FDA 510(k) Decisions During November, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K153086 11/20/2015 RX ACCUNET Embolic Protection System ABBOTT VASCULAR Aruna Akkapeddi
K152573 11/25/2015 4Sight ACCUTOME, INC. ADAM PICKHOLTZ
K150637 11/19/2015 Aerin Medical Wand Model FG011 Aerin Medical, Inc. Scott Wolf
DEN150001 11/20/2015 RELIZORB ALCRESTA, INC. ROBERT GALLOTTO
K143630 11/18/2015 Invisalign System ALIGN TECHNOLOGY, INC. Margaret Anderson
K152939 11/25/2015 Picasso Plus, Picasso Lite Plus AMD GROUP LLC SCOTT A. EDWARDS
K150645 11/19/2015 AN1087 Dosimeter ANDERSEN STERILIZERS, INC. William K. Andersen
K150644 11/18/2015 AN85/AN86 EO Indicators ANDERSEN STERILIZERS, INC. William K. Andersen
K151585 11/18/2015 Andersen EOGas 4 SteriTest Andersen Sterilizers, Inc. William K Andersen
K150646 11/18/2015 EOGas 4 Ethylene Oxide Gas Sterilizer ANDERSEN STERILIZERS, INC. WILLIAM K. ANDERSEN
K152058 11/18/2015 Tyvek Sterilization Pouches with Chevron Seal Andersen Sterilizers,Inc. William K Andersen
K150612 11/16/2015 Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) ANHUI ANYU LATEX PRODUCTS CO., LTD NONE PROVIDED
K150609 11/16/2015 Annuy Latex Surgeon's Gloves (Powdered and Powder Free) ANHUI ANYU LATEX PRODUCTS CO., LTD NONE PROVIDED
K150102 11/05/2015 SnoreSounds APPIAN MEDICAL, INC. MICHAEL J THOMAS
K152272 11/23/2015 Arrow Endurance Extended Dwell Peripheral Catheter System ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) TRACY LARISH
K152046 11/24/2015 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K152252 11/16/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K152382 11/12/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K153115 11/23/2015 Arthrex Univers Apex, Size 5 Stem ARTHREX, INC. COURTNEY SMITH
K152740 11/16/2015 Radifocus Glidewire ASHITAKA FACTORY OF TERUMO CORP. PHEBE VARGHESE
K152151 11/10/2015 ATAL 9 ATLAIM CORPORATION JOHN ROSS
K152923 11/05/2015 BD ChloraShield IV Dressing with CHG Antimicrobial AVERY DENNISON BELGIE BVBA LISA BARTAKOVICS
K150800 11/12/2015 Valved Safety Centesis Catheter B. Braun Medical Inc Nancy Skocypec
K152618 11/12/2015 PANTHER Cutter Stapler B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD LINA YUN
K150942 11/25/2015 Contour Next USB Blood Glucose Monitoring System BAYER HEALTHCARE JENNIFER L. GREGORY
K152057 11/24/2015 OsteoCool V-3 RF Ablation System BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K150963 11/05/2015 AnsCare ChitoClot Pad BENQ MATERIALS CORPORATION Kenix Chang
K151469 11/25/2015 CORVUS Radiation Therapy Planning System BEST NOMOS VINEET GUPTA
K150388 11/12/2015 Dental Implant System BIO CONCEPT CO., LTD HUA CAO
K151903 11/06/2015 Slendertone connect Abs BIO-MEDICAL RESEARCH LTD. ANNE-MARIE KEENAN
K151692 11/20/2015 BioArchitects Patient Specific Cranial/Craniofacial Plate BioArchitects USA, LLC Mark E. Ulrich
K151019 11/03/2015 SternaLock« 360 Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K151974 11/13/2015 Polaris Spinal System BIOMET SPINE ALEXANDRA BECK
K150571 11/20/2015 3i T3 Short Implants BIOMET3I CHRIS MCKEE
K151296 11/19/2015 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) BIOS S.R.L. RICCARDO PISATI
K153102 11/23/2015 QuadraSphere Microspheres BIOSPHERE MEDICAL, S.A. Alix Fonlladosa
K152853 11/20/2015 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary BOSTON SCIENTIFIC CORP. CARAH KUCHARSKI
K151315 11/10/2015 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle BOSTON SCIENTIFIC CORPORATION YINGYING GAO
K153049 11/13/2015 LithoVue System BOSTON SCIENTIFIC CORPORATION JEANNE O'TOOLE
K152570 11/02/2015 Bovie J-Plasma Precise 360 Handpiece BOVIE MEDICAL CORPORATION BRIAN KUNST
K150353 11/13/2015 BTL-4000 BTL INDUSTRIES, INC Jan Zarsky
K150514 11/20/2015 Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters C.R. Bard, Inc. James R. Davis
K151125 11/24/2015 AVAflex Vertebral Balloon System CAREFUSION Joy Greidanus
K153058 11/10/2015 CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. LEILEI LI
K153142 11/25/2015 Carestream DRX-1 System with DRX Plus 4343 Detectors CARESTREAM HEALTH, INC. VICTORIA WHEELER
K150397 11/09/2015 Divine 9 CarraShield Labs, Inc. Dean Fresonke
K151638 11/13/2015 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter Cathera, Inc. Victor Ham
K150684 11/18/2015 WASTON General Spinal System CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD Jack Lu
K150825 11/20/2015 Collagen Dural Regeneration Matrix COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K150550 11/24/2015 SilverCoat Silicone Foley Catheter COVALON TECHNOLOGIES, INC. Kim Crooks
K151376 11/05/2015 superDimension Navigation System Covidien LLC Jenny Jiang
K152349 11/23/2015 Star+ VPS Scannable Impression Material DANVILLE MATERIALS LLC DONG HUA
K151682 11/17/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Daxwell, LLC Frank Zhang
K143310 11/19/2015 MoisturemeterD DELFIN TECHNOLOGIES LTD. Theodore Sullivan
K150985 11/19/2015 Medihoney Wound Gel DERMA SCIENCES, INC. SHARMINI ATHERAY
K133178 11/24/2015 LUXATOR LX HANDPIECE DIRECTA AB HENRIC KARSK
K152110 11/20/2015 e-1 etchants E DENTAL PRODUCTS JEFF BANYAS
K153023 11/06/2015 Ablatherm Integrated Imaging EDAP TECHNOMED, INC. MARC OCZACHOWSKI
K151414 11/20/2015 IQQA Guide EDDA TECHNOLOGY XIAOLAN ZENG
K152225 11/24/2015 Edwards eSheath Introducer Set EDWARDS LIFESCIENCES KAREN REYNOLDS
K152762 11/23/2015 Fogarty Occlusion Catheter EDWARDS LIFESCIENCES, LLC. Naren Murugan
K152713 11/20/2015 8MP Color LCD Monitor, RadiForce RX850, RX850-AR EIZO CORPORATION HIROAKI HASHIMOTO
K152580 11/03/2015 rescuenet ENDOCHOICE, INC. DANIEL HOEFER
K152435 11/20/2015 PassAssist LED Light Fiber ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K152434 11/20/2015 XprESS Multi-Sinus Dilation System ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K150219 11/05/2015 Equashield Closed System drug Transfer Device (CSTD) EQUASHIELD MEDICAL LTD Raymond J Kelly
K152490 11/25/2015 DERMABOND PRINEO Skin Closure System ETHICON, INC. DONNA MARSHALL
K152183 11/02/2015 EXELINT SecureTouch Safety Hypodermic Needle EXELINT INTERNATIONAL CO. Navid Hamid
K151470 11/02/2015 Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus FIRST QUALITY HYGIENIC, INC. Melanie Leibowitz
K152953 11/05/2015 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE NORTH AMERICA Denise Oppermann
K152138 11/05/2015 FDR D-EVO GL Flat Panel Detector System FUJIFILM MEDICAL SYSTEM U.S.A., INC. Katherine Y Choi
K152983 11/12/2015 FUJIFILM SonoSite iViz Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K151378 11/24/2015 Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators Fujirebio Diagnostics, Inc. Diana Dickson
K150488 11/13/2015 Humelock II Reversible Shoulder System FX SOLUTIONS Jean-Jacques Martin
K152567 11/06/2015 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System GE Healthcare Ayesha Pergadia
K150298 11/12/2015 Entropy Module, E-ENTROPY-01 GE HEALTHCARE FILAND OY JOEL KENT
K152758 11/18/2015 Venue 50 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K152242 11/24/2015 G3? Active Plate« Large Fragment System GENESIS FRACTURE CARE, INC. MICHAEL BOTTLANG
K151504 11/16/2015 ICS Impulse GN OTOMETRICS ANDERS RASMUSSEN
K150358 11/12/2015 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K150094 11/19/2015 Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Good Clean Love, Inc. Wendy Strgar
K143497 11/04/2015 Safety Auto-Disable Syrine with Needle (Auto-Lock) GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD HU YIHAN
K150923 11/06/2015 Breast Pump Guangzhou Jinxinbao Electronic Co.,Ltd Jiacheng Guo
K152495 11/23/2015 Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K152838 11/24/2015 HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 HARDY DIAGNOSTICS WENDY HADLEY
K152846 11/24/2015 HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 HARDY DIAGNOSTICS WENDY HADLEY
K151656 11/25/2015 HEARTWAY Power Mobility Scooter HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K150916 11/10/2015 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO HemCon Medical Technologies, Inc. Jody Oyama
K151679 11/27/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) HEZE YUZE GLOVE CO., LTD LILY ZHU
K152661 11/16/2015 HICAT Air HICAT GmbH Frederik Kunze
K152592 11/02/2015 PROBEAT-V Hitachi, Ltd.,Health Care Company NAOYA NISHIMURA
K152723 11/13/2015 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices HOLOGIC, INC CATHERINE EATON
K153219 11/20/2015 ProFlu+ Assay HOLOGIC, INC. RON DOMINGO
K150528 11/25/2015 Cortisol Saliva Luminescence Immunoassay IBL INTERNATIONAL GMBH NICOLA KAISER
K150799 11/19/2015 Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula INNOVACYN, INC. Victor Torcat Mallen
K153150 11/24/2015 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 Inova Diagnostics, Inc. Gabriella Lakos
K151819 11/10/2015 Integrity Spine Lumbar Interbody Fusion System INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM LISA PETERSON
K153073 11/16/2015 UroNav (Version 2.0) INVIVO CORPORATION Kenneth Revennaugh
DEN150008 11/02/2015 INVOcell INVO BIOSCIENCE Kathleen Karloff
K143142 11/06/2015 JDENTALCARE Implant System J DENTAL CARE S.r.l Giacomo Grandi
K153031 11/17/2015 RANGE/DENALI/MESA Spinal System K2M, Incorporated NANCY GIEZEN
K150743 11/12/2015 Water Based Personal Lubricant with Flavours KAREX INDUSTRIES SDN. BHD. MS. MARY GOH YIN
K150525 11/20/2015 SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S. CHEN
K152236 11/04/2015 KATOR Suture Anchor KATOR LLC Robert Hoy
K150006 11/06/2015 Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing KCI USA, INC. MELANIE AVILA
K151382 11/09/2015 Patient Contoured Implant-PEEK (PCI-PEEK) KLS MARTIN L.P. JENNIFER DAMATO
K152203 11/06/2015 UTERMOHLEN CRYO PROFESSIONAL KONINKLIJKE (ROYAL) UTERMOHLEN MR.D VAN HOOF
K152270 11/13/2015 Denture base resin KOREA ENGINEERING PLASTICS CO., LTD. SONG-YI CHONG
K152282 11/20/2015 Cam Lock Plating System LIFE SPINE, INC RANDY LEWIS
K151739 11/23/2015 Revision Femoral Stem LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K151605 11/16/2015 Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves Lucenxia Prescience AG Robert Hill
K151607 11/16/2015 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG Robert Hill
K152848 11/17/2015 AUTOLAP SYSTEM M.S.T Medical Surgery Technologies LTD Tami Harel
K152041 11/17/2015 Renaissance X System Mazor Robotics Ltd. Ayelet Matia
K152318 11/17/2015 MD-2300S Ultrasonic A/B Scanner for Ophthalmology MEDA CO.,LTD Yusheng ZHANG
K151632 11/05/2015 Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental MEDELA AG Orlando Antunes
K143669 11/23/2015 MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter MEDGYN PRODUCTS, INC. AMAR AGADI
K150698 11/20/2015 Gemini Sterilization Wrap MEDLINE INDUSTRIES, INC. Jennifer Mason
K143693 11/06/2015 MEDLINE SHARPS CONTAINERS MEDLINE INDUSTRIES, INC. Matt Clausen
K150238 11/27/2015 SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color MEDLINE INDUSTRIES, INC. CLAIRE WELLINGHOFF
K151773 11/20/2015 CONCORDE Bullet Lumbar Interbody System Medos International, Sarl JACLYN PORSOLT
K151227 11/16/2015 KYPHON XPEDE Bone Cement MEDTRONIC KATHY L REMSEN
K152623 11/12/2015 ATLANTIS Anterior Cervical Plate System MEDTRONIC SOFAMOR DANEK USA, INC LAVEEDA LEFLORE
K152277 11/13/2015 PIVOX(tm) Oblique Lateral Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Lila Joe
K152248 11/05/2015 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K152285 11/10/2015 illumigene Pertussis DNA Amplification Assay MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K151925 11/06/2015 Elation Wireguided Balloon Dilation Catheter MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K152298 11/16/2015 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base MICROPORT ORTHOPEDICS, INC. BYRON LEDBETTER
K151825 11/16/2015 Viradius Neurowire MIVI NEUROSCIENCE, INC. RANDY LABOUNTY
K151872 11/02/2015 Avance Y-Connector S MOLNLYCKE HEALTH CARE, US LLC ANGELA BUNN
K152004 11/17/2015 Nanova Universal Composite NANOVA BIOMATERIALS INC ANDREW RITTS
K152643 11/02/2015 EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana NANTONG EGENS BIOTECH CO., LTD. Yan Cao
K150561 11/25/2015 NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System Narang Medical Limited Vivek Narang
K152936 11/13/2015 Sirius Max Dental Diode Curing Light NATIONAL DENTAL INC. EDWIN FIRST
K151609 11/06/2015 ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 NDS SURGICAL IMAGING LLC Jim Leng
K153182 11/25/2015 SELF- COMPRESSIVE SCREW NEOSTEO JD WEBB
K151383 11/04/2015 NeuViz 128 Multi-slice CT Scanner System NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K151403 11/02/2015 Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K151080 11/05/2015 Nihon Kohden CSM 1901 Bedside Monitor Nihon Kohden Tom Bento
K152256 11/05/2015 RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151361 11/06/2015 Nox RIP Belts & Cables NOX MEDICAL ehf KOLBRUN E OTTOSDOTTIR
K151275 11/13/2015 MAKO Device nVision Medical Surbhi Sarna
K152055 11/23/2015 Ceramax Skin Barrier Cream OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K151738 11/20/2015 Single Use Aspiration Needle NA-U200H OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K151191 11/24/2015 OES ELITE Telescopes, Protective Tube OLYMPUS WINTER & IBE GMBH KATHARINA SCHNACKENBURG
K152779 11/25/2015 Avex CX2 Opal Orthodontics by Ultradent Products Marie Hess
K150688 11/05/2015 IdentEvent OPTIMA NEUROSCIENCE, INC. Ryan T. Kern
K150268 11/06/2015 CerOX OR-NIM MEDICAL LTD. MICHA OESTEREICH
K151946 11/09/2015 Thermofit ORFIT INDUSTRIES EDDY MAROVOET
K152295 11/03/2015 Talon DistalFix Antegrade/Retrograde Femoral Nail ORTHOPEDIC DESIGNS NORTH AMERICA, INC. Robin Wilson
K151432 11/05/2015 NaturalLine Abutment OT MEDICAL GMBH MARTINA BEHLAU
K152067 11/23/2015 Ponto bone anchored hearing system OTICON MEDICAL AB Carolina Anker Wessling
K151852 11/10/2015 PacEndo Sodium Hyprochlorite PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K152711 11/20/2015 Parcus GFS Naked PARCUS MEDICAL, LLC PAUL VAGTS
K150504 11/16/2015 GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor PCI MEDICAL, INC. Kevin Mader
K150558 11/12/2015 Eclipse System Pelvalon, Inc. MILES ROSEN
K150618 11/24/2015 PENTAX Medical EPK-i7010 Video Processor with GI Family PENTAX OF AMERICA, INC. KRISHNA GOVINDARAJAN
K153022 11/18/2015 Philips IntelliSpace Cardiovascular PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Dave J.W. Bierhuizen
K150299 11/19/2015 Gmate SMART Blood Glucose Monitoring System Philosys Inc. Linda Chan
K152259 11/19/2015 InFill Interbody Fusion Device Pinnacle Spine Group, LLC Rebecca K Pine
K150077 11/25/2015 SonicLift PRETIKA CORPORATION Thomas Nichols
K151798 11/16/2015 Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K151154 11/10/2015 FIBERGRAFT BG Morsels PROSIDYAN INC. CHARANPREET S BAGGA
K142941 11/02/2015 Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. PT MEDISAFE TECHNOLOGIES Anil Taneja
K151212 11/04/2015 Ziostation2 QI IMAGING, LLC RICHARD BALL
K152695 11/18/2015 8 CH Knee SPEEDER QUALITY ELECTRODYNAMICS, LLC. KATHLEEN ARAS
K152847 11/17/2015 DIVA ZSP5812CMI with QUBYX PerfectLum bundle QUBYX LTD. MARC LEPPLA
K153060 11/10/2015 Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S RAYENCE CO., LTD KEVIN KIM
K151901 11/05/2015 AirView RESMED LTD. Jasjit Baveja
K143584 11/02/2015 PGA RESORBA, PGA RESOQUICK, GLYCOLON RESORBA MEDICAL GMBH KARL JOSEF BECK
K150455 11/19/2015 RT2 Trabeculite Titanium Cervical Cage System RHAUSLER, INC. TERRY JOHNSTON
K142211 11/25/2015 OT EQUATOR Rhein '83 SRL Claudia Nardi
K152962 11/02/2015 HS70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KYEONG-MI PARK
K151186 11/27/2015 Stay Fresh Hydrocolloid dressing SARASOTA MEDICAL PRODUCTS, INC. WALTER F. LEISE
K151004 11/17/2015 PULLUP« Adjustable Juxtacortical Fixation Device SBM SCIENCES FOR BIO MATERIALS DENIS CLEMENT
K151265 11/24/2015 SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring System SD BIOSENSOR YEON PARK
K152426 11/09/2015 Wrist - Type Fully Automatic Digital Blood Pressure Monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K153096 11/25/2015 LARIAT RS Suture Delivery Device SentreHEART, Inc. KIT CARIQUITAN
K150436 11/13/2015 ComboRehab SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. Jianping Kang
K150168 11/04/2015 Dimension Tacrolimus Flex« Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) SIEMENS HEALTHCARE DIAGNOSTICS Anna Marie Kathleen Ennis
K151792 11/20/2015 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics,Inc. Philip Liu
K152928 11/13/2015 Multitom Rax SIEMENS MEDICAL SOLUTIONS USA, INC. DARREN A. DORMAN
K151752 11/12/2015 SOMATOM Emotion 6/16 Siemens Medical Solutions USA, Inc. Eve Davis
K142955 11/24/2015 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power SIEMENS MEDICAL SOLUTIONS USA, INC. Kimberly Mangum
K150713 11/02/2015 syngo.CT Myocardial Perfusion SIEMENS MEDICAL SOLUTIONS USA, INC. EVE DAVIS
K151209 11/06/2015 InterOss SigmaGraft, Inc Megan Holden
K152757 11/13/2015 SIGN Hip Construct (SHC) SIGN FRACTURE CARE INTERNATIONAL Rob Teeter
K150790 11/16/2015 REDAPT Porous Acetabular Shell and Cemented Liner SMITH & NEPHEW, INC. JEFF SPRAGUE
K152976 11/12/2015 VLP Mini-Mod Talus Plates Smith & Nephew, Inc. Samantha Staubach
K152000 11/25/2015 SMV Scientific Bone Plate and Screw System SMV Scientific Nephi Zufelt
K151713 11/06/2015 LILLIPUP PMP, LILLIPUT PMP INTEGRATED SORIN GROUP ITALIA S.R.L. LUIGI VECCHI
K150329 11/05/2015 elance Vital Signs Monitor, Central Monitor Software SPACELABS HEALTHCARE Al Van Houdt
K152181 11/12/2015 Turbo-Power Laser Atherectomy Catheter SPECTRANETICS, INC. Priscila Tapia
K151770 11/20/2015 Libra Pedicle Screw System Spinal Balance Inc. Anand Agarwal
K151710 11/19/2015 SNaP Wound Care System SPIRACUR, INC. LAWRENCE HU
K151928 11/06/2015 PUR Dental Implant System STERNGOLD DENTAL, LLC MARIA RAO
K151667 11/13/2015 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm Stryker Rhoda M Santos
K152304 11/19/2015 Tritanium PL Cage Stryker SIMONA VOIC
K152641 11/20/2015 Pi Drive Plus Motor, Extender STRYKER CORPORATION DEVAL PATEL
K142617 11/20/2015 ArcCHECK SUN NUCLEAR CORPORATION Noel Downey
K150259 11/06/2015 CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L TAIWAN SURGICAL CORPORATION Hsiu-Ping Huang
K150603 11/27/2015 Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Teleflex Medical, Inc. Lori Pfohl
K151791 11/19/2015 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir TERUMO CARDIOVASCULAR SYSTEMS CORPORATION JAIME LEE
K152525 11/10/2015 TR BAND Radial Compression Device TERUMO MEDICAL CORPORATION LIANG LU
K151759 11/06/2015 Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS THE BINDING SITE GROUP LTD. STEPHANIE THOULESS
K151816 11/19/2015 TLC-2000 Therapeutic Medical Laser System Theralase Inc. Roger Dumoulin-White
K151673 11/27/2015 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K152785 11/25/2015 XIDF-AWS801, Angio Workstation, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K153075 11/13/2015 Klassic Knee System TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K151034 11/21/2015 PainKARE TrioWave Technologies Huiyou Zhu
K152019 11/16/2015 HairMD TROPHY SKIN, INC. IMRAN KARIM
K153180 11/25/2015 Tyber Medical MST Trauma Screw TYBER MEDICAL LLC Mark F. Schenk
K150386 11/05/2015 Tyece OTC TENS Device TYECE LTD Parshid Falahati
K152678 11/17/2015 TYRX Neuro Antibacterial Envelope TYRX, INC. REGINA NOVAK
K151344 11/19/2015 Cytoflex Tefguard Ti-Enforced Membrane Unicare Biomedical, Inc. Stan Yang
K152255 11/16/2015 BoneCam Suture Anchors VALERIS MEDICAL DANIEL LANOIS
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