FDA 510(k) Applications Received During April, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K201148 04/29/2020 EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License Abbott Medical Alyssa Timmers
K201181 04/30/2020 EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System Abbott Medical Charlie Pickrell
K201116 04/27/2020 Abiomed 23 Fr Sheath Abiomed Inc. Sandy Fowler
K201115 04/27/2020 Next Generation Balloon Dilation System Acclarent Inc. David Locke
K200944 04/08/2020 UNIEXPERT 2 PLUS Adani Vladimir Linev
K200950 04/09/2020 Ventricular Catheter Aesculap, Inc. Kathy A. Racosky
K201020 04/17/2020 BriefCase Aidoc Medical, Ltd. Nimrod Epstein
DEN200026 04/16/2020 EndeavorRx Akili Interactive Labs Inc. Scott Kellogg
K200995 04/16/2020 InsigniaÖ Anterior Cervical Plate System Alphatec Spine, Inc. Sandy Gill
K200936 04/08/2020 InvictusÖ CT Spinal Fixation System Alphatec Spine, Inc. Ruby Zheng
K201098 04/24/2020 Ambu Duodeno System Ambu Innovation GmbH Oliver V Ruepprecht
K201106 04/24/2020 IntraMarX 3D Radiopaque Marker AnX Robotica Corp. Steven Gu
K201076 04/22/2020 Anchor Dual Lumen Guidewire Catheter Aqure Medical, Inc. Jie Xia
K201112 04/27/2020 AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International Inc. Shajunath Nirupama
K201132 04/28/2020 Arthrex Compression Screws Arthrex Inc. Samantha Passman
K200895 04/03/2020 Univers Revers Modular Glenoid System, Half Augment Baseplate Arthrex Inc. Ivette Galmez
K201134 04/28/2020 Arthrex NanoScope System Arthrex, Inc. Heli F Chambi Infantas
K200870 04/01/2020 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Jocelyn Kersten
K201099 04/24/2020 BD PhaSeal Optima Closed System Drug Transfer Device Becton, Dickinson and Company Amy Honey
K200868 04/01/2020 SI-Restore Sacroiliac Joint Fixation System Biofusion Medical Rylan Reed
K200959 04/10/2020 Biolox« delta Ceramic Heads, Biolox« delta Option Ceramic Heads MR Labeling Biomet UK Ltd. Caleb Barylski
K201040 04/01/2020 Bioflux Software II Biotricity Spencer LaDow
K200981 04/14/2020 Mega Plus MIS Spine System BK Meditech, Co., Ltd Byoungjun Park
K201022 04/20/2020 REAL INTELLIGENCE CORI (CORI) Blue Belt Technologies, Inc. Corrine Herlinger
K201159 04/30/2020 WallFlex Colonic Stent System with Anchor Lock Delivery System Boston Scientific Corporation Catherine Sanford
K200957 04/09/2020 Brainsway Deep TMS System Brainsway Ltd. Ahava Stein
K200980 04/14/2020 Auto 3D Bladder Volume Tool Butterfly Network, Inc. Brian Sawin
K200923 04/07/2020 Single-use Surgical Mask BYD Precision Manufacturer Co.Ltd. Yubo Guan
K201111 04/27/2020 GentleMax Pro Plus Candela Corporation Yverre Bobay
K201122 04/27/2020 Canon non-mydriatic retinal camera CR series Canon Inc. Akira Hirai
K200887 04/02/2020 AS-10 Canon, Inc. Akira Hirai
K200856 04/01/2020 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie SAS Peter Kelley
K200883 04/02/2020 CarboClear« Cervical Plate System Carbofix Orthopedics Ltd. Yael Rubin
K200894 04/03/2020 Agape Cooling Personal Lubricant CC Wellness LLC Marlent Perez
K200920 04/06/2020 Idys ALIF ZP 3DTi Clariance, SAS Fadwa Bahr
K201007 04/17/2020 In-Ka Ureteral Balloon Dilatation Catheter Coloplast Corp Cori Ragan
K201023 04/20/2020 iTotal« Identity Posterior Stabilized Knee Replacement System Conformis, Inc. Nancy Giezen
K200871 04/01/2020 Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator Control Medical Technology Shawn Fojtik
K201000 04/16/2020 Biodesign Staple Line Reinforcement Cook Biotech Incorporated Nick Wang
K201086 04/23/2020 Advincula Delineator Uterine Manipulator CooperSurgical, Inc. Kyle Hooper
K200863 04/01/2020 Tiger« Occipital-Cervical-Thoracic Spinal Fixation System CoreLink, LLC Steve Mounts
K200888 04/03/2020 OMNIBotics Knee System Corin Ltd. Christina Rovaldi
K201067 04/22/2020 CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) CUPID Limited Durgesh Garg
K200991 04/15/2020 EVOL Spinal Interbody System Cutting Edge Spine, LLC Kyle Kuntz
K200916 04/06/2020 Patient Administration Set Cyclomedica Australia Pty Ltd Niamh Mc Aree
K201063 04/21/2020 DANNIK Disposable Monopolar Laparoscopic Instrument Dannik Olga Haberlad
K201140 04/29/2020 Axeos Dentsply Sirona Karl J. Nittinger
K201074 04/22/2020 Delta III Lithotripter Dornier MedTech America, Inc. John Hoffer
K200859 04/01/2020 Infinity M300 Draeger Medical Systems, Inc. Thomas Ostrowski
K201124 04/27/2020 TOPAZ Mobile DR System DRGEM Corporation Ki-Nam Yang
K201069 04/22/2020 VibrantVue Scleral Saline Dry Eye Innovations, LLC Donald R. Sanders
K200909 04/06/2020 Hemo Control (optional Add Pack Hemo Control DM) EKF-diagnostic GmbH Andrew J. Rutter
K201018 04/17/2020 Encision AEM enTouch 2X Scissor Encision Inc. Pete Geary
K201143 04/29/2020 VICRYL Mesh Ethicon, Inc. Valerie Smith Beyer
K201145 04/29/2020 X-Pac Expandable Lumbar Cage System Expanding Innovations, Inc. Mbithi Muthini
K201131 04/28/2020 firefly T-2 Firstkind Limited Neil Buckley
K200948 04/08/2020 Fitbit ECG App Fitbit, Inc. Shruti Rajagopalan
K200973 04/13/2020 Synapse 3D Cardiac Tools FUJIFILM Corporaton Randy Vader
K200964 04/10/2020 Sonosite PX Ultrasound System FUJIFILM SonoSite, Inc. Sudipta Chakrabarti
K200997 04/16/2020 Lumipulse G CA19-9-N Fujirebio Diagnostics, Inc. Kristin Maddaloni
K200998 04/16/2020 Versana Active GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K201087 04/23/2020 CORBEL Spacers Globus Medical, Inc. Jennifer Antonacci
K201107 04/24/2020 Opera Lebody (Gold), Opera Lebody (Zafiro) GTG Wellness Co., Ltd. Sang Won Jun
K200897 04/03/2020 Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) Hartalega SDN. BHD. Kuan Kam Hon
K200988 04/15/2020 Maximus System Hill-Rom Services Pte Ltd Alvin Tan
K201042 04/20/2020 PROBEAT-CR Hitachi Ltd. Tomoyuki Seino
K200866 04/01/2020 Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) Hologic, Inc. Anila Tarte
K200975 04/13/2020 Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum Huntleigh Healthcare Limited Steve Monks
K200966 04/10/2020 Icare HOME Tonometer Icare Finland Oy Hannes Hyvonen
K200858 04/01/2020 Mini Sterilizable Tray Implant Direct Sybron Manufacturing, LLC Reina Choi
K201149 04/29/2020 CoLink Plating System In2Bones USA, LLC Christine Scifert
K201150 04/29/2020 InMode RF Multi-System InMode Ltd. Amit Goren
K200947 04/08/2020 InMode System with the Morhpeus8 Applicators InMode Ltd. Amit Goren
K200874 04/01/2020 TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End Innovasis, Inc. Marshall McCarty
K201146 04/29/2020 Ion Endoluminal System Intuitive Surgical, Inc. Jennifer Siu
K200890 04/03/2020 Invacare Perfecto2V Oxygen Concentrator Invacare Corporation Elijah Wreh
K201043 04/20/2020 Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) iRay Technology Taicang Ltd. Junjie Qian
K201004 04/16/2020 Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W iRay Technology Taicang Ltd. Meng Li
K200941 04/08/2020 Rapid LVO iSchemaView Inc. Jim Rosa
K200939 04/08/2020 Electronic Blood Pressure Monitor Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Rui Li
K201006 04/17/2020 K2M Navigation Instruments K2M, Inc. Oonagh Lahiff
K201096 04/24/2020 CO2mbiLED Karl Storz Endoscopy America, Inc. Winkie Wong
K201135 04/28/2020 Image1 S CCU, Image1 S 4U Camera Head Karl Storz Endoscopy-America, Inc. Alita McElroy
K201052 04/21/2020 KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. Jennifer Damato
K200907 04/06/2020 Thales 3D Mr Scanner LAP GmbH Laser Applikationen Martin Pfabel
K200896 04/03/2020 Solstice CCI Life Spine Inc. Angela Batker
K200875 04/01/2020 ArtiSential Laparoscopic Instruments - Electrodes LivsMed Inc. Dong Wook Lee
K200860 04/01/2020 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) M.I. Tech Co., Ltd Inae Kim
K200910 04/06/2020 BOSS Balloon Guide Catheter Marblehead Medical Kristin Mortenson
K200935 04/08/2020 Mazor X Mazor Robotics Ltd. Shiran Conforti
K200902 04/03/2020 ClickClean Medeon Biodesign, Inc. Tsung-Yu Hsieh
K201136 04/28/2020 CureÖ Lumbar Plate System Meditech Spine, LLC Bruce Dunaway
K200960 04/10/2020 Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industires, Inc. Adam Ostrower
K200949 04/09/2020 HEALIX ADVANCE Anchor with DYNATAPE Suture Medos International SARL Elizabeth Messana
K201068 04/22/2020 Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface Medtronic, Inc. Sammie C. Joseph-Fredericks
K201118 04/27/2020 Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level Medtronic, Inc. Jen Correa
K201011 04/17/2020 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Alexandra Theisen
K200967 04/10/2020 mCare(R) Powder Free Nitrile Orange Examination Gloves Mercator Medical (Thailand) LTD. Dariusz Jan Krezymon
K201056 04/21/2020 NeuroBlate System Monteris Medical, Inc. David H. Mueller
K201117 04/27/2020 Gold Anchor Naslund Medical AB Tomas Naslund
K200878 04/02/2020 Natus NeuroWorks Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K201101 04/24/2020 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil NeoCoil, LLC Katie Gonzalez
K200927 04/07/2020 Transept Cervical Plate System Neurostructures, Inc. Moti Altarac
K200969 04/13/2020 NEXXT MATRIXX System Nexxt Spine LLC Andy Elsbury
K201010 04/17/2020 Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite Nobio Ltd. Galit Gershon
K201141 04/29/2020 FIRMM Nous Imaging, Inc. Todd Deckard
K200867 04/01/2020 Implantswiss Dental Implant System and Implantswiss Dental Abutment System Novodent SA Cem Kocer
K200956 04/09/2020 NuVasive Thoracolumbar Plates NuVasive, Incorporated Daniela Mahan
K201078 04/22/2020 NuVasive« ACP System NuVasive, Incorporated Ivanna Lopez
K200914 04/06/2020 Healix Compression Screw System Nvision Biomedical Technologies, Inc Diana Langham
K201151 04/29/2020 O-Mec 690 Series Laparoscopes OMEC Medical, Inc. Claire Nippress
K200977 04/13/2020 Modular Toga Operating Room Innovations, Inc. Mark McBride
K201013 04/17/2020 Optixon 1-Day Optixon Inc. Oh Jeong Ju
K200892 04/03/2020 Harvey(R) Surgical Assistant OrthAlign Inc Karyl Haskell
K201005 04/16/2020 FullFocus Paige.AI, Inc Jillian Sue
K201048 04/21/2020 SherpaPak Pediatric Liver Transport System Paragonix Technologies Lisa Anderson
K201083 04/23/2020 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors Parcus Medical, LLC Paul Vagts
K201137 04/28/2020 Asept Surgical Face Mask PFM Medical, Inc Jessica Jho
K200911 04/06/2020 MIRA Adapter Phakos Olivier Aumaitre
K200974 04/13/2020 QLAB Advanced Quantification Software Philips Healthcare Travis Catania
K200917 04/06/2020 Azurion R2.1 Philips Medical Systems Nederland BV Michelle Campbell
K201053 04/21/2020 PercuNav Image Fusion and Interventional Navigation Philips Ultrasound, Inc Travis Catania
K201012 04/17/2020 EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System Philips Ultrasound, Inc. Deep Pal
K200952 04/09/2020 Hummingbird Tympanostomy Tube System Preceptis Medical, Inc Steve Anderson
K201079 04/22/2020 Aurora« Anterior Lumbar Plate Sytstem Prism Surgical Design Pty Ltd. Emma May Young
K200899 04/03/2020 Quantib AI Node Quantib BV Floor van Leeuwen
K200889 04/03/2020 iMac 27 & PL 4.0 Quantum-Spectra LLC Marc Leppla
K200921 04/06/2020 qER Qure.ai Technologies Pooja Rao
K201119 04/27/2020 ChartCheck Radformation, Inc. Kurt Sysock
K201058 04/21/2020 Accuvue+ Radmedix LLC Gabriel Issa
K200984 04/14/2020 Guardian Needle Electrode Rhythmlink International, LLC Gabriel Orsinger
K201120 04/27/2020 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K201002 04/16/2020 Safey Pocket Spirometer Safey Medical Devices Pvt Ltd Taher Ali Moiyed
K200885 04/02/2020 Meridian Anterior Plate System, Regatta Lateral Plate System SeaSpine Orthopedics Corporation Aly Alvarez
K200879 04/02/2020 SeaSpine Meridian System, SeaSpine Regatta Lateral System SeaSpine Orthopedics Corporation Aly Alvarez
K201073 04/22/2020 Seaspine WaveForm C Interbody System SeaSpine Orthopedics Corporation Aly Alvarez
K201109 04/27/2020 CO2 Laser Therapy System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K200976 04/13/2020 SR-8230, SR-8230S Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K201162 04/30/2020 Essence 55SP Large Monitor System Shenyang Torch-Bigtide Digital Technology Co., Ltd. Fu Ailing
K200864 04/01/2020 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K200979 04/13/2020 DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System Shenzhen Mindray Bio-Medical Electronics Co., LTD. Shi Jufang
K201156 04/30/2020 ARTIS pheno (VE2) Siemens Medical Solution USA, Inc. Patricia D. Jones
K201130 04/28/2020 ACUSON Juniper Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc. Hyunjung Lee
K201034 04/20/2020 Syngo.CT CaScoring Siemens Medical Solutions USA, Inc. Tabitha Estes
K201062 04/21/2020 syngo Ultrasound Apps Suite (sUSAS) Siemens Medical Solutions, USA, Inc. Christine Dunbar
K201054 04/21/2020 SOMNscreenn plus Somnomedics GmbH Stephanie Wolski
K200862 04/01/2020 Feelix Stethoscope Sonavi Labs, Inc. Ian McLane
K201059 04/21/2020 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K201029 04/20/2020 Sapphire« Spinal System, Sapphire X Anterior Cervical Plate Spinal System Spinal Elements, Inc. Julie Lamothe
K200958 04/10/2020 MODULIF-A Anterior Lumbar Interbody Fusion System Spinal Stability, LLC David Krueger
K200989 04/15/2020 Reliance Endoscope Processing System STERIS Corporation Jennifer Nalepka
K200880 04/02/2020 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System Stryker GmbH Jackie Perri
K200869 04/01/2020 Gamma3 System Stryker Trauma GmbH Sanja Jahr
K200933 04/07/2020 Syntec Non-Sterile Steinmann Pins System Syntec Scientific Corporation Nicole Tseng
K200881 04/02/2020 Oral-B iO Test Drive Power Brush Trial Program Kit The Proctor & Gamble Company Michael A. Kaminski
K200926 04/07/2020 OrthoGold 100 Tissue Regeneration Technologies, LLC John Warlick
K200954 04/09/2020 Glaucoma Module Topcon Healthcare Solutions, Inc. Ramya Sundaram
K201035 04/20/2020 ETHICON Linx Esophagus Sizing Tool Torax Medical, Inc. Joseph Ciccone
K200961 04/10/2020 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K200955 04/09/2020 Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch Vascutek Ltd Heidi Forsyth
K200990 04/15/2020 VIDAvision VIDA Diagnostics Inc. Sandra Stapleton
K201064 04/21/2020 V30 System, V20 System, V10 System, V-FR Handpiece Viora Ltd. Simona F. Krant
K201080 04/22/2020 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K201090 04/23/2020 Structur CAD VOCO GmbH M. TH. Plaumann
K200972 04/13/2020 Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc Marge Walls-Walker
K200929 04/07/2020 Hair Growth System Xuzhou Kernel Medical Equipment Co., Ltd. Wang Jing
K200905 04/06/2020 HealthMammo Zebra Medical Vision Ltd. Flair Bar


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