FDA 510(k) Applications Received During June, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151687 06/23/2015 QuantorView 3DISC AMERICAS SIGRID SMITT-JEPPESEN
K151748 06/29/2015 Clean & More 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K151455 06/01/2015 3Shape Abutment Designer Software 3Shape A/S Hanne Nielsen
K151566 06/10/2015 Abbott ARCHITECT Total T4 Calibrators ABBOTT LABORATORIES Lisa Lukowski
K151636 06/17/2015 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control ABBOTT MEDICAL OPTICS INC Christine Chun
K151595 06/12/2015 On Call Express Pro Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K151554 06/09/2015 Occlusion Perfusion Catheter ADVANCED CATHETER THERAPIES, INC. PAUL JOSEPH FITZPATRIC
K151725 06/26/2015 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS SUN CHOI
DEN150028 06/19/2015 PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. EDWARD HYLAND
K151696 06/23/2015 Caiman Seal and Cut Technology AESCULAP, INC. Denise Adams
K151722 06/25/2015 Slim UP ULTRA AIME MEDICAL INC PAUL GUILBAUD
K151717 06/25/2015 twion Alber GmbH Bernd Engels
K151464 06/01/2015 Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit ALERE SCARBOROUGH, INC. ANGELA DRYSDALE
K151690 06/23/2015 Alere i Instrument, Alere i Influenza A & B, Alere i Strep A ALERE SCARBOROUGH, INC. Angela Drysdale
K151599 06/12/2015 iSy Implant System Altatec GmbH Colleen Boswell
K151648 06/18/2015 Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System Altus Partners, LLC Claudia Hill
K151585 06/11/2015 Andersen EOGas 4 SteriTest Andersen Sterilizers, Inc. William K Andersen
K151460 06/01/2015 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD. LIU YI
K151724 06/26/2015 AngioDynamics Mariner Angiographic Catheters ANGIODYNAMICS, INC. TERI JUCKETT
K151694 06/23/2015 Gammex PI Hybrid Surgical Gloves ANSELL HEALTHCARE PRODUCTS, LLC Vasudev Dobariya
K151480 06/02/2015 Epix Electrosurgical Probe with Smoke Evacuation APPLIED MEDICAL RESOURCES FRANS VANDENBROEK
K151513 06/04/2015 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow Internation, Inc. (subsidiary of Teleflex Inc.) Tracy Larish
K151732 06/26/2015 Arthrex Fracture Plates ARTHREX, INC. COURTNEY SMITH
K151527 06/08/2015 Arthrex Univers Revers CA Heads and Adapters ARTHREX, INC. COURTNEY SMITH
K151660 06/19/2015 MultiFIX S Knotless Fixation System ArthroCare Corporation Laura Kasperowicz
K151459 06/01/2015 Integra Total Ankle Replacement System Ascension Orthopedics Frederic Testa
K151678 06/22/2015 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K151772 06/30/2015 Actreen Mini Intermittent Urinary Catheters B. BRAUN MEDICAL INC. SIERRA M. MERTZ
K151505 06/04/2015 Coronis Uniti Barco N.V. Franky Dubois
K151742 06/29/2015 Contour Next Control Solution BAYER HEALTHCARE JENNIFER L. GREGORY
K151482 06/02/2015 BCR-30-min BIÖ and RBIP-ST30Ö Readout Accessory BCR DIAGNOSTICS, INC. BORIS ROTMAN
K151489 06/02/2015 Retrieval bag system BEACON SURGICAL, INC. ALLAN ALWARD
K151698 06/24/2015 BD Angiocath IV Catheter, BD Insyte IV Catheter BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. HENRY BOLAND
K151766 06/30/2015 BD Single Use, Hypodermic Syringe BECTON, DICKINSON AND COMPANY MURTAZA RANA
K151589 06/12/2015 BD MAX CT/GC/TV, BD MAX INSTRUMENT BECTON, DICKINSON, AND COMPANY KATIE COYLE
K151469 06/01/2015 CORVUS Radiation Therapy Planning System BEST NOMOS VINEET GUPTA
K151692 06/23/2015 BioArchitects Patient Specific Cranial/Craniofacial Plate BioArchitects USA, LLC Mark E. Ulrich
K151621 06/16/2015 BioHorizons CAD/CAM Abutments BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K151688 06/23/2015 chromID MRSA bioMerieux, Inc. Jewell Coulson
K151615 06/15/2015 TiTHON Staple with OsseoTi Technology BIOMET MANUFACTURING CORP. Patricia Sandborn Beres
K151483 06/02/2015 Biomet Spine Fusion System Biomet Spine LLC. Ted Kuhn
K151603 06/12/2015 Arcos One-piece Femoral Revision System Biomet, Inc. Tracy Johnson
K151744 06/29/2015 Passeo-18 Peripheral Dilation Catheter BIOTRONIK, INC. JON BRUMBAUGH
K151760 06/29/2015 Barricade Embolization Coil System BLOCKADE MEDICAL REBECCA K. PINE
K151610 06/15/2015 Comet Pressure Guidewire BOSTON SCIENTIFIC CORPORATION JAMES KLEINEDLER
K151613 06/15/2015 iLab Polaris Multi-Modality Guidance System BOSTON SCIENTIFIC CORPORATION ARLENE ROCHE
K151516 06/05/2015 Capillus82 Capillus, LLC PATRICIA SCHNOOR
K151635 06/17/2015 CapsoCam (SV-1) CapsoVision, Inc. AZIMUN JAMAL
K151499 06/04/2015 CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor CARETAKER MEDICAL, LLC JEFF POMPEO
K151638 06/17/2015 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter Cathera, Inc. Victor Ham
K151535 06/08/2015 Cavex Cream Alginate CAVEX HOLLAND BV RICHARD WOORTMAN
K151597 06/12/2015 Family of Steam Sterilizers B 28 series CEFLA S.C. SILVIA SANSAVINI
K151565 06/10/2015 Xpert« TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit CEPHEID KERRY J. FLOM
K151672 06/22/2015 Cerner CareAware Event Management CERNER CORPORATION SHELLEY S. LOOBY
K151683 06/22/2015 SleepWeaver Advance Pediatric Nasal CPAP Mask Circadiance, LLC David Groll
K151569 06/10/2015 Tranberg CLS Laser Fiber Clinical Laserthermia Systems AB Lars Erik Eriksson
K151676 06/22/2015 Retracta Detachable Embolization Coil COOK INCORPORATED DAVID LEHR
K151649 06/18/2015 Valleylab FT10 Electrosurgical Platform COVIDIEN Sharon McDermott
K151548 06/09/2015 VersaOne Bladed Trocar, VersaOne Bladeless Trocar COVIDIEN Trang Huynh
K151659 06/19/2015 ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks Covidien LLC Mary Mellows
K151500 06/04/2015 Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) CUSTOM ORTHOPAEDIC SOLUTIONS Peter D O'Neill
K151568 06/10/2015 Arthrex OrthoVis Preoperative Plan Custom Orthopaedic Solutions, Inc. Peter O'Neill
K151501 06/04/2015 OrthoVis Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS,INC. Justin Baker
K151514 06/05/2015 Prestige DANVILLE MATERIALS LLC DONG HUA
K151570 06/10/2015 Carestation 620/650/650C DATEX-OHMEDA, INC. JAMES RASKOB
K151682 06/22/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Daxwell, LLC Frank Zhang
K151496 06/03/2015 Latitude-C Cervical Interbody Spacer System Degen Medical Craig Black
K151525 06/08/2015 Amia Automated PD System with Sharesource DEKA RESEARCH AND DEVELOPMENT ROGER LEROUX
K151619 06/16/2015 Prime&Bond Elect Universal Dental Adhesive DENTSPLY INTERNATIONAL INC. HELEN LEWIS
K151509 06/04/2015 GSI TympStar Pro Middle Ear Analyzer Diagnostic Group, dba Grason-Stadler Ron Rolfsen
K151487 06/02/2015 Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method Diatron US, Inc. Frank Matusazak
K151580 06/11/2015 D.N.E. External Fixation System DNE, LLC NICHOLAS RICCIONE
K151485 06/02/2015 GENESIS DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K151458 06/01/2015 Double Medical Universal Spine System Double Medical Technology Inc DA ZENG
K151693 06/23/2015 Dr-Ho's Foot Pad Electrode DRTV ASIA LTD MICHAEL HO
K151575 06/11/2015 Dynarex Eye Cups DYNAREX CORPORATION JAMES HURLMAN
K151561 06/10/2015 Leksell Gamma Knife Icon ELEKTA INSTRUMENT AB MATILDA FORSBERG
K151666 06/19/2015 Leksell GammaPlan ELEKTA INSTRUMENT AB MATILDA FORSBERG
K151686 06/23/2015 HumanPen Ergo II ELI LILLY AND COMPANY, INC. CHRISTINE A. PHILLIPS
K151540 06/08/2015 MC BIO Supertack Tack 3mm, 4mm and 5mm ELI-KA TECHNOLOGIES LUIGI GIROTTO
K151552 06/09/2015 ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II ELITechGroup Valerie Gourdon
K151594 06/12/2015 Ellipse Supplemental Instrument Trays Ellipse Technologies, Incorporated Cora Sim
K151475 06/02/2015 EndoChoice Select Injection Needle ENDOCHOICE, INC. THERON GOBER
K151567 06/10/2015 ENDOPLUS hand-held laparoscopic instruments ENDOPLUS Matthew Gudeman
K151640 06/18/2015 ELTRAC 471 ENRAF-NONIUS B.V. ANNE-MARIE VAN MAURIK
K151650 06/18/2015 SMARTez elastomeric infusion pump Epic Medical Pte Ltd Freddie Lee
K151668 06/19/2015 S-scan ESAOTE S.P.A. DONATELLA RAGGHIANTI
K151715 06/25/2015 T3 Software Etiometry, Inc. DIMITAR BARONOV
K151479 06/02/2015 EV-820 OTC Pain Relief TENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Robert Tu
K151491 06/03/2015 Falck Medical Multifunction Tonometer, FAT1 FALCK MEDICAL, INC FRANCIS FALCK
K151470 06/01/2015 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
K151473 06/01/2015 NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module FOCUS MEDICAL, LLC. John B Lee
K151662 06/19/2015 iRestore Freedom Laser Therapy, Inc. Craig Nabat
K151474 06/01/2015 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEM U.S.A., INC. MARY MOORE
K151502 06/04/2015 ARCHITECT ROMA Fujirebio Diagnostics, Inc. Diana Dickson
K151674 06/22/2015 Ultraviolet Sun Tanning Lamp G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH MICHAEL ANDERS
K151528 06/08/2015 Powder Free Nitrile (Black) Examination Gloves GALLANT QUALITY SDN. BHD. SUMATHI SARAVANA SAMI
K151503 06/04/2015 NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE GBUK Enteral Limited Mark Thompson
K151541 06/08/2015 G-Fix GC America Inc. Mark Heiss
K151731 06/26/2015 Rainbow Paste Stain GENOSS BYUNGSUN KIM
K151723 06/26/2015 Rainbow Trans GENOSS SANGPIL YOON
K151665 06/19/2015 SUSTAIN Additional Implants GLOBUS MEDICAL INC. KELLY J BAKER
K151504 06/04/2015 ICS Impulse GN OTOMETRICS ANDERS RASMUSSEN
K151587 06/11/2015 Digital Automatic Wrist Blood Pressure Monitor MD3200 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K151583 06/11/2015 Digital Automatic Wrist Blood Pressure Monitor MD3900 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K151478 06/02/2015 Wondfo CR3 Keyless Split Sample Cup GUANGZHOU WONDFO BIOTECH CO., LTD. BEN CHEN
K151463 06/01/2015 Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components HANSEN MEDICAL, INC. Elisa Aldridge
K151730 06/26/2015 Magellan Robotic System HANSEN MEDICAL, INC. TODD MILHOLLAND
K151684 06/22/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K151642 06/18/2015 Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC JIANQIU FANG
K151656 06/19/2015 HEARTWAY Power Mobility Scooter HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K151679 06/22/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) HEZE YUZE GLOVE CO., LTD LILY ZHU
K151689 06/23/2015 MetaNeb 4 System Hill-Rom Services Pte Ltd Huifang Zhu
K151542 06/08/2015 A-Oss HIOSSEN INC. David Kim
K151626 06/17/2015 ET III Bio-SA Fixture System HiOSSEN Inc. David Kim
K151559 06/10/2015 ImmuLisa Enhanced Centromere Antibody ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K151757 06/29/2015 IMMEDIATELOAD Dental Implant System IMMEDIATELOAD S.A. GIOVANNI CANINO
K151771 06/30/2015 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K151740 06/26/2015 JAZZ System Implanet, S.A. Regis Le Couedic
K151576 06/11/2015 Neon EEG Incereb Ltd PAUL PHILLIPS
K151534 06/08/2015 HemosIL D-Dimer HS INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K151616 06/15/2015 AT235 INTERACOUSTICS A/S ERIK NIELSEN
K151564 06/10/2015 Telio CAD Abutment Solutions IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K151468 06/01/2015 ARIX Wrist System Jeil Medical Corporation Jiwon Kang
K151727 06/26/2015 Everest Spinal System K2M, INC NANCY GIEZEN
K151481 06/02/2015 Sahara Stabilization System K2M, INC NANCY GIEZEN
K151721 06/25/2015 FIJI SUN FLUORESCENT TANNING UNIT KDB INC. (DBA) SPERTI SUNLAMP JAMES SHEPERD
K151465 06/01/2015 AeroDR SYSTEM 2 KONICA MINOLTA, INC. SHIGEYUKI KOJIMA
K151750 06/29/2015 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile KOSSAN INTERNATIONAL SDN. BHD. CHO SOW FONG
K151719 06/25/2015 REVE134 KW EAR LAB, INC Sungwoo Cho
K151677 06/22/2015 LnK Cervical Interbody Fusion Cage System L&K BIOMED Co.,Ltd. Yerim An
K151702 06/24/2015 Reusable Full Silicone Cover LAERDAL MEDICAL AS MARI KAADA
K151600 06/12/2015 R-40 EEG Amplifier LIFELINES LTD. Michael Hulin
K151611 06/15/2015 OneTouch Ultra Plus Flex Blood Glucose Monitoring System LIFESCAN EUROPE NIKI SKELLY
K151739 06/26/2015 Revision Femoral Stem LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K151605 06/15/2015 Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves Lucenxia Prescience AG Robert Hill
K151607 06/15/2015 Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Lucenxia Prescience AG Robert Hill
K151644 06/18/2015 Masimo Root Vital Signs Monitoring System and Accessories MASIMO CORPORATION MARGUERITE THOMLINSON
K151593 06/12/2015 Cellvizio 100 Series System with Confocal Miniprobes MAUNA KEA TECHNOLOGIES SOPHIE REHAULT
K151531 06/08/2015 MasterLoc Stem MEDACTA INTERNATIONAL MICHAEL G. LOITERMAN
K151632 06/17/2015 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
K151522 06/05/2015 DEFENDO Bronchoscopy Suction Valve MEDIVATORS, INC. Jeff Kasoff
K151754 06/29/2015 Glide-On Vinyl Examination Gloves MEDLINE INDUSTRIES, INC. Jennifer Mason
K151628 06/17/2015 Medline ENFit Connectors MEDLINE INDUSTRIES, INC. STEPHANIE BLAIR
K151773 06/30/2015 CONCORDE Bullet Lumbar Interbody System Medos International, Sarl JACLYN PORSOLT
K151511 06/04/2015 ROSA Spine MEDTECH S.A. MICHAEL CHRIST
K151758 06/29/2015 ALAR Nasal Valve Stent MEDTRONIC XOMED INC. GABRIELA ANCHONDO
K151532 06/08/2015 KYPHON ELEMENT Inflatable Bone Tamp MEDTRONIC, INC. PAMELA EDWARDS
K151523 06/05/2015 Uncoated Tubing and Connector Components MEDTRONIC, INC. JACQUELINE A. HAUGE
K151768 06/30/2015 Menicon Saline Rinse Solution MENICON CO.,LTD. TOHRU KAWAGUCHI
K151762 06/29/2015 PediatrOS RigidTack/FlexTack MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K151497 06/04/2015 EN Snare Endovascular Snare System MERIT MEDICAL SYSTEMS INC MARK MULLANEY
DEN150029 06/22/2015 Permaseal MICRO INTERVENTIONAL DEVICES, INC. LINDA MORGAN
K151671 06/22/2015 Disposable Multistage Dilation Balloon Catheter MICRO-TECH (NANJING) CO., LTD. BECK LI
K151543 06/08/2015 Graft Delivery Device with Integrated Stylet Micromedics Inc. (d/b/a Nordson Medical) Amy L Peterson
K151763 06/29/2015 PerioLase Nd:YAG Pulsed Dental Laser System MILLENNIUM DENTAL TECHNOLOGIES, INC. DAVID M HARRIS
K151536 06/08/2015 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm MRI INTERVENTIONS, INC. E F WADDELL
K151557 06/10/2015 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine NANTONG EGENS BIOTECH CO., LTD. BEN CHEN
K151476 06/02/2015 Beactive Brace NATURES PILLOWS, INC. WILLIAM McALISTER
K151609 06/15/2015 ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 NDS SURGICAL IMAGING LLC Jim Leng
K151558 06/10/2015 Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System NEUROTHERAPIES RESET GMBH. MICHAEL PELHAM MORRIS OLIVE
K151706 06/24/2015 Specular Microscope CEM- 530 NIDEK CO., LTD. YONEJI MIZUNO
K151654 06/18/2015 PROW FUSION NLT SPINE LTD Eti Zinger
K151708 06/24/2015 RECON system - Compression Screws NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151701 06/24/2015 Tenodesis screw system NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151472 06/01/2015 NuVasive CoRoent Lumbar System NuVasive, Incorporated Martin A Yahiro
K151538 06/08/2015 NuVasive PEEK Corpectomy Railed System NuVasive, Incorporated Olga Lewis
K151651 06/18/2015 NuVasive X-CORE Mini Cervical Expandable VBR System NUVASIVE, INCORPORATED Olga Lewis
K151571 06/10/2015 Mini Needle OCUJET, LLC REBECCA K. PINE
K151738 06/26/2015 Single Use Aspiration Needle NA-U200H OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K151743 06/29/2015 THUNDERBEAT Open Fine Jaw OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K151737 06/26/2015 MedicVOD System Orpheus Medical Ltd. Asaf Omer
K151488 06/02/2015 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Orthofix, Inc. Jacki Geren
K151746 06/29/2015 Dyevert Contrast Modulation System OSPREY MEDICAL, INC. MELANIE HESS
K151553 06/09/2015 Anterior Cervical Plate System Osteomed Implantes, LTDA J.D. WEBB
K151608 06/15/2015 4plus6Line Abutment System OT MEDICAL GMBH Martina Behlau
K151466 06/01/2015 MrOpen Paramed S.r.l. Luisella De Benedetti
K151518 06/05/2015 BRUSH&BOND PLUS Parkell, Inc. David Mott
K151572 06/11/2015 Penumbra Smart Coil PENUMBRA, INC. CHARLES DENAULT
K151623 06/16/2015 Penumbra System 110 Aspiration Tubing Penumbra, Inc. Michaela Mahl
K151604 06/15/2015 23ga Chandelier Illuminator, 25ga Chandelier Illuminator PEREGRINE SURGICAL LTD. RYAN O'LEARY
K151598 06/12/2015 VesselNavigator Rel. 1.0 PHILIPS MEDICAL SYSTEMS NEDERLAND BV LISELOTTE KORNMANN
K151736 06/26/2015 Philips IntelliVue GuardianSoftware PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH MICHAEL ASMALSKY
K151681 06/22/2015 IntelliVue Patient Monitor PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH JOHANNES SCHMID
K151761 06/29/2015 SureSigns VS3, SureSigns VS4 PHILLIPS MEDICAL SYSTEMS Greg Li
K151658 06/19/2015 Gmate Origin Blood Glucose Monitoring System Philosys Inc. LINDA CHAN
K151521 06/05/2015 Phoenix Thera-Lase System PHOENIX THERA-LASE SYSTEMS, LLC GARY BELLINGER
K151562 06/10/2015 Resultz Lice & Egg Removal Kit Piedmont Pharmaceuticals, LLC Kathleen G. Palma
K151630 06/17/2015 G.o.c.c.l.e.s. PIERREL PHARMA S.R.L. FABIO VELOTTI
K151461 06/01/2015 Hybernite RT PLASTIFLEX GROUP NV RAF VAN ROY
K151530 06/08/2015 CardioChek Plus Test System POLYMER TECHNOLOGY SYSTEMS, INC. Megan Burns
K151545 06/09/2015 CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K151728 06/26/2015 CoStorSol plus G PRESERVATION SOLUTIONS, INC. GARY SWANSON
K151584 06/11/2015 AttraX Putty PROGENTIX ORTHOBIOLOGY B.V. YVONNE P. BOVELL
K151646 06/18/2015 ProTech Plus PROTECH PROFESSIONAL PRODUCTS, INC. ADAM BLOCH
K151620 06/16/2015 Firefly Peritoneal Dialysis Connector Disinfection System PURACATH MEDICAL, INC. JOHN ASHLEY
K151709 06/24/2015 Hi-Light Diagnostic Ultrasound Systems Qingdao Hisense Medical Equipment Co., Ltd. Wang Wei
K151612 06/15/2015 NewTom VGi evo QR S.r.l. LORENZO BORTOLOTTI
K151753 06/29/2015 16 ch Tx/Rx Knee SPEEDER Quality Electrodynamics, LLC Kathleen Aras
K151629 06/17/2015 Guardian 1000 Quanta System SpA Francesco Dell'Antonio
K151492 06/03/2015 Kudu R82 A/S Kent Rasmussen
K151707 06/24/2015 EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i RAYENCE CO., LTD KEVIN KIM
K151661 06/19/2015 Renovo Life Hard Carbon Coated Drill Bit Renovo Life LLC Harold Crowder
K151578 06/11/2015 Carbamazepine Gen 4 Roche Diagnostics Operations (RDO) David Tribbett
K151756 06/29/2015 STERISPINE LC CAGE SAFE ORTHOPAEDICS Pierre Dumouchel
K151747 06/29/2015 STERISPINE PS SAFE ORTHOPAEDICS Pierre Dumouchel
K151506 06/04/2015 Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula Salter Labs Mara Caler
K151685 06/22/2015 GUA60A, GU60A-65 SAMSUNG ELECTRONICS CO., LTD. Chulsin Kim
K151663 06/19/2015 RS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. KYEONG-MI PAK
K151639 06/18/2015 ABL80 FLEX and ABL80 FLEX CO-OX SENDX MEDICAL INC VIBEKE AGERLIN
K151745 06/29/2015 FULL CARE Disposable PVC Nelaton Catheter SHAOXING FUQING HEALTH PRODUCTS CO., LTD. DEAN WU
K151653 06/18/2015 8ch Foot Ankle Coil SHENZHEN RFTECH CO., LTD. KE XI
K151699 06/24/2015 BEAUTIFIL II Enamel SHOFU DENTAL CORPORATION Mauro Malyzyner
K151700 06/24/2015 BEAUTIFIL II Gingiva SHOFU DENTAL CORPORATION MAURO MALZYNER
K151718 06/25/2015 iFuse Implant System SI-BONE, INC. ROXANNE DUBOIS
K151462 06/01/2015 SI-TECHNOLOGY« SI-DESIS« SCREWS SI-TECHNOLOGY, LLC CHRIS DONNER
K151529 06/08/2015 Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. JULIE WARREN
K151767 06/30/2015 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
K151486 06/02/2015 Biograph mCT and mCT Flow PET/CT Scanners Siemens Medical Solutions USA, Inc. ALAINE MEDIO
K151579 06/11/2015 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151645 06/18/2015 MAMMOMAT Fusion Siemens Medical Solutions USA, Inc. Darren Dorman
K151752 06/29/2015 SOMATOM Emotion 6/16 Siemens Medical Solutions USA, Inc. Eve Davis
K151765 06/30/2015 SOMATOM Perspective SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K151749 06/29/2015 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc. Eve Davis
K151704 06/24/2015 Diplomat« Spinal System SIGNUS Medizintechnik GmbH Jochim Schneider
K151560 06/10/2015 QuickPlan Siris Medical Colin M Carpenter
K151512 06/04/2015 Star 60 SKANRAY TECHNOLOGIES PRIVATE LIMITED MAHADEVAN J
K151713 06/25/2015 LILLIPUP PMP, LILLIPUT PMP INTEGRATED SORIN GROUP ITALIA S.R.L. LUIGI VECCHI
K151637 06/17/2015 UPT Series Medical RO Water System Specialty Water Technologies Alex Clark
K151770 06/30/2015 Libra Pedicle Screw System Spinal Balance Inc. Anand Agarwal
K151705 06/24/2015 Lotus Posterior Cervical/Thoracic Spinal System SPINAL ELEMENTS, INC. CECILIA SILVA
K151741 06/26/2015 HA Minuteman G3 MIS Fusion Plate SPINAL SIMPLICITY LLC JULIE MCKEE
K151581 06/11/2015 Leva Spacer System SPINE WAVE, INC. GAIL YAEKER-DAUNIS
K151695 06/23/2015 Romeo posterior osteosynthesis system SPINEART FRANCK PENNESI
K151710 06/24/2015 SNaP Wound Care System SPIRACUR, INC. LAWRENCE HU
K151622 06/16/2015 St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electroph St. Jude Medical Maria Obreztchikova
K151590 06/12/2015 Straumann RN Gold Abutment for Bridge STRAUMANN USA, LLC CHRISTOPHER KLACZYK
K151667 06/19/2015 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm Stryker Rhoda M Santos
K151726 06/26/2015 AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer Stryker Corporation Garry T Hayeck
K151755 06/29/2015 OASYS(r) System Stryker Corporation Garry T Hayeck
K151769 06/30/2015 Anchorage 2 CP System STRYKER GMBH KURDEA LYON
K151520 06/05/2015 Oscar 2 SunTech Medical, Inc. Charles Setzer
K151680 06/22/2015 Powder Free Nitrile Patient Examination Gloves, Blue Color SUQIAN XINGYE GLOVE CO, LTD JIAN ZHONG-DENG
K151617 06/15/2015 Livewire Electrophysiology Catheter SURGICAL INSTRUMENT SERVICE AND SAVINGS INC (DBA MEDLINE REN BRANDI J. PANTELEON
K151592 06/12/2015 Gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. Xue Fang Zhou
K151526 06/08/2015 Zone, ZoneFree, Zone A1 SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K151655 06/18/2015 CO2RE System SYNERON MEDICAL LTD. Ruthie Amir
K151588 06/11/2015 maxFit II Dental Implant System Taiwan Implant Technology Company, Ltd. Ching-Chieh Huang
K151471 06/01/2015 Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation Phebe Varghese
K151759 06/29/2015 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
K151508 06/04/2015 IRENE Locking Compression Plate System TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD YIFAN FU
K151596 06/12/2015 Endoskeleton TCS Interbody Fusion Device TITAN SPINE, LLC JANE RODD
K151673 06/22/2015 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K151735 06/26/2015 TriMed Humeral Supracondylar Fixation System TriMed, Inc. Michael Capellan
K151647 06/18/2015 Uberlube UBERLUBE LLC JACK MAGNUSEN
K151533 06/08/2015 Respiratory Gating for Scanners VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151657 06/19/2015 Shielded Applicator Set, Cervical Stop VARIAN MEDICAL SYSTEMS, INC PETER J. CORONADO
K151456 06/01/2015 Small Bone Nail Implant VILEX IN TENNESSEE, INC SYLVIA SOUTHARD
K151714 06/25/2015 Disposable Endoscope Valves Set A WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED LIJUAN ZHANG
K151733 06/26/2015 Xenco Medical Pedicle Screw System Xenco Medical, LLC GUSTAVO PRADO
K151601 06/12/2015 SECURE-LOOP XIROS LTD STEPHEN SEED
K151764 06/30/2015 YAMAHACHI PMMA DISKS YAMAHACHI DENTAL PRODUCTS USA, INC. LAWRENCE G. GREENWALD
K151586 06/11/2015 Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K151498 06/04/2015 Breathing circuit bacterial/viral filter ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. HU JUBIN
K151716 06/25/2015 Cable-Ready Cable Grip System: Cable-Ready Bone Plate System ZIMMER, INC. Patrick McCullagh
K151490 06/03/2015 PRETTAU ANTERIOR T0 ZIRKONZAHN GMBH HEINRICH STEGER


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