez
K200178 01/24/2020 Ez3D-i /E3 Ewoosoft Co., Ltd. Young Seok Kim
K200169 01/23/2020 VFS1 Bipolar Electrosurgical Generator FHC, Inc. Kelly Moeykens
K200041 01/08/2020 FlexPointer 1.5 Single Use, FlexTube 3 Single Use Fiagon GmbH Dirk Mucha
K200043 01/08/2020 Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range Field Orthopaedics Pty Ltd Kieran Leacy
K200061 01/13/2020 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) Galil Medical Inc. Amy Mckinney
K200158 01/22/2020 LOGIQ E10 GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC Tracey Ortiz
K200138 01/21/2020 Versana Premier GE Medical Systems Ultrasound and Tracey Ortiz
K200119 01/21/2020 LOGIQ E10s GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K200047 01/09/2020 ExcelsiusGPS Cranial 1.0 Module Globus Medical Inc. Jennifer Antonacci
K200025 01/06/2020 Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K200023 01/06/2020 Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit Gold Standard Diagnostics Napoleon Monce
K200108 01/17/2020 GEO 1st MTP Joint Arthrodesis Plating System Gramercy Extremity Orthopedics, LLC Michael P. Simpson
K200018 01/03/2020 HAD1717MC H&abyz Nam Kyu Hur
K200173 01/23/2020 Stone Retrieval Balloon Hangzhou AGS MedTech Co., Ltd. Chunqi Han
K200134 01/21/2020 Jimushi Sterile Urethral Catheter for single use Hangzhou Jimushi Meditech Co., Ltd. Fenlong Wu
K200019 01/03/2020 Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) Hartalega NGC Sdn. Bhd. Kuan Mun Leong
K200235 01/30/2020 KONG-TL VBR System, KONG-C VBR System icotec ag Marina Hess
K200224 01/29/2020 SEA-LINK Anterior Cervical Plate System Indius Medical Technologies Pvt. Ltd. Aditya Ingalhalikar
K200203 01/28/2020 Infrascanner InfraScan, Inc. Baruch Ben Dor
K200212 01/28/2020 Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled Innovative Health, LLC. Rick Ferreira
K200060 01/13/2020 Reprocessed NRG Transseptal Needle Innovative Health, LLC. Rick Ferreira
K200033 01/07/2020 HemosIL von Willebrand Factor Antigen Instrumentation Laboratory Co. Nikita Malladi
K200027 01/06/2020 Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter Jiangsu Caina Medical Co., Ltd. Jianwei Pan
K200243 01/31/2020 ACUVUE (senofilcon A) Soft Contact Lens Multifocal Johnson & Johnson Vision Care, Inc. Scott Durland
K200161 01/22/2020 3MP Monochrome Digital Mammography LCD Monitor MS-S300 Jvckenwood Corporation Hideki Tengeiji
K200072 01/14/2020 KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid Kimberly-Clark Corporation Juan Marquez
K200141 01/21/2020 Oxi-W System LD Technology LLC Albert MAAREK
K200070 01/13/2020 ARx Spinal System Life Spine Inc. Angela Batker
K200148 01/22/2020 LightForce Orthodontic System (LFO System) LightForce Orthodontics Amos N Benninga
K200180 01/24/2020 MTS Omadacycline 0.002 - 32 ug/mL Liofilchem s. r. l. Fabio Brocco
K200022 01/06/2020 FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System LiverMoreTech Inc. Jae Hong Kim
K200010 01/02/2020 FilmArray BCID2 Control Panel M416 Maine Molecular Quality Controls, Inc. Joan Gordon
K200075 01/14/2020 3DMetal Diaphyseal Femoral Cones Medacta International SA Stefano Baj
K200130 01/21/2020 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA Stefano Baj
K200048 01/09/2020 MectaLIF Anterior Simple Medacta International SA Stefano Baj
K200122 01/21/2020 MOTO PFJ System Medacta International SA Stefano Baj
K200132 01/21/2020 Ashvins MedicalCommunications GmbH Martin Schinkmann
K200225 01/30/2020 Arctic Sun Stat Temperature Management System Medivance, Inc. Jacquelyn Borinski
K200245 01/31/2020 EXPEDIUM« Spine System; EXPEDIUM VERSE« Spine System Medos International S?rl Rhoda Maddonni
K200074 01/14/2020 O-arm O2 Imaging System Medtronic Inc. Dean Honkonen
K200007 01/02/2020 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar MicroPort Orthopedics Inc. Allen Mamaril
K200082 01/15/2020 BD Univia RightFit Enteral Extension Sets and Transitional Adapters MPS Medical, Inc. Barry Kazemi
K200079 01/14/2020 ClearPoint System and Accessories MRI Interventions, Inc Pete Piferi
K200124 01/21/2020 InCore MPJ System Nextremity Solutions, Inc. Elise Fox
K200040 01/08/2020 Universal Base Conical Connection (CC) Nobel Biocare AG Bernice Jim
K200195 01/27/2020 NES Reprocessed Visions PV .014P RX Digital IVUS Catheter Northeast Scientific, Inc. Matthew Farley
K200204 01/28/2020 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Rachel Gilbert
K200236 01/30/2020 VITROS BRAHMS PCT Reagent Pack and Calibrators Ortho Clinical Diagnostics Ann M Quinn
K200052 01/10/2020 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System Orthofix Inc. Natalia Volosen
K200246 01/31/2020 JPS JuniOrtho Plating System Orthofix Srl Gianluca Ricadona
K200097 01/16/2020 Response BandLoc Spinal Fixation OrthoPediatrics Corp. Jackie Jaskula
K200090 01/16/2020 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) PENTAX of America, Inc. William Goeller
K200179 01/24/2020 Collaboration Live Philips Healthcare Paul Elias
K200095 01/16/2020 Streamline Navigated Instruments Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Kurtis Hunsberger
K200131 01/21/2020 BruxZir Steel Prismatik Dentalcraft, Inc. So Hyun Park
K200168 01/23/2020 Dermapose Access Puregraft LLC Olivia Kim
K200234 01/30/2020 Surgical laser fibers Quanta System Spa Francesco DellÆAntonio
K200104 01/17/2020 Oxylight RAJA Trading Company, Inc. Robert J Adipietro
K200094 01/16/2020 speX LP Support Catheter Reflow Medical Krystal Santiago
K200226 01/30/2020 RetroFix Retrofix Screws, LLC Keith A Barritt
K200032 01/07/2020 ReWalk P6.0 ReWalk Robotics Ltd. Ofir Koren
K200135 01/21/2020 RGK Daily Range Wheelchairs RGK Wheelchairs, Ltd. Devin McElroy
K200065 01/13/2020 cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. Kaitlyn Hameister
K200121 01/21/2020 Route 92 Medical 088 Access System, 110 cm Route 92 Medical Inc. Kathy Tansey
K200133 01/21/2020 hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream Safecare Biotech (Hangzhou) Co., Ltd. Selina Zhang
K200216 01/28/2020 4K UHD Camera System Scivita Medical Technology Co., Ltd. Ruqin Wu
K200118 01/21/2020 Diode Laser Therapy Device Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200116 01/21/2020 PicoSecond Nd: YAG Laser System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200016 01/03/2020 uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
K200024 01/06/2020 uMR 570 Shanghai United Imaging Healthcare Co., Ltd. Xin GAO
K200036 01/08/2020 AI-ECG Tracker Shenzhen Carewell Electronics Co., Ltd. Chang Liu
K200026 01/06/2020 Disposable ECG Cable Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K200069 01/13/2020 Disposable SpO2 Sensor Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K200001 01/02/2020 MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., LTD Shi Jufang
K200015 01/03/2020 ePM Series Patient monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yanhong Bai
K200189 01/27/2020 Luna Dental Implant System- Healing Abutment Shinhung MST Co., Ltd. Jae Soo Song
K200199 01/27/2020 ADVIA Centaur CA 125II Siemens Healthcare Diagnostics, Inc. Fatima Pacheco
K200215 01/28/2020 ADVIA Centaur CEA Assay Siemens Healthcare Disgnostics Inc. Mey Lyn Vasquez
K200213 01/28/2020 Biograph mMR with syngo MR E11P-AP01 system software Siemens Medical Solutions, USA, Inc. Cordell L. Fields
K200140 01/21/2020 Silhouette Instalift Silhouette Lift Inc. Anthony DiBernardo
K200227 01/30/2020 Journey II XR Knee Instrument Smith & Nephew, Inc Meenakshi Gupta
K200170 01/23/2020 SpineNet SSP System SpineNet LLC King Floyd
K200126 01/21/2020 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
DEN200001 01/10/2020 Cell-Free DNA BCT Streck, Inc. Deborah Kipp
K200117 01/21/2020 Trevo NXT ProVue Retriever Stryker Germaine Fu
K200206 01/28/2020 AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter Stryker Neurovascular Shazia Hakim
K200205 01/28/2020 Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled Stryker Sustainability Solutions Mia McCorkel
K200064 01/13/2020 OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft SurGenTec, LLC Travis Greenhalgh
K200049 01/09/2020 Senhance Surgical System TransEnterix, Inc. Kaitlyn Alexander
K200242 01/31/2020 StaClear Syringe TriboFilm Research, Inc. Jackson Thornton
K200183 01/24/2020 CS 9600 Trophy Marie-Pierre Labat-Camy
K200063 01/13/2020 AeroEclipse* ONE BAN Trudell Medical International Marianne Tanton
K200240 01/31/2020 Turbett Instrument Pod Turbett Surgical Inc. Rob Turbett
K200182 01/24/2020 EzRay Air Portable (Model: VEX-P300) Vatech Co., Ltd Daniel Kim
K200120 01/21/2020 LiteSaber Wire Torque Assist Device Vesatek, LLC David Look
K200185 01/24/2020 SYLFIRM X Viol Co., Ltd. Chai Kyoung Woo
K200113 01/17/2020 LINK TrabecuLink Tibial Cones Waldemar Link GmbH & Co. KG Stefanie Fuchs
K200247 01/31/2020 Fusion Quattro Extraction Balloon Wilson-Cook Medical, Inc Tiffanny A Thomas
K200110 01/17/2020 SANDRO Dual WON TECH Co., Ltd. Lana Hong
K200162 01/22/2020 Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) Wuhan Greentek Pty Ltd. Yarong Liu
K200136 01/21/2020 Shear Wave Quantificational Ultrasound Diagnostic System Wuxi Hisky Medical Technologies Co., Ltd. Jinhua Shao
K200167 01/23/2020 QuikClot Control+ Z-Medica, LLC Soraya King
K200112 01/17/2020 Zimmer Hip Joint Replacement Zimmer GmbH Thomas Lincoln
K200209 01/28/2020 Persona Personalized Knee System Zimmer, Inc. Gregory Foster


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