FDA 510(k) Applications Received During September, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K192593 09/20/2019 Confirm Rx Insertable Cardiac Monitor Abbott Laura Sparks
K192541 09/16/2019 DigiX FDX Allengers Medical Systems Limited Sanjeev K. Marjara
K192434 09/05/2019 DualX Lumbar Intervertebral Body Fusion Device Amplify Surgical Inc Andy Choi
K192532 09/16/2019 Arthrex SwiveLock Anchor Arthrex Inc. Ivette Galmez
K192441 09/06/2019 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K192556 09/17/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Jocelyn Kersten
K192428 09/05/2019 AFX Femoral Implant with Inserter Cayenne Medical Shima Hashemian
K192448 09/06/2019 Delta Xtend Revers Shoulder System DePuy(Ireland) Ashley Goncalo
K192453 09/09/2019 DIAMOND-5A/6A/8A DRGEM Corporation Ki-Nam Yang
K192400 09/03/2019 EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG DRTECH Corporation Choul-Woo Shin
K192421 09/04/2019 EpiFaith Syringe Flat Medical Co., Ltd Shao Wei Tseng
K192422 09/04/2019 Steerable Introducer 12F Freudenberg Medical LLC Mary Prunty
K192426 09/05/2019 Signa Voyager, Signa Voyager Quantum GE Healthcare(Tianjin) Company Limited Yuan Ma
K192391 09/03/2019 Spectralis HRA+OCT and Variants Heidelberg Engineering GmbH Arianna Schoess Vargas
K192512 09/12/2019 Focus 35C Detector, Trimax 35C Detector iRay Technology Taicang Ltd. Meng Li
K192433 09/05/2019 LZI Methadone II Enzyme Immunoassay Lin-Zhi International, Inc Bernice Lin
K192398 09/03/2019 Millenium HX Mar Cor Purification, Inc. Mike Halliday
K192455 09/09/2019 Merge PACS Merge Healthcare Incorporated Amy Tannenbaum
K192427 09/05/2019 Ablation Confirmation NeuWave Medical, Inc. Neda Chini
K192760 09/30/2019 NuVasive Modulus XLIF Interbody System NuVasive, Incorporated Jessica LeBlanc
K192435 09/05/2019 NuVasive NuvaLine NuVasive, Incorporated Manthan Damani
K192566 09/18/2019 Reach and CQ'ENCE Circular Staplers Reach Surgical, Inc. Mark Goldin
K192474 09/10/2019 VERA Reflexion Health, Inc. Walter Cordiglia
K192515 09/13/2019 BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K192402 09/03/2019 syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. Alaine Medio
K192526 09/13/2019 Spine Wave Navigated Instruments Spine Wave, Inc. Amy Noccioli
K192598 09/20/2019 Bashir S-B Endovascular Catheter Thrombolex, Inc. Amy Katsikis
K192424 09/05/2019 Mobius3D Varian Medical Systems, Inc Peter J. Coronado
K192465 09/09/2019 DigiFix Sterile Kit Virak Orthopedics, LLC Virak Tan
K192425 09/05/2019 Hair Boom 69, Hair Boom Air, Ulike Hair UpUp Won Tech Co., Ltd. Jake Yu
K192416 09/04/2019 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System Zimmer GmbH Roberto Tommasini


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact