FDA 510(k) Decisions During June, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K172556 06/29/2018 TubeClear System Actuated Medical, Inc. Michael T. Britton
K180988 06/08/2018 Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K172895 06/18/2018 AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 Ageless Health Industrial Co., Ltd Victor Wan
K172770 06/22/2018 AIROS 6 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K172779 06/22/2018 AIROS 8 Sequential Compression Device AIROS Medical, Inc. Darren Behuniak
K173225 06/15/2018 Interlude and private label Unscented 3-piece compact applicator tampon ALBAAD fem Shlomo Helvits
K181298 06/13/2018 Harmony XL Multi-Application Platform Alma Lasers Inc. Rekha Anand
K181281 06/11/2018 Altus Spine Pedicle Screw System Altus Partners, LLC Mark Melton
K172981 06/08/2018 Reusable SpO2 Sensors, Disposable SpO2 Sensors APK Technology Co., Ltd. Caifang Wang
K181141 06/27/2018 OverStitch Endoscopic Suturing System and Accessories Apollo Endosurgery Maritza Ward
K180026 06/01/2018 Bowel Management Device, Bowel Management Irrigation Set Applied Medical Technology, Inc. Michelle Scott
K181301 06/14/2018 Smart External Drain (SED) System Aqueduct Critical Care, Inc. Thomas Clement
K180191 06/05/2018 SuperBall Meniscal Repair System Arcuro Medical Ltd. Lee Ranon
K180427 06/06/2018 ARK Fentanyl Assay ARK Diagnostics, Inc. Cherry Mun
K173376 06/14/2018 ASI Evolution Arlington Scientific, Inc. (ASI) David Binks
K180594 06/22/2018 Knotless SutureTak Anchors Arthrex, Inc. Ivette Galmez
K181280 06/14/2018 Patello-Femoral Wave (Kahuna) Arthroplasty System Arthrosurface, Inc. Dawn J. Wilson
K180675 06/13/2018 Atlas Spine Expandable Cervical Interbody System Atlas Spine, Inc. Thomas Smith
K181474 06/28/2018 ArtiClip LAA Exclusion System AtriCure, Inc. Jonathan McElwee
K181465 06/25/2018 SpaceOAR System Augmenix, Inc. Marcus Garcia
DEN170004 06/22/2018 Ellipsys Vascular Access System Avenu Medical, Inc Rebecca K. Pine
K173803 06/11/2018 Omnican fine B. Braun Medical Inc. Kimberly Smith
K172831 06/12/2018 Perfusor« Space Syringe Infusion Pump System B.Braun Medical Inc Tracy Maddock
K173361 06/26/2018 IV Administration Set B.Braun Medical Inc. Nancy Skocypec
K173780 06/14/2018 EchoMD Automated Ejection Fraction Software Bay Labs, Inc. Charles Cadieu
K172783 06/12/2018 Access hs Tnl Beckman Coulter, Inc. Kerrie Sue Oetter
K172787 06/14/2018 Access hsTnl Beckman Coulter, Inc. Jennifer Lee Bennett
K180493 06/22/2018 A3 Total Knee System Beijing AK Medical Co., Ltd. Aiguo Liu
K172846 06/26/2018 Uterine Manipulator Beijing HangTian KaDi Technology R&D Institute Liying Zhang
K173066 06/22/2018 OSSEODUO Shaver and Drill System Bien-Air Surgery SA Adil Slimani
K180577 06/22/2018 BioPlex 2200 25-OH Vitamin D Kit Bio-Rad Laboratories Arlene Carillo
K181368 06/20/2018 VITEK 2 AST-YS Micafungin (<=0.06 - =>8 ?g/mL) bioMerieux, Inc. Jolyn Tenllado
K173139 06/19/2018 Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus Bionime Corporation Kay Wu
K173977 06/14/2018 CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module Biosense Webster, Inc. Phuong Chau
K180238 06/01/2018 CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT Biosense Webster, Inc. Phuong Chau
K180785 06/22/2018 iSLEEVE Introducer Set Boston Scientific Corporation Toni Guidarelli
K180726 06/18/2018 Savion DLVR Guidewire, Savion FLX Guidewire Boston Scientific Inc. Jake Baldauf
K181343 06/12/2018 HeartSee Cardiac P.E.T. Processing Software Bracco Diagnostics Inc. Patrice Marchildon
K180813 06/14/2018 BTL 799-2 BTL Industries, Inc. David Chmel
K181012 06/04/2018 BUHLMANN fCAL ELISA BUHLMANN Laboratories AG Alicja Ritz
K180560 06/18/2018 Sherlock 3CG+ T ip Confirmation System C.R. Bard, Inc. Christopher M. Phillips
K180724 06/25/2018 SPIRA Open Matrix LLIF Camber Spine Technologies LLC Sean S. Bishop
K180809 06/21/2018 Eclipse II Carestream Health, Inc Diane Koetter
K172725 06/08/2018 VT Dressing Kits Carilex Medical, Inc. Henry Kao
K180839 06/07/2018 AT 030 Carl Zeiss Meditec AG Christian Muenster
K180858 06/27/2018 CALLISTO eye Carl Zeiss Meditec AG Christian Muenster
K181348 06/20/2018 Cartiva SCI Disposable Instrumentation Set Cartiva, Inc. Tanya Eberle
K173259 06/13/2018 Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories Case Medical, Inc Tania Lupu
K180959 06/11/2018 Phenom 27 Catheter Cathera, Inc. Victor Ham
K172807 06/04/2018 Silicone Foley Catheter for single use Changzhou Rongxin Medicine Minimal Invasion Technology Ping Liu
K180800 06/01/2018 Colonic Plus Regular, Small, and Straight Shape Hydrokit Colonic Plus Rosa Alvarez
K180738 06/14/2018 COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter Compactcath, Inc. Naama S. Breckler
K173414 06/22/2018 Advance Biliary Balloon Catheter Cook Incorporated Colin Jacob
K181144 06/28/2018 Angled Tip Ureteral Catheter Cook Incorporated Chelsea Woods
K171609 06/04/2018 Check-Flo Performer Introducer Micropuncture Radial Artery Access Set Cook Incorporated Jennifer Allman
K181351 06/14/2018 Double Flexible Tipped Wire Guides Cook Incorporated Jennifer Allman
K173155 06/07/2018 Pakter Curved Needle Set Cook Incorporated Johnathan Liu
K172551 06/15/2018 Trinity PLUS Acetabular Shell Corin USA Limited Rachel King
K181085 06/21/2018 LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated Covidien James R. Davis
K181389 06/19/2018 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform Covidien Celso Duran
K181410 06/29/2018 MotoCLIP/HiMAX Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K172788 06/25/2018 MONETÖ Anterior Cervical Interbody Fusion Cage System CTL Medical Corporation Tosan Onosode
K180709 06/06/2018 truSculpt RF Device; truSculpt; truSculpt 3D Cutera, Inc. Brad Renton
K180674 06/25/2018 EVOL« ha-C Cervical Interbody Fusion System Cutting Edge Spine, LLC Kyle Kuntz
K172457 06/28/2018 Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM Deltex Medical Limited Mark Baylis
K181438 06/26/2018 Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay Diazyme Laboratories Inc. Abhijit Datta
K173975 06/01/2018 UF(II) Wide Fixture DIO Corporation Jiae Park
DEN170043 06/12/2018 DreaMed Advisor Pro DreaMed Diabetes, Ltd. Eran Atlas
K173164 06/29/2018 Ecolab POU Water Filter Ecolab Inc. Jennifer Willner
K172780 06/06/2018 SD1 Ultrasonic Pocket Doppler Edan Instruments Inc Alice Yang
K172721 06/07/2018 FOCAL ONE EDAP Technomed, Inc. Hugo Embert
K180766 06/11/2018 Endiscope, Endiscope Cervical Elliquence, LLC Paul D. Buhrke
K180640 06/04/2018 SmartClip Soft Tissue Marker Elucent Medical, Inc. Debra Kridner
K180904 06/08/2018 Sniper Infusion Catheter with Balloon Occlusion Embolx, Inc Greg Haistead
K181364 06/20/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K172346 06/19/2018 sterEOS Workstation EOS imaging Mathias Breuil
K173162 06/28/2018 GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide Ethicon, Inc Julie Tom Wing
K180829 06/28/2018 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh Ethicon, Inc Stephanie Saati
K171422 06/11/2018 Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color Ever Global (Vietnam) Enterprise Corp Jerry Lin
K181207 06/06/2018 Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Everyway Medical Instruments CO., LDT. Paul Hung
K180581 06/22/2018 UV Lamps for Sunlamp Products Feilo Sylvania Germany GmbH Achim Tonat
K181290 06/15/2018 Fusion Bx 2.0 Focal Healthcare Inc. Karen Zhou
DEN170089 06/05/2018 Curve Positive Airway Pressure System FRESCA Medical Mary Lou Mooney
K172121 06/07/2018 Digital Thermometer Fudakang Industrial Co., Ltd Bob Yu
K180995 06/25/2018 Vscan Extend GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K180152 06/22/2018 gel-e Flex gel-e, Inc. Elsa Abruzzo
K180188 06/07/2018 Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K172842 06/18/2018 GCE704 Breast Pump Globalcare Chiara Cavagnolo
K181068 06/29/2018 CREO« Stabilization System, REVERE« Stabilization System Globus Medical Inc. Kelly J. Baker
K180690 06/25/2018 Navigation Instruments Globus Medical Inc. Lori Burns
K180136 06/01/2018 BioNude Lubricant Good Clean Love, Inc. Wendy Strgar
K172765 06/01/2018 Smart Moves Complete Great Lakes Orthodontics Ltd David Graver
K172835 06/11/2018 GRI-Alleset Veress Needle GRI Medical and Electronic Technology Co., Ltd. Martin Paugh
K180646 06/27/2018 Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Halyard Health Christine L. Macauley
K180505 06/14/2018 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) Hartalega Sdn. Bhd. Kuan Kam Hon
K180364 06/27/2018 HD LifeSciences Cervical IBFD System HD LifeSciences LLC John Sullivan
K173028 06/21/2018 BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software HealthSTATS International Pte Ltd Ngak Hwee Chua
K173070 06/08/2018 HSW Resection Instruments Henke-Sass, Wolf GmbH Anna Reifschneider
K170835 06/15/2018 Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE Hightech Development Martin Boros
K172011 06/14/2018 LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) HMicro, Inc. Kim Tompkins
K180824 06/22/2018 VaPro 2 Intermittent Catheter Hollister Incorporated Michelle Schiltz-Taing
K180681 06/13/2018 Aptima Combo 2 Assay (Panther System) Hologic, Inc. Jeffrey Hergesheimer
K181121 06/28/2018 Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro Home Well Trading LTD Martin Gurovich
K180612 06/07/2018 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts Howmedica Osteonics Corp aka Stryker Orthopaedics Emily DiMambro
K181363 06/13/2018 EcoVue Sterile and Non-Sterile Ultrasound Gels HR Pharmaceuticals, Inc. Colby Wiesman
K180849 06/11/2018 Vinyl Examination Glove (Clear, Non-Colored) Huifu Trading Co., Ltd Kangkang Wang
K172821 06/11/2018 Ti-one 101 TS Dental Implant System Hung Chun Bio-S Co.,Ltd. Jethro Liou
K180729 06/28/2018 FaSet Fixation System Huvexel Co., Ltd Sung Hee-Lee
K172745 06/05/2018 ImmuGlo HEp-2 Elite IFA IMMCO Diagnostics, Inc. Kevin Lawson
K181113 06/15/2018 CoLinkÖ Afx Plating System In2Bones USA, LLC Rebecca Wahl
K180377 06/20/2018 Fracture and Correction System In2Bones USA, LLC Rebecca Wahl
K181325 06/17/2018 Aspiration Guide Catheter; Retraction Aspirator Inari Medical Eben Gordon
K180719 06/14/2018 InMode Diolaze System InMode MD Ltd. Amit Goren
K180189 06/01/2018 InMode System with Fractora3D/3D-90 Applicators Inmode MD Ltd. Amit Goren
K180710 06/19/2018 Reprocessed DecaNav Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amanda Babcock
K180975 06/25/2018 QUANTA Flash HMGCR Reagents Inova Diagnostics, Inc. Roger Albesa
K173961 06/05/2018 Straumann BLX Implant System Institut Straumann AG Viviana Horhoiu
K180791 06/21/2018 Straumann BLX Surgical Cassette Institut Straumann AG Anna Vianna
K180045 06/01/2018 Omnipod DASH Insulin Management System Insulet Corporation Matthew King
K173717 06/21/2018 Integra TITAN Reverse Shoulder System Integra LifeSciences Corporation Kathleen McGuire
K173577 06/07/2018 Guarded Luer Connector International Medical Industries Inc. Brandon Hunt
K180769 06/26/2018 SecurAcath Interrad Medical Inc Denise Lenz
K181316 06/14/2018 POGO Automatic Blood Glucose Monitoring System Intuity Medical, Inc. Robb Hesley
K173573 06/07/2018 Tetric CAD Ivoclar Vivadent AG Sandra Cakebread
K172938 06/14/2018 Disposable Sterile Needle Jiangsu Caina Medical Co., Ltd. Jun Lu
K172499 06/01/2018 NEOSHIELD JMS North America Corporation Sho Hosoki
K180847 06/19/2018 Neutrogena Light Therapy Acne Mask+ Johnson & Johnson Consumer Inc. Timothy Kline
K180856 06/19/2018 Neutrogena Light Therapy Aging Mask+ Johnson & Johnson Consumer, Inc. Cindy R. Abraham
K181119 06/26/2018 Range (Denali and Mesa) Spinal Systems K2M, Inc. Nancy Giezen
K180401 06/14/2018 TiWAVE-CÖ Porous Titanium Cervical Cage Kalitec Direct, LLC Scott Winn
K180855 06/01/2018 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System KCI USA, Inc. Kimberly McCoy
K151721 06/22/2018 FIJI SUN FLUORESCENT TANNING UNIT KDB INC. (DBA) SPERTI SUNLAMP JAMES SHEPERD
K173116 06/28/2018 KJ ZIRCONIA Implant System KJ Meditech Co., Ltd Hyukki Moon
K180722 06/11/2018 CAPERE Thrombectomy System KP Medcure, Inc. Samuel Shaolian
K181230 06/25/2018 Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA Largan Medical Co. Ltd. Amy Tien
K181232 06/29/2018 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co. Ltd. Amy Tien
K180447 06/04/2018 reVive Light Therapy LED Cleansing System LED Technologies, Inc. Lloyd Nelson
K172985 06/14/2018 Ligation Device Leo Medical Co., Ltd. Yunpeng Ma
K180885 06/20/2018 HairMax Laser Lexington International, LLC David Michaels
K180332 06/08/2018 17HK700G-W LG Electronics Jinhwan Jun
K180749 06/15/2018 Life Spine SIMPACT Sacroiliac Joint Fixation System Life Spine Inc. Randy Lewis
K180166 06/22/2018 Life Spine Lumbar Fixation System (SENTRY) Life Spine, Inc. Randy Lewis
K173700 06/19/2018 PICOPLUS Laser System Lutronic Corporation Jhung Won Vojir
K171798 06/01/2018 Silverwear Silver Pro Garment Device Media Plus, LLC Rita Vacco
K180720 06/27/2018 Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel Medibio Usa LLC. Jatin Rajani
K173348 06/21/2018 0.9% Sodium Chloride Injection, USP Medline Industries, Inc. Matt Clausen
K172954 06/15/2018 Medline Prevention CoolZone Gown Medline Industries, Inc. Pauline Maralit
K173787 06/11/2018 X-MESH« Expandable Cage System, OCELOT« Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE« System, CONCORDE« Inline Lumbar Interbody System, CONCORDE« Curve Lumbar Interbody Medos International SARL Sheree Geller
K180021 06/29/2018 Proton Positioing and Immobilization Devices MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radi Alena Newgren
K180122 06/07/2018 TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large) Medtronic, Inc. Nancy Cameron
K180325 06/01/2018 Single Use MultiClip Device Micro-Tech (Nanjing) CO., Ltd Becky Li
K180761 06/18/2018 SD LTM STIM Cortical Stimulator micromed S.p.A. Monica Camillo
K173330 06/01/2018 PanNAT STEC Test Micronics, Inc Karen Hedine
K173200 06/11/2018 SOFIA Plus Aspiration Catheter MicroVention, Inc. Naomi Gong
K180815 06/22/2018 MIM - SPECTRA Quant MIM Software Inc. Lynn Hanigan
K180282 06/22/2018 MIS Internal Hex Dental Implant System MIS Implants Technologies Ltd. Arbel Shezaf
K173856 06/26/2018 Express 4 Sleep appliance/CPAP Sidekick appliance Moses Appliances LLC Allen J. Moses
K181437 06/21/2018 Pure Vu System Motus GI Medical Technologies Ltd. Hagit Ephrath
K180100 06/14/2018 MRIaudio PREM System MRIaudio Joe Caruso
K173905 06/19/2018 Surgic Pro, Surgic Pro+ Nakanishi Inc. Kimihiko Satoh
K173815 06/29/2018 Allergan Botox Needle Electrode Natus Manufacturing Limited Maria Connolly
K180290 06/14/2018 Natus Brain Monitor Amplifier Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta
K173936 06/15/2018 Natus Photic Stimulator Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Sanjay Mehta
K180565 06/13/2018 PEAK NS033CF, PEAK NS017CF Neosil Co., Ltd Woo-ryong Ryou
K173725 06/26/2018 NeuMoDx GBS Assay NeuMoDx Molecular, Inc. Kay Fuller
K180306 06/08/2018 Nexy Next Sight srl Arianna Dalla Ba
K180608 06/05/2018 Lunoa System NightBalance BV Sophia Lam
K181202 06/06/2018 Sentry IVC Filter Novate Medical Ltd. Gordon Crowley
K180038 06/29/2018 NuVasive Pulse System NuVasive, Incorporated Olga Lewis
K180895 06/27/2018 Alleye Oculocare Medical AG Lucas Bachmann
K180449 06/08/2018 Single Use Aspiration Needle NA-U200H Olympus Medical Systems Corp. Toshiyuki Nakajima
K172909 06/07/2018 ELEVARE, PERFECTIO 4 Omm Imports d/b/a Zero Gravity Zivan Habibi
K180993 06/28/2018 Beacon Advanced CO2 Laser System OmniGuide, Inc Sam Wade
K180660 06/08/2018 Avanti Optovue, Inc. Indu Lakshman
K180921 06/28/2018 Sapphire II PRO Balloon Dilatation Catheter OrbusNeich Medical Trading Inc. John Pazienza
K180743 06/20/2018 Balanced Knee Revision System - Offset Junction Box Ortho Development Corporation Dan Petersen
K180459 06/07/2018 VERASENSE for Zimmer Biomet Persona OrthoSensor, Inc. Deborah Johnson
K180947 06/07/2018 Orthopantomograph OP 3D PaloDEx Group Oy Terho Turkumaki
K173032 06/07/2018 Paxman Scalp Cooler Paxman Coolers Limited Richard Paxman
K180008 06/20/2018 Penumbra System Penumbra, Inc. Richard Kimura
K181329 06/25/2018 EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay Phadia AB Carina Magnusson
K173507 06/15/2018 Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 Philips Healthcare (Suzhou) Co., Ltd. Gordon Shu
K181264 06/07/2018 QLAB Advanced Quantification Software Philips Ultrasound Inc. Penny Greco
K173503 06/11/2018 Pollogen Legend System Pollogen Ltd. Einat Shammai
K172483 06/21/2018 Kopac Sterile Needle Poonglim Pharmatech Inc. Cho Hee Min
K173189 06/08/2018 Lumfuse TP Precifit Medical Ltd Zhen Yu (Eric) Wu
K173053 06/06/2018 POWDER FREE LATEX EXAMINATION GLOVE Professional Latex Sdn Bhd Yoon Lim Kok
K181050 06/13/2018 Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) Qualimed SRL Tereza Uhrova
K180989 06/13/2018 PEDRA-17F Digital Flat Panel X-ray Detector Radisen Inc. John Lim
K180502 06/14/2018 S128 Anterior Lumbar Interbody Fusion (ALIF) System Renovis Surgical Technologies Inc. Anthony DeBenedictis
K180497 06/15/2018 Scone Mask ResMed Ltd Kim Kuan LEE
K173147 06/20/2018 SuperNO2VA Et Device Revolutionary Medical Devices, Inc. David M. Kane
K180583 06/28/2018 LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD Richard Wolf Medical Instruments Corporation Michael Loiterman
K180452 06/12/2018 White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim Riverstone Resources SDN BHD Suresh Kumar
K181492 06/22/2018 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K180481 06/29/2018 Servator B SALF Solution S.A.L.F. spa Carmelo Gagliano
K180701 06/25/2018 SafePath Suturing System SafePath Medical, Inc. Howard L. Schrayer
K181436 06/22/2018 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test Sekisui Diagnostics, LLC Shelly Harris
K173156 06/08/2018 Integrated CardioRespiratory System Sensydia, Inc. Thomas Bruggere
K181413 06/27/2018 uDR 592h, uDR 596i Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K180926 06/06/2018 uMR 560 Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K180925 06/06/2018 uMR 570 Shanghai United Imaging Healthcare Co.,Ltd. Shumei Wang
K180260 06/12/2018 Powder Free Vinyl Patient Examination Gloves (Yellow, White) Shanxi Hongjin Plastic Technology Co., Ltd Wu Zhigang
K181051 06/22/2018 IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm Shape Memory Medical Meghan Reu
K180331 06/22/2018 Wireless Pain Relieve Device Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan
K173045 06/05/2018 Oximeter Shenzhen Greatmade Tech limited Mei Mei
K170886 06/21/2018 HOMED Mesh Nebulizer Shenzhen Homed Medical Device Co,.Ltd. Shengming Shi
K180956 06/07/2018 Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator Shenzhen Roundwhale Technology Co., Ltd. Kevin Zhang
K180454 06/27/2018 Shockwave Medical Intravascular Lithotripsy (IVL) System Shockwave Medical, Inc. Plessy Paul
K180649 06/11/2018 BeautiCem Veneer Kit Shofu Dental Corporation Mauro Malzyner
K181279 06/13/2018 Ysio Max Siemens Medical Solutions, Inc. Denise Adams
K180661 06/05/2018 SIGMA Sterilization Pouch and Roll Sigma Medical Supplies Corp. Mason Huang
K180672 06/06/2018 Sterilization Pouch/Roll Made with Tyvek Sigma Medical Supplies Corporation Mason Huang
K181271 06/13/2018 Signature Orthodontic System Signature Orthodontics Alfred Charles Griffin
K172961 06/11/2018 LIAC HWL Sit Sordina Iort Technologies Spa Alessia Giaffreda
K180134 06/29/2018 Ensizor Monopolar Endoscopic Scissors Slater Endoscopy, LLC John Starkey
K180124 06/12/2018 ZQuiet Sleeping Well,LLC Daniel Webster
K172823 06/12/2018 Portex NRFit Epidural Needles Smiths Medical ASD, Inc. Sunita Teekasingh
K172410 06/01/2018 Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters Smiths Medical ASD, Inc. Michael R. Johnson
K172800 06/14/2018 Portex« Lancet Point Spinal Needles with NRFitÖ connectors, Portex« Pencil Point Spinal Needles with NRFitÖ connectors Smiths Medical ASD, Inc. Michael R. Johnson
K180621 06/06/2018 EchoMark, EchoMark LP Sonavex, Inc. David Narrow
K180472 06/19/2018 ViSi Mobile Monitoring System Sotera Wireless, Inc. Lan Herrington
K173706 06/08/2018 Piccolo Implants and Accessories Southern Implants (Pty) Ltd. Lauranda Breytenbach
K172536 06/20/2018 Atlas Percussion Adjusting Instrument Spinalight, Inc Stanford Pierce
K181203 06/28/2018 Juliet Ti Spineart Frank Pennesi
K173574 06/26/2018 DenSeeMammo Statlife Stephane Ragusa
K181429 06/13/2018 CELERITY 20 HP Biological Indicator STERIS Corporation Anthony Piotrkowski
K181442 06/13/2018 VERIFY Assert Self-Contained Biological Indicator STERIS Corporation Anthony Piotrkowski
K180500 06/04/2018 VariAx 2 System Stryker GmbH Paul Nelson
K180436 06/06/2018 T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System Stryker Trauma GmbH Heike Gustke
K180985 06/08/2018 Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses Supervision Optimax SDN BHD Yap Peak Geeh
K173455 06/14/2018 SurgTech Bipolar Head System SurgTech, Inc., Xuegong Yu
K180389 06/29/2018 Venera 508 Deep Vein Thrombosis (DVT) Prevention System Suzhou Minhua Medical Apparatus Supplies Co. Ltd. Michael Ying
K172068 06/01/2018 Kenz Cardico1211 Suzuken Co.,Ltd. Eiji Yamaguchi
K180593 06/05/2018 Vbeam Prima Laser System Syneron-Candela Sharon Timberlake
K172975 06/21/2018 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins û MR Conditional, DePuy Synthes Variable Angle Positioning Pins û MR Conditional, DePuy Synthes Wire Mount û MR Conditional, DePuy Synthes Cerclage Positioning Pin û MR Conditional Synthes (USA) Products LLC/DePuy Orthopaedics Inc Suchitra Basu
K181093 06/12/2018 SyMRI SyntheticMR AB Maria Almesaker
K172234 06/01/2018 Oxygen Concentrator SysMed (China) Co., Ltd Jian Yue
K172221 06/06/2018 VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 TaiDoc Technology Corporation Anne Kuo
K173093 06/05/2018 TAMA BEMS device TAMA Research Corporation Ali Shambayati
K181358 06/20/2018 Televere Digital Dental Imaging System Televere Systems, Inc. Randell Quaal
K180818 06/13/2018 Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) Tenon Medical, Inc. Kal Mentak
K173908 06/15/2018 DESS Dental Smart Solutions Terrats Medical SL Roger Terrats
K180950 06/22/2018 Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) Terumo Cardiovascular Systems Corporation Adam Pickholtz
K173821 06/05/2018 LungQ Software Thirona Corporation Eva van Rikxoort
K173316 06/19/2018 SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device TransMed7, LLC James Vetter
DEN160006 06/22/2018 everlinQ endoAVF System TVA Medical, Inc. Noah Bartsch
K180712 06/06/2018 Coconut Infused Hybrid Personal Lubricant United Consortium Stephanie Morris
K172833 06/12/2018 E-XPE Acetabular Components and U-Motion II Acetabular Cup United Orthopedic Corporation Gimpel Chien
K181404 06/28/2018 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Varian Medical Systems, Inc. Peter J. Coronado
K172586 06/22/2018 Vios Monitoring SystemÖ Model 2050 Vios Medical, Inc. Amit Patel
K180911 06/20/2018 Visura Technologies TEECAD System Visura Technologies, LLC Eric Sandberg
K172345 06/18/2018 IU Implant System Warantec Co.,Ltd. Dong-Hwa Jang
K180832 06/06/2018 SALVATION External Fixation System Wright Medical Technology, Inc. Rachel Roberts
K173595 06/22/2018 Shear Wave Quantificational Ultrasound Diagnostic System Wuxi Hisky Medical Technologies Co., Ltd. Jinhua Shao
K170826 06/22/2018 Perfadex Plus XVIVO Perfusion AB Kathleen Johnson
K180617 06/01/2018 Hair Up Y&J BIO Co, Ltd., Kwang Sic Kim
K172983 06/13/2018 HealthCCS Zebra Medical Vision Ltd. Matan Neeman
K172763 06/04/2018 Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Zhejiang Kindley medical devices Co.,Ltd Yong Zhang
K180861 06/13/2018 Vinyl Examination Glove (Clear, Non-Colored) Zhicheng Trading Co., Ltd. Chong Zhao
K180562 06/28/2018 TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT Zirkonzahn Gmbh Julian Steger
K181484 06/18/2018 Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue Zirkonzahn Srl Sandra Leitner
K180865 06/28/2018 ZMI Self-Adhesive Electrodes ZMI Electronics, Ltd. Wayne Chen
K171197 06/30/2018 Zuga Dental Implant System Zuga Medical, Inc. Chan Wang


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