FDA 510(k) Decisions During November, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K181643 11/16/2018 SmartBag (SmartPouch) 11 Health Technologies Limited Michael Seres
K183159 11/26/2018 3M Clarity Aligners 3M Company Yanine Garcia-Quezada
K181381 11/23/2018 A.B. Dental Devices Dental Implants System A.B Dental Device Ltd. Gabi Krauss
K182687 11/23/2018 Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System ACCURAY INCORPORATED Keith Picker
K181911 11/02/2018 Interlude 100% Cotton Tampon ALBAAD fem Shlomo Helvits
K181454 11/21/2018 DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal Alcon Laboratories, Inc. Sherri Lakota
K182988 11/29/2018 Afinion HbA1c Dx on Afinion 2 Alere Technologies AS Monica Vallestad
K180207 11/28/2018 Non-contact Infrared Thermometer Alicn Medical (Shenzhen), Inc Meisong Fang
K182808 11/09/2018 Aspida« Anterior Lumbar Plating System Alphatec Spine, Inc. Ruby Zheng
K182746 11/27/2018 ATEC ALIF and LLIF Spacer System Alphatec Spine, Inc. Cynthia Adams
K181286 11/30/2018 Ambu aScope RLS Slim Ambu A/S Camilla Wismar
K182083 11/09/2018 Catalys Precision Laser System AMO Manufacturing USA, LLC James Patrick Garvey II
K180650 11/15/2018 Amsel Endo Occluder Amsel Medical Corporation Yoram Levy
K182992 11/28/2018 BGM014 Blood Glucose Monitoring System Apex Biotechnology Corp. Lisa Liu
K181123 11/21/2018 ApnoDent Appliance ApnoMed, Inc. Joseph Yousefian
K182090 11/16/2018 AposTherapy System APOS Medical Assets Ltd. Cliff Bleustein
K182653 11/14/2018 Voyant Maryland Fusion Device Applied Medical Resources Corp. Andrew Nguyen
K182815 11/30/2018 XVWeb 3D Apteryx, Inc. Mark Gniewek
K182779 11/21/2018 ARK EDDP Assay ARK Diagnostics, Inc. Cherry Mun
K182391 11/30/2018 ASI Automated ASI RPR Test for Syphilis on the ASI Evolution Arlington Scientific, Inc. (ASI) David Binks
K180395 11/09/2018 EZ-IO Intraosseous Vascular Access System Arrow International, Inc. (Subsidiary of Teleflex, Inc.) Frank Pelc
K180430 11/23/2018 Digistat Smart Central ASCOM UMS srl unipersonale Paolo Burchietti
K182248 11/13/2018 Aspire Venting Tube Aspire Bariatrics, Inc Monica Ferrante
K181288 11/05/2018 Athelas One Athelas Inc. Tanay Tandon
K182418 11/29/2018 V3 Segmental Plating System Atlas Spine, Inc. Thomas Smith
K182565 11/09/2018 AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. Jonathan McElwee
K181140 11/16/2018 Axis Chena Cervical PEEK Spacer System Axis Orthopaedics Craig Wilcox
K182255 11/15/2018 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) Aziyo Biologics, Inc. Wendy Perreault
K180801 11/05/2018 Actreen Hi-Lite Cath, Actreen Hi-Lite Set B. Braun Medical Inc. Anita J. Nemeth
K182249 11/30/2018 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Bausch & Lomb Incorporated Barbara Klube-Falso
K182276 11/01/2018 MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit Bayer Medical Care Inc. Katie Dillon
K182273 11/01/2018 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Bayer Medical Care Inc. Lisa A. Ewing
K181427 11/29/2018 BD MAX Enteric Viral Panel, BD MAX Instrument Becton, Dickinson and Company Laura Stewart
K181221 11/30/2018 BD PhaSeal Optima Closed System Transfer Device Becton, Dickinson and Company Amy Honey
K182600 11/30/2018 Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Better Care Plastic Technology Co., Ltd Zhu Chuyan
K182270 11/02/2018 Cellene CO2 Laser System Bio-Med USA Inc. Young Chi
K180966 11/09/2018 FilmArray Pneumonia Panel BioFire Diagnostics, LLC Kristen J. Kanack
K181324 11/15/2018 FilmArray Pneumonia Panel plus BioFire Diagnostics, LLC Kristen J. Kanack
K182764 11/27/2018 Biop Digital Colposcope Biop Medical Ltd. Ilan Landesman
K182030 11/08/2018 Faros Mobile Bittium Biosignals Ltd. Taneli Vaaraniemi
K182338 11/09/2018 Blue Sky Bio Computerized Orthodontic Bracket System Blue Sky Bio Albert Zickmann
K180343 11/16/2018 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer Bonraybio Co., Ltd. Clare Huang
K182169 11/27/2018 AdVance XP Male Sling Boston Scientific Corporation Kaitlyn Rainbow
K182324 11/26/2018 EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit BTG International, Inc. Benjamin Hornsey
K181497 11/14/2018 HPM-6000UF BTL Industries, Inc. David Chmel
K182427 11/02/2018 Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K181646 11/16/2018 Celesteion, PCA-9000A/3, V6.5 Canon Medical Systems Corporation Paul Biggins
K183013 11/26/2018 Vitrea Software Package, VSTP-001A Canon Medical Systems Corporation Paul Biggins
K182596 11/02/2018 Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System Canon Medical Systems Corporation Paul Biggins
K181667 11/29/2018 Thoraguard System Centese, Inc. Evan Luxon
K182967 11/23/2018 Visor System Cerebrotech Medical Systems, Inc. Dawnel Scott
K180683 11/07/2018 Certa Dose Pediatric Midazolam 5mg/mL IM Syringe Certa Dose, Inc. Caleb Hernandez
K182306 11/22/2018 Sunkingdom Slit Lamp Chongqing Sunkingdom Medical Instrument Co Ltd Joy Tse
K181292 11/15/2018 PrimeSightÖ UNITY 9000 Video Processor, PrimeSightÖ UNITY 9100 Video Processor Cogentix Medical, Inc. Christa Blaisdell
K181963 11/14/2018 ostaPek Interbody Fusion Cages coLigne, AG Robert Lange
K182757 11/29/2018 Espire Elbow Pro, Espire Elbow Hybrid College Park Industries, Inc. Deborah Mackmin
K180469 11/06/2018 ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent Coloplast Corp Cori Ragan
K182134 11/26/2018 ARiX RAD Radiographic System Compania Mexicana De Radiologia CGR, S.A. DE C.V. Tonatiuh Monroy Soberon
K182882 11/14/2018 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control Conmed Corporation Orjada Dervishleri
K182304 11/23/2018 Hyper GP (tisilfocon A) Daily Wear Contact Lens CONTAMAC LTD. Rob McGregor
K180792 11/30/2018 Arterial Pressure Monitoring Set/Tray Cook Incorporated Johnathan Liu
K181757 11/06/2018 G?nther Tulip« Vena Cava Filter Retrieval Set Cook Incorporated Steven Lawrie
K180557 11/23/2018 Greene Renal Transplant Stent Set Cook Incorporated Yuan Zhou
K182980 11/16/2018 Zilver 518 Biliary Stent, Zilver 635 Biliary Stent Cook Ireland Ltd Cathrina McHale
K183038 11/26/2018 Corin Optimized Positioning System (OPS) Plan Corin USA Lucinda Gerber
K182772 11/19/2018 Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil Covidien Jennie van Diemen
K182451 11/06/2018 BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider Covidien, LLC Rebecca Clark
K181434 11/14/2018 SporView Rapid Read Biological Indicator SteamPlus Test Pack Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar
K182220 11/07/2018 Curbell branded Patient Monitoring Cables Curbell Medical Products, Inc. Michael Winter
K180247 11/01/2018 DAEHAN Adhesive Surface Electrodes Daehan Medical Systems Co., Ltd. Da Pin Jeong
K180184 11/16/2018 Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System Dentalpoint AG Anja Lieberherr
K182288 11/20/2018 TPH Spectra ST Flowable Composite Restorative Dentsply Sirona Karl Nittinger
K182405 11/02/2018 Dexcom Pro Q Continuous Glucose Monitoring System Dexcom, Inc Luke Olson
K182467 11/07/2018 Simplexa GBS Direct, Simplexa GBS Positive Control Pack DiaSorin Molecular LLC Sharon Young
K182329 11/08/2018 SureCure Orthodontic Aligner System Digital Orthodontic Care Jeff Sheppard
K182977 11/21/2018 Isolette 8000 Plus Draeger Medical Systems, Inc. Karen Otrupchak
K182245 11/30/2018 EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System Edwards Lifesciences, LLC Christine Chun
K180881 11/16/2018 HemoSphere Advanced Monitor, HemoSphere Pressure Cable Edwards Lifesciences, LLC Chirag Shah
K181684 11/08/2018 VAMP Plus Venous/Arterial Blood Management Protection System Edwards Lifesciences, LLC Ye Seul Kim
K182369 11/27/2018 gammaCore Sapphire Electrocore, Inc. Mike Romaniw
K182444 11/06/2018 ERBEFLO Olympus Scope Port Connector Erbe USA, Inc. John Tartal
K181886 11/14/2018 VivaSight-DL System ETView Ltd. Yoram Levy
K181880 11/29/2018 VivaSight-SL (TVT) system ETView Ltd. Yoram Levy
K182462 11/08/2018 Exactech Alteon Highly Polished Femoral Stem Exactech, Inc. Zach Sharrah
K182346 11/26/2018 TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Exactech, Inc. Meredith May
K180047 11/08/2018 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System Fiab SpA Alberto Calabro
K182663 11/30/2018 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System FineMEC Co., Ltd. William H. McGrail
K180363 11/01/2018 Clear-Tip EUS-FNA Finemedix Co. Ltd. Heon Sik Lee
K182684 11/23/2018 HammerTechTM Fixation System Fusion Orthopedics, LLC Eli Jacobson
K180917 11/20/2018 GC Acrylic Primer GC America Inc. Mark Heiss
K181403 11/02/2018 Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR GE Healthcare Michel Genuer
K181985 11/15/2018 Voluson E6, Voluson E8, Voluson E10 GE Healthcare Bryan Behn
K182626 11/16/2018 OEC One GE Hualun Medical Systems Co., Ltd. Lifeng Wang
K181934 11/06/2018 Vivid T8, Vivid T9 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K182277 11/21/2018 Versana Premier GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K182838 11/08/2018 Geistlich Derma-Gide Geistlich Pharma AG Marco Steiner
K180840 11/30/2018 UNO Negative Pressure Wound Therapy System Genadyne Biotechnologies, Inc. Andrew Goh
K181846 11/06/2018 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolu Globus Medical Inc. Lori Burns
K180495 11/30/2018 Tinnitus Sound Generator Module GN Hearing A/S Lars Hagander
K180463 11/14/2018 Apoller Flow Light Cure Flowable Composite Greenway YW LLC Scott Yin
K181696 11/30/2018 ChitoZolve Gyrus ACMI, Inc Dolan Mills
K182528 11/15/2018 Nitrile Glove Powder Free Black Haining Medical Products Co., Ltd. Zhiming Yao
K180645 11/16/2018 Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) Hartalega Sdn Bhd Mr. Kuan Kam Hon
K180786 11/02/2018 Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff HARTALEGA SDN. BHD. Kuan Kam Hon
K181297 11/21/2018 DENTIOIII series (DENTIOIII, DENTIOIII-S) HDX WILL CORP. Lee Myoung-Joon
K183009 11/26/2018 HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES Hemostatix Medical Technologies, LLC Jeff Cobb
K181604 11/28/2018 Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite HRS Co., Ltd. Seunghwan Go
K181273 11/01/2018 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K181939 11/06/2018 icobrain icometrix NV Jan Verheyden
K182298 11/16/2018 hemochroma PLUS System Immunostics, Inc. Junghee Kim
K181897 11/15/2018 Reprocessed Marinr Diagnostic EP Catheter Innovative Health, LLC. Amanda Babcock
K182265 11/20/2018 CodMan Certas Plus Programmable Valve Integra LifeSciences Corp. Nancy MacDonald
K182801 11/27/2018 Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable Integra LifeSciences Corporation Jennifer Siu
K181639 11/02/2018 Panta 2 Arthrodesis Nail System Integra Lifesciences Corporation Blesson Abraham
K180732 11/08/2018 MiroCam Capsule Endoscope System IntroMedic Co., Ltd. Jinyoung Lee
K181090 11/14/2018 Invacare« Solara« 3G and Solara« 3G Spree Manual Wheelchairs Invacare Corporation Elijah N. Wreh
K181806 11/20/2018 ARIX Sternal System Jeil Medical Corporation Ahhyeon Woo
K180546 11/21/2018 Jet Power Injectable PICC Jet Medical, Inc. Courtney Nix
K182649 11/09/2018 Enteral Feeding Syringes with Enfit Connectors Jiangsu Kangbao Medical Experiment Co., Ltd Qian Li
K182498 11/30/2018 Advanced Skin Renewing Device Jiangsu Unimed Laser Technology Co., Ltd. Simon Wang
K181890 11/09/2018 Brainlab Compatible K2M Navigation Instruments K2M Nancy Giezen
K182182 11/15/2018 YUKON OCT Spinal System K2M Nancy Giezen
K180665 11/28/2018 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2M, LLC. Nancy Giezen
K182652 11/20/2018 COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 Kangfu Medical Equipment Factory Zelong Cao
K182696 11/20/2018 Telepack X LED KARL STORZ Endoscopy-America, Inc Winkie Wong
K182162 11/07/2018 OptiBond eXTRa Universal Kerr Corporation Mohammad Saad Ansari
K181469 11/09/2018 Cryotop«US-flash and Cryotop«US-scoop Kitazato Corporation Futoshi Inoue
K182431 11/26/2018 Konicaminolta DI-X1 Konica Minolta, Inc. Tsutomu Fukui
K181750 11/15/2018 SITZMARKS Konsyl Pharmaceuticals Frank Gunsallus III
K181857 11/20/2018 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Kossan International Sdn. Bhd. Cho Sow Fong
K182699 11/26/2018 Selethru PTCA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd. Zane Wang
K180607 11/23/2018 Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit KRONUS, Inc. Brian Deis
K183117 11/15/2018 PathLoc-L MIS Spinal System L&K Biomed Co., Ltd. Jihyeon Seo
K182674 11/13/2018 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Largan Medical Co., Ltd Amy Tien
K182523 11/01/2018 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan Medical Co., Ltd. Amy Tien
K182916 11/16/2018 Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr LeMaitre Vascular John N. Bradsher
K182380 11/28/2018 AEON Endoscopic Stapler Lexington Medical, Inc. Douglas MacBride
K182470 11/26/2018 Plateau Spacer System Life Spine Angela Batker
K182557 11/02/2018 MTS Eravacycline 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K183023 11/30/2018 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K183030 11/30/2018 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) Luminex Molecular Diagnostics, Inc. Tina Ip
K180180 11/02/2018 HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) M.I. Tech Co., Ltd. Inae Kim
K181559 11/09/2018 Neurosign V4 Intraoperative Nerve Monitor Magstim Company Ltd. Tom Campbell
K182077 11/02/2018 Mazor X System (Mazor X Stealth Edition) Mazor Robotics Ltd. Marina Hefetz
K181693 11/28/2018 SMS Femoral Stem Medacta International SA Stefano Baj
K180643 11/23/2018 MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) MedCu Technologies, Ltd. Gadi Borkow
K180415 11/02/2018 Invia White Foam NPWT Medela AG Georges Hakim
K182352 11/21/2018 SP-LINKÖ System Medical Designs LLC Kristi Vondra
K181820 11/01/2018 Medline Unite Mini Plates and Screws Medline Industries, Inc. Jennifer Mason
K181781 11/05/2018 DynaClipTM Bone Staple MedShape, Inc. Jack Griffis
K183174 11/26/2018 FlexCath Advance Steerable Sheath and Dilator Medtronic CryoCath LP Natalie Sadeghi
K182104 11/02/2018 NavLock Trackers, Robotic Reference Frame Medtronic Navigation Jainam Shah
K182121 11/02/2018 CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Medtronic Sofamor Danek USA, Inc. Erikka Edwardsen
K182957 11/21/2018 Heli-FX EndoAnchor System Medtronic Vascular, Inc. Janelle Wong Keller
K181918 11/08/2018 CardioInsight Cardiac Mapping System Medtronic, Inc. Janell Colley
DEN180040 11/30/2018 Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit Meridian Bioscience, Inc. Jack Rogers
K182559 11/05/2018 PREMIER Platinum HpSA PLUS Meridian Bioscience, Inc. Jack Rogers
K182216 11/06/2018 Merit Syringe Merit Medical Systems, Inc John Skousen
K182279 11/06/2018 Merit Syringe Merit Medical Systems, Inc. John Skousen
K181443 11/23/2018 Accula RSV Test Mesa Biotech, Inc. Barbara Stevens
K181689 11/15/2018 Nexcomp Meta Biomed Co., Ltd. Suk Song Oh
K182097 11/14/2018 React 71 Catheter Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K182101 11/14/2018 Riptide Aspiration System (React 71 Catheter) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K181819 11/06/2018 SMARTRELEASE Endoscopic Soft Tissue Release System MicroAire Surgical Instruments LLC Glenn Gerstenfeld
K182472 11/08/2018 Cepheid Xpert GBS LB Control Panel Microbiologics, Inc. Tina Sobania
DEN180030 11/19/2018 QMS Plazomicin Immunoassay Microgenics Corporation Minoti Patel
K181195 11/02/2018 ClearPoint System MRI Interventions, Inc. Pete Piferi
K181731 11/20/2018 MR Compatible Aspiration Kit MRI Interventions, Inc. Pete Piferi
K181137 11/16/2018 IT-III active System Neobiotech Co., Ltd. Young-Ku Heo
K182958 11/16/2018 1.5T 16ch Breast Coil NeoCoil, LLC Katie Gonzalez
K182195 11/09/2018 ArcoÖ-SA Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K181590 11/08/2018 Neurostructures Cavetto« [MAX] Cervical Cage System NeuroStructures, Inc. Kathleen Wong
K181709 11/16/2018 Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc. David Pezet
K181501 11/02/2018 Afina NeuroVision Imaging, LLC Pepe Davis
K182201 11/16/2018 StratumÖ Foot Plating System Nextremity Solutions, Inc. Adam Finley
K182508 11/13/2018 SaxxonyÖ Posterior Cervical Thoracic System Nexxt Spine LLC Andy Elsbury
K182616 11/02/2018 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System NinePoint Medical, Inc. Eman Namati
K182606 11/21/2018 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies ULC (now a part of Stryker) Agatha Szeliga
K181266 11/01/2018 Implantswiss Dental Implant System, Implantswiss Dental Abutment System Novodent SA Cem Kocer
K180550 11/20/2018 NuVasive Monolith Cervical Corpectomy System NuVasive, Incorporated Martin Yahiro
K180498 11/28/2018 NuVasive Reline Fenestrated Screws, High V+ Bone Cement NuVasive, Incorporated Martin Yahiro
K180668 11/15/2018 Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N Olympus Medical Systems Corp. Toshiyuki Nakajima
K182587 11/29/2018 Device Electrosurgical Generator ESG-150 Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K181992 11/09/2018 Heat Pain Pro Omron Healthcare, Inc. Renee Thornborough
K182481 11/09/2018 HEM-6410T-ZM Wrist Blood Pressure Monitor Omron Healthcare, Inc. Renee Thornborough
K182166 11/08/2018 Wrist Blood Pressure Monitor Model BP4350 Omron Healthcare, Inc. Renee Thornborough
K182127 11/02/2018 Wrist Blood Pressure Monitor Model BP6100 Omron Healthcare, Inc. Renee Thornborough
K182274 11/20/2018 Orbit Subretinal Delivery System Orbit Biomedical, Inc. Michael Keane
K182360 11/09/2018 Teleport Microcatheter OrbusNeich Medical Trading Inc. John Pazienza
K181112 11/26/2018 Orchestrate 3D Orchestrate 3D Todd Ehrler
K182096 11/02/2018 Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs Owens & Minor Halyard, Inc. Angela L. Bunn
K181396 11/16/2018 Oral Device OA, Oral Device S Passion for Life Healthcare (UK) Limited Paul Earps
K182181 11/29/2018 Persyst 14 EEG Review and Analysis Software Persyst Development Corporation Dari Darabbeigi
K182353 11/27/2018 EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay Phadia AB Carina Magnusson
K181831 11/15/2018 IntelliVue Multi-Measurement Module MMX Philips Medizin Systeme Boeblingen GmbH Stefan Breuer
K182857 11/09/2018 EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System Philips Ultrasound, Inc. Kym Rupp
K180918 11/30/2018 Planmed Verity Planmed Oy Lars Moring
K182581 11/21/2018 PlayMakar Sport Muscle Stimulator, Model PRO-500 PlayMakar Inc. Mike Williams
K182598 11/13/2018 VersaLinkÖ Fixation System Premia Spine Ltd. Ron Sacher
K181816 11/29/2018 Ceramic Denture Zirconia Ceramics Block Qinhuangdao Silide Ceramic Technology Co., Ltd Lou ChunHua
K180478 11/13/2018 RectalPro 75 Endorectal Balloon QLRAD International Ltd. Arjen Winkel
K182442 11/06/2018 MiniGuard Arterial Safety Valve Quest Medical, Inc. Tosan Onosode
K181948 11/16/2018 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil RAPID Biomedical GmbH Christian Zimmermann
K182218 11/30/2018 FerriSmart Analysis System Resonance Health Analysis Services Pty Ltd Celine Royet
K180573 11/23/2018 Responsive Arthroscopy Interference Screw System Responsive Arthroscopy LLC Doug Kohrs
K180949 11/08/2018 Steribite RJR Surgical, Inc. John Redmond
K182095 11/05/2018 Tina-quant Transferrin ver.2 (urine application) Roche Diagnostics Operations (RDO) Lindsay Jones
K182654 11/19/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card Safecare Biotech (Hangzhou) Co., Ltd. Alex Qiu
K180838 11/06/2018 SaliPen Saliwell Ltd. Ben Z. Beiski
K181998 11/15/2018 CardioBand ECG Event Recorder Samsung Semiconductor Inc. Bhupinder Singh
K181704 11/21/2018 Transpara ScreenPoint Medical BV Nico Karssemeijer
K180381 11/07/2018 Powder Free Vinyl Patient Examination Gloves Shanxi Hongjin Plastic Technology Co., Ltd Wu Zhigang
K182133 11/20/2018 Infrared Thermometer Shenzhen AOJ Medical Technology Co., Ltd. Qihuan Zhao
K182291 11/20/2018 6MP Color LCD Monitor (C61W+) Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K182530 11/09/2018 BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co.,Ltd. Wenhau Yan
K180432 11/19/2018 AI-ECG Platform Shenzhen Carewell Electronics., Ltd Chang Liu
K182603 11/14/2018 Z6 Diagnostic Ultrasound System Shenzhen Mindray Bio-medical Electronics Co., LTD Jiang Xiaoyong
K182715 11/20/2018 Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System Shenzhen Wisonic Medical Technology Co., Ltd. Jiang Xiaosan
K182983 11/27/2018 iFuse Implant System« SI-BONE, Inc. Roxanne Dubois
K182098 11/01/2018 N Latex FLC kappa assay, N Latex FLC lambda assay Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K181613 11/06/2018 MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D Siemens Medical Solutions USA, Inc. Cordell L. Fields
K182179 11/16/2018 AdvantageRib Anterior System SIG Medical Corp. Andrew Davison
K181759 11/09/2018 PowerDot PD-01MT Smartmissimo Technologies Pte Ltd Alexey Pisarev
K182535 11/19/2018 R3 Anteverted Liners Smith & Nephew, Inc. Meenakshi Gupta
K182109 11/16/2018 REDAPT Modular Acetabular Shell Smith & Nephew, Inc. Meenakshi Gupta
K183010 11/28/2018 Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks Smith & Nephew, Inc. Brad Sheals
K182543 11/14/2018 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package snap40 Ltd Edwin Lindsay
K180631 11/08/2018 Silk Voice Sofregen Medical, Inc. Anh Hoang
K180388 11/30/2018 Transcend 365 miniCPAP System Somnetics International, Inc. Eric Becker
K180979 11/16/2018 PureFlex Arterial Cannulae Sorin Group Italia S.r.l Luigi Vecchi
K181850 11/14/2018 Inversa Implants Southern Implants (Pty) Ltd Lauranda Breytenbach
K182484 11/09/2018 VERITON CT whole body SPECT/CT system Spectrum Dynamics Medical Ltd Igor Naroditsky
K181837 11/02/2018 Spinal Elements Ti-Bond coated devices Spinal Elements Inc. Julie Lamothe
K182604 11/14/2018 New Era Step Up Skin Laser, LLC Michelle Hokama
K182931 11/20/2018 VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag Steris Corporations Jennifer Nalepka
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K182105 11/14/2018 JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant United Consortium Stephanie Morris
K182909 11/21/2018 Roth Net Retriever Product Line United States Endoscopy Group, Inc. Carroll Martin
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K180601 11/02/2018 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) Villa Sistemi Medicali S.p.A. Paolo Casagrande Santin
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