FDA 510(k) Applications Received During May, 2020

FDA 510(k) Number Submission Date Device Name Applicant Contact
K201174 05/01/2020 TruDi Curette Acclarent, Inc. Leena Sorathia
K201194 05/04/2020 Acuity 200Ö (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K201341 05/20/2020 AcQMap 3D Imaging and Mapping Catheter Acutus Medical, Inc. Karla Schaffner
K201220 05/06/2020 Aerus Medical Guardian,model F170A Aerus Medical LLC Andrew Eide
K201199 05/04/2020 Jada System Alydia Health Colby Holtshouse
K201203 05/04/2020 Cliq Aspirator Anest Iwata Sparmax Co., Ltd. Lika Lo
K201212 05/05/2020 Voyant Open Fusion Device Applied Medical Resources Corp. Sherif Nakhla
K201235 05/07/2020 Arthrex MaxForce MTP Compression Plates and Screws Arthrex Inc. Rebecca R. Homan
K201330 05/19/2020 Tigereye CTO-Crossing Catheter Avinger, Inc. Thomas Lawson
K201313 05/18/2020 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) Aziyo Biologics, Inc. Wendy Perreault
K201288 05/14/2020 ExpanSure Large Access Transseptal Dilator Baylis Medical Company Inc. May Tsai
K201405 05/28/2020 LabPro Data Management System Beckman Coulter Inc. Christina Thomas
K201423 05/29/2020 MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ?g/mL) Beckman Coulter, Inc. Elaine Duncan
K201234 05/07/2020 BD SoloShot Mini Syringe/ BD Auto Disable Syringe Becton, Dickinson, and Company Avital Merl
K201243 05/08/2020 Disposable Specimen Retrieval Bag Beijing Biosis Healing Biological Technology Co., Ltd. Jiali Zhou
K201350 05/21/2020 CORVUS Best Nomos Vineet Gupta
K201178 05/01/2020 iLab Polaris Multi-Modality Guidance System Boston Scientific Kevin Lam
K201170 05/01/2020 Athletis PTA Balloon Dilatation Catheter Boston Scientific Corporation Jennifer Mrkvicka
K201276 05/13/2020 ExacTrac Dynamic Brainlab AG Chiara Cunico
K201251 05/11/2020 CarboClear Navigated Instruments CarboFix Orthopedics Ltd. Hila Wachsler-Avrahami
K201373 05/26/2020 DRX-Compass Carestream Health, Inc Duane Gutowski
K201337 05/20/2020 InPen System Companion Medical, Inc. Jasper Benke
K201333 05/19/2020 SABER .035 PTA Dilatation Catheter Cordis Corporation Kyungyoon Kang
K201179 05/01/2020 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable Covidien llc Ligia Mastronardi
K201247 05/11/2020 Intraoral Sensor Dentium Co., Ltd (ICT Branch) Sangwoo Lee
K201347 05/21/2020 DePuy ATTUNEÖáTotal Knee System DePuy Orthopaedics, Inc. Karen Mahoney
K201321 05/18/2020 DePuy Synthes 2.7mm VA LCP Clavicle Plate System DePuy Synthes Stacey Bonnell
K201365 05/22/2020 True 3D Viewer EchoPixel, Inc. Michael Gabler
K201280 05/13/2020 Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery LLC Nathan Anderson
K201207 05/05/2020 CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K201279 05/13/2020 ASSISTO Universal Applicator Clamping Device Geomed Medizin-Technik GmbH & Co. KG Hanno Haug
K201299 05/15/2020 HD Steth HD Medical, Inc. Stephanie Anderson
K201252 05/11/2020 Spectralis HRA+OCT and variants Heidelberg Engineering GmbH Christoph Schoess
K201217 05/06/2020 HemoCue Hb 301 System HemoCue AB Maria Fagerberg
K201343 05/20/2020 Triathlon Total KneeSystem Howmedica Osteonics Corp. dba Stryker Orthopaedics Shikha Khandelwal
K201311 05/18/2020 PF4 IgG assay Immucor GTI Diagnostics, Inc. Allison Stray
K201296 05/15/2020 i-Rapha Solution IRM Inc Kim Yun Ik
K201225 05/06/2020 Neodent Implant System - GM Helix Implants 7.0 JJGC Industria e Comercio de Materiais Dentarios S.A. Mariana Soares Hartmann
K201355 05/21/2020 Endomat Select, IBS Shaver Software, License Karl Storz SE & Co. KG Alexey Davidov
K201334 05/20/2020 Keystone Dental XL Dental Implant System Keystone Dental Inc. Linda Jalbert
K201184 05/01/2020 Lascod Impression Materials Lascod Spa Gualtiero Cozzi
K201338 05/20/2020 Allograft MIS Delivery System LifeNet Health Brittany Beasley
K201232 05/07/2020 Limbus Contour Limbus AI Inc. Jon Giambattista
K201223 05/06/2020 LZI Tramadol Enzyme Immunoassay Lin-Zhi International, Inc. Bernice Lin
K201310 05/15/2020 Accipiolx MaxQ Al Ltd. Joshua Schulman
K201390 05/27/2020 Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) Medline Industires, Inc. Adam Ostrower
K201319 05/18/2020 Medline UNITE Jones Fracture Screw System Medline Industires, Inc. Jennifer Mason
K201224 05/06/2020 Electrosurgical Generator and Accessories Medrange Helen Xie
K201362 05/22/2020 CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement Medtronic Shweta Sharma
K201327 05/19/2020 NavLock Trackers Medtronic Navigation Taylor Gold West
K201175 05/01/2020 StealthStation Cranial Software v1.3.0 Medtronic Navigation Inc. Amelia Striegel
K201189 05/01/2020 Stealthstation S8 Spine Software v1.3.0 Medtronic Navigation, Inc. Jason Woehrle
K201267 05/12/2020 Adaptix Interbody System with Titan nanoLOCK Surface Technology Medtronic Sofamor Danek Diamond Wallace
K201407 05/28/2020 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, INC. Usman Rashid
K201166 05/01/2020 Temno Elite Biopsy System Merit Medical Systems, Inc Niloufar Samimi
K201172 05/01/2020 CFP-3131, CFP-2222 MX Imaging, Inc. John Ross
K201414 05/29/2020 Rotium Bioresorbable Wick Nanofiber Solutions, LLC Jason Chakroff
K201272 05/12/2020 Geneva Nucletron BV Rigo Meens
K201286 05/14/2020 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch Nurse Assist, LLC Romeo Crisologo
K201200 05/04/2020 Visera Elite II Video System Center Olympus Medical Systems Corp. Toshiyuki Nakajima
K201227 05/06/2020 Phantom« Hindfoot TTC/TC Nail System Paragon 28, Inc. Haylie Hertz
K201271 05/12/2020 Benchmark BMX96 Access System Penumbra, Inc. Matthew Benenati
K201352 05/21/2020 3D Auto LAA Philips Healthcare Travis Catania
K201339 05/20/2020 The NOxBOXi Nitric Oxide Delivery System Praxair, Inc. Dave Loflin
K201177 05/01/2020 RadGil2 R3 X-Ray L.L.C Robert Hase
K201186 05/01/2020 KY Grosz Jelly RB Health (US) LLC Elizabeth Viguerie
K201389 05/27/2020 Resoundant Acoustic Driver System Resoundant Inc John Hartigan
K201168 05/01/2020 ECG Monitor App Samsung Electronics Co., Ltd Taejong Jay Yang
K201240 05/08/2020 Mariner Cap System SeaSpine Orthopedics Corporation Alicia McArthur
K201369 05/22/2020 AVA (Augmented Vascular Analysis) See-Mode Technologies Pte. Ltd. Sadaf Monajemi
K201293 05/14/2020 Ureterorenoscope System Shanghai AnQing Medical Instrument Co., Ltd. Shuwen Fan
K201211 05/05/2020 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K201202 05/04/2020 MI View&GO Siemens Medical Solutions USA, Inc. Clayton Ginn
K201198 05/04/2020 S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable Smith & Nephew Janice Haselton
K201349 05/21/2020 Smith+Nephew Arthroscopes Smith & Nephew Katheen Solomon
K201370 05/22/2020 Multiflex Tinnitus Technology Starkey Laboratories, Inc. Ka Zoua Xiong
K201336 05/20/2020 DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm Synthes (USA) Products, LLC Pol Fort Grebol
K201214 05/05/2020 t:slim X2 Insulin Pump with Interoperable Technology Tandem Diabetes Care, Inc. Ashley Reynolds
K201277 05/13/2020 Oral-B Dry Mouth Oral Rinse The Proctor & Gamble Company Michael A Kaminski
K201255 05/11/2020 TSolution« One Total Knee Application THINK Surgical, Inc. Meliha Mulalic
K201315 05/18/2020 PERFORM Humeral System û Stem Tornier, Inc. Renee Stoffel
K201244 05/08/2020 Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices TransMed7, LLC James Vetter
K201248 05/11/2020 Syringe Holder accessory Vapocoolshot, Inc. Jacob Leibovici
K201216 05/05/2020 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P. DuMontelle
K201164 05/01/2020 Venus Viva MD Device Venus Concept USA Inc. Yoni Iger
K201340 05/20/2020 AQUILA 320 D / AQUILA 320 S VMI Tecnologias LTDA Siele Santos
K201307 05/15/2020 VisCalor VOCO GmbH M. Th. Plaumann
K201298 05/15/2020 VX1 Volta Medical Th?ophile Mohr Durdez
K201361 05/22/2020 PNEUMOCLEAR W.O.M. WORLD OF MEDICINE GmbH Soeren Markworth
K201364 05/22/2020 LINK TrabecuLink Femoral Cones Waldemar Link GmbH & Co. KG Stefanie Fuchs
K201322 05/18/2020 Entuit Nasal Jejunal Feeding Tube Wilson-Cook Medical, Inc Tiffanny A Thomas
K201406 05/28/2020 Picowon WON TECH Co., Ltd. Jake Yu
K201360 05/21/2020 Reusable and Disposable SpO2 Sensors Xinkang Medical Instrument Co. Ltd. Xu Changsheng


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