FDA 510(k) Applications Received During March, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K160666 03/09/2016 Dentiq3D 3D INDUSTRIAL IMAGING CO.,LTD. Jin Sa Kim
K160818 03/24/2016 STERRAD« NX Sterilizer with ALLClearÖ Technology ADVANCED STERILIZATION PRODUCTS Jamie Byun
K160755 03/18/2016 Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap AHLSTROM NONWOVENS LLC GARY JACKSON
K160862 03/29/2016 AirStrip RPM AirStrip Technologies, Inc. Andy Miller
K160609 03/03/2016 AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric Alcon Laboratories, Inc. Alicia M. Plesnarski
K160646 03/07/2016 XYcor« Expandable Spinal Spacer System Alphatec Spine, Inc Renee Murphy
K160784 03/22/2016 CAM Titanium Blanks ALTATEC GMBH COLLEEN BOSWELL
K160766 03/21/2016 Ambu USR, Ambu M AMBU A/S CAMILLA WISMAR
K160782 03/22/2016 BracePaste Adhesive American Orthodontics Trang Adams
K160791 03/23/2016 AmorChem Titanium Porous Fixation Device AmorChem Holdings, Inc. KEVIN MCBRIDE
K160758 03/18/2016 PeriCoach OTC ANALYTICA LTD. GEOFF DALY
K160710 03/15/2016 Oasis Lacrimal Intubation Set ANODYNE VALERIE ANDERSON
K160730 03/16/2016 Instrument kits ANTHOGYR Therese CANDAU
K160667 03/09/2016 Anybattery C2 Rechargeable Battery Anybattery, Inc. Ed Speegle
K160581 03/01/2016 K3PRO Konus Additional Abutments and Implants ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG RICHARD DONACA
K160574 03/01/2016 K3PRO SURGICAL TRAY ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG RICHARD DONACA
K160785 03/22/2016 Worker Guidewire ARGON MEDICAL DEVICES, INC. SUZANNE CHEANG
K160857 03/29/2016 HF 718BD X-Ray System ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION GUIDO ARQUILLA
K160669 03/09/2016 ClariFix Device ARRINEX, INC. VAHID SAADAT
K160659 03/08/2016 ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) ASAHI INTECC CO., LTD. CARROLL COUNCILMAN
K160682 03/10/2016 CONTOUR NEXT ONE Blood Glucose Monitoring System ASCENSIA DIABETES CARE Roger Sonnenburg
K160830 03/25/2016 Integra External Fixation System Ascension Orthopedics Jayana Kenana
K160702 03/14/2016 ZION Anterior Cervical Fixation System Astura Medical TROY TAYLOR
K160582 03/01/2016 WiCap Athena GTX Sean Mahoney
K160827 03/25/2016 Pantheris Catheter AVINGER, INC. Golnaz Moeini
K160757 03/18/2016 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) AXIS-SHIELD DIAGNOSTICS LIMITED CLAIRE I. DORA
K160651 03/08/2016 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY Matthew Trachtenberg
K160657 03/08/2016 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube BECTON, DICKINSON AND COMPANY Branden Reid
K160578 03/01/2016 Nustat XR Beeken Biomedical, LLC DAN O'HARA
K160747 03/18/2016 Angel Catheter BIO2 MEDICAL, INC. CHRISTOPHER E. BANAS
K160854 03/28/2016 MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture Biomet Manafacturing Corp. Adam Cargill
K160751 03/18/2016 Symphion Endoscope and Symphion Cervical Sheath BOSTON SCIENTIFIC BROOKE CUDDY
K160845 03/28/2016 Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device BOSTON SCIENTIFIC CORPORATION Yingying Gao
K160823 03/25/2016 NC Quantum Apex PTCA Dilatation Catheter BOSTON SCIENTIFIC CORPORATION JANE HORAN
K160637 03/07/2016 Rotatable Snares BOSTON SCIENTIFIC CORPORATION Michael Secondini
K160866 03/30/2016 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit C.R. BARD, INC. LAURIE SANG
K160861 03/29/2016 Proxis Ureteral Access Sheath C.R. Bard, Inc. Beatrice Wan
K160875 03/30/2016 Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH, INC. Megan Middaugh
K160746 03/18/2016 CARDIOLINE touchECG CARDIOLINE S.p.A Emanuele Ercoli
K160840 03/28/2016 ECG100+, ECG200+ CARDIOLINE S.p.A EMANUELE ERCOLI
K160764 03/21/2016 AirLife Autofill Humidification Chamber CAREFUSION 2200, INC. ERIKA FERNANDEZ
K160723 03/16/2016 OnSight 3D Extremity System CARESTREAM HEALTH, INC. Carolyn Wagner
K160867 03/30/2016 Pavati Z40.2 Zirconia CCRI, INC. ROBIN CARDEN
K160589 03/01/2016 Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe CERTA DOSE, INC. SARAH HANSSEN
K160731 03/17/2016 LumFix Spinal Fixation Sytem CG BIO CO., LTD. YUNA JEONG
K160775 03/21/2016 ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems CHOICE SPINE LP KIM FINCH
K160806 03/24/2016 Verza Guidance System CIVCO MEDICAL INSTRUMENTS CO., INC. Amanda Stahle
K160800 03/23/2016 DuoCem COLTENE/WHALEDENT AG Silke Wallaschek
K160858 03/29/2016 CompactCath Intermittent Urinary Catheter COMPACTCATH INC. Naama Stauber Breckler
K160629 03/07/2016 InPen COMPANION MEDICAL, INC. JASPER BENKE
K160859 03/29/2016 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) CONTAMAC LTD. ROB MCGREGOR
K160869 03/30/2016 Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft COOK BIOTECH INCORPORATED Perry W. Guinn
K160887 03/31/2016 Cook Intraosseous Infusion Needles COOK INCORPORATED JULIA FERGUSON
K160884 03/31/2016 CXI Support Catheter COOK INCORPORATED Daniel J. Corbin
K160593 03/01/2016 Indy OTW Vascular Retriever COOK INCORPORATED Chad Schulenburg
K160891 03/31/2016 Ultrathane Endoureterotomy Stent Set Cook Incorporated Kara Kanorr
K160803 03/23/2016 Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens CooperVision, Inc. Roya Borazjani
K160679 03/10/2016 WoundClot9 CORE SCIENTIFIC CREATION LTD. YUVAL YASKIL
K160656 03/08/2016 CorSens CorSens Medical Ltd. Yoram Levy
K160718 03/15/2016 Vital Sync Informatics Manager & Virtual Patient Monitoring Platform COVIDIEN Timothy Holwick
K160654 03/08/2016 GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) Covidien LLC Rebecca Magnanimo
K160725 03/16/2016 EndoFLIP CROSPON LTD. JOHN O'DEA
K160636 03/07/2016 iPEP System and vPEP D R BURTON HEALTHCARE LLC DENNIS COOK
K160828 03/25/2016 Dentium Implantium & SuperLine Prosthetics DENTIUM CO., LTD. Sangpil Yoon
K160626 03/07/2016 ATLANTIS Abutment for HIOSSEN ET implant DENTSPLY SIRONA Helen Lewis
K160825 03/25/2016 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA Helen Lewis
K160700 03/14/2016 ATTUNE Revision Knee System Depuy (Ireland) Jaime Weeks
K160650 03/08/2016 LIAISON HAV IgM, LIAISON Control HAV IgM DiaSorin Inc. John Walter
K160762 03/21/2016 Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set DIAZYME LABORATORIES ABHIJIT DATTA
K160704 03/14/2016 myPatch-s DMS-SERVICE LLC LYNDA COLE
K160761 03/21/2016 DW-1C DONGWON MEDICAL CO., LTD. Gil Haeng Lee
K160591 03/01/2016 D.O.R.C. Disposable Cryo Probe DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV DANIELLE SLEEGERS
K160790 03/22/2016 Acclarix LX8 Diagnostic Ultrasound System Edan Instruments Inc Queena Chen
K160876 03/30/2016 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K160645 03/07/2016 PreSep Oligon Oximetry Catheter EDWARDS LIFESCIENCES, LLC Deana Boushell
K160668 03/09/2016 HumaPen Savvio Eli Lilly and Company, Inc. Christine A. Phliips
K160752 03/18/2016 HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length ETHICON ENDO-SUREGERY, LLC MARJORIE MEDINA
K160663 03/09/2016 Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) EVOLUTION SPINE, LLC Ashton Kouzbari
K160697 03/14/2016 Gibralt« Spine System and Gibralt« Occipital Spine System Exactech, Inc. Dawn Davisson
K160722 03/16/2016 CorticaLINK Spinal Fusion Platform FACETLINK DBA LINKSPINE MASSIMO CALAFIORE
K160707 03/14/2016 CustomizedBone Service FIN-CERAMICA FAENZA SPA Monticelli Marina
K160797 03/23/2016 FMX314 Surgical Platform Fortimedix Surgical B.V. DIRKJAN BAKKER
K160735 03/17/2016 CATSmart FRESENIUS KABI AG Barry G. Hicks
K160749 03/18/2016 CRIT-LINE III Blood Chamber II FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC Denise Oppermann
K160674 03/10/2016 Fujifilm Sonosite Vevo MD Imaging System FUJIFILM SONOSITE, INC. SCOTT PAULSON
K160734 03/17/2016 SonoSite SII Ultrasound System FUJIFILM SonoSite, Inc. Patricia Liau
K160621 03/04/2016 SIGNAPioneer GE HEALTHCARE GLEN SABIN
K160618 03/03/2016 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T GE MEDICAL SYSTEMS, LLC Jason Ma
K160633 03/07/2016 G3(TM) Active Plate(R) Small Fragment System GENESIS FRACTURE CARE, INC. Michael Bottlang
K160872 03/30/2016 PolyPlex Wound Dressing GLOBAL HEALTH SOLUTIONS, LLC Bradley Burnam
K160597 03/02/2016 INDEPENDENCE MIS Spacers GLOBUS MEDICAL INC. Kelly J. Baker
K160664 03/09/2016 Aqueduct 100 Cervical Dilator GTIMD LLC RICHARD DEMELLO
K160763 03/21/2016 ally Liquid Personal Lubricant GUY & O'NEILL, INC. THOMAS MISGEN
K160717 03/15/2016 ally Warming Liquid Personal Lubricant GUY & O'NEILL, INC. THOMAS MISGEN
K160709 03/14/2016 HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves Halyard Health Gwendolyn George
K160802 03/23/2016 Infrared Forehead Thermometer, FT-100A HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. JIAQIANG WAN
K160870 03/30/2016 Hospira Administration Sets HOSPIRA, INC. DAVID BLONSKI
K160742 03/17/2016 NoCoding1 Plus Blood Glucose Monitoring System i-SENS, INC. Joon Ho Jung
K160885 03/31/2016 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K160673 03/10/2016 Insulin Algorithms System INSULIN ALGORITHMS Josh Davidson
K160811 03/24/2016 CRW STEREOTACTIC SYSTEM INTEGRA LIFESCIENCES CORPORATION TIMOTHY CONNORS
K160773 03/21/2016 Yarlap II INTERNATIONAL TRADE GROUP, INC. BRENT C. REIDER
K160630 03/07/2016 Invacare Platinum Mobile Oxygen Concentrator INVACARE CORPORATION ELIJAH N. WREH
K160798 03/23/2016 IPS e.max« Press Abutment Solutions for Viteo Base Ti IVOCLAR VIVADENT AG Sandra Cakebread
K160602 03/02/2016 JustRight Surgical Vessel Sealing System JustRight Surgical Jenifer Kennedy
K160675 03/10/2016 Powder free vinyl patient examination glove, colored (yellow) KAIXING PLASTIC PRODUCTS CO., LITD. Dan ny
K160721 03/16/2016 Vado Steerable Sheath KALILA MEDICAL, INC. Carrie Neuberger
K160631 03/07/2016 Keos Lumbar IBFD KEOS MARK F. SCHENK
K160864 03/29/2016 Cryotop Vitrification Kit and Cryotop Thawing Kit KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K160863 03/29/2016 PBS(-), Phosphate Buffered Saline KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K160610 03/03/2016 Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set KOBOLD, LLC Brian Stoddart
K160895 03/31/2016 Initia Total Hip System & BIOCERAM AZUL(R) HEAD KYOCERA Medical Corporation Cheryl Hastings
K160643 03/07/2016 ENROUTE 0.014 Guidewire LAKE REGION MEDICAL MICHAEL DUNNING
K160644 03/07/2016 Lelo Hex Natural Rubber Latex Condom LELO Inc. Pavle Sedic
K160878 03/30/2016 OPTIS Metallic Stent Optimization E.4 SW LIGHTLAB IMAGING, INC. PADMINI SURAVARAM
K160893 03/31/2016 HANAROCare ReJu M.I.TECH CO.,LTD HWANG MI-SUNG
K160623 03/04/2016 FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture M/S. MERIL ENDO SURGERY PRIVATE LIMITED Umesh Sharma
K160665 03/09/2016 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 MAQUET CRITICAL CARE AB CARINA LUNDBERG
K160695 03/14/2016 Talymed Suspension Marine Polymer Technologies, Inc. Sergio Finkielsztein
K160605 03/02/2016 MectaLIF Anterior Stand-Alone MEDACTA INTERNATIONAL MICHAEL G. LOITERMAN
K160698 03/14/2016 LigaPASS MEDICREA INTERNATIONAL S.A. DAVID RYAN
K160756 03/18/2016 PASS OCT Spinal System MEDICREA INTERNATIONAL S.A. David Ryan
K160640 03/07/2016 PASS XS Spinal System MEDICREA INTERNATIONAL S.A. David Ryan
K160837 03/25/2016 MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM MEDINET SRL STEFANO BERNUCCI
K160604 03/02/2016 CureÖ Anterior Cervical Plate (ACP) System MEDITECH SPINE, LLC BRUCE DUNAWAY
K160846 03/28/2016 AmplifEYE MEDIVATORS, INC. Jeff Kasoff
K160642 03/07/2016 Medline ENFit Syringe Medline Industries, Inc. Stephanie Blair
K160660 03/08/2016 Medline Waste Station Medline Industries, Inc. Matt Clausen
K160879 03/30/2016 CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems Medos International S?rl KIRSTEN LEMULLER
K160804 03/23/2016 INTRAFIX(TM) Advance Tibial Fastener System MEDOS INTERNATIONAL SARL KRISTINE CHRISTO
K160860 03/29/2016 MiniMed Quick-serter MEDTRONIC MINIMED Noreen Bajwa
K160713 03/15/2016 Stealth-Midas System MEDTRONIC POWERED SURGICAL SOLUTIONS DEEP PAL
K160689 03/11/2016 Reveal LINQ MEDTRONIC, INC. Eric Kalmes
K160809 03/24/2016 Reveal LINQ MEDTRONIC, INC. Dianna L Johannson
K160677 03/10/2016 MICRORUPTOR 6 MERIDIAN AG FRANZISKA GOTSCHI
K160829 03/25/2016 illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 MERIDIAN BIOSCIENCE, INC. MICHELLE L. SMITH
K160771 03/21/2016 Destiknee Total Knee System MERIL HEALTHCARE PRIVATE LIMITED Umesh Sharma
K160699 03/14/2016 VIRTU Lumbar Spacer System Met 1 Technologies, LLC Dan Gerbec
K160641 03/07/2016 Solitaire Platinum Revascularization Device, 6x40 mm Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kenney
K160625 03/04/2016 Disposable Hot Biopsy Forceps MICRO-TECH (NANJING) CO., LTD. BECKY LI
K160706 03/14/2016 ReNew V Handpiece Laparoscopic Instruments MICROLINE SURGICAL, INC. ANU GAUR
K160685 03/11/2016 Surveyor S4 Mobile Monitor Mortara Instrument, Inc. Sarah Weber
K160594 03/01/2016 MRWire Guide Wire NANO4IMAGING GMBH CHRISTOPH R. MANEGOLD
K160874 03/30/2016 Nanovis Intervertebral Body Fusion System and FortiCore« NANOVIS LLC Matthew Hedrick
K160745 03/18/2016 neoBLUE compact LED Phototherapy System NATUS MEDICAL INCORPORATED THERESE LEGGIERE
K160739 03/17/2016 Cranial COVER Neos Surgery S.L. Eduard Garcia
K160703 03/14/2016 NeuroStar TMS Therapy System NEURONETICS, INC. Judy P. Ways
K160617 03/03/2016 Large Screws Range NEWCLIP TECHNICS Gaelle LUSSORI
K160816 03/24/2016 Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) NEXMED TECHNOLOGY CO., LTD Ellen Xu
K160820 03/24/2016 PressON Pro Spinal Fixation System Nexus Spine, LLC Jared Crocker
K160865 03/30/2016 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
K160608 03/03/2016 NormaTec Pulse and NormaTec Pulse Pro NORMATEC INDUSTRIES, LP Peter Novello
K160889 03/31/2016 BIB Stent Placement Catheter NUMED, INC. NICHELLE LAFLESH
K160598 03/02/2016 REBOA Balloon Catheter NUMED, INC. NICHELLE LAFLESH
K160728 03/16/2016 NutraStim Hair Laser Helmet NUTRA LUXE MD LLC GLORIA AVENDANO
K160639 03/07/2016 Electrosurgical Generator ESG-200 OLYMPUS WINTER & IBE GMBH Katharina Campbell
K160712 03/15/2016 VITROS Chemistry Products hsCRP Reagent Ortho Clinical Diagnostics Marlene Hanna
K160720 03/16/2016 Carriere Motion Clear Class II ORTHO ORGANIZERS, INC. COLLEEN BOSWELL
K160670 03/10/2016 ET US SS Prosthetic system OSSTEM IMPLANT CO., LTD. HEE KWON
K160881 03/30/2016 Tablo Console OUTSET MEDICAL, INC. LESLIE TRIGG
K160611 03/03/2016 P-ARTIS P-CURE LTD. MICHAEL MARASH
K160577 03/01/2016 PacEndo Chlorhexidine PAC-DENT INTERNATIONAL, INC. Wenying Zhu
K160832 03/25/2016 Penumbra Smart Coil PENUMBRA, INC. Charles DeNault
K160743 03/17/2016 Philips Ingenuity CT Philips Medical Systems (Cleveland), Inc. Susan Quick
K160807 03/24/2016 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System PHILIPS ULTRASOUND, INC. PENG CUI
K160595 03/01/2016 PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI Derya Dikici
K160627 03/07/2016 Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution QFIX Nadia Sookdeo Harhen
K160606 03/02/2016 BC-5D Hematology Control R & D SYSTEMS, INC. RAVI KOMMINENI
K160788 03/22/2016 RIOScan (RPS500) RAY CO., Ltd Changhwan Lee
K160579 03/01/2016 Xmaru View V1 and Xmaru PACS, Medical Image Processing Software RAYENCE CO., LTD Kevin Kim
K160848 03/28/2016 Wingman 18 Crossing Catheter ReFlow Medical, Inc. Rebecca K Pine
K160836 03/25/2016 Menai System ResMed Ltd Greg Dockar
K160822 03/24/2016 S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV RESMED LTD JASJIT BAVEJA
K160614 03/03/2016 Xcite Clinical Station RESTORATIVE THERAPIES INC. Andrew Barriskill
K160655 03/08/2016 OrthoButton CL RIVERPOINT MEDICAL EDWIN ANDERSON
K160795 03/23/2016 United Urologics Intermittent Catheter ROBLING MEDICAL Diane Peper
K160877 03/30/2016 United Urologics Closed System Catheter ROBLING MEDICAL, INC. Diane Peper
K160684 03/11/2016 Atteris No-Sting Skin Protectant ROCHAL INDUSTRIES LLC WILLIAM J. COULSTON
K160729 03/16/2016 Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 Roche Diagnostics Adam Clark
K160847 03/28/2016 Rockwell Medical CitraPure Acid Concetrate ROCKWELL MEDICAL ROBERT CHIOINI
K160786 03/22/2016 RODO Abutment System RODO MEDICAL, INC Michael Parsons
K160681 03/10/2016 CenterCross Ultra Catheter ROXWOOD MEDICAL, INC Grace Li
K160799 03/23/2016 GenNarino SALIWELL LTD. BEN Z. BEISKI
K160850 03/28/2016 Nucleoss Tpure Implant System SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI EZGI ERDEM
K160781 03/22/2016 Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves SEMPERIT INVESTMENTS ASIA PTE. LTD. CLEMENS EICHLER
K160853 03/28/2016 Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) Flower Cai
K160596 03/02/2016 BEAUTIFIL II LS SHOFU DENTAL CORPORATION Mauro Malzyner
K160652 03/08/2016 iFUSE Implant System SI-BONE, INC. ROXANNE DUBOIS
K160647 03/07/2016 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 Siemens Healthcare Diagnostics Inc. Matthew Gee
K160724 03/16/2016 ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. KATHLEEN DRAY-LYONS
K160770 03/21/2016 Vent-Os Sinus Dilation family SINUSYS CORPORATION Lloyd H. Griese
K160738 03/17/2016 ZUK Select Knee System SMITH & NEPHEW, INC. BRAD SHEALS
K160603 03/02/2016 SMV Scientific Schanz Screws SMV SCIENTIFIC NEPHI ZUFELT
K160613 03/03/2016 Soberlink Cellular Device and Sober Sky Web Portal SOBERLINK HEALTHCARE LLC JENNA COSTA
K160856 03/28/2016 SpineView X-Pac Expandable Lumbar Cage System Spine View, Inc. Mbithi Muthini
K160716 03/15/2016 The Nanostim Introducer Kit St Jude Medical, Inc Brittany Cunningham
K160600 03/02/2016 Freedom Spinal Cord Stimulator System STIMWAVE TECHNOLOGIES INCORPORATED Elizabeth Greene
K160585 03/01/2016 XN CAL Streck Deborah Kipp
K160590 03/01/2016 XN CHECK STRECK DEBORAH KIPP
K160588 03/01/2016 XN CHECK BF STRECK DEBORAH KIPP
K160586 03/01/2016 XN-L CHECK STRECK DEBORAH KIPP
K160715 03/15/2016 AccuLIF TL and PL Cage STRYKER CORPORATION AAKASH JAIN
K160693 03/14/2016 Neptune E-SEP Smoke Evacuation Pencil STRYKER CORPORATION MAIREAD TWOMEY
K160813 03/24/2016 EasyStep STRYKER GMBH Garry T. Hayeck
K160612 03/03/2016 Sumitomo Proton Therapy System SUMITOMO HEAVY INDUSTRIES, LTD KATSUHIRO NARASAKI
K160662 03/09/2016 Surefire Infusion System SUREFIRE MEDICAL, INC Lynne Aronson
K160740 03/17/2016 Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K160744 03/17/2016 LOOK PTFE Suture Surgical Specialties Corporation Karen Sanchez
K160584 03/01/2016 Surgical Navigation Advanced Platform (SNAP) SURGICAL THEATER, LLC Kevin Murrock
K160787 03/22/2016 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet SYNCRO MEDICAL INNOVATIONS, INC. Sabry Gabriel
K160607 03/02/2016 PicoWay Laser System SYNERON CANDELA CORPORATION Ruthie Amir
K160896 03/31/2016 ULTRASHAPE POWER SYSTEM SYNERON MEDICAL LTD Ruthie Amir
K160680 03/10/2016 VisioFocus Mini, VisioFocus Smart TECNIMED S.R.L. Cinzia Bellifemine
K160819 03/24/2016 Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit THE BINDING SITE GROUP LTD. JON LAUDER
K160792 03/23/2016 Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound THE PROMETHEUS GROUP Joshua Bird
K160694 03/14/2016 Disposable Endotracheal tube, sterile, AccuCuff TIANJIN MEDIS MEDICAL DEVICE CO., LTD. ZHENCHUANG YANG
K160592 03/01/2016 SUPERCATH 6 TOGO MEDIKIT CO., LTD. Daisuke Nagamizu
K160615 03/03/2016 ORTHODONTIC CERAMIC BRACKETS 1.1 TOMY, INC JINICHI WATANABE
K160587 03/01/2016 Aquilion ONE (TSX-305A/3) V7.3 Toshiba Medical Systems Corporation Paul Biggins
K160632 03/07/2016 Vantage Titan 1.5T, MRT-1510, V3.6 Software TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K160821 03/24/2016 Tria Sapphire TRIA BEAUTY, INC. Heather Tanner
K160835 03/25/2016 Titan 3W TZORA ACTIVE SYSTEMS LTD. Adi Shemer
K160855 03/28/2016 U&U Enteral Syringe U&U MEDICAL TECHNOLOGY CO.,LTD BLACK WANG
K160648 03/07/2016 MiniMed Quick-Set« MiniMed Sure-T« MiniMed Silhouette« MiniMed Mio« UNOMEDICAL A/S John M Lindskog
K160815 03/24/2016 Interstitial Needles VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K160882 03/31/2016 PaX-i3D Green Premium (Model: PCT-90LH) VATECH CO., LTD Daniel Kim
K160754 03/18/2016 Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) VENCLOSE, INC. MAI LY WILCOX
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