FDA 510(k) Decisions During April, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K141770 04/22/2015 LUNA CPAP AND AUTO-CPAP SYSTEM 3B MEDICAL, INC ALEX LUCIO
K143258 04/09/2015 PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) 4WEB,INC. JESSEE HUNT
K150974 04/29/2015 aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K142820 04/30/2015 BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric M ABB Optical Group, LLC John Kenyon
K150510 04/02/2015 Total Bilirubin ABBOTT LABORATORIES SUSHMA RAO
K133002 04/16/2015 i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials ABBOTT POINT OF CARE INC. MELISSA ROBINSON
K150172 04/07/2015 ACCLARENT SE Inflation Device ACCLARENT, INC. JAMES PATRICK GARVEY II
K143541 04/22/2015 Relieva SpinPlus Balloon Sinuplasty System ACCLARENT, INC. Pavan Sethi
K143269 04/14/2015 Delivery Analysis ACCURAY INCORPORATED Keith Picker
K150330 04/30/2015 Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) ACON Laboratories, Inc. Qiyi Xie
K143385 04/06/2015 Acumed Ankle Plating System Acumed, llc Nathan Wolf
K142454 04/03/2015 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS SUN CHOI
K141687 04/02/2015 AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K150660 04/16/2015 Alcyone MEMS Cannula (AMC) System ALCYONE LIFESCIENCES, INC. ELSA CHI ABRUZZO
K150457 04/10/2015 AlfaSight 9000 Thermographic System ALFA THERMODIAGNOSTICS, INC. Daniel Beilin
K132663 04/20/2015 I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM ALLIANCE INTERNATIONAL CO., LTD. JEN KE-MIN
K143372 04/02/2015 AWARE AMBIENT CLINICAL ANALYTICS ALLEN BERNING
K150163 04/23/2015 Otowave 202 Portable Tympanometer AMPLIVOX, LTD. Chris Roerig
K141984 04/29/2015 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K143536 04/16/2015 Voyant Fine Fusion Device APPLIED MEDICAL RESOURCES JESSICA CHO
K142569 04/03/2015 Aptis Medical Distal Radio Ulnar Joint Implant APTIS MEDICAL, LLC. Bryann Babb
K150256 04/30/2015 SILVERLON BURN CONTACT DRESSINGS ARGENTUM MEDICAL C.Richard Foster
K143702 04/09/2015 Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc. David L Roger
K143749 04/03/2015 Arthrex Distal Radius System Arthrex, Inc. Laura Medlin
K150456 04/29/2015 Arthrex Plates, Screws, and Staples Arthrex, Inc. David L Rogers
K142056 04/09/2015 LIOLI IOL DELIVERY SYSTEM AST PRODUCTS, INC. William Lee
DEN140030 04/01/2015 SpaceOAR System AUGMENIX , INC. Noel Rolon
K150821 04/10/2015 MDNG-3220 (Nio 3MP LED) Barco Lieven De Wandel
K150860 04/16/2015 Nitroglycerin Sets with DUO-VENT Spike BAXTER HEALTHCARE CORPORATION DHIRAJ BIZZUL
K141932 04/10/2015 AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS BECKMAN COULTER, INC. ANTHONY DENNIS
K143610 04/09/2015 BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems Inc. John Roberts
K150059 04/28/2015 BD FlowSmart Set BECTON, DICKINSON COMPANY AVITAL MERL
K150191 04/17/2015 GammaBeam 500 Best Theratronics Limited Mike de van der Schueren
K143336 04/01/2015 Biomet Microfixation OmniMax MMF System BIOMET MICROFIXATION Lauren Jasper
K150235 04/22/2015 CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels BOSTON SCIENTIFIC CORPORATION MAYLIN TRUESDELL
K133697 04/10/2015 BREAST-MED TISSUE MARKER BREAST-MED, INC. MICHAEL NELSON
K143280 04/23/2015 BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens Brien Holden Vision Pty Ltd. Randall May
K150051 04/08/2015 Exilite BTL Industries, Inc. Jan Zarsky
K142445 04/13/2015 PINPOINT GT SAFETY INTRODUCER NEEDLE C.R. BARD, INC. AMY MCMANUS
K142083 04/17/2015 TRUE FLOW VALVULOPLASTY PERFUSION CATHETER C.R. BARD, INC. AARON CONOVALOFF
K150083 04/14/2015 Sidecar External Working Channel C2 THERAPEUTICS THERESA BRANDNER-ALLEN
K150016 04/06/2015 Vertessa Lite CALDERA MEDICAL, INC. Vicki Gail
K150023 04/06/2015 Vertessa Lite Y-Mesh CALDERA MEDICAL, INC. Vicki Gail
K150326 04/16/2015 PicoWay Laser System Candela Corporation Ruthie Amir
K150579 04/29/2015 Cardinal Health External Fixation System CARDINAL HEALTH TATYANA BOGDAN
K143016 04/20/2015 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home CARDINAL HEALTH Tatyana Bogdan
K150732 04/13/2015 Diamondback 360 Peripheral Orbital Atherectomy System CARDIOVASCULAR SYSTEMS, INC. Blair Buth
K143675 04/10/2015 FORE-SIGHT Elite Absolute Tissue Oximeter CAS MEDICAL SYSTEMS, INC. Ron Jeffrey
K143024 04/28/2015 CAS-One Liver CAScination AG Matthias Peterhans
K150010 04/02/2015 Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port Cedic S.r.l. Tiziana Melis
K141880 04/16/2015 BIOPOR AOC POROUS POLYETHYLENE, CEREPOR CEREMED, INC. CHELSEA MITCHELL
K143599 04/17/2015 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 Chemtron Biotech, Inc. Jane Zhang
K142216 04/21/2015 Tranberg CLS Thermal Therapy System Clinical Laserthermia Systems AB Lars-Erik Eriksson
K150798 04/24/2015 Codent Low Speed Dental Handpieces and Accessories CODENT TECHNICAL INDUSTRY CO., LTD. Chin-Ting Wen
K142745 04/01/2015 125mL CT Syringe COEUR, INC. Erin Rheinscheld
K143077 04/06/2015 Trevo XP ProVue Retriever (6X25mm) CONCENTRIC MEDICAL, INC. Bill Hyatt
K142535 04/23/2015 ConMed Mixing and Delivery Kit CONMED CORPORATION Dionne Sanders
K141362 04/23/2015 PULSE OXIMETER CMS50EW CONTEC MEDICAL SYSTEMS CO., LTD. Diana Hong
K141737 04/08/2015 CONVENTUS PHS SYSTEM CONVENTUS ORTHOPAEDICS, INC. KENT LIND
K142094 04/10/2015 COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM COPAN ITALIA S.P.A. TINA WU
K150836 04/29/2015 OUTBACK Elite Re-Entry Catheter CORDIS CORPORATION, A JOHNSON & JOHNSON CO. MICHELLE RAGOZZINO RODGERS
K142761 04/03/2015 Corin TaperFit Hip Stem CORIN USA Diana L Nader-Martone
K143506 04/16/2015 BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL COVIDIEN TIMOTHY HOLWICK
K143018 04/02/2015 Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors Covidien Wei Zhao
K142839 04/29/2015 GenCut Core Biopsy System Covidien LLC Jenny Jiang
K143654 04/03/2015 Valleylab LS10 Generator COVIDIEN LLC DONALD HENTON
K150413 04/02/2015 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator CyMedica Orthopedics, Inc. Kereshmeh Shahriari
K150400 04/06/2015 Renu Gel CYTOPHIL, INC. BOB VOIGTS
K150033 04/20/2015 Air Compressible Limb Therapy System DAESUNG MAREF CO., LTD. JAE-WHA LEE
K143530 04/24/2015 Aespire View Datex-Ohmeda, Inc. Michelle Huettner
K141747 04/20/2015 RHINOGUARD DAVIS MEDICAL MICHELLE LOTT
K143475 04/03/2015 VAPR Tripolar Suction Electrode Depuy Mitek Susan Kagan
K143551 04/28/2015 Compex Wireless USA DJO, LLC GINA FLORES
K142986 04/17/2015 SagiNova Eckert & Ziegler BEBIG GmbH Michel Lafuente
K140348 04/23/2015 INTERBODY CAGE EISERTECH, LLC LUKAS EISERMANN
K150106 04/03/2015 2MP Color LCD Monitor, RadiForce RS240 EIZO CORPORATION HIROAKI HASHIMOTO
K150516 04/13/2015 DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS EL.EN ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K150656 04/23/2015 PRECICE Intramedullary Limb Lengthening System Ellipse Technologies, Incorporated Rebecca Shelburne
K140360 04/10/2015 HEALTH KIOSK ENGAGEMENTHEALTH, LLC JORGE MILLAN
K142421 04/09/2015 G-scan Brio ESAOTE, S.P.A. Donatella Ragghianti
K141827 04/17/2015 EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE EUROIMMUN U.S., Inc. MICHAEL A LOCKE
K143659 04/09/2015 Equinoxe Mega Prosthesis EXACTECH, INC. Thomas McNamara
K150223 04/28/2015 Facet-Link Stabilization Platform FACET-LINK, INC. Massimo Calafiore
K150473 04/16/2015 FlexPointer 1.5 mm FIAGON GMBH DR. DIRK MUCHA
K143666 04/23/2015 Noblex Long Pulse Alexandrite Laser FINEMEC CO.,LTD. GHUN HEE LEE
K143723 04/09/2015 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro FOTONA D.D. STOJAN TROST
K141997 04/01/2015 CRIT-LINE IV SYSTEM FRESENIUS MEDICAL CARE DENISE OPPERMANN
K150430 04/17/2015 Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor FUDAKANG INDUSTRIAL CO., LTD BOB YU
K142456 04/10/2015 GPS Spacers G SURGICAL, LLC Donald Grafton
K143140 04/20/2015 G-Premio BOND GC AMERICA, INC. Dr. Mark Heiss
K142646 04/30/2015 XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and Genadyne Biotechnologies, Inc Chien Ming
K143574 04/21/2015 Melodi Prime Breast Pump Genadyne Biotechnologies, Inc. Chien Ming GOH
K150649 04/30/2015 G3 Active Plate Large Fragment System GENESIS FRACTURE CARE, INC. MICHAEL BOTTLANG,
K143591 04/15/2015 Dorsal Appliance GERGENS ORTHODONTIC LAB Chris Morrison
K143527 04/20/2015 IPM Wound Gel Bio, IPM Derm Gel Bio GLYCOBIOSCIENCES, INC Kevin Drizen
K143733 04/03/2015 Digital Automatic Wrist Blood Pressure Monitor MD2400 Grandway Technology (Shenzhen) Limited Patrick Chow
K143312 04/21/2015 Portrait GBS Assay GREAT BASIN CORPORATION Chuck Owen
K141349 04/10/2015 Disposable sterile needle retractable safety syringe GUANGDONG HAIOU MEDICAL APPARATUS STOCK CO., LTD SALON CHEN
K150602 04/07/2015 CR3 Keyless Split Sample Cup Morphine - Methamphetamine GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K142824 04/14/2015 LX-100 Hair Growth Stimulation System Hairlabs International Inc James Britt
K150110 04/23/2015 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - White, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant - Dawn Blue, Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin P HARTALEGA NGC SDN. BHD. Kuan Mun Leong
K150103 04/23/2015 Nitrile Powder Free Examination Gloves (Orange) Tested For Use With Chemotherapy Drugs HARTALEGA SDN BHD Kuan Kam Hon
K150791 04/24/2015 Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC JIANQIU FANG
K150490 04/17/2015 UnicLine Mobile Heka Dental A/S Claus van der Goot
K142551 04/16/2015 QANS (Quantitative Autonomic Nervous System) Monitoring System HHSsystems, LLC HOWARD G. HINDIN
K133033 04/08/2015 HIDREX PSP1000 HIDREX GMBH STEFANIE D BANKSTON
K142911 04/10/2015 ZM Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) HUAILAI ZM PLASTIC PRODUCTS CO., LTD ZHUAHAO ZHANG
K141619 04/06/2015 LUOFUCON SILVER FOAM DRESSING HUIZHOU FORYOU MEDICAL DEVICES CO, LTD CHARLES SHEN
K150293 04/15/2015 EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) I-SEE VISION TECHNOLOGY INC. ISAAC HUANG
K142994 04/21/2015 IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD. Mick Fenton
K143731 04/14/2015 IMPLANET Spine System (ISS) IMPLANET S.A. Regis Le Couedic
K142519 04/15/2015 InterActive Complete Surgical Tray Implant Direct Sybron Manufacturing , LLC Debleena Sinha
K150913 04/30/2015 INCITE ANCHORED CERVICAL INTERBODY DEVICE INCITE INNOVATION JOHN KIRWAN
K150183 04/09/2015 ApexM InControl Medical, LLC Jessica Andreshak
K150813 04/30/2015 iTClamp50 INNOVATIVE TRAUMA CARE INC Ian Atkinson
K150155 04/08/2015 NOVA Lite DAPI ANA Kit INOVA DIAGNOSTICS, INC. Gabriella Lakos
DEN140039 04/09/2015 NOVA View Automated Fluorescense Microscope INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K150428 04/16/2015 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs INTEGRA LIFESCIENCES CORP. Judith E O'Grady
K141643 04/24/2015 YARLAP INTERNATIONAL TRADE GROUP, INC. BRENT C REIDER
K150343 04/03/2015 V8 Transluminal BAV Catheter InterValve, Inc. Mark Ungs
K143132 04/02/2015 IS4000 8mm Harmonic ACE Curved Shears INTUITIVE SURGICAL, INC. EARLE CANTY
K150837 04/29/2015 IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps INTUITIVE SURGICAL, INC. SARAH RIZK
K150164 04/03/2015 Monobond Etch & Prime IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K143575 04/03/2015 Accu-Dent XD Tray, Accu-Dent XD Syringe IVOCLAR VIVADENT, INC. Donna Marie Hartnett
K143241 04/13/2015 MDT Navigable Brain Biopsy Cannula IZI MEDICAL PRODUCTS LLC Qiang Cao
K143034 04/22/2015 Jintronix JINTRONIX INC. Mark Evin
K150182 04/23/2015 Neodent Implant System- CM Drive Implants JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S Jacson Cambruzzi
K142930 04/17/2015 Exam Vue DR JPI HEALTHCARE CO., LTD Wonsik (Stanley) Youn
K143465 04/09/2015 MASTERmatic LUX Kaltenbach & Voigt Gmbh Stefan Trampler
K141781 04/09/2015 KOGENT SPETZLER LIGHTED SUCTION TUBES KATALYST SURGICAL, LLC MERYL KOCH
K143053 04/03/2015 KIMGUARD ONE-STEP Sterilization Wrap KIMBERLY-CLARK HEALTH CARE MONICA KING
K150060 04/02/2015 J2A Dental Implant System, J2C Dental Implant System KJ MEDITECH CO., LTD Goong-san Nam
K142330 04/09/2015 Kobold Ring and Tandem Applicator Set KOBOLD, LLC Spencer Fillmore
K143332 04/14/2015 Fast Sphyg by Koven KOVEN TECHNOLOGY, INC. HEATHER BELL
K143360 04/03/2015 LnK Cervical Interbody Fusion Cage System L&K BIOMED Co., Ltd Yerim An
K143363 04/22/2015 VENUS Spinal Fixation System L&K BIOMED Co., Ltd. Ki-Hyang Kim
K150507 04/03/2015 Santis Pedicle Screw System LANTERNA MEDICAL TECHNOLOGIES Horace Hale
K150098 04/09/2015 LightStim Professional 2-Panel Light LED INTELLECTUAL PROPERTIES, LLC STEVE MARCHESE
K142253 04/23/2015 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K143249 04/07/2015 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K150229 04/07/2015 SOLSTICE OCT System LIFE SPINE, INC Randy Lewis
K141934 04/02/2015 PHYSICA KR KNEE SYSTEM LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K150747 04/02/2015 EzDent-i /E2/Prora View LK Consulting Group USA, Inc. Priscilla Chung
K142964 04/30/2015 VALIDATE Anemia Calibration Verification/ Linearity Test Kit MAINE STANDARDS COMPANY, LLC James Champlin
K142581 04/09/2015 APTUS Foot System MEDARTIS AG ANDREA SCHWEIZER
K143238 04/24/2015 C3 Wave MEDCOMP (MEDICAL COMPONENTS) Courtney Nix
K150134 04/21/2015 Basic, Dominant Flex, KV-6 MEDELA AG ORLANDO ANTUNES
K150499 04/21/2015 Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty MEDELA AG ORLANDO ANTUNES
K143447 04/17/2015 Dilapan-S Medicem Technology s.r.o. Adam Vlcek
K142163 04/20/2015 MALE CIRCUMCISION KITS:RAPIDECLAMP MEDICFIT TECHNOLOGY SDN BHD JIGAR SHAH
K150286 04/27/2015 Medline Enteral Feeding Sets MEDLINE INDUSTRIES, INC. Stephanie Blair
K143480 04/02/2015 Euphora Rapid Exchange Balloon Dilatation Catheter MEDTRONIC INC. John Kilmartin
K150460 04/28/2015 KYPHON (R) HV-R(R) Bone Cement MEDTRONIC SOFAMOR DANCK USA, INC. Kathy L. Remsen
K143019 04/08/2015 CD HORIZON Spinal System, IPC POWEREASE System Medtronic Sofamor Danek USA, Inc. Lila Joe
K150567 04/09/2015 MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT Medtronic, Inc. Bruce Backlund
K150777 04/24/2015 Artoura Breast Tissue Expander MENTOR WORLDWIDE LLC Manchi Cheung
K143255 04/09/2015 Prelude SNAP Splittable Sheath Introducer MERIT MEDICAL SYSTEMS, INC. Alina Stubbs
K143341 04/21/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K150302 04/10/2015 PROFEMUR Preserve Classic Stem MICROPORT ORTHOPEDICS INC. MATT PAUL
K150133 04/20/2015 PROFEMUR Preserve Size 1-3 Hip Stems MICROPORT ORTHOPEDICS, INC. BYRON LEDBETTER
K142883 04/17/2015 MindChild Meridian M100 Fetal Heart Rate Monitor Mindchild Medical Jim Robertson
K150705 04/13/2015 FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator Minimally Invasive Devices, Inc. Trudie L Seeger
K142647 04/13/2015 mint Lesion MINT MEDICAL GMBH Jochen Neuhaus
K142918 04/24/2015 EndoTool SubQ MONARCH MEDICAL TECHNOLOGIES STUART LONG
K150746 04/14/2015 JUSHA-M52C Medical Display NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MA JING
K150842 04/28/2015 JUSHA-M53 Medical Display NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD JING MA
K140233 04/06/2015 ULTRASONIC SCALER NANNING BAOLAI MEDICAL INSTRUMENT CO., LTD. MIKE GU
K143706 04/10/2015 FortiBridge Anterior Cervical Plate System Nanovis Spine LLC Matthew Hedrick
K143440 04/20/2015 Natus Quantum NATUS MEDICAL INCORPORATED SANJAY MEHTA
K143252 04/23/2015 Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange) NEEDLETECH PRODUCTS, INC. Dennis Shay
K143344 04/09/2015 NeoMed NeoConnect Enteral Syringes with ENFit Connector NEOMED, INC. TONY LAIR
K143327 04/13/2015 Neoss Ti Reinforced Membrane Neoss Ltd Karin Darle Olsson
K150647 04/08/2015 Polyscrew Pedicle Screw System New Era Orthopedics, LLC Mark De Baca
K150993 04/23/2015 NICO TRIOwand NICO CORPORATION JAY DITTMAN
K142624 04/24/2015 Neuromaster G1 MEE200 Nihon Kohden Corporation Natalie Kennel
K143351 04/29/2015 iCase Contact Lens Case Novabay Pharmaceuticals, Inc Charles Francavilla
K143523 04/06/2015 Airlock osteosynthesis plate system NOVASTEP Gilles AUDIC
K143684 04/23/2015 NuVasive Reline System NUVASIVE INCORPORATED OLGA LEWIS
K143595 04/29/2015 NuVasive(R) CCX-L Interbody System NuVasive, Incorporated Cynthia Adams
K141914 04/15/2015 PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. Ke-Min Jen
K150633 04/29/2015 ULTRA Telescopes OLYMPUS WINTER & IBE GMBH KATHARINA SCHNACKENBURG
K150212 04/20/2015 DeScribe Transparent PFD Patch ON Light Sciences, Inc. David Sell
K142141 04/23/2015 STARBAND, STARLIGHT ORTHOMERICA PRODUCTS, INC. DAVID L.HOOPER
K150506 04/08/2015 ELIAN Digital Diagnostic X-ray System OSKO, INC. WANG CHOI
K150607 04/09/2015 Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml OSSEON LLC Keith Burger
K143338 04/01/2015 Argulated Locking Plates OSTEOMED L.P. Anita Zacherl
K140453 04/17/2015 OSTEOTEC SILICONE FINGER IMPLANT OSTEOTEC LTD ELIZABETH CLINTON-PARKER
K141812 04/02/2015 MYGAIT STIMULATION SYSTEM OTTO BOCK HEALTHCARE PRODUCTS GMBH RENE URTZ
K143253 04/09/2015 O-MAR PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V. JAN VAN DE KERKHOF
K150227 04/02/2015 Disposable Blood Pressure Cuff Guard PINHU SAMA MEDICAL PACKING CO., LTD. MA JIANZHONG
K150206 04/03/2015 InFill Interbody Fusion Devices PINNACLE SPINE GROUP, LLC REBECCA K. PINE
K150254 04/28/2015 Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Sarah Pleaugh
K141913 04/06/2015 PJUR SILICONE BASED LUBRICANT: PJUR BACKDOOR ANAL GLIDE AND ANALYSE ME! PJUR GROUP LUXEMBOURG SA CANDACE F CEDERMAN
K142282 04/23/2015 HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) PRECEPTIS MEDICAL KEITH LELAND
K143353 04/02/2015 Hahn Tapered Implant System PRISMATIK DENTALCRAFT, INC. Brandon Shepard
K150331 04/09/2015 18ch T/R Knee Coil Quality Electrodynamics, LLC Kathleen Aras
K142262 04/10/2015 AUTION CHECK PLUS QUANTIMETRIX CORP. KALYNA SNYLYK
K142058 04/22/2015 RAYSCAN A-EXPERT RAY CO., LTD ANDEW PAENG
K142247 04/17/2015 RAYSCAN A-EXPERT 3D RAY CO., LTD KYUNGHA SEO
K142217 04/02/2015 Reliance Interspinous Plate System Reliance Medical Systems, LLC Jeremy Alsup
K142867 04/29/2015 Reliance Posterior Cervical-Thoracic System Reliance Medical Systems, LLC Bret M. Berry
K150283 04/29/2015 Republic Spine Dark Star Spinal System REPUBLIC SPINE, LLC RUSTY MCCARVER
K143272 04/30/2015 ApneaLink Air RESMED GERMANY INC. Sandra Grunwald
K150108 04/22/2015 Reverse Medical Micro Vascular Plug System REVERSE MEDICAL CORPORATION LAURA HEATON
K143405 04/16/2015 Option (TM) ELITE Vena Cava Filter 100cm System REX MEDICAL, LP Erich Bressler
K143744 04/14/2015 MicroCross Catheter ROXWOOD MEDICAL, INC. GRACE LI
K141047 04/14/2015 LC CALCIUMHYDROXIDE LINER S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN CHRISTIAN BOETTCHER
K141482 04/24/2015 KI-20 SAEYANG MICROTECH CO LTD Priscilla Chung
K150165 04/02/2015 GC85A SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K150545 04/02/2015 Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K142687 04/13/2015 Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd Xuezhi Yin
K142186 04/17/2015 DIODE LASER HAIR REMOVAL SYSTEM SHENZHEN GSD TECH. CO., LTD. Diana Hong
K150204 04/10/2015 DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K141683 04/03/2015 ELECTRONIC BLOOD PRESSURE MONITOR SHENZHEN URION TECHNOLOGY CO., LTD. AUTUMN LIU
K150714 04/17/2015 SI-BONE iFuse Implant System SI-BONE, Inc. Roxanne Dubois
K150843 04/24/2015 syngo«.via (version VB10A) Siemens AG Martin Meyer
K150132 04/13/2015 IMMULITE IGF Control Module, IMMULITE Gastrin Control Module Siemens Healthcare Diagnostics Asha Gartland
K141999 04/22/2015 ADVIA CENTAUR TSH Siemens Healthcare Diagnostics Inc. Alex Hsu
K143400 04/08/2015 SOMATOM Definition AS/AS+ SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
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K150361 04/30/2015 ViSi Mobile Monitoring System Sotera Wireless, Inc. Carson Krupp
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K143333 04/14/2015 Revital-Ox RESERT Solution Test Strip STERIS Corporation Anthony Piotrkowski
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