FDA 510(k) Applications Received During October, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K153034 10/19/2015 aap LOQTEQ VA Radius Set 2.5 AAP IMPLANTATE AG Christian Zietsch
K153093 10/26/2015 FIRMap Catheter ABBOTT ELECTROPHYSIOLOGY DENNIS POZZO
K153086 10/26/2015 RX ACCUNET Embolic Protection System ABBOTT VASCULAR Aruna Akkapeddi
K153055 10/20/2015 ACE Electrosurgical Resection and Vaporization Electrodes Series Ace Medical Devices Pvt. Ltd. Vikas Sethi
K153111 10/28/2015 TOUAREG CloseFitÖ UNP 2.75mmD Adin Dental Implants Systems Ltd. Ilana Lutvak
K152960 10/07/2015 ELAN 4 Motor System AESCULAP, INC. PETER STOLL
K153117 10/28/2015 AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM AESKU. SYSTEMS GMBH & CO. KG TOM STECKLUM
K152968 10/08/2015 Arsenal Spinal Fixation System ALPHATEC SPINE, INC RENEE MURPHY
K152931 10/05/2015 Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II Infant Resuscitator AMBU A/S LINE KAGENOW SVENSTRUP
K152939 10/05/2015 Picasso Plus, Picasso Lite Plus AMD GROUP LLC SCOTT A. EDWARDS
K153021 10/15/2015 Fingertip Pulse Oximeter A310 AMEMO INC HUA XIE
K152972 10/08/2015 Amendia Stand-Alone Cervical System AMENDIA, INC. KRISTEN ALLEN
K152920 10/02/2015 Savannah-T« Pedicle Screw System AMENDIA, INC. KRISTEN ALLEN
K153017 10/15/2015 Voyant Fine Fusion APPLIED MEDICAL RESOURCES JESSICA CHO
K152905 10/01/2015 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer ARC DEVICES LIMITED GARY BROGAN
K153115 10/28/2015 Arthrex Univers Apex, Size 5 Stem ARTHREX, INC. COURTNEY SMITH
K153106 10/27/2015 ASAHI Fielder XT-A, ASAHI Fielder XT-R ASAHI INTECC CO., LTD. Yoshihiko Fukui
K152994 10/13/2015 Adaptivo Aurora Technology Development, LLC Gustavo H Olivera
K152923 10/05/2015 BD ChloraShield IV Dressing with CHG Antimicrobial AVERY DENNISON BELGIE BVBA LISA BARTAKOVICS
K153079 10/23/2015 Axeo 3 Patient Monitor AXEO MEDICAL TECHNOLOGIES, LLC Stamatios Parimeros
K152898 10/01/2015 DIODE LASER THERAPY SYSTEMS BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD XIN WANG
K153019 10/15/2015 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes BIO PROTECH, INC. DANIEL WOO
K152984 10/09/2015 Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes BIO PROTECH, INC. DANIEL WOO
K153102 10/26/2015 QuadraSphere Microspheres BIOSPHERE MEDICAL, S.A. Alix Fonlladosa
K152995 10/13/2015 BioMonitor 2-AF, BioMonitor 2-S BIOTRONIK, INC. Jon Brumbaugh
K153064 10/22/2015 Blue Sky Bio Zygomatic Implant System BLUE SKY BIO, LLC Michele Vovolka
K153066 10/22/2015 BostonSight IC Corneal Lens, BostonSight IC Scleral Lens Boston Foundation for Sight Eugene Bonte
K153088 10/26/2015 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System BOSTON SCIENTIFIC CORPORATION ASHLEY SANTOS
K153049 10/20/2015 LithoVue System BOSTON SCIENTIFIC CORPORATION JEANNE O'TOOLE
K153138 10/30/2015 Cerdak Basic BU POLYSCIENCES EQUIPMENT & TRADING, LLC N. T. UMAMAHESWARAN
K153058 10/21/2015 CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. LEILEI LI
K153142 10/30/2015 Carestream DRX-1 System with DRX Plus 4343 Detectors CARESTREAM HEALTH, INC. VICTORIA WHEELER
K153103 10/26/2015 CARESTREAM Vue PACS CARESTREAM HEALTH, INC. Diane Koetter
K153148 10/30/2015 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) YON YU
K153085 10/26/2015 Q Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. Qifei Liu
K153107 10/27/2015 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine VEOÖ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System CHOICE SPINE, LP KIM FINCH
K153004 10/13/2015 Clear Guide SCENERGY CLEAR GUIDE MEDICAL Jack Kent
K153050 10/20/2015 Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard Co-Innovation Biotech Co., Ltd Hong Feng
K152927 10/05/2015 BRILLIANT EVERGLOW COLTENE/WHALEDENT AG SILKE WALLASCHEK
DEN150049 10/26/2015 Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm CONCENTRIC MEDICAL, INC. JIM LEATHLEY
K152969 10/08/2015 ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY CONMED CORPORATION DIONNE SANDERS
K152926 10/05/2015 AQUACEL Ag Surgical SP Dressing CONVATEC LIMITED AARON SIBLEY
K153092 10/26/2015 Ally Uterine Positioning System CooperSurgical, Inc. Roaida Johnson
K152903 10/01/2015 REVIVAL(TM) Modular Revision Hip Stem CORIN USA DIANA L. NADER-MARTONE
K152999 10/13/2015 CorPath 200 System CORINDUS, INC. Tal Wenderow
K153074 10/22/2015 Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal COVIDIEN Karin Desjardins
K152913 10/02/2015 GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle CREGANNA MEDICAL ASLO BUSINESS AS CREGGANNA TACTX MEDICAL ORLA HICKEY
K153144 10/30/2015 TIO-H DIGITAL RADIOGRAPHY SENSOR DENTTIO, INC. YOUNG HAN
K152978 10/09/2015 DeRoyal Angiography Kits DEROYAL INDUSTRIES, INC. Elizabeth Wheeler
K152989 10/13/2015 Mammotome revolve Dual Vacuum Assist Biopsy System DEVICOR MEDICAL PRODUCTS, INC. SHAWNA M. ROSE
K152977 10/08/2015 DG PACS DICOM GRID, INC. LAUREN STILL
K152970 10/08/2015 Dynarex Xeroform Petrolatum Dressing DYNAREX CORPORATION JAMES HURLMAN
K152911 10/02/2015 EarlySense Insight Sytem EarlySense Ltd. Dalia Argaman
K153045 10/19/2015 SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator EASYMED INSTRUMENT CO., LTD. Jeffery Wu (Tingjie Wu)
K152937 10/05/2015 EMG Powder Free Nitrile Examination Glove (Blue) with Peppermint Scented ECO MEDI GLOVE SDN. BHD. SURESH KUMAR
K153023 10/15/2015 Ablatherm Integrated Imaging EDAP TECHNOMED, INC. MARC OCZACHOWSKI
K153069 10/22/2015 Edwards Balloon Catheter EDWARDS LIFESCIENCES CHRIS KENNELLY
K152980 10/09/2015 Flo Trac sensor, Volume View sensor Edwards Lifesciences, LLC Andrew S Mazurkiewicz
DEN150048 10/16/2015 gammaCore Non-invasive Vagus Nerve Stimulator electroCore, LLC Mike Romaniw
K153011 10/14/2015 iViewDose R1.0 Elekta Limited Maurice Paine
K152918 10/02/2015 Gun Oil, Pink, Gun Oil H2O, Pink Water EMPOWERED PRODUCTS, INC. MATT CARR
K153044 10/19/2015 Sentimag System, Sentimark Magnetic Marker Systerm ENDOMAGNETICS LTD. ANDREW SHAWCROSS
K153052 10/20/2015 Erchonia PL Touch ERCHONIA CORPORATION Steven Shanks
K153039 10/19/2015 MRI Dynamic Analysis Plus Esaote S.p.A. DONATELLA RAGGHIANTI
K153057 10/21/2015 FitRiteÖ Total Hip Arthroplasty System EXCERA ORTHOPEDICS, INC. SCOTT COLERIDGE
K152953 10/07/2015 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE NORTH AMERICA Denise Oppermann
K152983 10/09/2015 FUJIFILM SonoSite iViz Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K153145 10/30/2015 Lumipulse G TP-N Immunoreaction Cartridge Set Fujirebio Diagnostics, Inc. Diana Dickson
K153127 10/29/2015 everX Posterior GC AMERICA INC. MARK HEISS
K153130 10/30/2015 Initial LiSi Block GC AMERICA INC. MARK HEISS
K153136 10/30/2015 Initial LiSi Press GC AMERICA INC. MARK HEISS
K153003 10/13/2015 SIGNA Pioneer GE HEALTHCARE Andrew Menden
K152993 10/13/2015 MUSE Cardiology Information System GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. AMY YANG
K153037 10/19/2015 LOGIQ V1/ LOGIQ V2 GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC Tracey Ortiz
K153123 10/29/2015 Genesys Spine Apache Interbody Fusion System GENESYS SPINE Dave Lamb
K152955 10/07/2015 Great Basin Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC. Chuck Owen
K153135 10/30/2015 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jin Liang
K153016 10/15/2015 aoni Natural Rubber Latex Condom Guangzhou Daming United Rubber Products Ltd. Yongbing Xie
K153046 10/19/2015 HAMILTON-MR1 HAMILTON MEDICAL AG KATRIN VOGT
K152949 10/06/2015 WebPAX HEART IMAGING TECHNOLOGIES, LLC Robert Judd
K153056 10/21/2015 Hermes Medical Imaging Suite v5.6 HERMES MEDICAL SOLUTIONS, AB JOAKIM ARWIDSON
K153090 10/26/2015 Reprocessed Diagnostic Ultrasound Catheter INNOVATIVE HEALTH, LLC RAFAL CHUDZIK
K152996 10/13/2015 Molteno3 Glaucoma Implant INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) BRYAN WEINMANN
K153137 10/30/2015 HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls INSTRUMENTATION LABORATORY CO. Carol Marble
K153041 10/19/2015 Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling INTEGRA LIFESCIENCES CORPORATION Timothy Connors
K152897 10/01/2015 Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory INTEGRA LIFESCIENCES CORPORATION JENNIFER SIEGEL
K153126 10/29/2015 da Vinci Xi Hasson Cone INTUITIVE SURGICAL INC. VISHAL KANANI
K153073 10/22/2015 UroNav (Version 2.0) INVIVO CORPORATION Kenneth Revennaugh
K153070 10/22/2015 Watch-PAT200U ITAMAR MEDICAL, LTD. KOBY SHEFFY
K153087 10/26/2015 IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved Ivy Sports Medicine, LLC John Dichiara
K153031 10/19/2015 RANGE/DENALI/MESA Spinal System K2M, Incorporated NANCY GIEZEN
K152975 10/08/2015 VDT985US Vicks SmartTemp Thermometer Kaz USA, Inc., a Helen of Troy Company Raj Kasbekar
K153027 10/16/2015 Cryotop US KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K153128 10/29/2015 Kolplast Cervical Sample Collection Kit KOLPLAST CI SA DANIELA FERACIN
K152981 10/09/2015 JET SET 4 DENTURE REPAIR RESIN LANG DENTAL MANUFACTURING COMPANY, INC DAVID LANG
K152935 10/05/2015 LiDCOunity Monitor LIDCO LTD ERIC MILLS
K153065 10/22/2015 The Hammertoe Correction System LIFE SPINE, INC Randy Lewis
K152961 10/07/2015 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY LLC JAMES CHAMPLIN
K153091 10/26/2015 IMPLANT 3D Media Lab S.r.l. Massimo Ivani
K153124 10/29/2015 DuraLazeTM HoLEP Laser Fiber MedKey, LLC Jeff Zerfas
K152948 10/06/2015 Medline Anti-Fog Solution Medline Industries, Inc. Matt Clausen
K153026 10/16/2015 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K153139 10/30/2015 Achieve ST Mapping Catheter, Catheter Connecting Cable MEDTRONIC, INC. Heath Taylor
K153038 10/19/2015 Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit MEDTRONIC, INC. NISARG SHAH
K153081 10/23/2015 Clear Bi-Light Michael Todd, LP Lilia Friend
K153071 10/22/2015 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Phuong Chau
K153077 10/23/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K152934 10/05/2015 MMS PTA Balloon Catheter MicroMedical Solutions, Inc. Gregory Mathison
K153053 10/20/2015 Traxcess Pro 14 Guidewire MICROVENTION, INC. SAPNA SINGH
K153059 10/21/2015 HF1202H PowerPlus Portable X-ray Equipment MINXRAY, INC. Keith Kretchmer
K153014 10/15/2015 Mobius3D MOBIUS MEDICAL SYSTEMS, LP STAN ESHELMAN
K153078 10/23/2015 LED Curing Light GT-2000 MONITEX INDUSTRIAL CO., LTD. Shu-Lung Wang
K152944 10/06/2015 Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems MORTARA INSTRUMENT, INC. ELEANORE DIAS
K153129 10/30/2015 dynaMX Tabbed Staple MX Orthopedics, Corp. Howard L. Schrayer
K152936 10/05/2015 Sirius Max Dental Diode Curing Light NATIONAL DENTAL INC. EDWIN FIRST
K153084 10/26/2015 Nephros S100 NEPHROS INC. JAMES SUMMERTON
K152954 10/07/2015 Quell NEUROMETRIX, INC. RAINER MAAS
K153097 10/26/2015 BelvedereÖ Lateral Plating System NEUROSTRUCTURES, INC. Moti Altarac
K152938 10/05/2015 DBB-06 Hemodialysis Delivery System NIKKISO, CO.,LTD. SEIYA RAIJYU
K153036 10/19/2015 NobelDesign Software NOBEL BIOCARE AB CHARLEMAGNE CHUA
K153043 10/19/2015 Noris Medical MBI Dental Implant System NORIS MEDICAL LTD. Simha Sibony
K152986 10/09/2015 StatStrip Xpress 2 Glucose Hospital Meter System NOVA BIOMEDICAL CORPORATION PAUL W. MACDONALD
K153054 10/20/2015 N5-1 NUGA MEDICAL CO., LTD JONG SOO LEE
K152943 10/05/2015 NuVasive Foundation-LL System NUVASIVE INCORPORATED CYNTHIA ADAMS
K152942 10/05/2015 NuVasiveNVM5 System NUVASIVE INCORPORATED Olga Lewis
K153105 10/27/2015 MLXÖ - Medial Lateral Expandable Lumbar Interbody System NuVasive, Incorporated Olga Lewis
K152945 10/06/2015 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K153009 10/14/2015 ULTRA Telescopes OLYMPUS, WINTER & IBE GMBH Katharina Schnackenburg
K152919 10/02/2015 OMNI Skirted Heads OMNILIFE SCIENCE INC. Vani Sindwani
K152991 10/13/2015 OptoWire Deux OPSENS Vanessa Mootoosamy
K153080 10/23/2015 RTVue XR OCT Avanti with AngioVue Software OPTOVUE, INC. EDWARD SINCLAIR
K152932 10/05/2015 BlastGen ORIGIO A/S TOVE KJAER
K153048 10/19/2015 AcceleDent Aura ORTHOACCEL TECHNOLOGIES, INC. Zaffer Syed
K153141 10/30/2015 DyeVert Contrast Modulation System OSPREY MEDICAL, INC. MELANIE HESS
K153015 10/15/2015 Transfer & Angled Abutment Osstem Implant Co., Ltd Hee Kwon
K152952 10/06/2015 E-Cath PAJUNK GmbH Medizintechnologie Christian G.H. Quass
K152951 10/06/2015 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray PARAGON MEDICAL, INC. MIKE GOSMEYER
K152930 10/05/2015 PeriFlux6000 PERIMED AB MARIA PRANS LILJEVRET
K152899 10/01/2015 Philips Lumify Diagnostic Ultrasound System PHILIPS HEALTHCARE, INC. PENNY GRECO
K153022 10/15/2015 Philips IntelliSpace Cardiovascular PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Dave J.W. Bierhuizen
K153099 10/26/2015 INCLUSIVE TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K153012 10/14/2015 Sofia Influenza A+B FIA QUIDEL CORPORATION EDWARD C. BREHM
K153060 10/21/2015 Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S RAYENCE CO., LTD KEVIN KIM
K153061 10/21/2015 Juno VPAP ST-A RESMED LTD Jean-Nicolas BOUDAUD
K153095 10/26/2015 ROP Resorbable Hemostasis Material Resorbable Orthopedic Products, LLC Barry E Constantine
K152957 10/07/2015 MultiCross Catheter ROXWOOD MEDICAL, INC. Grace Li
K152962 10/07/2015 HS70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KYEONG-MI PARK
K152946 10/06/2015 TEMPEDY SEIRATHERM GMBH MATTHIAS ROTH
K153149 10/30/2015 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. Ren Yunhua
K153146 10/30/2015 Infrared Ear Thermometer SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K153096 10/26/2015 LARIAT RS Suture Delivery Device SentreHEART, Inc. KIT CARIQUITAN
K152902 10/01/2015 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K153147 10/30/2015 Cios Connect Siemens Medical Solutions USA, Inc. Patricia D. Jones
K152928 10/05/2015 Multitom Rax SIEMENS MEDICAL SOLUTIONS USA, INC. DARREN A. DORMAN
K153131 10/30/2015 Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20? Hooded Acetabular Liner SIGNATURE ORTHOPAEDICS PTY LTD. DECLAN BRAZIL
K152976 10/08/2015 VLP Mini-Mod Talus Plates Smith & Nephew, Inc. Samantha Staubach
K153098 10/26/2015 KLOCKNER VEGA DENTAL IMPLANT SYSTEM SOADCO, S.L. MARIA MITJANETA
K153042 10/19/2015 TRYPTIK2C-plate Anterior Cervical Plate System SPINEART Franck PENNESI
K153082 10/23/2015 Rampart A Lumbar Interbody Fusion Device SPINEOLOGY, INC. JACQUELINE A HAUGE
K152922 10/02/2015 ViziShot FLEX SPIRATION, INC. Cyndy J Adams
K152958 10/07/2015 INEX Absorbable Nasal Implant SPIROX, INC. MIKE ROSENTHAL
K153006 10/14/2015 Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter STERILMED, INC. PATRICIA F KAUFMAN
K153119 10/29/2015 Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, SUMMIT INDUSTRIES LLC Tom Boon
K153033 10/19/2015 Digital Blood Pressure Monitor SUZHOU SUNSPIRI CO., LTD. JING ZHANG
K152956 10/07/2015 Pulp Canal Sealer, Pulp Canal Sealer EWT SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K152959 10/07/2015 Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes Sybron Dental Specialties Courtney Clark
K153067 10/22/2015 Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress SYBRON DENTAL SPECIALTIES Courtney Clark
K152915 10/02/2015 EYE-SYNC SyncThink, Inc. Daniel Beeler
K152973 10/08/2015 Dyna-Vision Telemonitoring System Techmedic Development International B.V. Rutger Brest van Kempen
K152933 10/05/2015 Vesalius TELEA ELECTRONIC ENGINEERING SRL Simona Daidone
K153089 10/26/2015 'cottony' II TAPE, PLEDGETS Teleflex Medical, Inc. Natalie Hichak
K153010 10/14/2015 Hudson RCI AquaPak Sterile Prefilled Nebulizers Teleflex Medical, Inc. Brian Gall
K153063 10/22/2015 PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM Teleflex Medical, Inc. HOLLY HALLOCK
K153076 10/23/2015 silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL Teleflex Medical, Inc. Natalie Hichak
K153140 10/30/2015 Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating TERUMO CARDIOVASCULAR SYSTEMS CORP. JOSHUA P. EWING
K153143 10/30/2015 Capiox Advance Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A. Brown
K153125 10/29/2015 IntraNovo Microcatheter Texas Medical Technologies, Inc. Aaron Chiu
K152947 10/06/2015 Disposable Temporary Pacing Cable TIGER MEDICAL PRODUCTS Veronica Lee
K153122 10/29/2015 Endoskeleton(r) TCS System TITAN SPINE, LLC Jane Rodd
K152966 10/07/2015 Aequalis Fx2 Tornier SAS JOVILA DODI
K153075 10/23/2015 Klassic Knee System TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K152967 10/08/2015 NERBRIDGE TOYOBO CO., LTD. YUTA KAWAKATSU
K153025 10/16/2015 Turbett Surgical Container TURBETT SURGICAL LLC ROB TURBETT
K152908 10/01/2015 UCP COMPACT DRUG TESTS UCP BIOSCIENCES, INC NANCY CHEN
K152924 10/05/2015 TIVA? VELANO VASCULAR TIFFINI DIAGE
K153101 10/26/2015 BladderScan Prime System VERATHON INCORPORATED Rhonda M Kops
K153018 10/15/2015 CELALUX 3 VOCO GMBH M TH. PLAUMANN
K153094 10/26/2015 Visions PV .035 Digital IVUS Catheter Volcano Corporation Neeta Sharma
K152904 10/01/2015 SYDNEY IVF EMBRYO BIOPSY MEDIUM WILLIAM A. COOK AUSTRALIA PTY, LTD. GORDANA POZVEK
K153008 10/14/2015 INVISION Total Ankle Revision System Wright Medical Technology, Inc. Tara Conrad
K152974 10/08/2015 ORTHOLOC« 3Di Foot Plating Reconstruction System Wright Medical Technology, Inc. Val Myles
K152906 10/01/2015 Disposable High Pressure Injector Syringe WUXI YUSHOU MEDICAL APPLICANCES CO., LTD Wu Feng
K152987 10/13/2015 Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System XENCO MEDICAL, LLC GUSTAVO PRADO
K153028 10/16/2015 Synmax Synthetic Patient Examination Vinyl Gloves, Powder Free, Blue ZIBO HUIYING MEDICAL PRODUCTS, CO. LTD. Fufang Wang


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