FDA 510(k) Decisions During December, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K151933 12/10/2015 BRX PRO Bruxism Guard 12TH MAN TECHNOLOGIES, INC. ALEX STENZLER
K152060 12/01/2015 3M Attest Rapid Readout Biological Indicator 1295 3M COMPANY MATT MORTENSEN
K152078 12/04/2015 Implant Studio 2015 3Shape Medical A/S Hanne Nielsen
K152155 12/17/2015 ARCHITECT 2nd Generation Testosterone Abbott Laboratories Regina Xavier Kumar
K152442 12/17/2015 Freestyle Freedom Blood Glucose Monitoring Sytem ABBOTT LABORATORIES Sai Sriharshada Tatavarty
K152721 12/08/2015 Cytal Wound Matrix ACELL, INC THOMAS GILBERT
K152417 12/01/2015 Adler MicroMed Laser Surgery Fibers ADLER MICROMED INC. BRIAN CHANDLER
K152639 12/11/2015 DR 600 AGFA HEALTHCARE N.V. Koren Vervoort
K150930 12/18/2015 Deployable Oxygen Generation System-Smaill (DOGS-S) AirSep Corporation Peter Weisenborn
K152968 12/30/2015 Arsenal Spinal Fixation System ALPHATEC SPINE, INC RENEE MURPHY
K152460 12/22/2015 Rectangular Corpectomy Cage Amendia, Inc. Bruce Hooper
K152291 12/17/2015 Sterisheet Sterilization Wrap ANDERSEN STERILIZERS, INC. WILLIAM K ANDERSEN
K150833 12/04/2015 iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System ANDON HEALTH CO.,LTD Yi Liu
K151168 12/22/2015 Nexodyn AOS Wound Care Solution APR Applied Pharma Research SA Giorgio Reiner
K153313 12/11/2015 SpeedLock Knotless Fixation System ARTHROCARE CORPORATION LAURA KASPEROWICZ
K153344 12/17/2015 Asahi REXEED-S Series Dialyzer Asahi Kasei Medical Co., Ltd. Hidenobu Nakazawa
K152047 12/23/2015 INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid ASCENSION ORTHOPEDICS WILLIAM GARZON
K152153 12/11/2015 MicroSpot Handpiece ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K152732 12/10/2015 AOS Small Fragment Plating System AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) Mark Steinhauer
K150787 12/02/2015 Universal Spike B. Braun Medical Inc. Tracy Maddock
K153158 12/28/2015 Solution Administration Sets with 0.2 Micron Filter BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K152852 12/22/2015 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) BAYER HEALTHCARE, LLC William R Walsh
K153210 12/21/2015 Defibrillator Analyzer Variable Load BC GROUP INTERNATIONAL, INC Mel Roche
K150815 12/17/2015 BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit Becton, Dickinson and Company Catherine(Katie) Bessette
K153257 12/11/2015 BD FlowSmart Set, MiniMed Pro-Set BECTON, DICKINSON AND COMPANY MATTHEW TRACHTENBERG
K150300 12/11/2015 Liquichek Cardiac Markers Plus Control LT Bio-Rad Laboratories Elizabeth Platt
K151321 12/09/2015 D-100 HbA1c, D-100 HbA1c Calibrator Pack Bio-Rad Laboratories, Inc. Jackie Buckley
K151876 12/30/2015 Bio2 Fusion Implant System Bio2 Technologies, Inc Janet Krevolin
K152157 12/11/2015 LC Bead LUMI BIOCOMPATIBLES UK LTD April Kent
K151295 12/01/2015 Biodenta Customized Abutment - Titanium BIODENTA SWISS AG DAVID ELIER
K152326 12/10/2015 Biomet Microfixation OmniMax MMF System BIOMET MICROFIXATION LAUREN JASPER
K150722 12/02/2015 EnFocus 2300, EnFocus 4400 BIOPTIGEN, INC. Tammy B Carrea
K152889 12/30/2015 SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS BIORENEW LABS, LLC JON DAVID
K150997 12/22/2015 RUBY STAR BISON MEDICAL CO., LTD SUN-WOO LEE
K153088 12/11/2015 AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System BOSTON SCIENTIFIC CORPORATION ASHLEY SANTOS
K151840 12/16/2015 Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation Nikki M Wahlberg
K152401 12/04/2015 Stingray LP Catheter BOSTON SCIENTIFIC CORPORATION KURTIS HUNSBERGER
K153298 12/10/2015 AccuCath Intravascular Catheter C.R. Bard, Inc. Casey Coombs
K152554 12/14/2015 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc. Kerrie Hamblin
K150585 12/31/2015 Ascent 3D CAO GROUP, INC. Robert K Larsen
K150769 12/14/2015 Cardinal Health Trochanteric IM Nail System Cardinal Health Tatyana Bogdan
K151445 12/21/2015 Cardinal Health Sterilization Wrap CARDINAL HEALTH 200, LLC MEGAN MIDDAUGH
K153492 12/24/2015 CareView 1800L CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. Leilei Li
K152467 12/09/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L. WAGNER
K151255 12/30/2015 Navigator Aesthetic Delivery System CARTICEPT MEDICAL INC CARRIBETH RAMEY
K152162 12/24/2015 Myray- HYPERION X5 CEFLA S.C. Silvia Sansavini
K153148 12/01/2015 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) YON YU
K152211 12/01/2015 PCT System CENTINEL SPINE, INC. JESSICA STAUB
K151226 12/03/2015 Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) CEPHEID Kerry J Flom
K151672 12/21/2015 Cerner CareAware Event Management CERNER CORPORATION SHELLEY S. LOOBY
K143013 12/11/2015 Spinal Inner Fixation System Changzhou Dingjian Medical Appliance Co., Ltd Li Quinsong
K151062 12/17/2015 WASTON Metallic Intramedullary Nail System CHANGZHOU WASTON MEDICAL APPLIANCE CO., LTD Jack Lu
K153085 12/21/2015 Q Series Diagnostic Ultrasound System CHISON MEDICAL IMAGING CO., LTD. Qifei Liu
K152515 12/18/2015 TOMCAT Cervical Spinal System CHOICE SPINE, LP Kim Finch
K152146 12/08/2015 High Speed Handpieces and Accessories CODENT TECHNICAL INDUSTRY CO., LTD. Chin-Ting Wen
K151126 12/18/2015 Foresight Intracardiac Echocardiography (ICE) System Colibri Technologies Inc. SAM MOSTAFAVI
K152243 12/09/2015 One Coat 7 Universal Coltene/Whaledent AG Silke Wallaschek
K153499 12/18/2015 EDGE Arthroscopic Energy System, Arthroscopic Energy System Probes, Arthroscopic Energy System Wireless Footswitch, Arthroscopic Energy System Corded Footswitch, Arthroscopic Energy System Foot Control, Extension ConMed Corporation Dionne Sanders
K152860 12/29/2015 HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL CONMED CORPORATION LISA ANDERSON
K150668 12/09/2015 Biodesign Enterocutaneous Fistula Plug COOK BIOTECH INCORPRATED Perry W Guinn
K150748 12/18/2015 Flexipet Denuding Pipette, Flexipet Manipulation Pipette COOK INCORPORATED NAOMI FUNKHOUSER
K150931 12/18/2015 MReye Embolization Coils Cook Incorporated Nozomi Yagi
K150964 12/18/2015 MReye Flipper Detachable Embolization Coil and Delivery System Cook Incorporated Nozomi Yagi
K153092 12/21/2015 Ally Uterine Positioning System CooperSurgical, Inc. Roaida Johnson
K152284 12/04/2015 COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS COTTON HIGH TECH S.L. Anna Garcia
K151279 12/16/2015 Counter OTC TENS Device, Model CSD-737Z COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Jiang Eagle
K151381 12/11/2015 Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye Covidien Danielle Mueller
K152586 12/30/2015 Beacon Fine Needle Fiducial System Covidien LLC RACHEL SILVA
K152306 12/11/2015 MotoBand? CP Implant System CROSSROADS EXTREMITY SYSTEMS, LLC VERNON HARTDEGEN
K151896 12/07/2015 Houdini Catheter Cruzar Medsystems, Inc. Tom Kramer
K151158 12/10/2015 ALP VasQcare Take Home System Currie Medical Specialties, Inc. Owen J Bry
K151496 12/15/2015 Latitude-C Cervical Interbody Spacer System Degen Medical Craig Black
K152767 12/14/2015 OTC12D AUTO RADIOGRAPHIC SYSTEM DEL MEDICAL, INC. JOHN HARTZELL
K152322 12/16/2015 Resolve 2.0 DENALI CORPORATION Jan G Stannard
K151926 12/14/2015 QuickRay HD Intraoral Sensor DENTERPRISE INTERNATIONAL, INC. CLAUDE BERTHOIN
K142313 12/10/2015 OneQ-SL Implant System DENTIS CO. LTD. Jeong Seop Keun
K152859 12/03/2015 Portable X-ray System (Model: MINIX-V / MINIX-S) DIGIMED CO., LTD. (DIGIMED CORPORATION UNTIL 31/12/2012) YOUNGBAE KWON
DEN150010 12/08/2015 Dignitana AB DigniCap System DIGNITANA AB JAN RICHARDSSON
K152508 12/31/2015 Ageless Health Medical Digital Thermometer DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD VICTOR WAN
K152172 12/14/2015 Econsole1 DRTECH CORPORATION CHOUL-WOO SHIN
K151878 12/01/2015 Video Colposcope EDAN INSTRUMENTS, INC. Queena Chen
K153011 12/11/2015 iViewDose R1.0 Elekta Limited Maurice Paine
K151686 12/30/2015 HumanPen Ergo II ELI LILLY AND COMPANY, INC. CHRISTINE A. PHILLIPS
K152370 12/22/2015 PRECICE Trauma Nail System Ellipse Technologies Incorporated John McIntyre
K152182 12/10/2015 Fuse Gastroscopy System ENDOCHOICE INC. DANIEL HOEFER
K151567 12/23/2015 ENDOPLUS hand-held laparoscopic instruments ENDOPLUS Matthew Gudeman
DEN150005 12/18/2015 Newa Skin Therapy System EndyMed Medical Ltd. Yoram Levy
K152406 12/23/2015 SalivaMAX FORWARD SCIENCE LLC Brian Pikkula
K150708 12/10/2015 2008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis Machine FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K153483 12/15/2015 Balloon controller PB-30 FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Aaron Ge
K152722 12/08/2015 neoV980 & neoV1470 Diode Lasers G.N.S NEO LASER LTD. GIL SHAPIRA
K150408 12/14/2015 V-STEADY, V-FAST G21 S.R.L. MAURIZIO FORONI
K152528 12/02/2015 Attachable Cath Lab Hemostasis Valve GALT MEDICAL CORP. DAVID DERRICK
K151063 12/15/2015 Monitor B40 GE MEDICAL SYSTEMS CHINA CO., LTD. Sun YanLi
K150354 12/10/2015 PAPAYA 3D Plus GENORAY CO., LTD. Kyoung-hwa Kim
K150782 12/14/2015 AbStats Gateway GI Logic Inc James Beeton
K152219 12/17/2015 PK AIM GYRUS ACMI INC NEIL KELLY
K150966 12/04/2015 HMB32 HAEMOPHARM BIOFLUIDS SRL GIUSEPPE TOMASINI
K151127 12/08/2015 higi Station higi SH LLC Colin Hill
K153223 12/09/2015 ProParaFlu+ Assay HOLOGIC, INC. RON DOMINGO
K151133 12/09/2015 PENTRA XLR HORIBA ABX SAS Caroline Ferrer
K151025 12/29/2015 iHearTest IHEAR MEDICAL, INC. ANGELA LEE FOREMAN
K152491 12/17/2015 MoMe Software Platform INFOBIONIC, INC. MATTHEW KING
K152996 12/17/2015 Molteno3 Glaucoma Implant INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP) BRYAN WEINMANN
K152875 12/21/2015 QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K150877 12/13/2015 ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS Instrumentation Laboratory Co. Carol Marble
K150682 12/18/2015 CUSA Excel+ INTEGRA LIFESCIENCES CORP. JENNIFER SIEGEL
K151364 12/28/2015 Intellijoint HIP(tm) System INTELLIJOINT SURGICAL INC. BRANDON GINGRICH
K152112 12/29/2015 VisualEyes INTERACOUSTICS A/S ERIK NIELSEN
K152436 12/07/2015 Suntanning Lamps Interlectric Corporation Ken C. Frazier
K152150 12/18/2015 V8 Balloon Aortic Valvuloplasty Catheter InterValve, Inc. Mark Ungs
K153126 12/09/2015 da Vinci Xi Hasson Cone INTUITIVE SURGICAL INC. VISHAL KANANI
K152330 12/23/2015 Expression MR400 MRI Patient Monitoring System INVIVO CORPORATION Rusty Kelly
K151074 12/22/2015 Magnetic Reasonance Imaging System JIANGSU MAGSPIN INSTRUMENT CO.,LTD LEO LI
K152323 12/14/2015 Disposable Infusion Needle, Safelock Disposable Infusion Needle JIANGYIN CAINA TECHNOLOGY CO., LTD JUN LU
K151991 12/11/2015 Safelock Disposable Blood Collection Set, Disposable Blood Collection Set JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K151481 12/21/2015 Sahara Stabilization System K2M, INC NANCY GIEZEN
K152644 12/31/2015 KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 KEELER LIMITED IRINA PROUTSKI
K152441 12/04/2015 KIRO Set KIRO ROBOTICS S.L. Naiara Telleria
K150817 12/21/2015 Dario Blood Glucose Monitoring System LabStyle Innovations Ltd. TRACEY WIELINSKI
K150841 12/29/2015 Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant LACLEDE, INC. Michael Pellico
K151934 12/07/2015 ROI-C Titanium-Coated Implant System LDR SPINE USA JAMES WILSON
K152175 12/04/2015 Upcera Dental Zirconia Blank for Aesthetic Restoration LIAONING UPCERA CO.,LTD Charles Shen
K151611 12/14/2015 OneTouch Ultra Plus Flex Blood Glucose Monitoring System LIFESCAN EUROPE NIKI SKELLY
K151370 12/17/2015 UV Lamps for Indoor Tanning Devices LIGHT SOURCES, INC. EUGENE CZAKO
K150934 12/21/2015 Powder Free Vinyl Patient Examination Glove (Non?-Sterile) LPL (HUI ZHOU) GLOVE LEE HONG CHONG
K152386 12/17/2015 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software LUMINEX MOLECULAR DIAGNOSTICS, INC. TINA IP
K153461 12/11/2015 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm MAQUET CRITICAL CARE AB Mirva Boothe
K151814 12/21/2015 SERVO-U Ventilator System, SERVO-n Ventilator System MAQUET CRITICAL CARE AB MARIA VON BAHR
K150831 12/22/2015 Cellvizio 100 Series System with Confocal Miniprobes MAUNA KEA TECHNOLOGIES Sophie Rehault
K152201 12/30/2015 MedActive Oral Gel and Spray MedActive Oral Pharmaceuticals, LLC. Brian Walker
K142125 12/22/2015 New Medax Biopsy Systems MEDAX SRL UNIPERSONALE Stefano Cavalieri
K143711 12/02/2015 Reaxon Plus MEDOVENT GMBH THOMAS FREIER
K151359 12/18/2015 ROSA Brain MEDTECH S.A. MICHAEL CHRIST
K153463 12/30/2015 CD HORIZON Spinal System, IPC POWEREASE System MEDTRONIC SOFAMOR DANEK USA, INC. Becky Ronner
K152121 12/01/2015 NuVent EM Sinus Dilation System MEDTRONIC XOMED, INC. Gabriela Anchondo
K151762 12/28/2015 PediatrOS RigidTack/FlexTack MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K152783 12/07/2015 Merit 20 mL Syringe Merit Medical Systems, Inc. CORY MARSH
K153071 12/23/2015 Solitaire Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Phuong Chau
K152001 12/10/2015 Sterile Repositionable Hemostasis Clipping Device Micro-Tech (Nanjing) CO.,Ltd. Becky Li
K153450 12/16/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
K150870 12/21/2015 HydroPearl Microspheres, HydroPearl Microspheres MICROVENTION, INC. NAOMI GONG
K153053 12/29/2015 Traxcess Pro 14 Guidewire MICROVENTION, INC. SAPNA SINGH
K143222 12/11/2015 FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical Inc Heidi Frey
K151396 12/09/2015 MIVI Mi-AXUS Guide Catheter MIVI NEUROSCIENCE, INC Matthew Ogle
K150898 12/18/2015 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm MOLLER MEDICAL GMBH JULIANE DRAGON
K153228 12/04/2015 NMI Port, NMI Port II NAVILYST MEDICAL, INC. Robin Fuller
K152857 12/17/2015 NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps NEOMED, INC. TONY LAIR
K150729 12/29/2015 SpectraShield 9500 Surgical N95 Respirator Nexera Medical Inc. Paul Sallarulo
K150792 12/17/2015 Next Science Wound Gel NEXT SCIENCE, LLC MATTHEW MYNTTI
K152548 12/21/2015 AXI+LINE Proximal Bunion Correction System NEXTREMITY SOLUTIONS, Inc. Ryan Schlotterback
K150079 12/10/2015 Regenomer« Syringe, Regenomer« Plug, Regenomer« Block NIBEC CO, LTD YOON-JEONG PARK
K152943 12/01/2015 NuVasive Foundation-LL System NUVASIVE INCORPORATED CYNTHIA ADAMS
K150828 12/18/2015 O-RING Condom O-RING Products LLC William Mistler
K152945 12/15/2015 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K152809 12/31/2015 Giraffe Incubator Carestation CS1 OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC. KENNY BELLO
K142785 12/17/2015 PRODIGY iConnect Blood Glucose Monitoring System OK BIOTECH CO., LTD. Jen Ke-Min
K153437 12/21/2015 Apex Revision Knee System OMNILIFE SCIENCE CHRISTINA ROVALDI
K141157 12/22/2015 BONDEASE TOPICAL SKIN ADHESIVE OPTMED, INC. STEPHANIE RAIS
K153306 12/18/2015 Imbibe Needle ORTHOVITA, INC. LYNN LUNDY
K152145 12/21/2015 OsteoMed ExtremiLOCK Wrist Plating System OSTEOMED Piedad Pena
K152267 12/15/2015 Remedy« Shoulder Spacer Osteoremedies LLC Chris Hughes
K153378 12/21/2015 Monster BITE Screw System PARAGON 28 Frank S. Bono
K152951 12/28/2015 Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera Sterilization Tray, Camera Sterilization Tray PARAGON MEDICAL, INC. MIKE GOSMEYER
K152636 12/17/2015 Laser Dock PATIENT POCKET, LLC ALLEN D SEFTEL
K152840 12/02/2015 Lantern Delivery Microcatheter PENUMBRA, INC. CHARLES DENAULT
K150854 12/14/2015 ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut PHADIA AB Carina Magnusson
K153480 12/16/2015 ClearVue850 Diagnostic Ultrasound System PHILIPS HEALTHCARE Saraswathi Deora
K153318 12/22/2015 Philips Eleva Workspot with SkyFlow Philips Medical Systems DMC GmbH MING XIAO
K151658 12/01/2015 Gmate Origin Blood Glucose Monitoring System Philosys Inc. LINDA CHAN
K142879 12/23/2015 BTM Wound Dressing POLYNOVO BIOMATERIALS PTY LTD Philip Powell
K151050 12/22/2015 Pacifier Activated Lullaby (PAL«) Power Medical Devices, LLC Patricia Palmer
K151413 12/18/2015 Always/Tampax bladder supports PROCTER & GAMBLE LENORE FAULHABER
K143514 12/11/2015 Panther StereoSeed PROWESS, INC. Rachel Scarano
K150806 12/16/2015 PulseFlowDF PulseFlow Technologies Les Lindsay
K152321 12/04/2015 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi QFIX NADIA SOOKDEO HARHEN
K152012 12/08/2015 EVO platform Quanta System SpA Francesco Dell'Antonio
K152714 12/21/2015 Quanta Forte QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K152292 12/07/2015 Respire Blue Series-EF Respire Medical Holding David Walton
K152624 12/07/2015 XSTAT 30, 3-PACK, XSTAT 30, 1-PACK REVMEDX, INC. AMY K. POINTER
K152542 12/24/2015 Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs RIVERSTONE RESOURCES SDN BHD SURESH KUMAR
K153401 12/21/2015 GR40CW SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K153408 12/21/2015 HM70A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD Jiyoung Kim
K152513 12/15/2015 8X-10-XXXX Camera System Santa Barbara Imaging Systems James Candy
K153189 12/17/2015 Beacon Tissue Marker (SE) SCION MEDICAL TECHNOLOGIES, LLC LOUIS LI
K151639 12/07/2015 ABL80 FLEX and ABL80 FLEX CO-OX SENDX MEDICAL INC VIBEKE AGERLIN
K151329 12/17/2015 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet SENTEC AG ANKE WEISBRICH
K150664 12/22/2015 NeoLas SHEAUMANN LASER, INC Katina Sousa
K152384 12/18/2015 Digital Electrocardiograph SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. Hongbo Zhong
K151810 12/17/2015 Bpump Blood Pressure Cuff SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K151699 12/10/2015 BEAUTIFIL II Enamel SHOFU DENTAL CORPORATION Mauro Malyzyner
K152451 12/11/2015 VINTAGE Art LF SHOFU DENTAL CORPORATION MAURO MALZYNER
K142826 12/22/2015 ADVIA Centaur Toxoplasma M (Toxo M) SIEMENS HEALTHCARE DIAGNOSTICS, INC. Matthew Gee
K153365 12/18/2015 ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K151767 12/11/2015 Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. Laura J. Duggan
K152283 12/24/2015 MAGNETOM Amira SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L FIELDS
K153208 12/31/2015 Internal Joint Stabilizer - Elbow SKELETAL DYNAMICS, LLC Ana M Escagedo
K150908 12/16/2015 XM-01 Electronic Automatic Blood Pressure Monitor Sky Innovation Technology ( Shanghai) Limited Charles Shen
K152566 12/02/2015 PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor SMITH & NEPHEW, INC. KATHERINE MARCACCIO
DEN140024 12/23/2015 cNEP Airway Sommetrics Richard Rose
K152341 12/14/2015 ViSi Mobile Monitoring System SOTERA WIRELESS, INC Carson Krupp
K152355 12/10/2015 Twin Peaks Lumbar Interbody Fusion System SPINEWAY Julien Thao my
K152958 12/04/2015 INEX Absorbable Nasal Implant SPIROX, INC. MIKE ROSENTHAL
K151114 12/11/2015 Medismart ( Latex Surgeon?s Gloves powdered ) and Medismart + (Latex Surgeon?s Gloves Powder Free, Polymer coated with protein ST.MARYS RUBBERS PVT. LTD. Srinivasan. S
K152115 12/17/2015 Renew NCP-5 External Counterpulsation System Stage 2 Innovations Richard Kotz
K152651 12/15/2015 AccuLIF TL and PL Cage STRYKER CORPORATION AAKASH JAIN
K152632 12/02/2015 XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory STRYKER CORPORATION SORAYA KING
K152532 12/18/2015 AERO -C Cervical Cage System STRYKER SPINE SORAYA KING
K153154 12/28/2015 Asnis JFX System Stryker Trauma AG Garry T. Hayeck
K152692 12/21/2015 Powder Free Vinyl Patient Examination Gloves (Green) Supermax Plastic Products Co., Ltd Wu Zhigang
K150524 12/16/2015 Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology Surgical Instrument Services and Savings, Inc Richard D Wynkoop
K151936 12/04/2015 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle SYNAPTIC MEDICAL LIMITED Yang Tiecheng
K152239 12/02/2015 Zero-P Natural Plate System Synthes (USA), LLC Beth Becotte
K153140 12/02/2015 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
K153376 12/16/2015 Advanced Perfusion System 1 Terumo Cardiovascular Systems Corporation Bryan Hann
K153143 12/02/2015 Capiox Advance Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A. Brown
K153213 12/03/2015 Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir Terumo Cardiovascular Systems Corporation Tierra A Brown
K152173 12/01/2015 Glidesheath TERUMO MEDICAL CORPORATION ERIN DOYLE
K152389 12/18/2015 Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit THE BINDING SITE GROUP LTD STEPHANIE THOULESS
K150676 12/23/2015 L-Mesitran Dressing Family II- Soft and Tulle Theo Manufacturing BV Monique Gottgens
K152774 12/21/2015 The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL THERMO FISHER SCIENTIFIC CYNTHIA KNAPP
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K152128 12/23/2015 2-in-1 Abdominal Muscle Training & Back Pain Relief System Tohkai Precision Electrical Manufactory (Shenzhen) Limited Yuk Wing Li
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K151916 12/18/2015 TRI Dental Implant System TRI DENTAL IMPLANTS INT. AG SANDRO VENANZONI
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K150992 12/16/2015 Vios Monitoring System VIOS MEDICAL, INC. MEGAN GRAHAM
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K150961 12/04/2015 EmbryoSlide Culture Dish VITROLIFE A/S BELINDA DUEHOLM
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K152582 12/03/2015 CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box VOLCANO CORPORATION NATHAN DA SILVA
K153369 12/22/2015 SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz VOLCANO CORPORATION Brian Park
K153094 12/31/2015 Visions PV .035 Digital IVUS Catheter Volcano Corporation Neeta Sharma
K152609 12/11/2015 GORE SYNECOR Biomaterial W.L GORE & ASSOCIATES, INC. BARBARA L. SMITH
K151900 12/11/2015 VariLift-L Interbody Fusion Device WENZEL SPINE, INC. BECKINAM NOWATZKE
K152851 12/24/2015 BrainPort V100 WICAB, INC. ROBERT BECKMAN
K152118 12/16/2015 Zenostar MT, Zenostar Color Liquids WIELAND DENTAL + TECHNIK GMBH & CO. KG BETINA KISTNER
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K152904 12/03/2015 SYDNEY IVF EMBRYO BIOPSY MEDIUM WILLIAM A. COOK AUSTRALIA PTY, LTD. GORDANA POZVEK
K151714 12/03/2015 Disposable Endoscope Valves Set A WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED LIJUAN ZHANG
K152038 12/22/2015 MammoGRIP Women's Imaging Solutions Enterprises LLC Nancy DeRobertis
K152974 12/11/2015 ORTHOLOC« 3Di Foot Plating Reconstruction System Wright Medical Technology, Inc. Val Myles
K150640 12/01/2015 RX-FIX Mini Rail External Fixator WRIGHT MEDICAL TECHNOLOGY, INC. LESLIE FITCH
K151890 12/23/2015 Medical Diode Laser Systems Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing
K151284 12/21/2015 Electric Double Breast Pumps Wuxi Xinzhongrui Baby Supplies Co.,Ltd Shaozhong Chen
K152987 12/11/2015 Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System XENCO MEDICAL, LLC GUSTAVO PRADO
K151498 12/18/2015 Breathing circuit bacterial/viral filter ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. HU JUBIN
K151907 12/30/2015 Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables ZIMMER, INC. PATRICK MCCULLAGH
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