FDA 510(k) Applications Received During December, 2016

FDA 510(k) Number Submission Date Device Name Applicant Contact
K163689 12/28/2016 3M Clear Tray Aligner 3M Unitek Corporation Yanine Garcia-Quezada
K163677 12/27/2016 Ortho System 3Shape A/S Hanne Nielsen
K163683 12/28/2016 A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor A&D COMPANY, LTD JERRY WANG
K163629 12/22/2016 Audit MicroControls Linearity FD Tumor Markers II Aalto Scientific, Ltd. Robert Burda
K163709 12/30/2016 FIRMap Catheter ABBOTT ELECTROPHYSIOLOGY DENNIS POZZO
K163406 12/05/2016 Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System ACON LABORATORIES INC. QIYI XIE
K163451 12/08/2016 Action Trackstander models TR1816, TR1820, TR2016, and TR2020 Action Manufacturing Inc. Alan Macht
K163593 12/21/2016 Additive Orthopaedics Bunion System Additive Orthopaedics, LLC. Gregory Kowalczyk
K163485 12/12/2016 SmartTouch Adherium (NZ) Ltd CHRIS MANDER
K163598 12/21/2016 Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek Heat-Seal Pouches with STERRAD Chemical Indicator ADVANCED STERILIZATION PRODUCTS NAZANIN YACOBI
K163551 12/19/2016 LenSx Laser System Alcon Laboratories, Inc. James Arganda
K163699 12/29/2016 ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook ALN Implants Chirurgicaux Alain Nigon
K163664 12/27/2016 Health-e-Connect System with IDA ALR TECHNOLOGIES SIDNEY CHAN
K163580 12/20/2016 ASD Oral Appliances AMERICAN SLEEP DENTISTRY RYAN GREGERSON
K163513 12/15/2016 Arrow Endurance Extended Dwell Peripheral Catheter System Arrow International, Inc. (subsidiary of Teleflex Inc.) Fallon Young
K163426 12/06/2016 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension ASAHI INTECC CO., LTD. Yasuyuki Kawahara
K163481 12/12/2016 HALF DOME Posterior Lumbar Interbody System Astura Medical Troy Taylor
K163408 12/05/2016 Isolator Multifunctional Linear Pen AtriCure Inc. Melissa Smallwood
K163529 12/16/2016 ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm) AVERY DENNISON CORPORATION LISA BARTAKOVICS
K163446 12/08/2016 AxoGen Nerve Cap AxoGen Corporation Mark L. Friedman
K163430 12/07/2016 Prontosan Wound Gel B. Braun Medical, Inc. Nancy Skocypec
K163420 12/06/2016 UltraScore Focused Force PTA Balloon BARD PERIPHERAL VASCULAR, INC. TIMOTHY WADE
K163530 12/16/2016 PrisMax Control Unit BAXTER HEALTHCARE CORP Chris Scavotto
K163591 12/20/2016 BD PosiFlush Heparin Lock Flush Syringe Becton Dickinson and Company Aakash Jain
K163637 12/23/2016 BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL) BECTON, DICKINSON & COMPANY MONICA E. GIGUERE
K163429 12/07/2016 B6 Beijing East Whale Imaging Technology Co., Ltd Sharon Fan
K163638 12/23/2016 Dental 5 Multi Diode laser BIO-MED USA INC YOUNG CHI
K163502 12/14/2016 iSR'obot Biopsy Kit Biobot Surgical Pte Ltd Lai Chee LIEW
K163467 12/12/2016 C-Line Orthodontic Ceramic Bracket BIOCETEC CO., LTD DAVE KIM
K163395 12/05/2016 Astroglide Diamond Silicone Gel Personal Lubricant BioFilm, Inc. Richard Hines
K163563 12/19/2016 VITEK 2 AST-GN Gentamicin (<=1 û >=16 ?g/mL) bioMerieux, Inc Cherece L. Jones
K163651 12/23/2016 ExpressBraid Graft Manipulation Biomet Manufacturing Corp. Vinay Bhal
K163627 12/22/2016 Shotel Ankle Arthrodesis Nail System BioPro, Inc. Dave Mrak
K163608 12/21/2016 HAART 300 Aortic Annuloplasty Device 19mm, HAART 300 Aortic Annuloplasty Device 21mm, HAART 300 Aortic Annuloplasty Device 23mm, HAART 300 Aortic Annuloplasty Device 25mm BioStable Science & Engineering Inc. Julie Thomas
K163660 12/27/2016 Pantera LEO BIOTRONIK, INC. Jon Brumbaugh
K163464 12/09/2016 Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) BMC MEDICAL.,LTD. Jiang Huiqi
K163622 12/22/2016 Lung Vision BODY VISION MEDICAL LTD. DORIAN AVERBUCH
K163700 12/29/2016 Bodycad Unicompartmental Knee System Bodycad Laboratories, Inc. Marc Chaunet
K163701 12/29/2016 Direxion and Direxion HI-FLO Torqueable Microcatheters BOSTON SCIENTIFIC CORPORATION LIZ JOHNSTON
K163399 12/05/2016 Tria Firm Ureteral Stent Boston Scientific Corporation Christine Shoemaker
K163536 12/16/2016 MALDI Biotyper CA (MBT-CA) System, MBT smart CA System BRUKER DALTONIK GMBH MARKUS KOSTRZEWA
K163510 12/15/2016 Poseidon Ultrasound System BUTTERFLY NETWORK, INC. BRIAN SAWIN
K163437 12/07/2016 hypodermic PinpointÖ GT Needle C. R. Bard, Inc. Jamie Howell
K163458 12/09/2016 Zenysis Short-Term Dialysis Catheter C.R BARD. INC. SILVIA DE LA BARRA
K163698 12/29/2016 OptiFix Open Absorbable Fixation System - 20 absorbable fasteners C.R. BARD INC, KATHERINE EARLE
K163684 12/28/2016 C2 CryoBalloon Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K163380 12/01/2016 Serranator Alto PTA Serration Balloon Catheter Cagent Vascular, LLC Carol Burns
K163615 12/22/2016 Snowden-Pencer MicroLap 3mm Laparoscopic Instruments CareFusion 2200 Inc Jane Weber
K163570 12/19/2016 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) Carolina Liquid Chemistries Corporation Mica A. Welsh
K163519 12/15/2016 RX DC CEFLA SC BORTOLOTTI LORENZO
K163439 12/08/2016 NaviENT ClaroNav Inc. Ahmad Kolahi
K163468 12/12/2016 Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered Cook Ireland Ltd. Jacinta Kilmartin
K163385 12/02/2016 Cortex Dental Implant System Cortex Dental Implants Industries Ltd. Michal Yeger
K163480 12/12/2016 Renamel NANO +plus Cosmedent, Inc Hiren Patel
K163556 12/19/2016 MediClear PreOp COVALON TECHNOLOGIES, INC. KIM CROOKS
K163620 12/22/2016 Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Covidien Nicole Genco
K163537 12/16/2016 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga Covidien llc LeeAnne Swiridow
K163654 12/23/2016 VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar Covidien llc Gary LeMere
K163552 12/19/2016 iPulse SmoothSkin BARE Hair Removal Device CYDEN LIMITED MIKE KIERNAN
K163542 12/16/2016 CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case Datascope Corp. Helder A. Sousa
K163714 12/30/2016 OSSIX BONE Datum Dental Ltd Arie Goldlust
K163605 12/21/2016 LEDEX WL070+ DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K163398 12/05/2016 ATLANTIS suprastructures Dentsply Sirona Karl Nittinger
K163418 12/06/2016 Diazyme DZ-Lite Total beta-hCG Test System Diazyme Laboratories Abhijit Datta
K163535 12/16/2016 my Patch sl DMS-SERVICE LLC LYNDA COLE
K163668 12/27/2016 SUITESTENSA EBIT srl Marco Fruscione
K163693 12/28/2016 IntraClude Intra-Aortic Occlusion Device Edwards Lifesciences LLC Lisa G. Hessabi
K163381 12/01/2016 HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable Edwards Lifesciences, LLC Chirag Shah
K163617 12/22/2016 REMbrandt Embla Systems Shane T Sawall
K163497 12/13/2016 EXPRTÖ Revision Hip System - EXPRTÖ Hip Distal Stem, EXPRTÖ Hip Standard Offset Proximal Body Implant, EXPRTÖ Hip Lateral Offset Proximal Body Implant, EXPRTÖ Hip Capture Bolt ENCORE MEDICAL, L.P. Teffany Hutto
K163541 12/16/2016 Magseed Magnetic Marker System ENDOMAGNETICS LTD ANDREW SHAWCROSS
K163435 12/07/2016 Entellus Medical Reinforced Anesthesia Needle Entellus Medical Inc. Megan Bernier
K163509 12/15/2016 XprESS ENT Dilation System Entellus Medical, Inc. Karen E. Peterson
K163523 12/15/2016 ECHELON CIRCULAR Powered Stapler Ethicon Endo-Surgery, LLC Carmen Ortiz
K163454 12/09/2016 ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm ETHICON ENDO-SURGERY, LLC Carmen Ortiz
K163548 12/16/2016 ENSEAL X1 Large Jaw Tissue Sealer Ethicon Endo-Surgery, LLC Marjorie Medina
K163645 12/23/2016 DERMABOND PRINEO Skin Closure System Ethicon, LLC Joice Pappan
K163539 12/16/2016 Ez3D-i / E3 EWOO SOFT Co., Ltd. Young Seok Kim
K163533 12/16/2016 EzDent-i; E2; ProraView EWOO SOFT CO., LTD. YOUNG SEOK KIM
K163524 12/15/2016 Vessel Dilator Fetzer Medical GmbH & Co. KG Harald Jung
K163416 12/05/2016 Fiagon Navigation û PointerTube Straight and PointerTube Keat FIAGON GMBH DIRK MUCHA
K163440 12/08/2016 Stealth Staple System FIRST RAY LLC ROBERT HOY
K163710 12/30/2016 BePOD« EZ Weil Screws Fournitures Hospitalieres Industrie Patricia Donnard
K163675 12/27/2016 Processor VP-7000, Light Source BL-7000 FUJIFILM Medical System U.S.A., Inc. Shraddha S More
K163624 12/22/2016 Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) FUJIFILM Medical Systems U.S.A., Inc. Dharaben Desai
K163521 12/15/2016 Lumipulse G LH Calibrators FUJIREBIO DIAGNOSTICS, INC DIANA DICKSON
K163534 12/16/2016 Lumipulse G FSH-N Calibrators Fujirebio Diagnostics, Inc. Diana Dickerson
K163546 12/16/2016 Lumipulse G Progesterone-N Calibrators Fujirebio Diagnostics, Inc. Stacey Dolan
K163544 12/16/2016 Lumipulse G Prolactin FUJIREBIO DIAGNOSTICS, INC. STACEY DOLAN
K163669 12/27/2016 Humeris Shoulder Fx Solutions Jean-Jacques Martin
K163507 12/14/2016 Triton Sponge System Gauss Surgical, Inc. Artie Kaushik
K163596 12/21/2016 LOGIQ P9 and LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K163619 12/22/2016 SIGNA PET/MR GE Medical Systems, LLC Janice M. Sich
K163652 12/23/2016 ePlex Instrument GenMark Diagnostics, Incorporated Alan Maderazo
K163636 12/22/2016 ePlex Respiratory Pathogen Panel GENMARK DIAGNOSTICS, INCORPORATED ALAN MADERAZO
K163412 12/05/2016 Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) Girgis Scope LLC Madgy S. Girgis
K163648 12/23/2016 Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 Series Grandway Technology (Shenzhen) Limited Patrick Chow
K163679 12/27/2016 Digital Automatic Blood Pressure Monitor MD3600 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K163571 12/19/2016 Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc. Suzette Chance
K163383 12/01/2016 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System GREENS SURGICALS PVT. LTD. Vinay Kumar
K163436 12/07/2016 Greiner Vacuette Urine Count and Culture, Mannitol tube GREINER BIO-ONE NA INC. MANFRED ABEL
K163603 12/21/2016 Digital Thermometer Guangzhou Jinxinbao Electronic Co., Ltd Mowu Zhu
K163611 12/22/2016 Pain Therapy Device Guangzhou Xinbo Electronic Co., Ltd. Sammy Li
K163373 12/01/2016 PK AIM Gyrus ACMI Inc. Graham A.L. Baillie
K163550 12/19/2016 Pobling MIITY 2 HABALAN MED & BEAUTY CO.,LTD RAY JEON
K163461 12/09/2016 Coolief* Cooled RF Probe Halyard Health, Inc. Monica King
K163704 12/29/2016 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card HEALGEN SCIENTIFIC LLC Jianqiu Fang
K163667 12/27/2016 RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) HEALTH BEACONS, INC. NANCY CONFREY
K163553 12/19/2016 Powder Free Nitrile Patient Examination Gloves, Blue HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD. Shaozhang Nan
K163394 12/05/2016 Hybrid3D Hermes Medical Solutions AB Joakim Arwidson
K163687 12/28/2016 OLINDA EXM Hermes Medical Solutions AB Joakim Arwidson
K163393 12/02/2016 Hi-Dow Wireless TENS/EMS System (Model HD-SN) Hi-Dow International, Inc. Eric Chen
K163378 12/01/2016 Monarch Airway Clearance System HILL-ROM SERVICES PTE LTD Huifang Zhu
K163528 12/16/2016 HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. Doug Thistlethwaite
K163505 12/14/2016 ARIETTA PRECISION HITACHI, LTD ANGELA VAN ARSDALE
K163486 12/12/2016 DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Tak· Plates, DuoTak· Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates HNM Total Recon, LLC Noah Roitman
K163623 12/22/2016 Quantra HOLOGIC, INC. Neil Kelly
K163449 12/08/2016 HyPHo Laser System Hyper Photonics SRL Isabella Carrer
K163659 12/27/2016 Crystal Vision I.C MEDICAL, INC. ELENA S. BUIGA
K163390 12/02/2016 iC-GPC Assay TM for use on the iC-SystemTM iCubate, Inc Carter Wells
DEN160062 12/28/2016 IlluminOss Bone Stabilization System IllminOss Medical, Inc. Fred Tobia
K163554 12/19/2016 hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test Immunostics, Inc. Antoinette Prusik
K163465 12/12/2016 hemochroma PLUS System IMMUNOSTICS, INC. ANTOINETTE PRUSIK
K163577 12/20/2016 Ecofit« Hip System Implantcast GmbH Juliane Hoeppner
K163549 12/16/2016 ClotTriever Thrombectomy System Inari Medical, Inc. Eben Gordon
K163560 12/19/2016 Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative Health, LLC. Rafal Chudzik
K163525 12/15/2016 QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls Inova Diagnostics, Inc. Peter Martis
K163538 12/16/2016 QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls INOVA DIAGNOSTICS, INC. ROGER ALBESA
K163456 12/09/2016 DuraGen Secure Dural Regeneration Matrix INTEGRA LIFESCIENCES CORPORATION YARA HAMID
K163457 12/09/2016 NeuraGen 3D Nerve Guide Matrix Integra LifeSciences Corporation Gabriella Green
K163443 12/08/2016 Interson USB Ultrasound System Interson Corporation David Asarnow
K163488 12/12/2016 Flex-Thread Clavicle Pin System INTRAFUSE LLC Robert Hoy
K163500 12/13/2016 IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Ion Beam Applications S.A. Anne-Sophie Grell
K163512 12/15/2016 Zio AT ECG Monitoring System IRHYTHM TECHNOLOGIES, INC. RICH LAGUNA
K163613 12/22/2016 Bluephase Style 20i IVOCLAR VIVADENT, AG SANDRA CAKEBREAD
K163628 12/22/2016 Idylla Respiratory (IFV-RSV) Panel JANSSEN PHARMACEUTICA NV SARAH PARSONS
K163518 12/15/2016 Digital Thermometer JOYTECH HEALTHCARE CO., LTD Ren Yunhua
K163471 12/12/2016 Kalitec Direct InSePtionÖ MIS Fixation System KALITEC DIRECT, LLC KEITH CANNAN
K163479 12/12/2016 R2P Metacross RX KANEKA CORPORATION TOSHIHIKO MOTOMINE
K163372 12/01/2016 RX Takeru Balloon Dilatation Catheter KANEKA CORPORATION Toshihiko Motomine
K163632 12/22/2016 Katalyst Cyclophotocoagulation Probe Katalyst Surgical, LLC Meryl Koch
K163516 12/15/2016 Braun No Touch + Forehead NTF3000 Thermometer Kaz USA, Inc., a Helen of Troy Company Rajesh Kasbekar
K163386 12/02/2016 Keos Lumbar IBFD Keos Mark F Schenk
K163405 12/05/2016 360KS Implant Positioning System Kico Knee Innovation Company PTY Limited Karl Rentsch
K163579 12/20/2016 KLS Martin Individual Patient Solutions KLS Martin LP Jennifer Damato
K163482 12/12/2016 Orthodontic Acrylic 2 Lang Dental Manufacturing Co., Inc. Dave Lang
K163647 12/23/2016 Revolve Envi 600 Advanced Adipose System LifeCell Corporation Anuja Yardi
K163397 12/05/2016 SMR Hybrid Glenoid System Limacorporate S.p.A. Michela Zanotto
K163517 12/15/2016 Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 ?g/mL LIOFILCHEM S.R.L. FABIO BROCCO
K163639 12/23/2016 LS-5 ePTFE Suture LSI SOLUTIONS Kevin Bentley
K163626 12/22/2016 ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit Luminex Corporation Kate Linak
K163572 12/19/2016 LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source LV Liberty Vision Corp. Paul T. Finger
K163522 12/15/2016 FilmArray Warrior Control Panel M290 Maine Molecular Quality Controls, Inc. Joan Gordon
K163498 12/13/2016 VALIDATE Heparin Calibration Verification/Linearity Test Kit MAINE STANDARDS COMPANY, LLC JAMES CHAMPLIN
K163643 12/23/2016 SIRIO H3 MASMEC SPA Domenico Marino
K163595 12/21/2016 IMPIX 3D Print Cages MEDICREA INTERNATIONAL S.A. David Ryan
K163688 12/28/2016 Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 MEDISONO, LLC JORGE MILLAN
K163401 12/05/2016 Nix Ultra Lice Treatment Kit MEDTECH PRODUCTS INC. JEAN BOYKO
K163565 12/19/2016 MR8 Drill System MEDTRONIC POWERED SURGICAL SOLUTIONS Deep Pal
K163581 12/20/2016 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments MEDTRONIC SOFAMOR DANEK USA, INC LAVEEDA LEFLORE
K163375 12/01/2016 INFINITYÖ OCT System Medtronic Sofamor Danek USA, Inc. Tejas Patel
K163460 12/09/2016 Reveal LINQ Insertable Cardiac Monitor MEDTRONIC,INC. Laura Danielson
K163575 12/19/2016 Inqwire Diagnostic Guide Wire Merit Medical Systems, Inc. Mark Mullaney
K163597 12/21/2016 VacLok AT Vacuum Syringe Merit Medical Systems, Inc. Angela Brady
K163578 12/20/2016 EasyTouch Safety Pen Needle MHC Medical Products, LLC. John Edmiston
K163376 12/01/2016 Mikro-Cath Pressure Catheter Millar, Inc. Jacqueline Jean-Baptiste
K163442 12/08/2016 Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft) Modern Medical Equipment Manufacturing Limited Thomas Tsz Fung Chan
K163696 12/29/2016 SleepImage System MyCardio, LLC dba SleepImage. Robert Schueppert
K163402 12/05/2016 NLZ Motor System NAKANISHI INC. Kimihiko Satoh
K163483 12/12/2016 PANA SPRAY Plus NAKANISHI, INC. Kimihiko Satoh
K163414 12/05/2016 Ultrasonic scaler NANNING VV DENTAL CO., LTD. Liang chaojun
K163672 12/27/2016 Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor NANOVA BIOMATERIALS, INC. ANDREW RITTS
K163425 12/06/2016 NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System NARANG MEDICAL USA CORPORATION Reginald Swift
K163452 12/09/2016 PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc. Robin Fuller
K163674 12/27/2016 Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry NEO COSMETIQUE NATHALIE VERNIN
K163526 12/16/2016 BilicocoonÖ Phototherapy System NEOMEDLIGHT Pierre Saint Girons
K163547 12/16/2016 MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 NEUROVIRTUAL USA, INC. Eduardo Faria
K163564 12/19/2016 SLIT LAMP SL-2000 NIDEK CO., LTD. Yoneji Mizuno
K163644 12/23/2016 Nihon Kohden QP-160AK EEG Trend Program Nihon Kohden Corporation Tom Bento
K163459 12/09/2016 Nihon Kohden Vital Sign Telemeter Nihon Kohden Corporation Tom Bento
K163600 12/21/2016 Kit Boxes and Kit Plates Nobel Biocare AB Charlemagne Chua
K163490 12/12/2016 StatStrip Xpress 2 Glucose Hospital Meter System Nova Biomedical Corporation Paul W. MacDonald
K163491 12/12/2016 NuVasive CoRoent Small Interbody System NuVasive, Incorporated Martin Yahiro
K163707 12/29/2016 NuVasive CoRoent Ti-C System NuVasive, Incorporated Cynthia Adams
K163469 12/12/2016 ViziShot 2 FLEX Olympus Surgical Technologies America Mary Anne Patella
K163475 12/12/2016 iVue Optovue, Inc. Edward J. Sinclair
K163566 12/19/2016 Hubble I System Orbbo Surgical, LLC. Eric Garofano
K163602 12/21/2016 Kepler I Cervical Plate System Orbbo Surgical, LLC. Eric Garofano
K163379 12/01/2016 KneeAlign 2 System OrthAlign, Inc. David Vancelette
K163433 12/07/2016 VITROS Chemistry Products GLU Slides Ortho Clinical Diagnostics Darlene J. Phillips
K163489 12/12/2016 OrthoSolutions 'System26' Bone Screws Ortho SOlutions UK Limited Craig Bluett
K163621 12/22/2016 Vitoss Bioactive (BA) Injectable Orthovita, Inc. John Rossman
K163557 12/19/2016 SS SA Fixture OSSTEM IMPLANT Co., Ltd. Mr. HeeKwon
K163382 12/01/2016 Oxitone 1000 Oxitone Medical Ltd. Leon Eisen
K163609 12/22/2016 Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet) PALL INTERNATIONAL SARL Karen Peterson-Doyle
K163423 12/06/2016 Orthopantomograph OP300 PaloDEx Group Oy Eric Schwandt
K163484 12/12/2016 Paxman Scalp Cooler Paxman Coolers Limited Richard PAXMAN
K163432 12/07/2016 Stellar LEAP PDG Product Design Group, Inc Torr Brown
K163614 12/22/2016 PENTAX Medical ED34-i10T, Video Duodenoscope PENTAX Medical Kanchana Iyer
K163618 12/22/2016 INDIGO Aspiration System PENUMBRA, INC. RICHARD KIMURA
K163370 12/01/2016 ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE PHADIA AB Carina Magnusson
K163410 12/05/2016 DigitalDiagnost C50 PHILIPS HEALTHCARE (SUZHOU) CO., LTD. ALINA ZHOU
K163584 12/20/2016 M3290B Philips IntelliVue Information Center iX Philips Medical Systems Theresa Poole
K163649 12/23/2016 SureSigns VS3; SureSigns VS4 Philips Medical Systems Greg Li
K163711 12/30/2016 IQon Spectral CT Philips Medical Systems (Cleveland), Inc. Steven Goldberg
DEN160056 12/01/2016 Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. Esther Abels
K163715 12/30/2016 Allura Xper R9 PHILIPS MEDICAL SYSTEMS NEDERLAND BV JEANETTE BECKER
K163473 12/12/2016 Upper Arm Blood Pressure Monitor Portal 724, LLC George Oneid
K163447 12/08/2016 Premium Plus Disposable Barrier Sleeve PREMIUM PLUS INTERNATIONAL LIMITED JESSICA MAO
K163374 12/01/2016 ALLYÖ Facet Screws PROVIDENCE MEDICAL TECHNOLOGY, INC. MARGARET WONG
K163474 12/12/2016 CAVUX CervicalCage-L SA System PROVIDENCE MEDICAL TECHNOLOGY, INC. EDWARD LIOU
K163590 12/20/2016 Psychemedics Microplate EIA for Benzodiazepines in Hair Psychemedics Corporation Virginia Hill
K163708 12/29/2016 QiF Blood and Fluid Warmer Quality In Flow Ltd. Neta Sherman
K163713 12/30/2016 Sofia Lyme FIA, Sofia Lyme Control Set Quidel Corporation Jennifer S Rial
K163462 12/09/2016 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX Radiometer Medical ApS Per Pape Thomsen
K163661 12/27/2016 P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil RAPID Biomedical GmbH Christian Zimmermann
K163666 12/27/2016 neuro inspire Rensihaw plc Roberto Liddi
K163585 12/20/2016 Responsive Orthopedics Total Hip Arthroplasty System Responsive Orthopedics, LLC Kathy Remsen
K163569 12/19/2016 Elecsys CMV IgM Roche Diagnostics Angelo Pereira
K163633 12/22/2016 cobas HbA1c Test, cobas b 101 system Roche Diagnostics Operations Patty Bates
K163694 12/28/2016 Rooti Rx ECG Event Recorder, Rooti Link APP Software Rooti Labs Ltd. Sue Chuang
K163673 12/27/2016 FortilinkÖ-C with TETRAfuseÖ 3D Technology RTI Surgical, Inc. Diana Taylor
K163691 12/28/2016 HS70A Diagnostic Ultrasound System Samsung Medison Co., Ltd. Emily Woo
K163610 12/22/2016 PIEZOTOME M+, PIEZOTOME M+ Handpiece SATALEC-ACTEON GROUP PHILIPPE GIRARD
K163604 12/21/2016 SeaSpine« Daytona« Small Stature Spinal System SeaSpine Orthopedics Corporation Gina Flores
K163422 12/06/2016 Shanghai Sanyou PEEK Cage System SHANGHAI SANYOU MEDICAL CO, LTD David Fan
K163655 12/23/2016 Sparkling Shanghai Wonderful Opto-Electrics Tech. Co., Ltd Amy Lee
K163606 12/21/2016 Digital Blood Pressure Monitor-Automatic Upper Arm Style Shenzhen Combei Technology CO., LTD Huaguang Meng
K163690 12/28/2016 DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Yang Zhaohui
K163470 12/12/2016 Galvanic Spa, Model: SKB-1405 ShenZhen Siken 3D Technology Development Co., Ltd. Kimi Xue
K163712 12/30/2016 Clover 50/Clover60/Clover70 Diagnostic Ultrasound System SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. JIANG XIAOSAN
K163568 12/19/2016 SHOFU RESIN GLAZE Shofu Dental Corporation Mauro Malzyner
K163658 12/23/2016 ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay Siemens Healthcare Diagnostics Inc. Darius Daruwala
K163478 12/12/2016 AcuNav Volume ICE Catheter Siemens Medical Solutions USA, Inc. Shelly Pearce
K163396 12/05/2016 ACUSON P500 Ultrasound System Siemens Medical Solutions USA, Inc. Shelly Pearce
K163421 12/06/2016 syngo.via MI Workflows Siemens Medical Solutions USA, Inc. Veronica Padharia
K163635 12/22/2016 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems Siemens Medical Solutions USA, Inc. Ultrasound Group Sulgue Choi
K163589 12/20/2016 SIGN IM Nail SIGN FRACTURE CARE INTERNATIONAL Robert Schmitt
K163625 12/22/2016 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System Signature Orthopaedics Pty Ltd. Declan Brazil
K163676 12/27/2016 Silhouette InstaLift SILHOUETTE LIFT, INC. DOUG ABEL
K163653 12/23/2016 NOVOS-NAIL Limb Lengthening System (LLS) Smith & Nephew Allison Chan
K163387 12/02/2016 PICO Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Samantha Neilson
K163427 12/06/2016 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K163634 12/22/2016 External Hex Implants SOUTHERN IMPLANTS (PTY) LTD LAURANDA BREYTENBACH
K163657 12/23/2016 Quantum Workstation Spectrum Medical Ltd Mark Drain
K163428 12/06/2016 HA Minuteman G3-R MIS Fusion Plate Spinal Simplicity Douglas B Snell
K163670 12/27/2016 Rampart One Lumbar Interbody Fusion Device SPINEOLOGY INC. Jacqueline A. Hauge
K163409 12/05/2016 Rampart(TM) T Lumbar Interbody Fusion Device Spineology Inc. Jacqueline A. Hauge
K163407 12/05/2016 Confirm Rx Insertable Cardiac Monitor (ICM) System St. Jude Medical, Inc. Jennifer Dunham
K163450 12/08/2016 VIVA combo RF System STARmed Co., Ltd. Jun-Young Jung
K163587 12/20/2016 VERIFY Incubator for Assert Self Contained Biological Indicators STERIS Corporation Anthony Piotrkowski
K163656 12/23/2016 Hoffmann LRF System Stryker GmbH Paul Nelson
K163494 12/13/2016 Summit Spine Channel Cervical Interbody Fusion System Summit Spine Eric Buescher
K163448 12/08/2016 GrindCare System SUNSTAR SUISSE S.A. Olivier Ducamp
K163455 12/09/2016 SurgiCube SURGICUBE INTERNATIONAL B.V. GER VIJFVINKEL
K163558 12/19/2016 Synapsys Ulmer Video Nystagmograph Synapsys SA Laetitia Baconnier
K163415 12/05/2016 SlimShape System Syneron Medical Ltd. Ruthie Amir
K163646 12/23/2016 Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator Terragene SA Maria Victoria Quiroga
K163531 12/16/2016 Advanced Perfusion System 1 TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BRYAN HANN
K163702 12/29/2016 Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K163640 12/23/2016 QZA and RS Dental Implant Systems TRINON Titanium GmbH Katja Lvova
K163586 12/20/2016 Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector TrovRx, Inc. dba Trovita Health Science William Brown
K163441 12/08/2016 Locking Cage, Full XPE Cup UNITED ORTHOPEDIC CORPORATION GIMPEL CHIEN
K163424 12/06/2016 AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON United State Endoscopy Group, Inc. Ganga Kolli
K163495 12/13/2016 AdvanCE capsule endoscope delivery device United States Endoscopy Group, Inc. Carroll Martin
K163492 12/13/2016 Oracle EUS Balloon; Oracle EUS latex balloon - Olympus Radial; Oracle EUS latex balloon - Olympus Linear; Oracle EUS latex balloon - Fujinon Radial; Oracle EUS latex balloon - Fujinon Linear United states Endoscopy Group, Inc. Carroll Martin
K163607 12/21/2016 ECG Acquisition Systems VALES & HILLS BIOMEDICAL TECH. LTD. Jianfang Liu
K163444 12/08/2016 Spectre guidewire Vascular Solutions, Inc. Beka Vite
K163705 12/29/2016 EzRay Air W Vatech Co., Ltd Daniel Kim
K163508 12/14/2016 PIVO Velano Vascular Tiffini Diage
K163506 12/14/2016 CoalesceÖ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System Vertera, Inc. Wei Allen Chang
K163703 12/29/2016 VIVIX-S 1417N VIEWORKS CO., LTD. JORDIN KIM
K163487 12/12/2016 Ultima HA Coated Half Pins and Wire Vilex in Tennessee, Inc Sylvia Southard
K163472 12/12/2016 Intra.Ox Handheld Tissue Oximeter VIOPTIX, INC. MARK LONSINGER
K163504 12/14/2016 Borrelia B31 ViraChip IgG Test Kit VIRAMED BIOTECH AG MARTIN KINTRUP+
K163695 12/28/2016 Borrelia B31 ViraChip IgM Test Kit Viramed Biotech AG Martin Kintrup
K163453 12/09/2016 VitalPatch« VitalConnect Platform VITAL CONNECT, INC. KEVIN POTGIETER
K163574 12/19/2016 Multi Modality Viewer Vital Images, Inc. Susan Atwood
K163576 12/19/2016 GORE SYNECOR Preperitoneal Biomaterial W. L. Gore & Associates, Inc. Michael J. Titus
K163511 12/15/2016 NovaGuard SA Pro Safety System WEST PHARMACEUTICAL SERVICES, INC. Ana Ladino
K163377 12/01/2016 Captura Disposable Bronchoscope Biopsy Forceps Wilson-Cook Medical Inc. Ashley Howard
K163650 12/23/2016 ORTHOLOC« 3Di Ankle Fusion Plating System Line Extension Wright Medical Technology, Inc. Rachel Roberts
K163388 12/02/2016 XPress BCD Breast Compression Device XPress BCD, LLC Peter Kremers
K163476 12/12/2016 Lubricity You First Services, Incorporated Jeffrey Eberhard
K163400 12/05/2016 Orbit Inserter YPSOMED AG STEPHAN AFFOLTER
K163665 12/27/2016 MATRx plus Zephyr Sleep Technologies Sabina Bruehlmann
K163543 12/16/2016 Biomet Fusion System Zimmer Biomet Spine Inc. Megan Fessenden


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