FDA 510(k) Applications Received During June, 2017

FDA 510(k) Number Submission Date Device Name Applicant Contact
K171908 06/26/2017 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing 3M Company Melissa Forth
K171634 06/02/2017 Ortho System 3Shape A/S Antje Marquardsen
K171941 06/28/2017 FreeStyle Precision Neo Blood Glucose Test Strips Abbott Diabetes Care Inc. Danielle Tayor
K171650 06/05/2017 Alere Afinion HbA1c and ACR on Afinion 2 analyzer Abbott Rapid Diagnostics Monica Vallestad
K171761 06/14/2017 ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. James Patrick Garvey II
K171687 06/07/2017 Relieva SpinPlus Nav Balloon Sinuplasty System Acclarent, Inc. James Patrick Garvey II
K171837 06/20/2017 TomoTherapy Treatment Delivery System with iDMS Accuray Incorporated Keith Picker
K171646 06/05/2017 ACISTCVi« Contrast Delivery System ACIST Medical Systems, Inc. Melissa Sommerfeld
K171629 06/02/2017 ABCcolla Bone Graft ACRO Biomedical Co., Ltd. Dar-Jen Hsieh
K171606 06/01/2017 AOS Anterolateral Proximal Humeral Plate Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K171720 06/12/2017 encevis AIT Austrian Institute of Technology GmbH Tilmann Kluge
K171792 06/16/2017 Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit Alere Scarborough, Inc. Angela Drysdale
K171816 06/19/2017 Kardia Band System AliveCor, Inc Prabhu Raghavan
K171876 06/23/2017 Ceramill Zolid HT+ white Amann Girrbach AG Debora Engel
K171857 06/21/2017 AMSure« Enteral Feeding Syringe with ENFit Tip Amsino International, Inc. Cathy Hong
K171921 06/27/2017 VenaCure EVLT NeverTouch Procedure Kit AngioDynamics, Inc. Hans Kjolhede
K171863 06/22/2017 Anjon Bremer Halo System Anjon Holdings, LLC Tommy Mitchell
K171737 06/12/2017 Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves Ansell Healthcare Products LLC Robert Mahler
K171886 06/26/2017 OverStitch SX Endoscopic Suturing System (ESS) Apollo Endosurgery Inc Maritza Ward
K171701 06/08/2017 GelPOINT Path Transanal Access Platform Applied Medical Resources Corp. Corinne Weisheit
K171684 06/07/2017 Epix Electrosurgical Probe with Smoke Evacuation Applied Medical Resources Corporation Aditi Iyengar
K171841 06/20/2017 Arthrex Shoulder System Arthrex Inc. David L. Rogers
K171613 06/01/2017 ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K171933 06/28/2017 ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter Asahi Intecc Co., Ltd. Yasuyuki Kawahara
K171812 06/19/2017 Nio Color 2MP (MDNC-2123) Barco NV Helena Soenen
K171953 06/29/2017 Bard Mission Disposable Core Biopsy Instrument Bard Peripheral Vascular, Inc. Susan Sheffield
K171671 06/06/2017 Prismaflex System 8.10 Baxter Healthcare Corporation Rick Lukacovic
K171802 06/19/2017 ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) Bayer HealthCare LLC Cindy R. Abraham
K171898 06/26/2017 Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs Better Care Plastic Technology Co., Ltd Zhu Chunyan
K171793 06/16/2017 Sequential Circulator SC-2004FC-OC Bio Compression Systems, Inc. Barbara J. Whitman
K171664 06/05/2017 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software Bio-Rad Laboratories, Inc. Sweta Patel
K171822 06/19/2017 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) Biotest Medical Corporation Fred Lee
K171785 06/15/2017 WowGoHealth Blood Glucose Monitoring System Biotest Medical Corporation Fred Lee
K171851 06/21/2017 SOFTXIL BISTOOL Eunhyun Bae
K171782 06/15/2017 Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy drugs Blue Sail Medical Co.,Ltd Robin Liu
K171648 06/05/2017 BM.IRIS Bluecore Co.,Ltd. Bill Choi
K171893 06/26/2017 Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) Bluestone Synergy Lisa Peterson
K171612 06/01/2017 ACUITY Pro Lead Delivery System Boston Scientific Corporation Lori Berends
K171809 06/19/2017 Epic Biliary Endoscopic Stent System Boston Scientific Corporation Thomas Hirte
K171913 06/26/2017 Rubicon 14, 18 and 35 Support Catheters Boston Scientific Corporation Ka Zoua Xiong
K171922 06/27/2017 Anatotemp Anatomic Dental Implant Healing Abutment Buckeye Medical Technologies LLC Terry B. Philibin
K171735 06/12/2017 PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set C.R. Bard, Inc. Jeremy Tidwell
K171751 06/13/2017 SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module Capsule Technologie, SAS James Hodge
K171957 06/29/2017 MaxZero Extension Sets with Needless Connector Carefusion 303 Inc. Viviana Lai
K171956 06/29/2017 Sterile Endoscope Biopsy Sampling Needle Changzhou Detain Medical Devices Co., Ltd. Zhengrong Ding
K171686 06/07/2017 Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System Choice Spine Kim Finch
K171877 06/23/2017 SLM-1ER, SLM-2ER, SLM-3ER Chongqing Kanghua Ruiming S&T Co., Ltd. Xi You
K171835 06/20/2017 Irradiation Aesthetic Device Chongqing Peninsula Medical Technology Co., Ltd. Zhang Sudi
K171639 06/02/2017 Trojan Supra Lubricated Polyurethane Male Condom Church & Dwight Co., Inc. Lisa Burns
K171767 06/14/2017 Cianna Medical SAVI Scout Reflector and SAVI Scout System Cianna Medical, Inc. Gary Mocnik
K171637 06/02/2017 OpClear System Cipher Surgical Ltd Justin Buch
K171702 06/08/2017 Exciplex308nm Clarteis Laurent Meilhac
K171677 06/06/2017 Clear Guide SCENERGY Clear Guide Medical Jack Kent
K171954 06/29/2017 ClearLine IV ClearLine MD Rick Romeo
K171862 06/22/2017 GALAXY G3 Mini Microcoil Delivery System Codman & Shurtleff, Inc Yoon Hee Beatty
K171747 06/13/2017 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and Codman & Shurtleff, Inc. Vivian Perez
K171653 06/05/2017 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up Codman & Shurtleff, Inc. Yoon Hee Beatty
K171855 06/21/2017 External Moisturizing Gel Combe Incorporated Richard Grabarz
K171805 06/19/2017 Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml ConceptoMed AS Marit Martinsen
K171725 06/12/2017 CuffLink Implant System CONMED Corporation Dionne Sanders
K171817 06/19/2017 Biodesign Diaphragmatic Hernia Graft Cook Biotech Incorporated Perry W. Guinn
K171897 06/26/2017 Approach CTO Microwire Guide Cook Incorporated Jennifer Allman
K171609 06/01/2017 Check-Flo Performer Introducer Micropuncture Radial Artery Access Set Cook Incorporated Jennifer Allman
K171810 06/19/2017 Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter Cook Incorporated Yan Li
K171603 06/01/2017 Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set Cook Incorporated Erum B. Nasir
K171912 06/26/2017 Double Flexible Tip Wire Guides Cook Incorporated Jennifer Allman
K171764 06/14/2017 Fixed Core Wire Guides Cook Incorporated Jennifer Allman
K171917 06/27/2017 Frova Intubating Introducer Cook Incorporated Kotei Aoki
K171853 06/21/2017 Liver Access and Biopsy Sets Cook Incorporated David Lehr
K171915 06/26/2017 Nathanson Transcystic Bile Duct Stone Exploration Pack Cook Incorporated Colin Jacob
K171662 06/05/2017 Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ure Cook Incorporated Carly Powell
K171600 06/01/2017 Renal Access Cobra Catheter, Kumpe Access Catheter Cook Incorporated Samuel Engelman
K171948 06/29/2017 Roadrunner Extra Support Wire Guide Cook Incorporated Jennifer Allman
K171604 06/01/2017 R÷sch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip Cook Incorporated Ian Herrman
K171820 06/19/2017 Transjugular Liver Access Sets Cook Incorporated David Lehr
K171601 06/01/2017 Ultraxx Nephrostomy Balloon Catheter Cook Incorporated Minjin Choi
K171602 06/01/2017 Williams Cystoscopic Injection Needle Cook Incorporated Rebecca Odulio (Li-chun Liu)
K171619 06/02/2017 14Fr Colon Decompression Set, Macon Colon Decompression Set Cook Ireland Ltd Laura Graham
K171623 06/02/2017 Nasal Pancreatic Drainage Set Cook Ireland Ltd Orla Gunning
K171685 06/07/2017 Med4 Elite Cool Systems, Inc. (dba Game Ready) Natalie Kennel
K171847 06/21/2017 Corin Optimized Positioning System (OPSÖ) Plan Corin USA Limited Kathy Trier
K171819 06/19/2017 Attain Assist CS Access Catheter Creganna Medical also doing business as Ceganna Tactx Medica Olivia Odhiambo
K171983 06/30/2017 Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory Creo Medical Ltd Keith Penny
K171626 06/02/2017 truFreeze System CSA Medical, Inc. Sherrie Coval-Goldsmith
K171909 06/26/2017 HAL for Medical Use (Lower Limb Type) CYBERDYNE Inc. Yohei Suzuki
K171694 06/07/2017 s-Clean TiN Coating Abutments Dentis Co., Ltd. Sun Chul Shin
K171622 06/02/2017 Dentium Ti-Base Dentium Co., Ltd. Sangpil Yoon
K171750 06/13/2017 Citric Complete Dry Citric Acid (45X) Dimesol USA, LLC Marlene Van Dyke
K171952 06/29/2017 Dimesol Tubing Sets for Hemodialysis Dimesol, Inc. Stephen P. Callaghan
K171772 06/14/2017 Ecosite Bulk Fill DMG USA Inc. Gordon Craig
K171729 06/12/2017 Fixtemp C&B Dreve Dentamid GmbH Reiner Altmann
K171836 06/20/2017 EarlySense Bed Sensing Unit EarlySense Ltd. Dalia Argaman
K171824 06/19/2017 Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System Edan Instruments Inc Alice Yang
K171900 06/26/2017 Acclarix AX4 Diagnostic Ultrasound System Edan Instruments, Inc Crystal Cai
K171942 06/28/2017 Electrocardiograph Edan Instruments, Inc. Alice Yang
K171943 06/28/2017 Electrocardiograph Edan Instruments, Inc. Alice Yang
K171799 06/16/2017 Elos Accurate Customized Abutment, Elos Prosthetic Screw Elos Medtech Pinol A/S Tina Friis Poulsen
K171845 06/20/2017 EMBA Hourglass Peripheral Embolization Device EMBA Medical Limited Veronica Reott
K171860 06/22/2017 Sureclear aligners Emergo Global Consulting, LLC Stuart R. Goldman
K171781 06/15/2017 eVox System Evoke Neuroscience, Inc. David Hagedorn
K171865 06/22/2017 F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring Farus, LLC Rahul Singh
K171879 06/23/2017 HylaGuard Moisturizing Cream Founders Science Group, LLC Ronald M. Gurge
K171789 06/15/2017 ARROW Reverse Porous Glenoid Fournitures Hospitalieres Industrie Patricia Donnard
K171652 06/05/2017 Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann
K171834 06/20/2017 G Surgical OCT Spinal System G Surgical LLC Donald Grafton
K171669 06/05/2017 g.Nautilus PRO g.tec medical engineering GmbH Christoph Guger
K171673 06/06/2017 Focus Cap GCE Medical Corporation Stanley Chang
K171800 06/16/2017 OEC Elite MiniView GE Hualun Medical Systems Co.Ltd. Lifeng Wang
K171643 06/02/2017 Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed Geistlich Pharma AG Marco Steiner
K171842 06/20/2017 Geistlich Wound Matrix Geistlich Pharma AG Jan van der Ploeg
K171736 06/12/2017 Geri Embryo Incubator and Geri Dish Genea Biomedx Pty Ltd Kea Dent
K171656 06/05/2017 Genesys Spine Apache Interbody Fusion System Genesys Spine Brian J. Bergeron
K171838 06/20/2017 TiLock2 Spinal System Genesys Spine William W. Sowers
K171752 06/13/2017 X-SURGE Genicon, Inc Katlyn Kachman
K171651 06/05/2017 EXCELSIUS GPS Globus Medical Inc. Kelly J. Baker
K171848 06/21/2017 FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Globus Medical Inc. Lori Burns
K171939 06/28/2017 ALVUE Balloon Dilation System Globus Medical, Inc. Lori Burns
K171885 06/26/2017 Radiance V4 GMV Soluciones Globales Internet S.A.U. Carlos Illana
K171867 06/22/2017 DrÆs Finder NEO Good Doctors Co.,Ltd. Sungro Joo
K171707 06/08/2017 GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A Gowoonsesang Cosmetics Co., Ltd Kyeong Tai Ko
K171926 06/27/2017 C5 Diagnostic Ultrasound System Guangzhou Sonostar Technologies Co., Ltd. Weizhong Cai
K171975 06/30/2017 HardyDisk AST Delafloxacin 5 ?g (DLX5) Hardy Diagnostics Rianna Malherbe
K171874 06/23/2017 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) HARTALEGA SDN. BHD. KUAN KAM HON
K171821 06/19/2017 2 Face / Face Evolution Heat In A Click Guy Levi
K171681 06/06/2017 Hermes Medical Imaging Suite v5.7 Hermes Medical Solutions AB Joakim Arwidson
K171719 06/09/2017 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K171888 06/26/2017 Non-contact infrared body thermometer Hetaida Technology Co., Ltd ZhenGuang Chen
K171977 06/30/2017 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer Hinacom Software and Technology, Ltd Yi Isabelle Sun
K171708 06/08/2017 ALOKA ARIETTA 850 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K171738 06/12/2017 Supria True64 Hitachi Healthcare Americas Corporation Doug Thistlethwaite
K171803 06/19/2017 HIVOX OTC Electrical Stimulator Hivox Biotek Inc. Linda Lin
K171599 06/01/2017 WiTouch Pro, WiTouch, Neubac Hollywog LLC Michael Treas
K171963 06/30/2017 Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes Hologic, Inc. Ron Domingo
K171768 06/14/2017 Trident« II Acetabular System Howmedica Osteonics Corp. aka Stryker Orthopaedics Valerie Giambanco
K171982 06/30/2017 DROPLET PEN NEEDLE HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska
K171825 06/19/2017 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument Hunan Handlike Minimally Invasive Surgery Co., Ltd Hu hanhan
K171881 06/23/2017 JAZZ Passer Band Implanet, S.A. Fabienne Larquey Cadiere
K171647 06/05/2017 BeneLife Premium Facial Treatment Pack, Model: QZ0701A Infinitus (China) Company Ltd. Judy Zhou
K171672 06/06/2017 065 Zenith, 074 Zenith InNeuroCo, Inc Marc Litzenberg
K171788 06/15/2017 Reprocessed Halo XP Diagnostic Electrophysiology Catheter Innovative Health, LLC. Amy Stoklas-Oakes
K171649 06/05/2017 Straumann CARES M-Series CAD/CAM System Institut Straumann AG Andreas Petermann
K171773 06/14/2017 Straumann n!ce Glass Ceramic A14 Blocks Institut Straumann AG Shokoufeh Khodabandeh
K171831 06/20/2017 Intra-Lock Bone Fixation System Intra-Lock International, Inc. Mary L. Jean
K171632 06/02/2017 da Vinci Xi Surgical System Intuitive Surgical, Inc Brandon Hansen
K171699 06/08/2017 da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System Intuitive Surgical, Inc Brandon Hansen
K171880 06/23/2017 IRRAflow CNS System IRRAS Inc. Dessi Lyakov
K171778 06/15/2017 MR Wireless Gating System, Model WGS-100 Ivy Biomedical Systems, Inc Nicole Bush
K171713 06/09/2017 Neodent Instrument Kits JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K171704 06/08/2017 CAPRI Corpectomy Cage System K2M Nancy Giezen
K171832 06/20/2017 Range/Denali/Mesa Spinal System K2M, Inc. Nancy Giezen
K171717 06/09/2017 AUTOCON III 400 KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin
K171748 06/13/2017 Vitrification Kit and Thawing Kit Kitazato Corporation Futoshi Inoue
K171716 06/09/2017 SKR 3000 Konica Minolta, Inc. Tsutomu Fukui
K171731 06/12/2017 KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit Kronus, Inc. Brian Deis
K171813 06/19/2017 OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System L&K BIOMED Co., Ltd. Yerim An
K171895 06/26/2017 Grivamax Hair Growth System Leana Orders, Inc. Leonid Krits
K171753 06/12/2017 BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 Leica Biosystems Newcastle Limited Bert Peerboom
K171906 06/26/2017 Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 ?g/mL Liofilchem s. r. l. Fabio Brocco
K171971 06/30/2017 Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer Lite-On Technology Corp. H.S.P.B. John Lo
K171610 06/01/2017 MC3 QuickFlow Dual Lumen Catheter MC3 Incorporated Martha Rumford
K171958 06/29/2017 PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE Mectron SPA Franco Zunino
K171928 06/27/2017 Med-Hot Thermal Imaging Systems Med-Hot Thermal Imaging Inc. Carol Chandler
K171640 06/02/2017 M-ARS ACL: Anatomic Ribbon Surgery System Medacta International SA Stefano Baj
K171758 06/14/2017 M.U.S.T. Combined Set Screws Medacta International SA Stefano Baj
K171966 06/30/2017 Mpact« 3D MetalÖ Implants and Augments 3D MetalÖ Medacta International SA Stefano Baj
K171618 06/02/2017 Symetrex Long Term Hemodialysis Catheter Medcomp (DBA Medical Components, Inc.) Courtney Nix
K171931 06/28/2017 Celerity ECG Cable Accessory Pack Medcomp (Medical Components, Inc.) Colton Muraira
K171798 06/16/2017 Silverwear Silver Pro Garment Device Media Plus, LLC Rita Vacco
K171890 06/26/2017 BEXCORE Breast Biopsy System, Biopsy Needle Medical Park CO., LTD Hye-Yeon Park
K171796 06/16/2017 Vial Adapter 15mm Medimop Medical Project Ltd. Jeffrey Ravel
K171938 06/28/2017 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set Medtronic Lee Grant
K171689 06/07/2017 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc. Kelly Anglin
K171866 06/22/2017 Sentrant Introducer Sheath with Hydrophilic Coating Medtronic Vascular, Inc. Wee Wen Leow
K171979 06/30/2017 Tubing Pack Medtronic, Inc. Renee Cveykus
K171641 06/02/2017 Accula Flu A/Flu B Test Mesa Biotech, Inc. Barbara E. Stevens
K171937 06/28/2017 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K171964 06/30/2017 LigaMetrics Suture Anchors Mortise Medical LLC Robert Hoy
K171884 06/23/2017 I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc Brian Sullivan
K171914 06/26/2017 CortinaÖ Lumbar Cage System NeuroStructures, Inc. Kathleen Wong
K171902 06/26/2017 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc Rainer Harjunpaa
K171765 06/14/2017 Nihon Kohden CO2 Monitor Nihon Kohden Corporation Thomas Bento
K171730 06/12/2017 FuckWater Non-Friction Products Inc. Marc Barrette
K171754 06/13/2017 NovaPACS Novarad Corporation Doug Merrill
K171791 06/16/2017 MAGEC« System NuVasive Specialized Orthopedics, Incorporated Manthan J. Damani
K171633 06/02/2017 NuVasive TLX Interbody System NuVasive, Incorporated Cynthia Adams
K171894 06/26/2017 NuVasive« PreceptÖ Spinal System NuVasive, Incorporated Marysa Loustalot
K171916 06/26/2017 Single Use Hot Biopsy Forceps FD-231 Olympus Medical Systems Corp. Toshiyuki Nakajima
K171692 06/07/2017 Instrument basket, for EndoEYE Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K171965 06/30/2017 Resection Electrodes with HF cable Olympus Winter & Ibe GmbH Jan-Oliver Upmeier
K171755 06/13/2017 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System Omega Medical Imaging, LLC John Newman
K171828 06/20/2017 ETCO2 Sensor Orantech Inc. Yunxi Xiong
K171734 06/12/2017 HP PRO Positioning Device Orfit Industries NV Eddy Marivoet
K171844 06/20/2017 Inspire ICE aka Inspire ICE Clear Brackets Ormco Corporation Tara Bonny
K171780 06/15/2017 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K171617 06/01/2017 OKI Surgical Planning Software Ortho Kinematics, Inc. Adam Deitz
K171698 06/08/2017 Smart Syringe Osprey Medical, Inc. Melanie Hess
K171774 06/14/2017 RPM Reinforced PTFE Mesh Osteogenics Biomedical, Inc. Shane Shuttlesworth
K171703 06/08/2017 PUMA System Panther Orthopedics, Inc. Kathryn Stecco
K171715 06/09/2017 HammerTube System Paragon 28 Frank S. Bono
K171936 06/28/2017 Peerbridge Cor(TM) System Peerbridge Health INc. Arthur A. Bertolero
K171872 06/23/2017 P50 Series Dental Operative Unit and Accessories Pelton & Crane Frank Ray
K171850 06/21/2017 Philips CT Big Bore Philips Medical Systems (Cleveland) Inc. Michael Chilbert
K171801 06/16/2017 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K171630 06/02/2017 LumFuse-TP Precifit Medical Ltd ZhenYu (Eric) Wu
K171657 06/05/2017 ShurFit 2C Lumbar Interbody Fusion System Precision Spine, Inc. Michael C. Dawson
K171667 06/05/2017 Powder Free Nitrile Examination Glove Professional Latex Sdn Bhd Yoon Lim Kok
K171868 06/22/2017 A1AT Genotyping Test Progenika Biopharma S.A., a Grifols Company Diego Tejedor
K171620 06/02/2017 PiCCO Catheter PULSION Medical Systems SE Ingrid Rohm
K171945 06/28/2017 Discovery Pico, Discovery Pico Plus Quanta System S.p.A. Francesco Dell'Antonio
K171711 06/09/2017 Thunder, Thunder VT, Thunder HR Quanta System S.p.A. Francesco Dell'Antonio
K171976 06/30/2017 Sofia Strep A+ FIA, Sofia 2 Analyzer Quidel Corporation Edward C. Brehm
K171974 06/30/2017 Solana RSV+hMPV Assay Quidel Corporation Ronald H. Lollar
K171896 06/26/2017 Feminine Personal Trainer (FPT) Ralston Group Russell Ralston
K171666 06/05/2017 MPR2 logO DATALOGGER Raumedic AG Reiner Thiem
K171605 06/01/2017 Elecsys CA 15-3 II Roche Diagnostics Adennis Cora
K171655 06/05/2017 cobas m 511 integrated hematology analyzer Roche Diagnostics Hematology, Inc. Dan Bracco
K171770 06/14/2017 cobas Cdiff Nucleic acid test for use on the cobas Liat System Roche Molecular Systems, Inc. Clare Santulli
K171661 06/05/2017 Scopis Extended Instrument Set EM Scopis GmbH Christopher ?zbek
K171861 06/22/2017 CAPILLARYS Hb A1c Sebia Karen Anderson
K171726 06/12/2017 LapBag Sejong Medical Co., Ltd. Yoojung Choi
K171741 06/12/2017 Laport Sejong Medical Co., Ltd. Yoojung Choi
K171615 06/01/2017 Xingyu Nitrile Powder Free Patient Examination Gloves, White color Shandong Xingyu Gloves Co., Ltd Xu Qiang
K171616 06/01/2017 Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color Shandong Xingyu Gloves Co., Ltd Xu Qiang
K171833 06/19/2017 Digital Blood Pressure Monitor-Wrist Style Shenzhen Combei Technology CO., LTD Huaguang Meng
K171978 06/30/2017 Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan
K171721 06/12/2017 Electrodes with silver conductive Shenzhen Konmed Technology Co., Ltd Tony Tony
K171722 06/12/2017 Electrodes with snap / Electrodes with pigtail Shenzhen Konmed Technology Co., Ltd Tony Tony
K171901 06/26/2017 uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) Shenzhen Mindray Bio-Medical Electronics Co., Ltd Yanhong Bai
K171891 06/26/2017 ZS3 Ultrasound System, z.one pro Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Zhai Pei
K171771 06/14/2017 ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay Siemens Healthcare Diagnostics Inc. Alan Haley
K171642 06/02/2017 Atellica IM Ferritin Assay Siemens Healthcare Diagnostics Inc. Kira Gordon
K171742 06/12/2017 N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 Siemens Healthcare Diagnostics Products GmbH Christine Perkins
K171766 06/14/2017 Acuson SC2000 Diagnostic Ultrasound System Siemens Medical Solutions Inc. Kevin Kong
K171905 06/26/2017 VISCO 360 Viscosurgical System Sight Sciences, Inc. Anne-Marie Ripley
K171743 06/12/2017 Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves Smart Glove Corporation Sdn.Bhd Khon Pu Foo
K171827 06/20/2017 ReddyPort NIV Access Elbow SMD Manufacturing, LLC Rian Wendling
K171674 06/06/2017 Angel Align System Smile Development Corp Ian Kitching
K171934 06/28/2017 Birmingham Hip (BH) Dual Mobility Insert Smith & Nephew, Inc. Mike Scott
K171794 06/16/2017 Smith & Nephew 25 Fluid Management System Smith & Nephew, Inc. Kathleen Solomon
K171968 06/30/2017 EchoGlo Needle Smiths Medical ASD, Inc. Michael R. Johnson
K171727 06/12/2017 Hydrocleanse Antimicrobial Skin and Wound Care Solution Sonoma Pharmaceuticals Brian W. Martin
K171935 06/28/2017 Alevicyn SG Antimicrobial Gel Sonoma Pharmaceuticals, Inc. Brian W. Martin
K171797 06/16/2017 TRYPTIK2 C-Plate Anterior Cervical Plate System Spineart Franck Pennesi
K171660 06/05/2017 Duo Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K171724 06/12/2017 Rampart L Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K171728 06/12/2017 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm Sterngold Dental, LLC Maria Rao
K171784 06/15/2017 Straumann Dental Implant System Straumann USA, LLC Jennifer M. Jackson
K171769 06/14/2017 Straumann PURE Ceramic Implants Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K171757 06/14/2017 Straumann Screw Retained Abutments Straumann USA, LLC (on behalf of Institut Straumann AG) Chanrasmey White
K171645 06/05/2017 CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle Strukmyer Medical Pamela Liberto
K171807 06/19/2017 ES2 Neuromonitoring Accessory Instruments Stryker Corporation Nikin Desai
K171840 06/20/2017 Stryker Consolidated Operating Room Equipment (CORE) 2 Console Stryker Corporation Nicholas Werner
K171628 06/02/2017 HBS2 Headless Bone Screw Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock
K171624 06/02/2017 IXOS Radius Plate System Stuckenbrock Medizintechnik GmbH Fabian Stuckenbrock
K171911 06/26/2017 Medline ReNewal Reprocessed Synthes External Fixation Systems Surgical Instrument Service and Savings Inc Stephanie Boyle Mays
K171869 06/22/2017 Sutter CURIS RF Generator Sutter Medizintechnik GmbH Ulrike Zeissler
K171665 06/05/2017 Microcatheter and guide-wire system Suzhou Hengrui Disheng Medical Co.,Ltd. Jingwen Li
K171889 06/26/2017 Reusable Blood Pressure Cuff Suzhou Minhua Medical Apparatus Supplies Co., LTD Yang Qidong
K171883 06/23/2017 Sysmex UF-5000 Fully Automated Urine Particle Analyzer Sysmex America, Inc. Sharita Brooks
K171709 06/08/2017 BR-FHUS Viewer 1.0 TaiHao Medical Inc. Hsin Hung (Simon) Lai
K171808 06/19/2017 TDM Plate and Screw System TDM Co. Ltd. Babu Periasamy
K171775 06/14/2017 Theradome LH80 PRO Theradome Inc. Tamim Hamid
K171829 06/20/2017 EndoNaut Therenva SAS Matthis HAMY
K171870 06/22/2017 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 û 8 ug/mL Thermo Fisher Scientific Cynthia Knapp
K171795 06/16/2017 Thommen Implant System Thommen Medical AG Daniel Snetivy
K171967 06/30/2017 MagVita TMS Therapy System Tonica Elektronik A/S Lise Terkelsen
K171962 06/30/2017 Klassic HD« Hip System Total Joint Othopedics, Inc. Chris Weaber
K171690 06/07/2017 Trident Extremity Fixation System Trident Orthopedics Al Austin
K171749 06/13/2017 Velofix(tm) Interbody Fusion System U&i Corporation Jee Ae Bang
K171823 06/19/2017 U&U Indicator tape and strip U&U Medical Technology Co., Ltd Xuebo Wang
K171631 06/02/2017 Standard Catheter Set Varian Medical Systems, Inc. Peter J. Coronado
K171733 06/12/2017 TrueBeam, TrueBeam STx, Edge Varian Medical Systems, Inc. Sara Muddell
K171946 06/29/2017 Gel-Bead Vascular Solutions, Inc. Lisa Gallatin
K171668 06/05/2017 Bluetooth blood pressure monitor Visiomed Group SA Eric Sebban
K171950 06/29/2017 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B) Visionary Optics LLC Donald R. Sanders
K171815 06/19/2017 Registrado Scan VOCO GmbH M. Th. Plaumann
K171678 06/06/2017 Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m Vyaire Medical, Inc. Leo Sohlberg
K171695 06/07/2017 First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana W.H.P.M., Inc. John Wan
K171621 06/02/2017 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor Welch Allyn, Inc. Mark Alsberge
K171611 06/01/2017 Double Lumen Ovum Aspiration Needles William A. Cook Australia Pty Ltd Gordana Pozvek
K171712 06/09/2017 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach William Cook Europe ApS Henriette Stordal Christiansen
K171625 06/02/2017 Single Lumen Ovum Aspiration Needles Willian A. Cook Australia Pty Ltd Gordana Pozvek
K171973 06/30/2017 Captura« Disposable Hot Biopsy Forceps Wilson-Cook Medical, Inc. Ashley Howard
K171969 06/30/2017 Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Ext Wilson-Cook Medical, Inc. Ashley Howard
K171607 06/01/2017 Bronchi and Gastrointestinal Cytology Brush Wilson-Cook Medical, Inc. / Cook Endoscopy Doris A. Hawks
K171852 06/21/2017 DARCO Locking Bone Plate System Wright Medical Technology, Inc. Val Myles
K171961 06/30/2017 Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) Xiamen Compower Medical Tech. Co. Ltd. Lifen Chen
K171680 06/06/2017 Infinity-Lock 3, Infinity-Lock 5 Xiros Ltd Stephen Seed
K171984 06/30/2017 Clickfine Pen Needle, Penfine Classic Pen Needle Ypsomed AG Stephan Affolter
K171804 06/19/2017 Zap-X Radiosurgery System Zap Surgical Systems Radhika Mohan Bodduluri
K171873 06/23/2017 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs Zhonghong Pulin Medical Products Co., Ltd. Jinge Li
K171907 06/26/2017 Vitality« Spinal Fixation System Zimmer Biomet Spine, Inc. Kelly Stratton
K171858 06/21/2017 Sidus Stem-Free Shoulder Zimmer GmbH Roberto Tommasini


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