| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K160666 |
03/09/2016 |
Dentiq3D |
3D INDUSTRIAL IMAGING CO.,LTD. |
Jin Sa Kim |
| K160818 |
03/24/2016 |
STERRAD« NX Sterilizer with ALLClearÖ Technology |
ADVANCED STERILIZATION PRODUCTS |
Jamie Byun |
| K160755 |
03/18/2016 |
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap |
AHLSTROM NONWOVENS LLC |
GARY JACKSON |
| K160862 |
03/29/2016 |
AirStrip RPM |
AirStrip Technologies, Inc. |
Andy Miller |
| K160609 |
03/03/2016 |
AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric |
Alcon Laboratories, Inc. |
Alicia M. Plesnarski |
| K160646 |
03/07/2016 |
XYcor« Expandable Spinal Spacer System |
Alphatec Spine, Inc |
Renee Murphy |
| K160784 |
03/22/2016 |
CAM Titanium Blanks |
ALTATEC GMBH |
COLLEEN BOSWELL |
| K160766 |
03/21/2016 |
Ambu USR, Ambu M |
AMBU A/S |
CAMILLA WISMAR |
| K160782 |
03/22/2016 |
BracePaste Adhesive |
American Orthodontics |
Trang Adams |
| K160791 |
03/23/2016 |
AmorChem Titanium Porous Fixation Device |
AmorChem Holdings, Inc. |
KEVIN MCBRIDE |
| K160758 |
03/18/2016 |
PeriCoach OTC |
ANALYTICA LTD. |
GEOFF DALY |
| K160710 |
03/15/2016 |
Oasis Lacrimal Intubation Set |
ANODYNE |
VALERIE ANDERSON |
| K160730 |
03/16/2016 |
Instrument kits |
ANTHOGYR |
Therese CANDAU |
| K160667 |
03/09/2016 |
Anybattery C2 Rechargeable Battery |
Anybattery, Inc. |
Ed Speegle |
| K160581 |
03/01/2016 |
K3PRO Konus Additional Abutments and Implants |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
RICHARD DONACA |
| K160574 |
03/01/2016 |
K3PRO SURGICAL TRAY |
ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG |
RICHARD DONACA |
| K160785 |
03/22/2016 |
Worker Guidewire |
ARGON MEDICAL DEVICES, INC. |
SUZANNE CHEANG |
| K160857 |
03/29/2016 |
HF 718BD X-Ray System |
ARQUILLA, INC. DBA X-CEL X-RAY CORPORATION |
GUIDO ARQUILLA |
| K160669 |
03/09/2016 |
ClariFix Device |
ARRINEX, INC. |
VAHID SAADAT |
| K160659 |
03/08/2016 |
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) |
ASAHI INTECC CO., LTD. |
CARROLL COUNCILMAN |
| K160682 |
03/10/2016 |
CONTOUR NEXT ONE Blood Glucose Monitoring System |
ASCENSIA DIABETES CARE |
Roger Sonnenburg |
| K160830 |
03/25/2016 |
Integra External Fixation System |
Ascension Orthopedics |
Jayana Kenana |
| K160702 |
03/14/2016 |
ZION Anterior Cervical Fixation System |
Astura Medical |
TROY TAYLOR |
| K160582 |
03/01/2016 |
WiCap |
Athena GTX |
Sean Mahoney |
| K160827 |
03/25/2016 |
Pantheris Catheter |
AVINGER, INC. |
Golnaz Moeini |
| K160757 |
03/18/2016 |
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) |
AXIS-SHIELD DIAGNOSTICS LIMITED |
CLAIRE I. DORA |
| K160651 |
03/08/2016 |
BD FlowSmart Set, MiniMed Pro-Set |
BECTON, DICKINSON AND COMPANY |
Matthew Trachtenberg |
| K160657 |
03/08/2016 |
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube |
BECTON, DICKINSON AND COMPANY |
Branden Reid |
| K160578 |
03/01/2016 |
Nustat XR |
Beeken Biomedical, LLC |
DAN O'HARA |
| K160747 |
03/18/2016 |
Angel Catheter |
BIO2 MEDICAL, INC. |
CHRISTOPHER E. BANAS |
| K160854 |
03/28/2016 |
MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture |
Biomet Manafacturing Corp. |
Adam Cargill |
| K160751 |
03/18/2016 |
Symphion Endoscope and Symphion Cervical Sheath |
BOSTON SCIENTIFIC |
BROOKE CUDDY |
| K160845 |
03/28/2016 |
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device |
BOSTON SCIENTIFIC CORPORATION |
Yingying Gao |
| K160823 |
03/25/2016 |
NC Quantum Apex PTCA Dilatation Catheter |
BOSTON SCIENTIFIC CORPORATION |
JANE HORAN |
| K160637 |
03/07/2016 |
Rotatable Snares |
BOSTON SCIENTIFIC CORPORATION |
Michael Secondini |
| K160866 |
03/30/2016 |
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit |
C.R. BARD, INC. |
LAURIE SANG |
| K160861 |
03/29/2016 |
Proxis Ureteral Access Sheath |
C.R. Bard, Inc. |
Beatrice Wan |
| K160875 |
03/30/2016 |
Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating |
CARDINAL HEALTH, INC. |
Megan Middaugh |
| K160746 |
03/18/2016 |
CARDIOLINE touchECG |
CARDIOLINE S.p.A |
Emanuele Ercoli |
| K160840 |
03/28/2016 |
ECG100+, ECG200+ |
CARDIOLINE S.p.A |
EMANUELE ERCOLI |
| K160764 |
03/21/2016 |
AirLife Autofill Humidification Chamber |
CAREFUSION 2200, INC. |
ERIKA FERNANDEZ |
| K160723 |
03/16/2016 |
OnSight 3D Extremity System |
CARESTREAM HEALTH, INC. |
Carolyn Wagner |
| K160867 |
03/30/2016 |
Pavati Z40.2 Zirconia |
CCRI, INC. |
ROBIN CARDEN |
| K160589 |
03/01/2016 |
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe |
CERTA DOSE, INC. |
SARAH HANSSEN |
| K160731 |
03/17/2016 |
LumFix Spinal Fixation Sytem |
CG BIO CO., LTD. |
YUNA JEONG |
| K160775 |
03/21/2016 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
CHOICE SPINE LP |
KIM FINCH |
| K160806 |
03/24/2016 |
Verza Guidance System |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
Amanda Stahle |
| K160800 |
03/23/2016 |
DuoCem |
COLTENE/WHALEDENT AG |
Silke Wallaschek |
| K160858 |
03/29/2016 |
CompactCath Intermittent Urinary Catheter |
COMPACTCATH INC. |
Naama Stauber Breckler |
| K160629 |
03/07/2016 |
InPen |
COMPANION MEDICAL, INC. |
JASPER BENKE |
| K160859 |
03/29/2016 |
OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) |
CONTAMAC LTD. |
ROB MCGREGOR |
| K160869 |
03/30/2016 |
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft |
COOK BIOTECH INCORPORATED |
Perry W. Guinn |
| K160887 |
03/31/2016 |
Cook Intraosseous Infusion Needles |
COOK INCORPORATED |
JULIA FERGUSON |
| K160884 |
03/31/2016 |
CXI Support Catheter |
COOK INCORPORATED |
Daniel J. Corbin |
| K160593 |
03/01/2016 |
Indy OTW Vascular Retriever |
COOK INCORPORATED |
Chad Schulenburg |
| K160891 |
03/31/2016 |
Ultrathane Endoureterotomy Stent Set |
Cook Incorporated |
Kara Kanorr |
| K160803 |
03/23/2016 |
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens |
CooperVision, Inc. |
Roya Borazjani |
| K160679 |
03/10/2016 |
WoundClot9 |
CORE SCIENTIFIC CREATION LTD. |
YUVAL YASKIL |
| K160656 |
03/08/2016 |
CorSens |
CorSens Medical Ltd. |
Yoram Levy |
| K160718 |
03/15/2016 |
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform |
COVIDIEN |
Timothy Holwick |
| K160654 |
03/08/2016 |
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm) |
Covidien LLC |
Rebecca Magnanimo |
| K160725 |
03/16/2016 |
EndoFLIP |
CROSPON LTD. |
JOHN O'DEA |
| K160636 |
03/07/2016 |
iPEP System and vPEP |
D R BURTON HEALTHCARE LLC |
DENNIS COOK |
| K160828 |
03/25/2016 |
Dentium Implantium & SuperLine Prosthetics |
DENTIUM CO., LTD. |
Sangpil Yoon |
| K160626 |
03/07/2016 |
ATLANTIS Abutment for HIOSSEN ET implant |
DENTSPLY SIRONA |
Helen Lewis |
| K160825 |
03/25/2016 |
MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology |
DENTSPLY SIRONA |
Helen Lewis |
| K160700 |
03/14/2016 |
ATTUNE Revision Knee System |
Depuy (Ireland) |
Jaime Weeks |
| K160650 |
03/08/2016 |
LIAISON HAV IgM, LIAISON Control HAV IgM |
DiaSorin Inc. |
John Walter |
| K160762 |
03/21/2016 |
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K160704 |
03/14/2016 |
myPatch-s |
DMS-SERVICE LLC |
LYNDA COLE |
| K160761 |
03/21/2016 |
DW-1C |
DONGWON MEDICAL CO., LTD. |
Gil Haeng Lee |
| K160591 |
03/01/2016 |
D.O.R.C. Disposable Cryo Probe |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
DANIELLE SLEEGERS |
| K160790 |
03/22/2016 |
Acclarix LX8 Diagnostic Ultrasound System |
Edan Instruments Inc |
Queena Chen |
| K160876 |
03/30/2016 |
PC ECG |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K160645 |
03/07/2016 |
PreSep Oligon Oximetry Catheter |
EDWARDS LIFESCIENCES, LLC |
Deana Boushell |
| K160668 |
03/09/2016 |
HumaPen Savvio |
Eli Lilly and Company, Inc. |
Christine A. Phliips |
| K160752 |
03/18/2016 |
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length |
ETHICON ENDO-SUREGERY, LLC |
MARJORIE MEDINA |
| K160663 |
03/09/2016 |
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) |
EVOLUTION SPINE, LLC |
Ashton Kouzbari |
| K160697 |
03/14/2016 |
Gibralt« Spine System and Gibralt« Occipital Spine System |
Exactech, Inc. |
Dawn Davisson |
| K160722 |
03/16/2016 |
CorticaLINK Spinal Fusion Platform |
FACETLINK DBA LINKSPINE |
MASSIMO CALAFIORE |
| K160707 |
03/14/2016 |
CustomizedBone Service |
FIN-CERAMICA FAENZA SPA |
Monticelli Marina |
| K160797 |
03/23/2016 |
FMX314 Surgical Platform |
Fortimedix Surgical B.V. |
DIRKJAN BAKKER |
| K160735 |
03/17/2016 |
CATSmart |
FRESENIUS KABI AG |
Barry G. Hicks |
| K160749 |
03/18/2016 |
CRIT-LINE III Blood Chamber II |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
Denise Oppermann |
| K160674 |
03/10/2016 |
Fujifilm Sonosite Vevo MD Imaging System |
FUJIFILM SONOSITE, INC. |
SCOTT PAULSON |
| K160734 |
03/17/2016 |
SonoSite SII Ultrasound System |
FUJIFILM SonoSite, Inc. |
Patricia Liau |
| K160621 |
03/04/2016 |
SIGNAPioneer |
GE HEALTHCARE |
GLEN SABIN |
| K160618 |
03/03/2016 |
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T |
GE MEDICAL SYSTEMS, LLC |
Jason Ma |
| K160633 |
03/07/2016 |
G3(TM) Active Plate(R) Small Fragment System |
GENESIS FRACTURE CARE, INC. |
Michael Bottlang |
| K160872 |
03/30/2016 |
PolyPlex Wound Dressing |
GLOBAL HEALTH SOLUTIONS, LLC |
Bradley Burnam |
| K160597 |
03/02/2016 |
INDEPENDENCE MIS Spacers |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K160664 |
03/09/2016 |
Aqueduct 100 Cervical Dilator |
GTIMD LLC |
RICHARD DEMELLO |
| K160763 |
03/21/2016 |
ally Liquid Personal Lubricant |
GUY & O'NEILL, INC. |
THOMAS MISGEN |
| K160717 |
03/15/2016 |
ally Warming Liquid Personal Lubricant |
GUY & O'NEILL, INC. |
THOMAS MISGEN |
| K160709 |
03/14/2016 |
HALYARD* PURPLE NITRILE û XTRA* Powder-Free Exam Gloves |
Halyard Health |
Gwendolyn George |
| K160802 |
03/23/2016 |
Infrared Forehead Thermometer, FT-100A |
HANGZHOU UNIVERSAL ELECTRONIC CO., LTD. |
JIAQIANG WAN |
| K160870 |
03/30/2016 |
Hospira Administration Sets |
HOSPIRA, INC. |
DAVID BLONSKI |
| K160742 |
03/17/2016 |
NoCoding1 Plus Blood Glucose Monitoring System |
i-SENS, INC. |
Joon Ho Jung |
| K160885 |
03/31/2016 |
HemosIL D-Dimer HS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K160673 |
03/10/2016 |
Insulin Algorithms System |
INSULIN ALGORITHMS |
Josh Davidson |
| K160811 |
03/24/2016 |
CRW STEREOTACTIC SYSTEM |
INTEGRA LIFESCIENCES CORPORATION |
TIMOTHY CONNORS |
| K160773 |
03/21/2016 |
Yarlap II |
INTERNATIONAL TRADE GROUP, INC. |
BRENT C. REIDER |
| K160630 |
03/07/2016 |
Invacare Platinum Mobile Oxygen Concentrator |
INVACARE CORPORATION |
ELIJAH N. WREH |
| K160798 |
03/23/2016 |
IPS e.max« Press Abutment Solutions for Viteo Base Ti |
IVOCLAR VIVADENT AG |
Sandra Cakebread |
| K160602 |
03/02/2016 |
JustRight Surgical Vessel Sealing System |
JustRight Surgical |
Jenifer Kennedy |
| K160675 |
03/10/2016 |
Powder free vinyl patient examination glove, colored (yellow) |
KAIXING PLASTIC PRODUCTS CO., LITD. |
Dan ny |
| K160721 |
03/16/2016 |
Vado Steerable Sheath |
KALILA MEDICAL, INC. |
Carrie Neuberger |
| K160631 |
03/07/2016 |
Keos Lumbar IBFD |
KEOS |
MARK F. SCHENK |
| K160864 |
03/29/2016 |
Cryotop Vitrification Kit and Cryotop Thawing Kit |
KITAZATO BIOPHARMA CO., LTD. |
FUTOSHI INOUE |
| K160863 |
03/29/2016 |
PBS(-), Phosphate Buffered Saline |
KITAZATO BIOPHARMA CO., LTD. |
FUTOSHI INOUE |
| K160610 |
03/03/2016 |
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set |
KOBOLD, LLC |
Brian Stoddart |
| K160895 |
03/31/2016 |
Initia Total Hip System & BIOCERAM AZUL(R) HEAD |
KYOCERA Medical Corporation |
Cheryl Hastings |
| K160643 |
03/07/2016 |
ENROUTE 0.014 Guidewire |
LAKE REGION MEDICAL |
MICHAEL DUNNING |
| K160644 |
03/07/2016 |
Lelo Hex Natural Rubber Latex Condom |
LELO Inc. |
Pavle Sedic |
| K160878 |
03/30/2016 |
OPTIS Metallic Stent Optimization E.4 SW |
LIGHTLAB IMAGING, INC. |
PADMINI SURAVARAM |
| K160893 |
03/31/2016 |
HANAROCare ReJu |
M.I.TECH CO.,LTD |
HWANG MI-SUNG |
| K160623 |
03/04/2016 |
FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture |
M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
Umesh Sharma |
| K160665 |
03/09/2016 |
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 |
MAQUET CRITICAL CARE AB |
CARINA LUNDBERG |
| K160695 |
03/14/2016 |
Talymed Suspension |
Marine Polymer Technologies, Inc. |
Sergio Finkielsztein |
| K160605 |
03/02/2016 |
MectaLIF Anterior Stand-Alone |
MEDACTA INTERNATIONAL |
MICHAEL G. LOITERMAN |
| K160698 |
03/14/2016 |
LigaPASS |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K160756 |
03/18/2016 |
PASS OCT Spinal System |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| K160640 |
03/07/2016 |
PASS XS Spinal System |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| K160837 |
03/25/2016 |
MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM |
MEDINET SRL |
STEFANO BERNUCCI |
| K160604 |
03/02/2016 |
CureÖ Anterior Cervical Plate (ACP) System |
MEDITECH SPINE, LLC |
BRUCE DUNAWAY |
| K160846 |
03/28/2016 |
AmplifEYE |
MEDIVATORS, INC. |
Jeff Kasoff |
| K160642 |
03/07/2016 |
Medline ENFit Syringe |
Medline Industries, Inc. |
Stephanie Blair |
| K160660 |
03/08/2016 |
Medline Waste Station |
Medline Industries, Inc. |
Matt Clausen |
| K160879 |
03/30/2016 |
CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems |
Medos International S?rl |
KIRSTEN LEMULLER |
| K160804 |
03/23/2016 |
INTRAFIX(TM) Advance Tibial Fastener System |
MEDOS INTERNATIONAL SARL |
KRISTINE CHRISTO |
| K160860 |
03/29/2016 |
MiniMed Quick-serter |
MEDTRONIC MINIMED |
Noreen Bajwa |
| K160713 |
03/15/2016 |
Stealth-Midas System |
MEDTRONIC POWERED SURGICAL SOLUTIONS |
DEEP PAL |
| K160689 |
03/11/2016 |
Reveal LINQ |
MEDTRONIC, INC. |
Eric Kalmes |
| K160809 |
03/24/2016 |
Reveal LINQ |
MEDTRONIC, INC. |
Dianna L Johannson |
| K160677 |
03/10/2016 |
MICRORUPTOR 6 |
MERIDIAN AG |
FRANZISKA GOTSCHI |
| K160829 |
03/25/2016 |
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 |
MERIDIAN BIOSCIENCE, INC. |
MICHELLE L. SMITH |
| K160771 |
03/21/2016 |
Destiknee Total Knee System |
MERIL HEALTHCARE PRIVATE LIMITED |
Umesh Sharma |
| K160699 |
03/14/2016 |
VIRTU Lumbar Spacer System |
Met 1 Technologies, LLC |
Dan Gerbec |
| K160641 |
03/07/2016 |
Solitaire Platinum Revascularization Device, 6x40 mm |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Ryan Kenney |
| K160625 |
03/04/2016 |
Disposable Hot Biopsy Forceps |
MICRO-TECH (NANJING) CO., LTD. |
BECKY LI |
| K160706 |
03/14/2016 |
ReNew V Handpiece Laparoscopic Instruments |
MICROLINE SURGICAL, INC. |
ANU GAUR |
| K160685 |
03/11/2016 |
Surveyor S4 Mobile Monitor |
Mortara Instrument, Inc. |
Sarah Weber |
| K160594 |
03/01/2016 |
MRWire Guide Wire |
NANO4IMAGING GMBH |
CHRISTOPH R. MANEGOLD |
| K160874 |
03/30/2016 |
Nanovis Intervertebral Body Fusion System and FortiCore« |
NANOVIS LLC |
Matthew Hedrick |
| K160745 |
03/18/2016 |
neoBLUE compact LED Phototherapy System |
NATUS MEDICAL INCORPORATED |
THERESE LEGGIERE |
| K160739 |
03/17/2016 |
Cranial COVER |
Neos Surgery S.L. |
Eduard Garcia |
| K160703 |
03/14/2016 |
NeuroStar TMS Therapy System |
NEURONETICS, INC. |
Judy P. Ways |
| K160617 |
03/03/2016 |
Large Screws Range |
NEWCLIP TECHNICS |
Gaelle LUSSORI |
| K160816 |
03/24/2016 |
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) |
NEXMED TECHNOLOGY CO., LTD |
Ellen Xu |
| K160820 |
03/24/2016 |
PressON Pro Spinal Fixation System |
Nexus Spine, LLC |
Jared Crocker |
| K160865 |
03/30/2016 |
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C S |
NONIN MEDICAL, INC. |
NANCY E. DEANGELO |
| K160608 |
03/03/2016 |
NormaTec Pulse and NormaTec Pulse Pro |
NORMATEC INDUSTRIES, LP |
Peter Novello |
| K160889 |
03/31/2016 |
BIB Stent Placement Catheter |
NUMED, INC. |
NICHELLE LAFLESH |
| K160598 |
03/02/2016 |
REBOA Balloon Catheter |
NUMED, INC. |
NICHELLE LAFLESH |
| K160728 |
03/16/2016 |
NutraStim Hair Laser Helmet |
NUTRA LUXE MD LLC |
GLORIA AVENDANO |
| K160639 |
03/07/2016 |
Electrosurgical Generator ESG-200 |
OLYMPUS WINTER & IBE GMBH |
Katharina Campbell |
| K160712 |
03/15/2016 |
VITROS Chemistry Products hsCRP Reagent |
Ortho Clinical Diagnostics |
Marlene Hanna |
| K160720 |
03/16/2016 |
Carriere Motion Clear Class II |
ORTHO ORGANIZERS, INC. |
COLLEEN BOSWELL |
| K160670 |
03/10/2016 |
ET US SS Prosthetic system |
OSSTEM IMPLANT CO., LTD. |
HEE KWON |
| K160881 |
03/30/2016 |
Tablo Console |
OUTSET MEDICAL, INC. |
LESLIE TRIGG |
| K160611 |
03/03/2016 |
P-ARTIS |
P-CURE LTD. |
MICHAEL MARASH |
| K160577 |
03/01/2016 |
PacEndo Chlorhexidine |
PAC-DENT INTERNATIONAL, INC. |
Wenying Zhu |
| K160832 |
03/25/2016 |
Penumbra Smart Coil |
PENUMBRA, INC. |
Charles DeNault |
| K160743 |
03/17/2016 |
Philips Ingenuity CT |
Philips Medical Systems (Cleveland), Inc. |
Susan Quick |
| K160807 |
03/24/2016 |
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
PHILIPS ULTRASOUND, INC. |
PENG CUI |
| K160595 |
03/01/2016 |
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator |
PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI |
Derya Dikici |
| K160627 |
03/07/2016 |
Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solution |
QFIX |
Nadia Sookdeo Harhen |
| K160606 |
03/02/2016 |
BC-5D Hematology Control |
R & D SYSTEMS, INC. |
RAVI KOMMINENI |
| K160788 |
03/22/2016 |
RIOScan (RPS500) |
RAY CO., Ltd |
Changhwan Lee |
| K160579 |
03/01/2016 |
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software |
RAYENCE CO., LTD |
Kevin Kim |
| K160848 |
03/28/2016 |
Wingman 18 Crossing Catheter |
ReFlow Medical, Inc. |
Rebecca K Pine |
| K160836 |
03/25/2016 |
Menai System |
ResMed Ltd |
Greg Dockar |
| K160822 |
03/24/2016 |
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV |
RESMED LTD |
JASJIT BAVEJA |
| K160614 |
03/03/2016 |
Xcite Clinical Station |
RESTORATIVE THERAPIES INC. |
Andrew Barriskill |
| K160655 |
03/08/2016 |
OrthoButton CL |
RIVERPOINT MEDICAL |
EDWIN ANDERSON |
| K160795 |
03/23/2016 |
United Urologics Intermittent Catheter |
ROBLING MEDICAL |
Diane Peper |
| K160877 |
03/30/2016 |
United Urologics Closed System Catheter |
ROBLING MEDICAL, INC. |
Diane Peper |
| K160684 |
03/11/2016 |
Atteris No-Sting Skin Protectant |
ROCHAL INDUSTRIES LLC |
WILLIAM J. COULSTON |
| K160729 |
03/16/2016 |
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 |
Roche Diagnostics |
Adam Clark |
| K160847 |
03/28/2016 |
Rockwell Medical CitraPure Acid Concetrate |
ROCKWELL MEDICAL |
ROBERT CHIOINI |
| K160786 |
03/22/2016 |
RODO Abutment System |
RODO MEDICAL, INC |
Michael Parsons |
| K160681 |
03/10/2016 |
CenterCross Ultra Catheter |
ROXWOOD MEDICAL, INC |
Grace Li |
| K160799 |
03/23/2016 |
GenNarino |
SALIWELL LTD. |
BEN Z. BEISKI |
| K160850 |
03/28/2016 |
Nucleoss Tpure Implant System |
SANLILAR TIBBI CIHAZLAR MED. KIM.SAN.TIC.LTD.STI |
EZGI ERDEM |
| K160781 |
03/22/2016 |
Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves |
SEMPERIT INVESTMENTS ASIA PTE. LTD. |
CLEMENS EICHLER |
| K160853 |
03/28/2016 |
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System |
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) |
Flower Cai |
| K160596 |
03/02/2016 |
BEAUTIFIL II LS |
SHOFU DENTAL CORPORATION |
Mauro Malzyner |
| K160652 |
03/08/2016 |
iFUSE Implant System |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K160647 |
03/07/2016 |
IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K160724 |
03/16/2016 |
ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KATHLEEN DRAY-LYONS |
| K160770 |
03/21/2016 |
Vent-Os Sinus Dilation family |
SINUSYS CORPORATION |
Lloyd H. Griese |
| K160738 |
03/17/2016 |
ZUK Select Knee System |
SMITH & NEPHEW, INC. |
BRAD SHEALS |
| K160603 |
03/02/2016 |
SMV Scientific Schanz Screws |
SMV SCIENTIFIC |
NEPHI ZUFELT |
| K160613 |
03/03/2016 |
Soberlink Cellular Device and Sober Sky Web Portal |
SOBERLINK HEALTHCARE LLC |
JENNA COSTA |
| K160856 |
03/28/2016 |
SpineView X-Pac Expandable Lumbar Cage System |
Spine View, Inc. |
Mbithi Muthini |
| K160716 |
03/15/2016 |
The Nanostim Introducer Kit |
St Jude Medical, Inc |
Brittany Cunningham |
| K160600 |
03/02/2016 |
Freedom Spinal Cord Stimulator System |
STIMWAVE TECHNOLOGIES INCORPORATED |
Elizabeth Greene |
| K160585 |
03/01/2016 |
XN CAL |
Streck |
Deborah Kipp |
| K160590 |
03/01/2016 |
XN CHECK |
STRECK |
DEBORAH KIPP |
| K160588 |
03/01/2016 |
XN CHECK BF |
STRECK |
DEBORAH KIPP |
| K160586 |
03/01/2016 |
XN-L CHECK |
STRECK |
DEBORAH KIPP |
| K160715 |
03/15/2016 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
AAKASH JAIN |
| K160693 |
03/14/2016 |
Neptune E-SEP Smoke Evacuation Pencil |
STRYKER CORPORATION |
MAIREAD TWOMEY |
| K160813 |
03/24/2016 |
EasyStep |
STRYKER GMBH |
Garry T. Hayeck |
| K160612 |
03/03/2016 |
Sumitomo Proton Therapy System |
SUMITOMO HEAVY INDUSTRIES, LTD |
KATSUHIRO NARASAKI |
| K160662 |
03/09/2016 |
Surefire Infusion System |
SUREFIRE MEDICAL, INC |
Lynne Aronson |
| K160740 |
03/17/2016 |
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology |
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
BRANDI J. PANTELEON |
| K160744 |
03/17/2016 |
LOOK PTFE Suture |
Surgical Specialties Corporation |
Karen Sanchez |
| K160584 |
03/01/2016 |
Surgical Navigation Advanced Platform (SNAP) |
SURGICAL THEATER, LLC |
Kevin Murrock |
| K160787 |
03/22/2016 |
Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet |
SYNCRO MEDICAL INNOVATIONS, INC. |
Sabry Gabriel |
| K160607 |
03/02/2016 |
PicoWay Laser System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K160896 |
03/31/2016 |
ULTRASHAPE POWER SYSTEM |
SYNERON MEDICAL LTD |
Ruthie Amir |
| K160680 |
03/10/2016 |
VisioFocus Mini, VisioFocus Smart |
TECNIMED S.R.L. |
Cinzia Bellifemine |
| K160819 |
03/24/2016 |
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit |
THE BINDING SITE GROUP LTD. |
JON LAUDER |
| K160792 |
03/23/2016 |
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound |
THE PROMETHEUS GROUP |
Joshua Bird |
| K160694 |
03/14/2016 |
Disposable Endotracheal tube, sterile, AccuCuff |
TIANJIN MEDIS MEDICAL DEVICE CO., LTD. |
ZHENCHUANG YANG |
| K160592 |
03/01/2016 |
SUPERCATH 6 |
TOGO MEDIKIT CO., LTD. |
Daisuke Nagamizu |
| K160615 |
03/03/2016 |
ORTHODONTIC CERAMIC BRACKETS 1.1 |
TOMY, INC |
JINICHI WATANABE |
| K160587 |
03/01/2016 |
Aquilion ONE (TSX-305A/3) V7.3 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K160632 |
03/07/2016 |
Vantage Titan 1.5T, MRT-1510, V3.6 Software |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
Paul Biggins |
| K160821 |
03/24/2016 |
Tria Sapphire |
TRIA BEAUTY, INC. |
Heather Tanner |
| K160835 |
03/25/2016 |
Titan 3W |
TZORA ACTIVE SYSTEMS LTD. |
Adi Shemer |
| K160855 |
03/28/2016 |
U&U Enteral Syringe |
U&U MEDICAL TECHNOLOGY CO.,LTD |
BLACK WANG |
| K160648 |
03/07/2016 |
MiniMed Quick-Set« MiniMed Sure-T« MiniMed Silhouette« MiniMed Mio« |
UNOMEDICAL A/S |
John M Lindskog |
| K160815 |
03/24/2016 |
Interstitial Needles |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K160882 |
03/31/2016 |
PaX-i3D Green Premium (Model: PCT-90LH) |
VATECH CO., LTD |
Daniel Kim |
| K160754 |
03/18/2016 |
Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) |
VENCLOSE, INC. |
MAI LY WILCOX |
| K160620 |
03/04/2016 |
Visaris Vision« (Vision C, Vision U. Vision V, Vision X) |
VISARIS D.O.O. BELGRADE |
MILAN RATKOVIC |
| K160810 |
03/24/2016 |
ViZion DR + Wireless |
Viztek LLC |
Bruce Ashby |
| K160774 |
03/21/2016 |
IonoStar Plus |
VOCO GMBH |
M. TH. PLAUMANN |
| K160583 |
03/01/2016 |
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip |
VOLCANO CORPORATION |
BRIAN PARK |
| K160783 |
03/22/2016 |
Procellera |
VOMARIS INNOVATIONS, INC. |
Timothy Joiner |
| K160793 |
03/23/2016 |
First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline) |
W.H.P.M., INC. |
John Wan |
| K160805 |
03/23/2016 |
NIO-P |
WAISMED LTD. |
Einat Swisa |
| K160880 |
03/30/2016 |
Photonica Professional |
Ward Photonics LLC |
Terry Ward |
| K160801 |
03/23/2016 |
Well Lead Extraction Bag |
WELL LEAD MEDICAL CO., LTD. |
HAN GUANG YUAN |
| K160753 |
03/18/2016 |
COOK Vacuum Pump |
WILLIAM A. COOK AUSTRALIA PTY LTD |
Gordana Pozvek |
| K160814 |
03/24/2016 |
Sydney IVF Sperm Cryopreservation Buffer |
WILLIAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K160890 |
03/31/2016 |
Howell Biliary Introducer Needle |
WILSON-COOK MEDICAL, INC. |
ASHLEY HOWARD |
| K160849 |
03/28/2016 |
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
CHIH-WEN TSAI |
| K160705 |
03/14/2016 |
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, |
Y. JACOBS MEDICAL, INC |
HUI JUN PARK |
| K160575 |
03/01/2016 |
CareSens Pen Needle, Softip Pen Needle |
YIDOBIO INC. |
KYUNG HEE YOON |
| DEN160012 |
03/16/2016 |
D2 Dressing |
Z-MEDICA, LLC |
SHEILA K. WALLIN |
| K160852 |
03/28/2016 |
Zia |
Zetta Medical Technologies, LLC. |
Main M. Ghazal |
| K160691 |
03/11/2016 |
Acne Light Therapy Wand |
ZUKO, INC. |
Jay Tapper |
