FDA 510(k) Applications Received During June, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
DEN160026 06/28/2016 23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia 23andMe, Inc. Lisa Charter
K161559 06/06/2016 Kuvia3D 4QIMAGING, LLC DBA QMETRICS EDWARD SCHREYER
K161696 06/20/2016 aap LOQTEQ« Distal Lateral Humerus Plate 2.7/3.5 AAP IMPLANTATE AG RENI SCHALLER
K161703 06/20/2016 LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer AAP IMPLANTATE AG RENI SCHALLER
K161747 06/24/2016 LOQTEQ« VA Distal Tibia Plate System: LOQTEQ« VA Distal Medial Tibia Plate 3.5; LOQTEQ« VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ« VA Distal Fibula Plate 2.7/3.5 aap Implantate AG Reni Schaller
K161697 06/20/2016 Acclarent NavWire Sinus Navigation Guidewire ACCLARENT, INC. ANNA HWANG
K161698 06/20/2016 Relieva UltirraNav Sinus Balloon Catheter ACCLARENT, INC. JAMES PATRICK GARVEY
K161794 06/30/2016 CENTURION Vision System (Active SentryTM) Alcon Research, Ltd. Paul Swift
K161625 06/13/2016 PixelShine ALGOMEDICA Jagdish Vij
K161656 06/16/2016 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor AMBU A/S CAMILLA WISMAR
K161658 06/16/2016 Anexa Wound Flush, Sterile Water & Sterile Normal Saline ANEXA BIOMEDICAL, INC. LENNY BUDLOO
K161596 06/09/2016 Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters AngioDynamics, Inc. Teri Juckett
K161605 06/10/2016 Smart External Drain (SED) System AQUEDUCT CRITICAL CARE, INC. Thomas Clement
K161765 06/27/2016 CG+ Arrow JACC ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, JULIE LAWSON
K161581 06/08/2016 Arthrex Synergy RF System ARTHREX, INC. William Heard
K161782 06/29/2016 Arthrex Univers Revers Shoulder Prosthesis System ARTHREX, INC. David L Rogers
K161539 06/03/2016 Arthrosurface Bone Screws ARTHROSURFACE, INC. DAWN J. WILSON
K161584 06/08/2016 ASAHI« Peripheral Vascular Guide Wire ASAHI Meister«16 ASAHI INTECC CO.,LTD. Yoshihiko Fukui
K161546 06/03/2016 R2P SlenGuide ASHITAKA FACTORY OF TERUMO CORPORATION PHEBE VARGHESE
K161587 06/08/2016 Memodyn Staple AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT AL AUSTIN
K161623 06/13/2016 Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL B. Braun Medical Inc. Nancy Skocypec
K161582 06/08/2016 DORA Tubing Sets for Hemodialysis Bain Medical Equipment (Guangzhou) Co., Ltd Sophia Shao
K161508 06/01/2016 Ceruloplasmin BECKMAN COULTER IRELAND INC. MARGUERITA SWEENEY
K161552 06/06/2016 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton Dickinson and Company John Blewitt
K161777 06/29/2016 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. Kimberly Geisler
K161553 06/06/2016 BD SafeAssist BECTON, DICKINSON AND COMPANY Meriam Youssef
K161692 06/20/2016 Diode Laser Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD GAO YURONG
K161560 06/06/2016 Fingertip Pulse Oximeter MD300CN310 BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. LEI CHEN
K161687 06/17/2016 D-10 Hemoglobin A1c Program BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K161533 06/02/2016 A1C EZ Glycohemoglobin Analysis System BioHermes Co., Ltd Rao Qiangying
K161669 06/16/2016 Waterlase Express Biolase, Inc. Alicia Mszyca
K161510 06/01/2016 VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) BIOMERIEUX, INC CHERECE L. JONES
K161592 06/09/2016 Persona Partial Knee System BIOMET, INC. Nicole J. Meredith
K161790 06/29/2016 iGlucose Blood Glucose Monitoring System BIONIME CORPORATION Tino Lee
K161632 06/13/2016 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) BIOS S.R.L. Riccardo Pisati
K161701 06/20/2016 CARTO ENT System BIOSENSE WEBSTER MELISSA C. SCHULTZ
K161704 06/20/2016 Phasor Drill BIOTEX, INC. RICHARD WAITE
K161670 06/16/2016 Lucid Q-PTP / HWA 55 BISON MEDICAL CO., LTD SUN WO
K161722 06/22/2016 VITRUVIAN ULTIMATE ASPIRATOR BLACK & BLACK SURGICAL, INC. CYNTHIA REES
K161568 06/07/2016 Bone Solutions Mixing and Delivery System BONE SOLUTIONS, INC. DREW DIAZ
K161628 06/13/2016 JAS Pulse(TM) Ultrasonic Therapy Bonutti Research, Inc. Patrick G. Balsmann
K161558 06/06/2016 Bovie 3.3mm Disposable Bipolar Ablator 90?, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55?, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60?, Non-Aspirating BOVIE MEDICAL CORPORATION Rubiela Maldonado
K161551 06/03/2016 TR-100 BTL INDUSTRIES, INC. Jan Zarsky
K161716 06/21/2016 TEETHAN 2.0 BTS S.P.A. VERONICA BARTOLINI
K161773 06/28/2016 CapsoCam Plus (SV-3) Capsule Endoscope System CapsoVision, Inc Azimun Jamal
K161607 06/10/2016 VISULUX CARL ZEISS MEDITEC AG Christian Muenster
K161654 06/15/2016 NuFACE Gel Primer Carol Cole Company Merle Kovacic
K161556 06/06/2016 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit Centers for Disease Control and Prevention (CDC) Yon Yu
K161619 06/13/2016 Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems Cepheid Scott A. Campbell
K161764 06/27/2016 SLIT LAMP, Model: YF-100 CHONGQING YEASN SCIENCE-TECHNOLOGY CO., LTD BING HU
K161544 06/03/2016 Trojan Chain Reaction Personal Lubricant CHURCH & DWIGHT CO., INC. Lisa Burns
K161545 06/03/2016 Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO., INC. Lisa Burns
K161507 06/01/2016 Cianna Medical SAVI Scout Reflector and SAVI Scout System CIANNA MEDICAL, INC. GARY MOCNIK
K161515 06/02/2016 eUnity Client Outlook Inc. Christie Eby
K161672 06/09/2016 SpeediCath Flex Coude Coloplast Corp. Rebecca S. Roberts
K161518 06/02/2016 PACS CORE/ENCORE COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Felipe Cuaranta Monroy
K161668 06/16/2016 ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) CONFORMIS, INC. AMITA SHAH
K161762 06/27/2016 DynaMatrix/Dynamatrix Plus COOK BIOTECH INCORPORATED Perry W. Guinn
K161504 06/01/2016 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray COOK INCORPORATED Steven Lawrie
K161801 06/30/2016 CrossCath Support Catheter Cook Incorporated Jessica Swafford
K161496 06/01/2016 Turbo-Flo PICC Sets COOK INCORPORATED Steven Lawrie
K161755 06/27/2016 Integrity-SI TM Fusion System CoorsTek Medical Steve Brown
K161641 06/14/2016 LOSPA IS ACP System CORENTEC CO., LTD J.S. DANIEL
K161537 06/03/2016 OTC TENS Device, Model PTS-IV COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD WENDY POON
K161804 06/30/2016 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider COVIDIEN DAWN D. TINDALL
K161557 06/06/2016 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K161566 06/06/2016 DMS Disposable Subdermal Needle Electrodes Daehan Medical Systems Co., Ltd. Dong Cheul Kim
K161674 06/16/2016 QuantumCam DDD-DIAGNOSTIC A/S Niels Sorensen
K161679 06/17/2016 s LDL-EX SEIKEN DENKA SEIKEN CO., LTD. Takayoshi Ishii
K161713 06/21/2016 Dentium CAD/CAM Abutments Dentium Co., Ltd Sangpil Yoon
K161526 06/02/2016 LIAISON CMV IgM Serum Control Set DiaSorin Inc. JOHN WALTER
K161522 06/02/2016 LIAISON EBV IgM Serum Control Set DiaSorin Inc. John Walter
K161646 06/15/2016 Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K161721 06/22/2016 Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set Diazyme Laboratories Abhijit Datta
K161497 06/01/2016 Dental Implants and Abutments Ditron Precision Ltd Moshe Orlev
K161771 06/28/2016 Medilas H Laser Fibers DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K161610 06/10/2016 EXPRT Revision Hip System Encore Medical, L.P. TEFFANY HUTTO
K161715 06/21/2016 EndyGel EndyMed Medical Ltd. Yoram Levy
K161663 06/16/2016 sTMS mini ENEURA INC CYNTHIA MERRELL
K161743 06/24/2016 Etgar Dental Implant System ETGAR MEDICAL INSTRUMENTS, LTD Yehudit PeÆer
K161726 06/22/2016 E-Pack Procedure Kit ETHICON, INC. ENZA DESERIO
K161513 06/02/2016 Anti-Borrelia burgdorferi US Westernblot (IgG) EUROIMMUN US MICHAEL LOCKE
K161727 06/22/2016 Eyenez Ophthalmic Camera EYENEZ LLC DR. KISLINGER
K161550 06/03/2016 DynaMesh-VENTRAL FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT STEFAN SCHNEEMELCHER
K161676 06/17/2016 Q13 SPIROLYSER« FIM MEDICAL LIZA PERRAT
K161686 06/17/2016 F&P InfoSmart FISHER & PAYKEL HEALTHCARE LTD. Jayanti Karandikar
K161516 06/02/2016 G Surgical Marksman MIS System G SURGICAL LLC Donald Grafton
K161567 06/07/2016 SIGNA Voyager GE HEALTHCARE Glen Sabin
K161588 06/08/2016 Vscan Extend GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC Tracey Ortiz
K161682 06/17/2016 GE Lunar DXA Bone Densitometers with enCORE version 17 GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC Nicole Landreville
K161706 06/20/2016 Vivid iq GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L Tracey Ortiz
K161574 06/07/2016 Discovery MI GE Medical Systems, L.L.C. Helen Peng
K161599 06/09/2016 UNO Negative Pressure Wound Therapy System GENADYNE BIOTECHNOLOGIES, INC. Chien Ming GOH
K161631 06/13/2016 MAMMI GENERAL EQUIPMENT FOR MEDICAL IMAGING JOSE MONTES
K161502 06/01/2016 MC1 Plus GENERAL PROJECT S.R.L. MORENO NALDONI
K161791 06/29/2016 Aer-O-Scope Colonoscope System GI View Ltd. Sharon Goldfarb
K161717 06/22/2016 Personal Kinetigraph (PKG) System GKC MANUFACTURING PTY LTD. BRENDAN FAFIANI
K161591 06/09/2016 QUARTEXÖ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments GLOBUS MEDICAL INC. Kelly J. Baker
K161707 06/21/2016 Madsen Zodiac GN OTOMETRICS Asif Muhammad
K161615 06/10/2016 Accurett H&O EQUIPMENTS, NV/SA Aline Franck
K161772 06/28/2016 FFRct HEARTFLOW, INC. Windi Hary
K161748 06/24/2016 SUPRIA w/guideShot Option HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K161575 06/07/2016 Affirm Lateral Arm Upright Biopsy Accessory HOLOGIC DEBBIE PEACOCK
K161569 06/07/2016 Trident« II Tritanium« Acetabular Shells and 6.5 mm Low Profile Hex Screws Howmedica Osteonics Corp. aka Stryker Orthopaedics Valerie Giambanco
DEN160025 06/27/2016 ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit ID-FISH TECHNOLOGY, INC JYOTSNA SHAH
K161593 06/09/2016 GMI Frontier Dental Implant System ILERIMPLANT S.L. ANTONIO COSO
K161601 06/09/2016 Dynamika IMAGE ANALYSIS LIMITED Mark Hinton
K161714 06/21/2016 Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K161769 06/28/2016 Reprocessed Supreme Diagnostic Electrophysiology Catheters INNOVATIVE HEALTH, LLC. Sharon Higgins
K161677 06/17/2016 Straumann Sterile Healing Solution Institut Straumann AG Christopher Klaczyk
K161730 06/23/2016 Wireless Digital Flat Panel Detector IRAY TECHNOLOGY (SHANGHAI) LTD. WEI PAN
K161579 06/07/2016 Watch-PAT200U ITAMAR MEDICAL, LTD. Koby Sheffy
K161746 06/24/2016 ARIX Hand System Jeil Medical Corporation Seungyong Lee
K161768 06/27/2016 LUCAS 3 Chest Compression System Jolife AB Malin Melander
K161488 06/01/2016 ESTETICA Dental Treatment Unit and Accessories KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K161555 06/06/2016 KARL STORZ NAV1 Electromagnetic Navigation System KARL STORZ Endoscopy America, Inc. Leigh Spotten
K161554 06/06/2016 ENDOFLATOR 40, ENDOFLATOR 50 KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K161766 06/27/2016 PathLoc-L MIS Spinal System L&K BIOMED Co., Ltd. Yerim An
K161673 06/16/2016 LacriPro Punctum Plug LACRIMEDICS, INC. REBECCA C. DUTTON
K161570 06/07/2016 Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium, Theia NPWT Foam Wound Dressing Kit-Large LC Medical Concepts, Inc. Dana M. Ledgerwood
K161798 06/30/2016 FacetBRIDGE« System LDR SPINE USA, INC. JAMIE WILSON
K161776 06/29/2016 Lenstec LC Injection system LENSTEC INC. JIMMY CHACKO
K161659 06/16/2016 FlexSeal Introducer Sheath with Hydrophilic Coating LIBRA MEDICAL INC. SEW-WAH TAY
K161636 06/14/2016 Lipogems System Lipogems International SpA CARLO RUSSO
K161495 06/01/2016 ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) LUMINEX CORPORATION CHRISTIE HUGHES
K161573 06/07/2016 FilmArray RP EZ Control Panel M265 MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K161585 06/08/2016 Mano and Mano Personal Lubricant Mano and Mano Proprietary Limited Katrina Allen
K161718 06/22/2016 MaxBlend 2, MaxBlend Lite Maxtec, LLC Bruce Brierley
K161635 06/14/2016 AMIStem-H Proximal Coating MEDACTA INTERNATIONAL SA STEFANO BAJ
K161741 06/24/2016 GMK UNI MEDACTA INTERNATIONAL SA Stefano Baj
K161725 06/22/2016 Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail MEDELA, INC ROBERT SOKOLOWSKI
K161493 06/01/2016 YO Home Sperm Test MEDICAL ELECTRONIC SYSTEMS, LTD MARCIA DEUTSCH
K161680 06/17/2016 MEDICON Spinal Spreading Systems MEDICON EG Joachim Schmid
K161627 06/13/2016 PASS LP Spinal System MEDICREA INTERNATIONAL S.A. DAVID RYAN
K161602 06/09/2016 Arctic Sun Temperature Management System Medivance, Inc. Stacci Cronk
K161638 06/14/2016 SPEEDTRAP Graft Preparation System MEDOS INTERNATIONAL SARL Jeffrey Dzialo
K161779 06/29/2016 MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter MedSource International, LLC Laura Riggen
K161637 06/14/2016 Poseidon OCT Spinal Fixation System Medyssey USA, Inc. Shawn Kim
K161649 06/15/2016 Virtu C Spinal Implant System Met 1 Technologies, LLC Dan Gerbec
K161500 06/01/2016 MEG-TORQ MICRO-NX Co., Ltd J. K. Jung
K161624 06/13/2016 MicrO2 OSA Device with Micro-Recorder MICRODENTAL, Inc. David Kuhns
K161728 06/22/2016 Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 MICROFILE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K161639 06/14/2016 Y-MIC MICRON CORPORATION Takashi Terui
K161803 06/30/2016 Traxcess .007 Mini Guidewire MICROVENTION, INC. SAPNA SINGH
K161797 06/30/2016 Avance Tubing, Avance Y-Connector, Avance ViewPad MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K161517 06/02/2016 Mortara Surveyor Patient Monitor MORTARA INSTRUMENT, INC. SARAH WEBER
K161737 06/23/2016 RELI REDIDIOX Dyed, RELI REDIDIOX, RELI REDIDIOX Undyed MYCO MEDICAL Sanjiv Kumar
K161536 06/03/2016 EasyOne Air Spirometer NDD MEDIZINTECHNIK AG JERRY MASIELLO
K161534 06/03/2016 EasyOne Pro Respiratory Analysis System NDD MEDIZINTECHNIK AG N/A N/A
K161519 06/02/2016 NeuroStar TMS Therapy System NEURONETICS, INC. JUDY P. WAYS
K161650 06/15/2016 Polysmith Sleep System, Model NTI7593 Neurotronics, Inc. David Pezet
K161608 06/10/2016 InterForm Cervical Interbody Cage System NEXT ORTHOSURGICAL ELLEN YARNALL
K161499 06/01/2016 VertiForm Posterior Fixation System NEXT ORTHOSURGICAL ELLEN YARNALL
K161681 06/17/2016 Nipro SafeTouch IV Catheter NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K161634 06/14/2016 IPS CaseDesigner NOBEL BIOCARE AB CHARLEMAGNE CHUA
K161598 06/09/2016 NobelZygoma 0? Nobel Biocare AB Charlemagne Chua
K161655 06/16/2016 On1 Concept NOBEL BIOCARE AB CHARLEMAGNE CHUA
K161792 06/30/2016 PINPOINT Endoscopic Fluorescence Imaging System Novadaq Technologies Inc. Jen Pendlebury
K161688 06/20/2016 Advanced Gynecological Applicator NUCLETRON BV RUDOLF VOS
K161751 06/24/2016 MAGEC« Spinal Bracing and Distraction System NUVASIVE SPECIALIZED ORTHOPEDICS, INC. REBECCA SHELBURNE WALKER
K161524 06/02/2016 Tangis Anterior Cervical Plate NVISION BIOMEDICAL TECHNOLOGIES, LLC DIANA L. LANGHAM
K161600 06/09/2016 Resection Electrodes OLYMPUS WINTER & IBE GMBH Katharina Campbell
K161520 06/02/2016 ELEOS Limb Salvage System Onkos Surgical, Inc. Jan Triani
K161622 06/13/2016 LensGiene Sterile Saline Solution Optics Laboratory, Inc. Patricia Chiu
K161547 06/03/2016 Transem and EchoGen Embryo Transfer Catheters ORIGIO A/S TOVE KJAER
K161505 06/01/2016 DyeVert NG Contrast Modulation System OSPREY MEDICAL, INC. MELANIE HESS
K161604 06/10/2016 OSSTEM Implant System OSSTEM IMPLANT CO., LTD. Hee Kwon
K161689 06/20/2016 OSSTEM Implant System - Abutment OSSTEM IMPLANT Co., Ltd. Hee Kwon
K161671 06/16/2016 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower OTICON MEDICAL AB Satu Hjartstam
K161731 06/23/2016 Cleveland Multiport Ventricular Catheter Set Parker Hannifin Corp. George Austria
K161739 06/24/2016 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses PEGAVISION CORPORATION Judith Hou
K161523 06/02/2016 INDIGO Aspiration System Penumbra, Inc. Aditi Kolla
K161506 06/01/2016 Penumbra Aspiration System Penumbra, Inc. Richard Kimura
K161640 06/14/2016 Penumbra System ACE 68 Reperfusion Catheter Penumbra, Inc. Charles DeNault
K161800 06/30/2016 OnSite-IV PHARMC, LLC CHRIS TICE
K161532 06/02/2016 Philips Avent Comfort Single/Twin Electric Breast Pump Philips Consumer Lifestyle-Innovation Site Eindhoven Marta Walker
K161563 06/06/2016 Allura Xper FD series and Allura Xper OR Table series Philips Medical Systems Nederland BV Jeanette Becker
K161531 06/02/2016 IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600 Philips Medizin Systeme Boeblingen GmbH Markus Stacha
K161767 06/27/2016 Philips IntelliVue GuardianSoftware PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH Michael Asmalsky
K161498 06/01/2016 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K161580 06/08/2016 Premier Sealant PREMIER DENTAL COMPANY PRODUCTS VINCENT D'ALESSANDRO
K161642 06/14/2016 CAVUXÖ Cervical Cage PROVIDENCE MEDICAL TECHNOLOGY, INC Margaret Wong
K161667 06/16/2016 Sapphire Infusion Pump Q Core Medical Ltd. Shimon Vaknin
K161724 06/22/2016 Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) RadioMed Corporation Leah Easley
K161613 06/10/2016 Hang&Go PAC RanD S.r.l. Simone Ceretti
K161691 06/20/2016 Direct LDL Cholesterol (LDL) RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K161684 06/17/2016 Quantum LB Reliance Orthodontic Products Inc. Paula Wendland
K161492 06/01/2016 Juno VPAP ST-A ResMed Ltd Jean-Nicolas Boudaud
K161778 06/29/2016 ToeTacÖ 10? Hammertoe Fixation System RESTORE SURGICAL LLC DBA INSTRATEK JEFF SEAVEY
K161734 06/23/2016 Vanguard Dental Unit RITTER CONCEPT GMBH WEN FANG
K161719 06/22/2016 Salter Labs Bubble Humidifier SALTER LABS MARA CALER
K161491 06/01/2016 Scopis Hybrid Navigation System EM Scopis GmbH Christopher Ozbek
K161535 06/03/2016 SeaSpine« NewPortÖ Spinal System SEASPINE ORTHOPEDICS CORPORATION Michelle Willis
K161577 06/07/2016 Arm-Type Fully Automatic Digital Blood Pressure Monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Ren Yunhua
K161521 06/02/2016 TAP Blood Collection Device Seventh Sense Biosystems, Inc. TIM RICHARDS
K161735 06/23/2016 Non-contact Forehead Thermometer Shenzhen Dongdixin Technology Co., Ltd. Siping Yuan
K161586 06/08/2016 The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) SHENZHEN HOMED MEDICAL DEVICE CO., LTD Shengming Shi
K161530 06/02/2016 Bluetooth blood pressure monitor SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. Dacheng Gong
K161525 06/02/2016 TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd Wu Zicui
K161708 06/21/2016 Arm automatic blood pressure monitor SHENZHEN PUMP MEDICAL SYSTEM CO., LTD XIE QIONGYU
K161712 06/21/2016 Arm automatic blood pressure monitor SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K161494 06/01/2016 Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) Siemens Healthcare Diagnostics, Inc. Laura J. Duggan
K161685 06/17/2016 syngo«.via protoNeo (Version VA10A) SIEMENS HEALTHCARE GMBH LAUREN BENTLEY
K161787 06/29/2016 ACUSON NX2 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Shelly Pearce
K161795 06/30/2016 MAGNETOM ESSENZA Siemens Medical Solutions USA, Inc. Cordell L. Fields
K161629 06/13/2016 CRYLREX SM ENG CO., LTD SOON-GU LEE
K161633 06/13/2016 REXLON, REXSIL SM ENG CO., LTD SOON-GU LEE
K161763 06/27/2016 Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device Smith & Nephew, Inc. Bradley Heil
K161665 06/16/2016 VLP Wrist Fracture System SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K161733 06/23/2016 INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C Sorin Group Italia S.r.l Luigi Vecchi
K161562 06/06/2016 Sound Options Tinnitus Treatment Sound Options Tinnitus Treatments Inc. Michael Chrostowski
K161548 06/03/2016 Osseointegrated Fixtures SOUTHERN IMPLANTS (PTY) LTD. LAURANDA BREYTENBACH
K161740 06/24/2016 D-SPECT Scanner, D-SPECT L Scanner Spectrum Dynamics Medical Ltd Igor Naroditsky
K161774 06/28/2016 i-Sil SPIDENT Co., Ltd. J. M. Ahn
K161710 06/21/2016 SAGICO IBF SYSTEM û ARIA LUMBAR, SAGICO IBF SYSTEM û ARION CERVICAL SPINAL ANALYTICS & GEOMETRICAL IMPANT CO, LLC JAMES J GIBSON
K161694 06/20/2016 ThresholdÖ Pedicular Fixation System Spineology Inc. JACQUELINE A. HAUGE
K161720 06/22/2016 Standard Clamp STANDARD BARIATRICS Alison Sathe
K161700 06/20/2016 SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters STERILMED, INC. Reuben Lawson
K161683 06/17/2016 SYSTEM 1E Liquid Chemical Sterilant Processing System STERIS CORPORATION Tricia Cregger
K161565 06/06/2016 DUO STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Juan Ye
K161514 06/02/2016 Precision Thin Reciprocating Blade, 0.010in. STRYKER CORPORATION Joanna McCarthy
K161753 06/24/2016 Hoffman LRF System STRYKER GMBH PAUL NELSON
K161693 06/20/2016 Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis STRYKER SUSTAINABILITY SOLUTIONS Scott English
K161744 06/24/2016 Symmetry Sharp Kerrison Rongeur Symmetry Surgical Inc. Lora Tjomstol
K161590 06/09/2016 MatrixRIB Fixation System SYNTHES (USA) PRODUCTS LLC THOMAS SHEA
K161616 06/13/2016 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannu Synthes USA Products, LLC Nina Rudolph
K161489 06/01/2016 Syntorr K-wire and Pin System SYNTORR INC DANIEL MARTIN
K161738 06/23/2016 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ?-Ketone Monitoring Systems TAIDOC TECHNOLOGY CORPORATION PAUL LIU
K161527 06/02/2016 Teco Creatinine Enzymatic Reagent Kit TECO DIAGNOSTICS, INC. XIAOYAN HU
K161758 06/27/2016 Weck Auto Endo10 Automatic Endoscopic Clip Applier TELEFLEX MEDICAL HOLLY HALLOCK
K161770 06/28/2016 Rusch Silicone Foley Catheter Teleflex Medical, Inc. Lori Pfohl
K161606 06/10/2016 Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH TERUMO EUROPE N.V. M.J. AERTS
K161785 06/29/2016 THD ANOPRESS THD SPA GIUSEPPINA GIANNINI
K161661 06/16/2016 Thermi RF Accessories THERMI Carrie Eddings
K161509 06/01/2016 3D OCT-1 Maestro Topcon Corporation Charles Reisman
K161789 06/29/2016 BLUEPRINT Patient Specific Instrumentation TORNIER SAS AYMEN AZAIEZ
K161742 06/24/2016 Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid Tornier, Inc. Laurie Lewandowski
K161597 06/09/2016 Tyber Medical BioTy« Nanotopography Trauma Screw TYBER MEDICAL LLC MARK F. SCHENK
K161723 06/22/2016 ulrich Transfer Set ulrich GmbH & Co. KG Sven Erdmann
K161705 06/20/2016 U2 Total Knee System E-XPE products UNITED ORTHOPEDIC CORPORATION KAREN HO
K161540 06/03/2016 Advanced Breast Template System VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K161576 06/07/2016 Esophagus Bougie Set Varian Medical Systems, Inc. Peter J. Coronado
K161702 06/20/2016 Endura guidewire Vascular Solutions, Inc. BEKA VITE
K161757 06/27/2016 Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads VICTOR MEDICAL INSTRUMENTS CO.,LTD. Yunhuo Chen
K161630 06/13/2016 Provicol QM Plus VOCO GMBH TH. PLAUMANN
K161756 06/27/2016 SyncVision System Volcano Corporation Elaine Alan
K161786 06/29/2016 ClearLumen II Thrombectomy System Walk Vascular, LLC David Look
K161503 06/01/2016 ORION YERIM ENGINEERING Co., Ltd. Won Gil Jeon
K161620 06/13/2016 Anatomical Shoulder Domelock Dome centric ZIMMER GMBH ROBERTO TOMMASINI
K161652 06/15/2016 DIAZIR ZXTGY (BEIJING) TECHNOLOGY CO., LTD N/A N/A


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