FDA 510(k) Decisions During August, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K153571 08/23/2016 Cavilon Advanced High Endurance Skin Protectant 3M HEALTH CARE MARIA RUIZ
K153731 08/25/2016 LifeFlow Rapid Infusion Device (LifeFlow Device) 410 Medical Innovation, LLC Galen Robertson
K161403 08/16/2016 A.R.C. Laser Surgical Fibers and Probes A.R.C. LASER GMBH ANGELA THYZEL
K153744 08/04/2016 A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) A1 GLOVE SDN BHD CONNIE YUNG
K161874 08/10/2016 Audit MicroControls Linearity DROP LQ Blood Glucose AALTO SCIENTIFIC, LTD. ROBERT BURDA
K161240 08/10/2016 Rhythm View Workstation (non-streaming) Abbott Electrophysiology Dennis Pozzo
K153375 08/12/2016 ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls ABBOTT LABORATORIES LAURA YELVIGI JOGLEKAR
K161985 08/07/2016 Steerable Guide Catheter ABBOTT VASCULAR Makena Mc Gowan
K153559 08/26/2016 OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System Accelerated Care Plus (ACP) Patrick Parker
K161278 08/08/2016 Cerafix Dura Substitute ACERA SURGICAL, INC. Matthew MacEwan
K152135 08/09/2016 Quantitative Electrocardiographic Detector (QED 2000) ACME Portable Machines, Inc. James Cheng
K161867 08/05/2016 On Call Pro Blood Glucose Monitoring System ACON LABORATORIES Qiyi Xie
K161445 08/16/2016 PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C ADAPTA MEDICAL, INC Adrian Elfe
K160239 08/10/2016 TAP 3, TAP 1 Airway Management, Inc. Dale Siebenmorgen
K161375 08/18/2016 Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit ALERE SCARBOROUGH, INC. Ashley Lucas
K160075 08/17/2016 Accent XL Alma Lasers Inc. Avi Farbstein
K160646 08/24/2016 XYcor« Expandable Spinal Spacer System Alphatec Spine, Inc Renee Murphy
K153494 08/25/2016 HQS Introducer (Model 2064-HQS) ALSEAL Jean-Francois M Delforge
K152931 08/29/2016 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator AMBU A/S LINE KAGENOW SVENSTRUP
K160766 08/17/2016 Ambu USR, Ambu M AMBU A/S CAMILLA WISMAR
K161405 08/19/2016 Valeo II Interbody Fusion Device System AMEDICA CORP. William D. Jordan
K160563 08/04/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD LIU YI
K160565 08/10/2016 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD LIU YI
K153286 08/19/2016 iHealth Align Gluco-Monitoring system Andon health Co., Ltd Yi Liu
K153278 08/19/2016 Wireless Smart Gluco-Monitoring System Andon Health Co., Ltd Yi Liu
K151047 08/31/2016 MTA Repair HP ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS Paulo Sergio Calixto de Oliveria
K153200 08/09/2016 SnoreRx Apnea Sciences Corporation James Fallon
K160248 08/05/2016 ArgenIS Titanium Abutments Argen Corporation Paul Cascone
K161066 08/10/2016 SpotLight CT Arineta Ltd. Ehud Dafni
K153596 08/09/2016 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control ARK DIAGNOSTICS, INC. KENNETH C. KASPER
K161315 08/18/2016 Vein Clamps, Artery Clamps AROS Surgical Instruments Corporation Fred Phleps
K161313 08/24/2016 ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K161108 08/29/2016 Arthrex VaultLock Glenoid ARTHREX, INC. Courtney Smith
K162074 08/22/2016 Werewolf RF20000 Controller, FLOW 50 Wand ARTHROCARE CORPORATION SHIRLEY HYINK
K161126 08/25/2016 ASAHI Corsair Pro ASAHI INTECC CO., LTD. CARROLL COUNCILMAN
K160702 08/23/2016 ZION Anterior Cervical Fixation System Astura Medical TROY TAYLOR
K153551 08/04/2016 ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. Axis-Shield Diagnostics Limited. Claire I Dora
K153297 08/12/2016 Perifix and Contiplex Catheter B. BRAUN MEDICAL INC LISA GIAQUINTO
K161986 08/04/2016 SIDEKICK and USHER Support Catheters BARD PERIPHERAL VASCULAR, INC. Melanie Hadlock
K153651 08/18/2016 Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems BECKMAN COULTER, INC. MICHAEL ROBERT LORENZ
K161306 08/08/2016 BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial BECTON DICKINSON ASHANTI C. BROWN
K161777 08/29/2016 BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems Becton Dickinson Infusion Therapy Systems, Inc. Kimberly Geisler
K161286 08/04/2016 IPL Therapy Machine BEIJING ADSS DEVELOPMENT CO., LTD YURONG GAO
K161324 08/12/2016 Raycell Mk2 Best Theratronics Limited MIKE DE VAN DER SCHUEREN
K161211 08/29/2016 Digital Thermometer BIOCARE ASIA CORPORATION LTD. KE-MIN JEN
K153573 08/11/2016 Converge BIOMEDICAL ENTERPRISES, INC Joe Soward
K161896 08/02/2016 Biomet Microfixation Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K153205 08/01/2016 IDSS ForceTriad Control Module BLACK DIAMOND VIDEO, INC Ragunath Muniandy
K152125 08/15/2016 Oral Surgery System and Accessories BONART CO., LTD. BANKSON TSAI
K153742 08/08/2016 Apollo Balloon Dilatation Catheter BrosMed Medical Co., Ltd. Tina Yin
K153440 08/18/2016 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set C.R BARD, INC. Darlene Hull
K161130 08/24/2016 ResolutionMD CALGARY SCIENTIFIC, INC. Kyle Peterson
K161245 08/05/2016 EP-TRACER System CARDIO TEK, BV OLIVER ROTH
K160840 08/12/2016 ECG100+, ECG200+ CARDIOLINE S.p.A EMANUELE ERCOLI
K160764 08/25/2016 AirLife Autofill Humidification Chamber CAREFUSION 2200, INC. ERIKA FERNANDEZ
K160723 08/30/2016 OnSight 3D Extremity System CARESTREAM HEALTH, INC. Carolyn Wagner
K161033 08/03/2016 AFXÖ Femoral Implant With Inserter CAYENNE MEDICAL, INC. SHIMA HASHEMIAN
K161619 08/29/2016 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
K161544 08/31/2016 Trojan Chain Reaction Personal Lubricant CHURCH & DWIGHT CO., INC. Lisa Burns
K161545 08/26/2016 Trojan XOXO Thin Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant CHURCH & DWIGHT CO., INC. Lisa Burns
K160806 08/05/2016 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. Amanda Stahle
K153347 08/19/2016 Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit CODMAN & SHURTLEFF, INC. Megan Herman
K152834 08/10/2016 Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 COLONPLUS EQUIPMENTS & SPECULUMS, S.L. Jorge Echevarria
K161518 08/17/2016 PACS CORE/ENCORE COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. Felipe Cuaranta Monroy
K153397 08/18/2016 S-Wire Guidewire System CONCERT MEDICAL, LLC Timothy S. Powers
K161100 08/10/2016 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses CONTAMAC LTD. ROB MCGREGOR
K160542 08/02/2016 5.0 Fr Arndt Endobronchial Blocker Set COOK INCORPORATED Kotei Aoki
K160219 08/03/2016 Hilal Embolization MicroCoils Cook Incorporated David Lehr
K160414 08/01/2016 Precision Point Biopsy Needle Guide Corbin Clinical Resources, LLC Kenneth K Kleinhenz
K160679 08/08/2016 WoundClot9 CORE SCIENTIFIC CREATION LTD. YUVAL YASKIL
K160331 08/12/2016 LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp Covidien Hong Zhu
K161105 08/18/2016 Reprocessed Compression Garments COVIDIEN WING NG
K160636 08/03/2016 iPEP System and vPEP D R BURTON HEALTHCARE LLC DENNIS COOK
K160281 08/04/2016 OSSIX PLUS Datum Dental Ltd. Arie Goldlust
K153549 08/04/2016 OSSIX VOLUMAX Datum Dental Ltd. Arie Goldlust
K160483 08/05/2016 Burn-out Cylinder and Angled Screw Abutments Dentium Co., Ltd Sangpil Yoon
K161030 08/26/2016 ATLANTIS Abutment for CONELOG implant Dentsply Sirona Helen Lewis
K160626 08/29/2016 ATLANTIS Abutment for HIOSSEN ET implant DENTSPLY SIRONA Helen Lewis
K161269 08/12/2016 CELTRA Press DENTSPLY SIRONA HELEN LEWIS
K153709 08/08/2016 Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet DEVICOR MEDICAL PRODUCTS, INC. SHAWNA ROSE
K160650 08/25/2016 LIAISON HAV IgM, LIAISON Control HAV IgM DiaSorin Inc. John Walter
K151458 08/22/2016 Double Medical Universal Spine System Double Medical Technology Inc DA ZENG
K160275 08/01/2016 Fuse Endoscopic System with FuseBox Processor EndoChoice Inc. Daniel Hoefer
K161199 08/01/2016 EndyMed Contour Handpiece ENDYMED MEDICAL LTD. Yoram Levy
K161663 08/23/2016 sTMS mini ENEURA INC CYNTHIA MERRELL
K162152 08/31/2016 ErbeÆs CO2 Tubing/Cap Sets Erbe USA, Inc. John Tartal
K161513 08/25/2016 Anti-Borrelia burgdorferi US Westernblot (IgG) EUROIMMUN US MICHAEL LOCKE
K153303 08/10/2016 EUROIMMUN Anti-West Nile Virus ELISA (IgG) EUROIMMUN US, INC. Michael Locke
K153308 08/12/2016 EUROIMMUN Anti-West Nile Virus ELISA (IgM) EUROIMMUN US, INC. Michael Locke
K153649 08/31/2016 Exactech« Novation« Element Press-fit Femoral Stem EXACTECH INC Thomas McNamara
K161266 08/11/2016 Athena Breast Pump EXPLORAMED NC7, INC JOHN CHANG
K153243 08/04/2016 Fehling-Punches Fehling Instruments GmbH & Co. KG Ulrike Lindner
K161877 08/05/2016 Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tam FIRST QUALITY HYGIENIC, INC. Melanie Leibowitz
K160797 08/26/2016 FMX314 Surgical Platform Fortimedix Surgical B.V. DIRKJAN BAKKER
K162045 08/18/2016 SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System FUJIFILM SonoSite, Inc. Jordan Grimmer
K161516 08/25/2016 G Surgical Marksman MIS System G SURGICAL LLC Donald Grafton
K160338 08/05/2016 Triton System GAUSS SURGICAL INC. ARTIE KAUSHIK
K160937 08/01/2016 Senolris GE Healthcare Mounir Zaouali
K161224 08/05/2016 LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Tracey Ortiz
K161588 08/31/2016 Vscan Extend GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC Tracey Ortiz
K161706 08/05/2016 Vivid iq GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L Tracey Ortiz
K161574 08/11/2016 Discovery MI GE Medical Systems, L.L.C. Helen Peng
K161397 08/31/2016 MAGiC GE Medical Systems, LLC Mary A. Mayka
K162052 08/18/2016 Sentinella 102, Sentinella 102 Horus GENERAL EQUIPMENT FOR MEDICAL IMAGING (ONCOVISION- JOSE MONTES
K161502 08/16/2016 MC1 Plus GENERAL PROJECT S.R.L. MORENO NALDONI
K161914 08/09/2016 Genesys Spine TiLock Cortical Spinal System Genesys Spine William W. Sowers
K161791 08/11/2016 Aer-O-Scope Colonoscope System GI View Ltd. Sharon Goldfarb
K160597 08/29/2016 INDEPENDENCE MIS Spacers GLOBUS MEDICAL INC. Kelly J. Baker
K160138 08/11/2016 Adhesive Electrodes GMDASZ MANUFACTURING CO., LTD CHARLES MACK
K161376 08/25/2016 DragonFly Surgical Drill System Grace Medical, Inc. William Graham
K160664 08/01/2016 Aqueduct 100 Cervical Dilator GTIMD LLC RICHARD DEMELLO
K161615 08/23/2016 Accurett H&O EQUIPMENTS, NV/SA Aline Franck
K161251 08/30/2016 CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests Hangzhou Clongene Biotech Co., Ltd Zheng Shujian
K160999 08/01/2016 Infra-red forehead thermometer HANGZHOU HUA'AN MEDICAL&HEALTH INSTRUMENTS CO., LTD AHNEO YANG
K160802 08/24/2016 Infrared Forehead Thermometer, FT-100A HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. JIAQIANG WAN
K160560 08/04/2016 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue) HARTALEGA SDN BHD KUAN KAM HON
K161006 08/04/2016 Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove HARTALEGA SDN. BHD. KUAN KAM HON
K152949 08/17/2016 WebPAX HEART IMAGING TECHNOLOGIES, LLC Robert Judd
K161772 08/24/2016 FFRct HEARTFLOW, INC. Windi Hary
K151542 08/03/2016 A-Oss HIOSSEN INC. David Kim
K152126 08/17/2016 UST-5550-R; UST-5536-R; L43K HITACHI ALOKA MEDICAL AMERICA, INC. ANGELA VAN ARSDALE
K161748 08/17/2016 SUPRIA w/guideShot Option HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K161575 08/10/2016 Affirm Lateral Arm Upright Biopsy Accessory HOLOGIC DEBBIE PEACOCK
K160022 08/17/2016 LUOFUCON Silicone Ag foam dressing HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. Guosheng Tan
K161148 08/09/2016 icobrain Icometrix Dirk Loeckx
K153756 08/04/2016 Microlyte Ag IMBED BIOSCIENCES, INC. ANKIT AGARWA
K151757 08/03/2016 IMMEDIATELOAD Dental Implant System IMMEDIATELOAD S.A. GIOVANNI CANINO
DEN150037 08/22/2016 ImPACT Computerized Neurocognitive Concussion Management Aid IMPACT APPLICATIONS, INC. MICHAEL ZAGORSKI
K153509 08/26/2016 GPS Angled Abutment IMPLANT DIRECT SYBRON MANUFACTURING LLC DEBLEENA SINHA
K160329 08/19/2016 InMode System MiniFX Handpiece InMode MD Ltd. Amit Goren
K161189 08/25/2016 Integra TITAN Reverse Shoulder System INTEGRA LIFESCIENCES CORPORATION William Garzon
K153276 08/07/2016 da Vinci Xi Surgical System INTUITIVE SURGICAL, INC. Brandon Hansen
K161355 08/25/2016 invendoscopy E200 System Invendo Medical GmbH Oliver V. Ruepprecht
K162001 08/31/2016 1.5T and 3.0T 16 CH GE Shoulder Coils INVIVO CORPORATION KEN REVENNAUGH
K152224 08/09/2016 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) ION BEAM APPLICATION S.A. ANNE-SOPHIE GRELL
DEN140040 08/01/2016 Nautilus BrainPulse 1000 JAN MEDICAL, INC. Paul Lovoi
K161864 08/02/2016 ARIX Foot System JEIL MEDICAL CORPORATION SEJIN RYU
K152091 08/18/2016 Fingertip Pulse Oximeter Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Li Xu
K152089 08/17/2016 Wrist Pulse Oximeter Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Li Xu
K160284 08/03/2016 JointPoint JOINTPOINT, INC. Noah D. Wollowick
K161098 08/22/2016 ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) JOOWON INNOVATION CO., LTD. LEE HAE-HANG
K160675 08/02/2016 Powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. Dan ny
K161933 08/16/2016 The Braun ThermoScan« 3 High Speed Compact Ear Thermometer Kaz USA, Inc., A Helen of Troy Company AMY LIU
K153364 08/19/2016 Kerecis SecureMesh Kerecis Limited Gudmundur Fertram Sigurjonsson
K151824 08/02/2016 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested KOSSAN INTERNATIONAL SDN. BHD. CHO SOW FONG
K151750 08/03/2016 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile KOSSAN INTERNATIONAL SDN. BHD. CHO SOW FONG
K160467 08/02/2016 Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim Kossan International Sdn. Bhd. Cho Sow Fong
K153476 08/23/2016 KATANA AVENCIA Block Kuraray Noritake Dental, Inc. Michio Takigawa
K161766 08/22/2016 PathLoc-L MIS Spinal System L&K BIOMED Co., Ltd. Yerim An
K161570 08/29/2016 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
K152642 08/26/2016 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode LCCS PRODUCTS LIMITED JAMES LIN
K161798 08/04/2016 FacetBRIDGE« System LDR SPINE USA, INC. JAMIE WILSON
K161037 08/15/2016 Tarsa-Link Stand-Alone Wedge Fixation System LIFE SPINE INC. RANDY LEWIS
K153065 08/01/2016 The Hammertoe Correction System LIFE SPINE, INC Randy Lewis
K160011 08/22/2016 H-Max S stem LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K161220 08/02/2016 ARIES« Flu A/B & RSV Assay LUMINEX CORPORATION WENDY RICKER
K161195 08/25/2016 Royal Condoms (Natural, Black Grape, Coffee, Strawberry, and Chocolate Flavors) M3 GLOBAL ENTERPRISES, LLC NEIL MEHTA
K161026 08/09/2016 NexSiteÖ HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) MARVAO MEDICAL DEVICES, LTD. Christopher Davey
K162119 08/29/2016 UreTron PF Series Probe MED-SONICS CORP. JENNIFER RAUTINE
K153329 08/04/2016 MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis MED-TECH WATER SYSTEMS INC BRIAN C KIM
K152659 08/25/2016 V10 MEDIANA CO., LTD KIM MIN HYE
K161249 08/19/2016 Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Medtronic Debra Taitague
K160983 08/24/2016 Kyphon HV-R Bone Cement MEDTRONIC INC PAMELA EDWARDS
K161210 08/12/2016 RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems Medtronic Sofamor Danek Ankit K. Shah
K161287 08/19/2016 DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak MEDTRONIC VASCULAR Nisarg Shah
K161402 08/18/2016 Bullfrog Micro-Infusion Device MERCATOR MEDSYSTEMS, INC. Kirk P. Seward
K161409 08/02/2016 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem Mermaid Medical A/S Pia Wissing Jensen
K160699 08/01/2016 VIRTU Lumbar Spacer System Met 1 Technologies, LLC Dan Gerbec
K153285 08/12/2016 EMS-200 META SYSTEMS CO., LTD. RAY JEON
K161292 08/15/2016 Distal Radius Plating System MIAMI DEVICE SOLUTIONS, LLC MARKKU BIEDERMANN
K153283 08/11/2016 VivoSight Dx Topical OCT System Michelson Diagnostics Ltd Martin Johns
K162077 08/11/2016 Laparoscopic Spray Applicator with Spinning Luers MICROMEDICS INC. (D/B/A NORDSON MEDICAL) AMY L. PETERSON
K161367 08/31/2016 HydroCoil Embolic System (HES) MICROVENTION, INC. SAPNA SINGH
K161452 08/31/2016 MicroPlex Coil System (MCS) - HyperSoft 3D MICROVENTION, INC. SAPNA SINGH
K160149 08/30/2016 Miret Grasper, Alligator, Miret Grasper, Maryland MIRET SURGICAL INC. AVI ROOP
K160379 08/25/2016 Exufiber Ag+ MOLNLYCKE HEALTH CARE, US LLC MEGAN BEVILL
K160685 08/04/2016 Surveyor S4 Mobile Monitor Mortara Instrument, Inc. Sarah Weber
K152289 08/17/2016 Alians Elbow Locking Plating System NEWCLIP TECHNICS Gaelle LUSSORI
K162075 08/11/2016 NICO TRIOwand NICO Corporation Sean Spence
K160865 08/05/2016 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S NONIN MEDICAL, INC. NANCY E. DEANGELO
K161230 08/25/2016 NuVasive Lumbar Interbody Implants NUVASIVE, INCORPORATED MARTIN YAHIRO
K152890 08/11/2016 SACCADOMETER PLUS, SACCADOMETER ADVANCED OBER CONSULTING SP. Z.O.O. JAN KRZYSZTOF OBER
K161034 08/19/2016 Microcyn Plus Wound Care Solution OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K161622 08/11/2016 LensGiene Sterile Saline Solution Optics Laboratory, Inc. Patricia Chiu
K150830 08/26/2016 CompleClear Plastic Orthodontic Bracket and Wire Appliance ORACREW PAWAN GAUTAM
K161267 08/11/2016 Response BandLoc Spinal Fixation ORTHOPEDIATRICS CORP. MARK FOX
K161505 08/03/2016 DyeVert NG Contrast Modulation System OSPREY MEDICAL, INC. MELANIE HESS
K160611 08/08/2016 P-ARTIS P-CURE LTD. MICHAEL MARASH
K161019 08/17/2016 Uroview FD PAUSCH MEDICAL GMBH Christian Stoian
K153678 08/08/2016 PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove PERMEADERM, INC. AUBREY WOODROOF
K161532 08/29/2016 Philips Avent Comfort Single/Twin Electric Breast Pump Philips Consumer Lifestyle-Innovation Site Eindhoven Marta Walker
K160743 08/08/2016 Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc. Susan Quick
K160455 08/25/2016 AneurysmFlow PHILIPS MEDICAL SYSTEMS NEDERLAND BV Jeanette Becker
K160147 08/10/2016 CT TrueView PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K161498 08/22/2016 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K153514 08/22/2016 Premium Plus C01/C02 LED Curing Light PREMIUM PLUS INTERNATIONAL LIMITED Jessica Mao
K162196 08/15/2016 Dell UP3216Q with QUBYX PerfectLum bundle QUBYX SOFTWARE TECHNOLOGIES INC. MARC LEPPLA
K161182 08/15/2016 Solana Trichomonas Assay QUIDEL CORPORATION RONALD H LOLLAR
K160382 08/11/2016 OT EQUATOR RHEIN'83 SRL CLAUDIA NARDI
K160943 08/26/2016 Bite Away Riemser Pharma Ronny Raasch
K160944 08/31/2016 ACCU-CHEK Guide Blood Glucose Monitoring System Roche Diabetes Care, Inc. Khone Saysana
K153540 08/04/2016 Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators SAFE SECURE PACKAGING CO., LTD HOWARD JIA
K162094 08/26/2016 RS80A Diagnostic Ultrasound System Samsung Medison Co., Ltd Kyeong-Mi Park
K161955 08/10/2016 5D Viewer SAMSUNG Medison Co., Ltd. Kyeong-Mi Park
K152471 08/04/2016 CAPO BULK FILL SCHUETZ DENTAL GMBH Anke Puent
K161234 08/03/2016 CASSI II Rotational Core Biopsy System Scion Medical Technologies, LLC Louis Li
K152390 08/18/2016 Medke Oximetry Finger Sensor Shenzhen Medke Technology Co., LTD Lao Chengxin
K160932 08/01/2016 8ch Foot Ankle Coil Shenzhen RF Tech Co., Ltd. Ke Xi
K160106 08/26/2016 LUNA DENTAL IMPLANT SYSTEM SHINHUNG MST Co., Ltd Sunbyung Lee
K161196 08/24/2016 SOMATOM Drive Siemens Medical Solutions USA, Inc. Kimberly Mangum
K152197 08/26/2016 Skypro, SP01 Mask Skypro Medical Supplies Company Cyrus Wong
K161289 08/03/2016 DURAFIBER Ag SMITH & NEPHEW MEDICAL LIMITED Samantha Neilson
K153209 08/04/2016 RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters, RENASYS TOUCH Carry Bag, Carry Strap, RENASYS Y-Connector, RENASYS TOUCH IV Pole/Bed Clamp, RENASYS TOUCH Class 2 Power Supply SMITH & NEPHEW MEDICAL LTD. LAURA REYNOLDS
K162129 08/31/2016 RENASYS-G Gauze Dressing Kits with Soft Port Smith & Nephew, Inc. Laura Reynolds
K153274 08/04/2016 Med-Tainer Single Deposit Container Snyder Industries, Inc. Herbert H Spann
K162030 08/19/2016 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle SOL-MILLENNIUM MEDICAL, INC JIM BARLEY
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