FDA 510(k) Applications Received During September, 2019

FDA 510(k) Number Submission Date Device Name Applicant Contact
K192554 09/17/2019 decimal3D .decimal, LLC. Kevin Erhart
K192550 09/17/2019 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H 3M Company Hilary B Hovde
K192673 09/26/2019 3MÖ ComplyÖ Hydrogen Peroxide Indicator Tape 1228 3M Company Mary Fretland
K192593 09/20/2019 Confirm Rx Insertable Cardiac Monitor Abbott Laura Sparks
K192769 09/30/2019 Impella CP Introducer Abiomed, Inc. Robert Stewart
K192665 09/25/2019 Accelerate Pheno System, Accelerate PhenoTest BC Kit Accelerate Diagnostics, Inc. Carrene Plummer
K192725 09/27/2019 Cytal Wound Matrix 3-Layer ACell, Inc. Michelle Huettner
K192581 09/19/2019 The NightBlocks Appliance Advanced Facialdontics LLC Scott Simonetti
K192471 09/10/2019 RHIN1 Stylus Aerin Medical Inc. Matthew M Hull
K192728 09/27/2019 Agnes Agnes Medical Co., Ltd SeungHwan Seo
K192723 09/27/2019 Coloring Liquid Aidite (Qinhuangdao) Technology Co., Ltd. Zhang Wei
K192484 09/10/2019 Fixone Biocomposite Anchor AJU Pharm Co., Ltd. Kim Jung Gil
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
K192485 09/10/2019 BioCode Respiratory Pathogen Panel (RPP) Applied BioCode, Inc. Robert Di Tullio
K192786 09/30/2019 Gatekeeper Balloon Catheter Arch Catheter, LLC Michael Zhadkevich
K192437 09/06/2019 Arterys MICA Arterys Inc. Sharon Cholowsky
K192532 09/16/2019 Arthrex SwiveLock Anchor Arthrex Inc. Ivette Galmez
K192441 09/06/2019 Arthrex SwiveLock Anchors Arthrex Inc. Jessica L. Singelais
K192782 09/30/2019 ASAHI CROSSWALK Peripheral Support Catheter Asahi Intecc Co., Ltd. Yasuyuki Kawuhara
K192599 09/20/2019 ASAHI PTCA Guide Wire ASAHI Gaia Next Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K192483 09/10/2019 MeDioStar ASCLEPION LASER TECHNOLOGIES GMBH Antje Katzer
K192690 09/26/2019 Upgrade Kit MR GUI PRO, MrJ 3300 Plus ASG Superconductors S.p.A. De Benedetti Luisella
K192492 09/11/2019 EL CAPITAN Anterior Lumber Interbody System Astura Medical, LLC Parker Kelch
K192570 09/18/2019 Atlas Spine Expandable Cervical Standalone Interbody System Atlas Spine, Inc. Thomas Smith
K192491 09/11/2019 Coolief Radiofrequency Generator (CRG) System Avanos Medical, Inc. Thomas Kozma
K192617 09/23/2019 Gemini 810+980 Soft Tissue Laser Azena Medical, LLC Lindsay Tilton
K192616 09/23/2019 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) Aziyo Biologics, Inc. Wendy Perreault
K192577 09/19/2019 Actreen Hi-Lite Intermittent Urinary Catheters B. Braun Medical Inc. Anita J. Nemeth
K192676 09/26/2019 Introcan Safety 2 IV Catheter 18-24 gauge B. Braun Medical Inc. Tracy Larish
K192452 09/09/2019 Lyograft B. Bruan Surgical, SA Pau Turon Dols
K192556 09/17/2019 Carnation Ambulatory Monitor Bardy Diagnostics, Inc Jocelyn Kersten
K192705 09/27/2019 MiniCap Extended Life PD Transfer Sets Baxter Healthcare Kimberly Garcia
DEN190042 09/16/2019 Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer Baxter Healthcare Corporation Kristen Bozzelli
K192538 09/16/2019 BD Syringe NRFit Lok and BD Syringe NRFit Slip Becton, Dickinson and Company Murtaza Rana
K192493 09/11/2019 BD Cathena (TM) Safety IV Catheter Becton, Dickinson Infusion Therapy Systems, Inc. Henry Boland
K192446 09/06/2019 CO2 Mainstream Module Beijing Kingst Commercial & Trade Co.,Ltd. Judong Gao
K192488 09/11/2019 CO2 Sidestream Module Beijing Kingst Commercial & Trade Co.,Ltd. Judong Gao
K192735 09/27/2019 Diode Laser Hair Removal Machine Beijing Lead Beauty S & T Co., Ltd Jiao Zhang
K192516 09/13/2019 Diode Laser 808nm Beijing Superlaser Technology Co., Ltd. Shi Shuang
K192519 09/13/2019 Multi-modality workstation Beijing Superlaser Technology Co., Ltd. Shi Shuang
K192774 09/30/2019 BioCardia 8F Morph DNA Deflectable Guide Catheter BioCardia Patrick Lee
K192430 09/05/2019 Epic 980 Biolase, Inc. Alicia Mszyca
K192738 09/27/2019 ETEST Delafloxacin (DFX) (0.002-32 ?g/mL) BioMerieux SA Sophie Quiblier
K192522 09/13/2019 TSV BellaTek Express and BellaTek Flex Abutments Biomet 3i LLC Krupal Patel
K192683 09/26/2019 Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads Biomet UK Ltd. Lisa Ingram
K192397 09/03/2019 TruDi Navigation System Biosense Webster David Locke
K192480 09/10/2019 Torpedo Gelatin Foam Biosphere Medical, S.A. Alix Fonlladosa
K192730 09/27/2019 CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV BioSystems S.A. Noelia Gil
K192611 09/20/2019 Cuffix Biovo Technologies Ltd. Barbara Sokoletsky
K192674 09/26/2019 Mixing and Delivery System Bone Solutions, Inc. Drew Diaz
K192403 09/03/2019 VK100 Percutaneous Vertebral Augmentation System BONWRx Ltd Ralph W. Carmichael
K192438 09/06/2019 Rhythmia HDxTM Mapping System Boston Scientific Corporation Lee Margolin
K192460 09/09/2019 Sentinel Cerebral Protection System Boston Scientific Corporation Eric Elliott
K192692 09/26/2019 Brainomix 360 e-CTA Brainomix Limited Gwilym Owen
K192549 09/17/2019 Byteflies Kit Byteflies NV Benjamin Vandendriessche
K192624 09/23/2019 ApneaTrak Cadwell Industries, Inc. James Blevins
K192715 09/27/2019 CRF Radiofrequency Ablation System Cambridge Interventional LLC Michael A. Arnold
K192506 09/12/2019 Vantage Galan 3T, MRT-3020, V6.0 Canon Medical Systems Corporation Paul Biggins
K192574 09/19/2019 Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Paul Biggins
K192632 09/23/2019 DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless Canon, Inc. Yamazaki Tatsuya
K192662 09/25/2019 CapsoCam Plus (SV-3) Capsule Endoscopy System CapsoVision, Inc. Azimun Jamal
K192442 09/06/2019 FFRangio CathWorks Ltd Asaf Azulay
K192428 09/05/2019 AFX Femoral Implant with Inserter Cayenne Medical Shima Hashemian
K192756 09/30/2019 Aquadex FlexFlow System 2.0 CHF Solutions, Inc. Dawn Li
K192642 09/24/2019 308nm Excimer System Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K192552 09/17/2019 Irradiation Cosmetic Device Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K192697 09/26/2019 Instinct Plus Endoscopic Clipping Device Cook Endoscopy Karthik Pillai
K192507 09/12/2019 LOSPA II Knee System Corentec Co., Ltd J.S. Daniel
K192656 09/25/2019 Optimized Positioning System (OPS) Insight Corin USA Lucinda Gerber
K192720 09/27/2019 GIA Stapler with Tri-Staple Technology Covidien Sarah Tang
K192534 09/16/2019 CrossBay Endometrial Tissue Sampler (ETS) CrossBay Medical Piush Vidyarthi
K192497 09/11/2019 EVOL ha - D Lateral Interbody Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K192643 09/24/2019 Dannik Laparoscopic Suction Irrigation System Dannik Olga Haberlad
K192711 09/27/2019 Dannik Titanium Ligation Clip Dannik Olga Haberlad
K192470 09/09/2019 DenMat Orthodontic Aligners DenMat Holdings, LLC Tom Juarez
K192412 09/04/2019 SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece DentalEZ, Inc. Robert Young
K192688 09/26/2019 s-Clean SQ-SL Implant System Regular Dentis Co., Ltd. Gyu Ri Kim
K192436 09/06/2019 Healing Abutments and Cover Screws Dentium Co., Ltd. Byung-sun Kim
K192682 09/26/2019 Orthocem, Ortho Bite Dentscare Ltda Roberta Uyara
K192409 09/04/2019 Midwest Rhino XE and Air Motor M Dentsply Sirona Karl Nittinger
K192530 09/16/2019 Surefil one Self-adhesive Composite Hybrid Dentsply Sirona Karl Nittinger
K192448 09/06/2019 Delta Xtend Revers Shoulder System DePuy(Ireland) Ashley Goncalo
K192749 09/30/2019 Dermadry Dermadry Laboratories inc. Maxime Calouche
K192787 09/30/2019 Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System Dexcom, Inc. Bryan Osborne
K192510 09/12/2019 DIAFIL & DIAFIL Capsule Diadent Group International Kab Sun Lee
K192392 09/03/2019 DiaPlus Diadent Group International Kab Sun Lee
K192586 09/19/2019 LIAISON« Folate Diasorin Inc. John C. Walter
K192573 09/18/2019 Dolphin Medical Imaging USB Ultrasound System Dolphin Medical Imaging, LLC Brian S. Heaney
K192408 09/04/2019 Custodiol HTK Solution Dr. Franz Kohler Chemie GmbH Clifton Czarnojon
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
K192743 09/30/2019 VisionX 2.4 Durr Dental SE Oliver Lange
K192564 09/18/2019 Disposable Gold Cup EEG Electrodes Dymedix Diagnostics, Inc. Todd Eiken
K192879 09/30/2019 Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System Edan Instruments, Inc Melody Huang
K192791 09/30/2019 Diagnostic Ultrasound System Edan Instruments, Inc. Stella Guo
K192514 09/12/2019 Patient Monitor Edan Instruments, Inc. Alice Yang
K192762 09/30/2019 Physio Flex Annuloplasty Ring Edwards Lifesciences LLC Milinda Mawley
K192768 09/30/2019 Temporary Fixation Pins EiserTech, LLC Lukas Eisermann
K192539 09/16/2019 Deka Luxea El..EN. Electronic Engineering SPA Paolo Peruzzi
K192482 09/10/2019 Elekta Unity Elekta Limited Nicholas Power
K192457 09/09/2019 Elos Accurate Customized Abutment Elos Medtech Pinol A/S Tina Friis Poulsen
K192413 09/04/2019 SiteSeal Femoral Compression Device Ensite Vacular, LLC Tom Reidy
K192661 09/25/2019 LATERA Absorbable Nasal Implant System Entellus Medical, Inc. (Aka Stryker ENT) Karen E. Peterson
K192544 09/16/2019 Erchonia Emerald Erchonia Corporation Steven Shanks
K192580 09/19/2019 STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device Ethicon, Inc Eleanor Zhou
K192589 09/20/2019 Everyway OTC TENS/EMS Combination EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Paul Hung
K192473 09/10/2019 Exsomed Wrist Plating System Exsomed Corporation Michael Zwolinski
K192592 09/20/2019 Axis Plating System Extremity Medical, LLC. Brian Smekal
K192421 09/04/2019 EpiFaith Syringe Flat Medical Co., Ltd Shao Wei Tseng
K192590 09/20/2019 CURA 778 FMI Medical Systems Inc. Dazhuang Meng
K192422 09/04/2019 Steerable Introducer 12F Freudenberg Medical LLC Mary Prunty
K192766 09/30/2019 Digital Intraoral Imaging Plate System Fsusen Technology Co., Ltd Elsa Li
K192440 09/06/2019 FDR SE Lite Fujifilm Corporation Randy Vader
K192664 09/25/2019 FUJIFILM Endoscope Model EC-760Z-V/L FUJIFILM Corporation Randy Vader
K192524 09/13/2019 Lumipulse G CA15-3 Fujirebio Diagnostics, Inc. Kristin Maddaloni
K192799 09/30/2019 Glenoid Baseplate with Screw FX Shoulder USA, Inc. Kathy Trier
K192464 09/09/2019 Injection Pen Needle Gangan Medical Technology Jiangsu Co., Ltd. Wu Shuhui
K192597 09/20/2019 Cytrans Granules GC America, Inc. Mark Heiss
K192686 09/26/2019 Revolution Maxima, Revolution Ace GE Hangwei Medical Systems Co.,Ltd. Haibo He
K192426 09/05/2019 Signa Voyager, Signa Voyager Quantum GE Healthcare(Tianjin) Company Limited Yuan Ma
K192667 09/25/2019 gel-e Flex+ gel OTC gel-e, Inc. Elsa Abruzzo
K192679 09/26/2019 Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use Gemtier Medical (Shanghai) Inc. Lenny Cao
K192678 09/26/2019 Genesys Spine Binary« Lumbar Plate System Genesys Spine Chloe Lance
K192609 09/20/2019 Globalcare Blood Pressure Monitor Globalcare Medical Technology Co., Ltd Janice Deng
K192633 09/23/2019 GUS831 Compressor Nebulizer Globalcare Medical Technology Co., Ltd. Janice Deng
K192744 09/30/2019 CORRIDOR Fixation System Globus Medical Inc. Kelly J. Baker
K192640 09/24/2019 Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump Guangzhou Yongyi Industrial Co., Ltd. Jian Zhongrong
K192691 09/26/2019 PatCom Single-Use Introducer H&A Mui Enterprises Inc. Tammy Mui
K192644 09/24/2019 GM501 SpermAir and GM501 SpermActive Hamilton Thorne Incorporated Donald Fournier
K192423 09/04/2019 MINT Product Family Hans Biomed Corporation Lucy Choi
K192700 09/26/2019 Xcam HDX WILL Corp. Myoung-Joon Lee
K192533 09/16/2019 Health Line CT CVC Health Line International Corporation Joel K. Faulkner
K192391 09/03/2019 Spectralis HRA+OCT and Variants Heidelberg Engineering GmbH Arianna Schoess Vargas
K192500 09/12/2019 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Honsun(Nantong)Co.,Ltd Iris Du
K192704 09/27/2019 Endofresh Digestive Endoscopy System HuiZhou Xzing Technology Co., Ltd. Yonglin Ni
K192754 09/30/2019 Avenger Radial Head System In2Bones USA, LLC Christine Scifert
K192399 09/03/2019 Infinity Angioplasty Balloon Catheter Infinity Angioplasty Balloon Company, LLC Tiffini Wittwer
K192695 09/26/2019 InMode System with the Morpheus8 (Fractora) Applicators Inmode MD Ltd. Amit Goren
K192659 09/25/2019 Omnipod Insulin Management System, Omnipod DASH Insulin Management System Insulet Corporation Julie Perkins
K192652 09/24/2019 TRV Interacoustics A/S Erik Nielsen
K192803 09/30/2019 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical Crystal Ong
K192512 09/12/2019 Focus 35C Detector, Trimax 35C Detector iRay Technology Taicang Ltd. Meng Li
K192385 09/03/2019 ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable ivWatch, LLC Holly Novak
K192417 09/04/2019 ARIX Cannulated Screw System Jeil Medical Corporation Sejin Ryu
K192545 09/16/2019 Potenza Jeisys Medical Incorporated Wonchel Choi
K192658 09/25/2019 Manual Wheelchair Jerry Medical Instrument (Shanghai) Co., Ltd. Jianguo Chen
K192551 09/17/2019 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle Jiangsu Caina Medical Co., Ltd. Xinyan Ruan
K192677 09/26/2019 Safety Insulin Pen Needle Jiangsu Caina Medical Co., Ltd. Jianwei Pan
K192681 09/26/2019 Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) Jiangsu Kangbao Medical Experiment Co., Ltd. Rujun Tang
K192405 09/03/2019 Image Guidance System for Radiotherapy Jiangsu Rayer Medical Technology Co., Ltd. Peng Li
K192670 09/25/2019 Neodent Instrument Kit Cases JJGC Industria e Comercio de Materiais Dentarios S.A. Luiza Vaccari Toppel
K192663 09/25/2019 Joimax Intracs System joimax GmbH Gary Mocnik
K192680 09/26/2019 Percusys« Plus Pedicle Screw System Joimax GmbH Gary Mocnik
K192449 09/06/2019 Joline Kyphoplasty System Allevo Joline GmbH & Co. KG Peter Kohlbecher
K192487 09/11/2019 EZ-TRAX Containment Device K1 Medical LLC Joseph Azary
K192727 09/27/2019 K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) Kamiya Biomedical Company Shawn Kaplan
K192523 09/13/2019 CMOS Video Esophagoscope SSU Karl Storz SE & Co. KG Alexey Davidov
K192386 09/03/2019 KeraStat Cream KeraNetics Luke Burnett
K192778 09/30/2019 Kinos Axiom Total Ankle System Kinos Medical Brian Garvey
K192540 09/16/2019 Kitazato ET Catheters Kitazato Corporation Futoshi Inoue
K192420 09/04/2019 Crownjun Nylon Suture Kono Seisakusho Co., Ltd. Hiroyuki Arai
K192481 09/10/2019 AccelFix Lumbar Plate System L&K Biomed Co., Ltd. KiHyang Kim
K192433 09/05/2019 LZI Methadone II Enzyme Immunoassay Lin-Zhi International, Inc Bernice Lin
K192604 09/20/2019 Servo-air 4.0 Ventilator System Maquet Critica Care AB David Ardanius
K192398 09/03/2019 Millenium HX Mar Cor Purification, Inc. Mike Halliday
K192753 09/30/2019 NeuralScan System Medeia, Inc. Slav Danev
K192713 09/27/2019 Altera Filter and HME/Filter Meditera Tibbi Malzeme San. ve Tic. A.S. Cenk Kilic Kalkan
K192563 09/17/2019 Altera gas Sampling Lines Meditera Tibbi Malzeme San. ve Tic. A.S. Cenk Kilic Kalkan
K192641 09/24/2019 Gemini Titan Sterilization Wrap Medline Industries, Inc. Jennifer Mason
K192646 09/24/2019 SYMPHONYÖ OCT System Medos International SARL Sheree Geller
K192508 09/12/2019 Medsynapse Ris Pacs & Medsynapse VNA Medsynaptic Private Ltd Ashish Dhawad
K192712 09/27/2019 Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter Medtronic Inc Sharon Fahy
K192389 09/03/2019 TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K192636 09/23/2019 TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) Medtronic, Inc. Nancy Cameron
K192414 09/04/2019 Praxiject 0.9% NaCl MedXL Inc. Premala Premanathan
K192614 09/23/2019 Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment MegaGen Implant CO., Ltd. You Jung Kim
K192444 09/06/2019 mCare« Powder Free Nitrile Black Examination Glove Mercator Medical (Thailand) LTD. Praneet Inthajak
K192455 09/09/2019 Merge PACS Merge Healthcare Incorporated Amy Tannenbaum
K192584 09/19/2019 BEACON Caresystem Model 00002144 Mermaid Care A/S Claus Lindholt
K192694 09/26/2019 PAL Single-Use Cannulas MicroAire Surgical Instruments Glenn Gerstenfeld
K192684 09/26/2019 HydroPearl Microspheres MicroVention, Inc. Analia Staubly
K192625 09/23/2019 PG Pro Microcatheter MicroVention, Inc., A Terumo Group Company Ganesh Balachandar
K192558 09/17/2019 Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter MIVI Neurovascular Janel Hurtado
K192572 09/18/2019 CNS Envision Moberg Research, Inc. Anna Rodriguez
K192542 09/16/2019 Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde Modern Medical Equipment Manufacturing, LTD. Jerry Cheung
K192447 09/06/2019 Superelastic Staple Neosteo Anne-Cecile Grandremy
K192781 09/30/2019 UroLift System Procedure Kit Sterilization Tray NeoTract, Inc. Brian Gall
K192764 09/30/2019 NeuroOne Cortical Electrode NeuroOne, Inc. Debra Kridner
K192427 09/05/2019 Ablation Confirmation NeuWave Medical, Inc. Neda Chini
K192578 09/19/2019 InCore TMT System Nextremity Solutions, Inc. Elise Fox
K192687 09/26/2019 TrellOssÖ-L MPF Nexxt Spine LLC Andy Elsbury
K192693 09/26/2019 Nuvo Nano Portable Oxygen Concentrator Nidek Medical Products, Inc. Olivia Mullen
K192469 09/09/2019 Nox Sleep System Nox Medical Kolburn E Ottosdottir
K192773 09/30/2019 ALLIVE Nu Eyne Co., Ltd Dong Seong Lee
K192582 09/19/2019 NuVasive CoRoent Small Interlock System NuVasive, Incorporated Jessica LeBlanc
K192760 09/30/2019 NuVasive Modulus XLIF Interbody System NuVasive, Incorporated Jessica LeBlanc
K192435 09/05/2019 NuVasive NuvaLine NuVasive, Incorporated Manthan Damani
K192645 09/24/2019 TrigonÖ Ti Stand-Alone Wedge Fixation System Nvision Biomedical Technologies, Inc. Diana Langham
K192669 09/25/2019 Extremely Thin 003, ZERO ZERO THREE Okamoto U.S.A., Inc. Yu Tadano
K192793 09/30/2019 Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I Olympus Medical Systems Corp. Toshiyuki Nakajima
K192498 09/11/2019 Single Use Injector Olympus Medical Systems Corp. Toshiyuki Nakajima
K192761 09/30/2019 Asimov-MKS Imaging System OnLume Inc. Greg Bange
K192629 09/23/2019 Spinalytics Optima Health Solutions International Corp. Farhad Ghani
K192785 09/30/2019 OptiScanner« 5000 Glucose Monitoring System Optiscan Biomedical Corporation Charles Zimliki
K192653 09/24/2019 Perseus Orthokey Italia S.r.l. Cristiano Paggetti
K192701 09/27/2019 DIBS (Digital Indirect Bonding System) OrthoSelect, LLC Steven N. Gardner
K192394 09/03/2019 Hi-Fatigue Bone Cement OSARTIS GmbH Volker Stirnal
K192495 09/11/2019 Black Diamond Navigation Instruments Osseus Fusion Systems Robert Pace
K192750 09/30/2019 AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip Parcus Medical, LLC Paul Vagts
K192710 09/27/2019 The Simple Locking Intramedullary (Slim) System Pega Medical Inc. Ariel R. Dujovne
K192802 09/30/2019 primeMidline Catheters PFM Medical, Inc. Mina Jiang
K192396 09/03/2019 Streamline MIS Spinal Fixation System Pioneer Surgical Technology, Inc. Michael Mach
K192800 09/30/2019 Streamline TL Spinal Fixation System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Kurtis Hunsberger
K192718 09/27/2019 Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology Pioneer Surgical Technology, Inc., DBA RTI Surgical, Inc. Linda Busklein
K192585 09/19/2019 Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K192450 09/06/2019 Precision Casting Solutions Total Hip System Precision Casting Solution, LLC Jim Moore
K192494 09/11/2019 NexGen Anterior Cervical Plate System Precision Spine Michael C. Dawson
K192732 09/27/2019 BodyGuardian Remote Monitoring System Preventice Technologies, Inc. Charles Rector
K192666 09/25/2019 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang
K192411 09/04/2019 Psoria-Shield AURORA Psoria-Shield John Yorke
K192517 09/13/2019 Psychemedics Microplate EIA for Cotinine in Hair Psychemedics Corporation Virginia Hill
K192525 09/13/2019 087 Balloon Guide Catheter System Q'Apel Medical LLC Ken Peartree
K192557 09/17/2019 Youjia Unscented Tampon with Plastic Applicators Qingdao Youjia Hygiene Technology Co., Ltd Huiying Zhao
K192535 09/16/2019 Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia Qinhuangdao Audental Metal Technology Co., Ltd. Wang Xi
K192600 09/20/2019 Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 quanta system spa Francesco Dell'Antonio
K192531 09/16/2019 QyScore Software Qynapse Olivier Courreges
K192418 09/04/2019 Phacoemulsification Needle (Tip) and Irrigation Sleeve Raico LLC Ravi Nallakrishnan
K192737 09/27/2019 RCT800 RAY CO., Ltd Changhwan Lee
K192566 09/18/2019 Reach and CQ'ENCE Circular Staplers Reach Surgical, Inc. Mark Goldin
K192724 09/27/2019 Propeller Sensor for Symbicort Reciprocal Labs Corporation Greg Dunkelberger
K192474 09/10/2019 VERA Reflexion Health, Inc. Walter Cordiglia
K192747 09/30/2019 Yxoss CBR« ReOss GmbH Michael Peetz
K192779 09/30/2019 Bunny Wax Personal Lubricant Reoxcyn, LLC Ellie Hartz
K192595 09/20/2019 ExSpiron 2Xi Respiratory Motion Susan K. Hamann
K192527 09/13/2019 Rochal Antimicrobial Wound Gel Rochal Industries, LLC William J. Coulston
K192583 09/19/2019 PicoLazer Laser System Rohrer Aesthetics, LLC Mark Rohrer
K192767 09/30/2019 Clear Aligner Royal Dental Lab Mo Yuyun
K192619 09/23/2019 Pitkar Locked Plating System S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar
K192561 09/17/2019 TRAUS SUS20 Saeshin Precision Co., Ltd. DongHa Lee
K192505 09/12/2019 HS50/HS60 Diagnostics Ultrasound System Samsung Medison CO., LTD. Scully Kim
K192569 09/18/2019 Diode Laser Therapy System San He Lefis Electronics Co., Ltd. Ning Li
K192783 09/30/2019 Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile Scientia Vascular LLC Amy McManus
K192719 09/26/2019 Osom Ultra Plus Flu A&B Test Kit Sekisui Diagnostics, LLC Nisha Li
K192445 09/06/2019 QwikCheck Chemical Indicators Serim Research Corporation Jackie Nelson
K192560 09/17/2019 Surgical Gown Shandong Kangli Medical Equipment Technology Co., Ltd. Zhuang Liu
K192627 09/23/2019 Laser Hair Growth Cap Shang Fa Biotechnology Co. Chung Ju Zhi
K192528 09/13/2019 CO2 Laser Therapy System Shangdong Huamei Technology Co., Ltd. Xu QingHua
K192521 09/13/2019 Intense Pulsed Light Treatment System Shangdong Huamei Technology Co., Ltd. Xu QingHua
K192672 09/26/2019 uPMR 790 Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K192601 09/20/2019 uWS-MR Shanghai United Imaging Healthcare Co., Ltd Xin Gao
K192630 09/23/2019 uWS-MI Shanghai United Imaging Healthcare Co., Ltd. Xin Gao
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
K192657 09/25/2019 Sterile High-pressure Angiographic Syringes for Single-use Shenzhen Boon Medical Supply Co., Ltd Mingan Mu
K192432 09/05/2019 IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 Shenzhen Bosidin Technology Co., Ltd. Wang Jiaoyan
K192404 09/03/2019 Patient Monitoring Cable (SpO2 Extension Cable) Shenzhen Coreray Technology., Ltd Simon Fan
K192466 09/09/2019 Air Compression Therapy System Shenzhen Lifotronic Technology Co., Ltd. Xiang Lei
K192410 09/04/2019 ZS3 and z.one pro Ultrasound Systems ShenZhen Mindray Bio-Medical Electronics Co., Ltd Jiang Haosen
K192547 09/17/2019 MAGLUMI 2000 HCG/?-HCG Shenzhen New Industries Biomedical Engineering Co., Ltd Jie Rao
K192608 09/20/2019 Disposable SpO2 Sensor Shenzhen SINO-K Medical Technology Co., Ltd. Lao Chengxin
K192499 09/11/2019 Cyber Blade Sidam s.r.l Andrea Tromba
K192790 09/30/2019 Atellica IM Total hCG (ThCG) Siemens Healthcare Diagnostics Inc. Mey Lyn Vasquez
K192777 09/30/2019 ADVIA Centaur CA 15-3 assay Siemens Healthcare Diagnostics, Inc. Anoop Joy
K192788 09/30/2019 ADVIA Centaur Cortisol (COR) Siemens Healthcare Diagnostics, Inc. Ian Thompson
K192496 09/11/2019 Magnetom Sola, Magnetom Altea and Magnetom Sola Fit Siemens Medical Solutions USA Inc. Cordell L Fields
K192462 09/09/2019 syngo.MR Applications Siemens Medical Solutions USA Inc. Cordell L. Fields
K192763 09/30/2019 syngo.CT CaScoring Siemens Medical Solutions USA, Inc. Tabitha Estes
K192402 09/03/2019 syngo.CT Extended Functionality Siemens Medical Solutions USA, Inc. Alaine Medio
K192620 09/23/2019 SNA-001 Silver Photoparticle Topical Gel Sienna Biopharmaceuticals, Inc. Paul Lizzul
K192755 09/30/2019 Soli-Lite LG4 Galileo Silhouet-Tone Corporation Eric Ghedin
K192588 09/19/2019 G-EYE System SMART Medical Systems Ltd. Adva Yoselzon
K192443 09/06/2019 Dextile Anatomical Mesh Sofradim Production Benjamin Rochette
K192475 09/10/2019 NemoFAB Software Nemotec S.L. Carlos Arias
K192571 09/18/2019 NemoScan Software Nemotec S.L. Carlos Arias
K192671 09/26/2019 Hemostatic Xerogel Sponge Solaplus Biotech Co., Ltd. Xiangui Shen
K192651 09/24/2019 ZAGA Zygomatic System Southern Implants (Pty) Ltd Lauranda G Breytenbach
K192606 09/20/2019 SAC2 - Electrode Cream Spes Medica S.r.l. Giogio Facco
K192603 09/20/2019 Spes Medica Subdermal Needle Electrodes Spes Medica S.r.l. Giorgio Facco
K192526 09/13/2019 Spine Wave Navigated Instruments Spine Wave, Inc. Amy Noccioli
K192775 09/30/2019 Niobe« Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri Stereotaxis, Inc. Kenneth H. Lock
K192722 09/27/2019 Padlock Clip defect closure system, Padlock Pro-Select defect closure device STERIS Corporation Tony Piotrkowski
K192401 09/03/2019 Straumann Screw-Retained Abutments Straumann USA, LLC Jennifer M Jackson
K192675 09/26/2019 VariAx Foot Stryker GmbH Jemin Dedania
K192429 09/05/2019 Dental Pain Eraser Synapse Dental Cosmo Haralambidis
K192615 09/23/2019 Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) Synovis Life Technologies, Inc. (Baxter International Inc.) Megan Sajjad
K192702 09/27/2019 DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Synthes (USA) Products LLC Jeffrey Krawiec
K192655 09/25/2019 Depuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products LLC Satapa Dhamankar
K192745 09/30/2019 DePuy Synthes Trauma Screws Synthes (USA) Products LLC / DePuy Orthopaedics Inc Keith Knapp
K192623 09/23/2019 LipiFlow Thermal Pulsation System TearScience Inc. Michelle Ricafort
K192490 09/11/2019 Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch Teleflex Medical Robin Haden
K192729 09/27/2019 Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific Cynthia Knapp
K192598 09/20/2019 Bashir S-B Endovascular Catheter Thrombolex, Inc. Amy Katsikis
K192388 09/03/2019 SonoVision Ultrasound Imaging System Tissue Differentiation Intelligence, LLC Christian Zaal
K192792 09/30/2019 TranS1 AxiaLIF Plus System TranS1 Kristen Allen
K192504 09/12/2019 Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. Rachel Osbeck
K192696 09/26/2019 TriMed ASET Foot Plating System TriMed, Inc. David Medoff
K192596 09/20/2019 ULab Systems Dental Aligner Kit uLab Systems, Inc. Charlie Wen
K192733 09/27/2019 RelieforMe TENS/EMS Device Model UPK-GE01 Umeheal Ltd. Rui Lin
K192647 09/24/2019 neria guard Infusion Set Unomedical a/s Mette Busk Henningsen
K192518 09/13/2019 Reusable Monopolar Active Cord US Endoscopy Gregory Land
K192424 09/05/2019 Mobius3D Varian Medical Systems, Inc Peter J. Coronado
K192454 09/09/2019 Wattson Temporary Pacing Guidewire Vascular Solutions Nancy Frame
K192511 09/12/2019 Venner PneuXÖ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 9.0 mm Venner Medical (Singapore) PTE Ltd Adrian P Waterton
K192415 09/04/2019 Study Watch with Irregular Pulse Monitor Verily Life Sciences LLC Connie Pascual
K192607 09/20/2019 LiteWalk Viasonix Ltd. Shlomi Deler
K192465 09/09/2019 DigiFix Sterile Kit Virak Orthopedics, LLC Virak Tan
K192757 09/30/2019 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor û bag of 20, VitalPatch 7D Biosensor û bag of 20 VitalConnect, Inc. Cynthia Merrell
K192559 09/17/2019 Acetabular Bone Screws (for MobileLink Acetabular Cup System) Waldemar Link GmbH & Co. KG Karen Sonnenberger
K192439 09/06/2019 JETi Peripheral Thrombectomy System Walk Vascular, LLC David Look
K192463 09/09/2019 PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border Winner Medical Co., Ltd. Dan Wang
K192425 09/05/2019 Hair Boom 69, Hair Boom Air, Ulike Hair UpUp Won Tech Co., Ltd. Jake Yu
K192635 09/23/2019 Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) WRP ASIA PACIFIC SDN BHD Hasnah Abdul Hamid
K192579 09/19/2019 X-Guide Surgical Navigation System X-Nav Technologies, LLC Fred Cowdery
K192637 09/24/2019 High Strength Suture Yunyi (Beijing) Medical Device Co., LTD Xiaowei Liu
K192478 09/10/2019 LT Antibacterial Alginate with Silver Dressing Zhejiang Longterm Medical Technology Co., Ltd. Claudia Zsang
K192416 09/04/2019 BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System Zimmer GmbH Roberto Tommasini
K192660 09/25/2019 Zimmer M/L Taper Hip Prosthesis Zimmer, Inc. Caleb Barylski


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