| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K143573 |
12/17/2014 |
Audit MicroControls Linearity FD Tumor Markers II |
AALTO SCIENTIFIC LTD. |
Robert Burda |
| K143571 |
12/17/2014 |
Audit MicroControls Linearity LQ Cystatin-C |
AALTO SCIENTIFIC, LTD. |
ROBERT BURDA |
| K143434 |
12/01/2014 |
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series |
ABBOTT MEDICAL OPTICS INC |
Nooshin Azizi |
| K143613 |
12/19/2014 |
PaxWire Occlusion Balloon System |
ACCESSCLOSURE, INC. |
Kelly Jabbal |
| K143541 |
12/15/2014 |
Relieva SpinPlus Balloon Sinuplasty System |
ACCLARENT, INC. |
Pavan Sethi |
| K143560 |
12/16/2014 |
CygneX I System |
Accuthera Inc. |
Eiji Tanabe |
| K143450 |
12/02/2014 |
Ackermann Intervertebral Body Fusion Device |
ACKERMANN INSTRUMENTE GMBH |
Rolf Ackermann |
| K143449 |
12/02/2014 |
ADH 200 Analyzer Software |
ADAMS MEDITECH LLC |
CECILIA L. YU |
| K143719 |
12/29/2014 |
Aeroneb USB Contoller System |
Aerogen Limited |
Martin Crehan |
| K143443 |
12/02/2014 |
VEGA Knee System, Columbus Total Knee System |
Aesculap Implants Systems, LLC |
Julie Tom Wing |
| K143729 |
12/29/2014 |
SterilContainer S |
AESCULAP, INC. |
Denise R Adams |
| K143630 |
12/22/2014 |
Invisalign System |
ALIGN TECHNOLOGY, INC. |
Margaret Anderson |
| K143740 |
12/30/2014 |
Battalion Universal Spacer System |
ALPHATEC SPINE, INC. |
Nadine Smith |
| K143604 |
12/18/2014 |
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters |
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
BASAK DEMIRCI |
| K143713 |
12/29/2014 |
Lustre PRO Light System |
AMBICARE HEALTH LTD |
Neil MacGilp |
| K143518 |
12/12/2014 |
Valeo Spacer System and Valeo II Interbody Fusion Device System |
Amedica Corp. |
William D. Jordan |
| K143580 |
12/18/2014 |
PeriCoach |
ANALYTICA LTD |
GEOFF DALY |
| K143757 |
12/31/2014 |
ANUTRA Feedback Aspiration Syringe |
ANUTRA MEDICAL, INC. |
CAMERON PERKINS |
| K143750 |
12/31/2014 |
MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System |
APEX BIO TECHNOLOGY CORP |
Hsue-Mei Lee |
| K143536 |
12/15/2014 |
Voyant Fine Fusion Device |
APPLIED MEDICAL RESOURCES |
JESSICA CHO |
| K143517 |
12/12/2014 |
Voyant Open Sealer-Divider Device |
APPLIED MEDICAL RESOURCES |
Jessica Cho |
| K143702 |
12/24/2014 |
Arthrex Blunt Tip Screws with Fiber Tape |
Arthrex, Inc. |
David L Roger |
| K143745 |
12/31/2014 |
Arthrex Corkscrew and SwiveLock Suture Anchors |
Arthrex, Inc. |
David L Rogers |
| K143749 |
12/31/2014 |
Arthrex Distal Radius System |
Arthrex, Inc. |
Laura Medlin |
| K143614 |
12/19/2014 |
Arthrex Low Profile Screws |
ARTHREX, INC. |
David L Rogers |
| K143519 |
12/12/2014 |
The MeDioStar NeXT Family |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K143482 |
12/08/2014 |
xevonta dialyzer |
B. Braun Avitum AG |
Giuliana Gavioli |
| K143632 |
12/22/2014 |
Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens |
Bausch & Lomb Incorporated |
Jessica Burger |
| K143538 |
12/15/2014 |
MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit |
BAYER MEDICAL CARE INC. |
LISA A. EWING |
| K143610 |
12/19/2014 |
BD INTIMA II CLOSED IV CATHETER |
Becton Dickinson Infusion Therapy Systems Inc. |
John Roberts |
| K143648 |
12/22/2014 |
BD MAX Enteric Parasite Panel, BD MAX Instrument |
BECTON, DICKINSON AND COMPANY |
PAUL SWIFT |
| K143462 |
12/04/2014 |
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) |
BENQ MATERIALS CORPORATION |
Kenix Chang |
| K143715 |
12/29/2014 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Better Plastic Co., Ltd. |
Du Wei |
| K143524 |
12/12/2014 |
Fiber Disks and Blocks (TRINIA) |
Bicon, LLC |
Richard Wu |
| K143492 |
12/08/2014 |
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece |
Bien-Air Surgery SA |
Judith Clerc |
| K143543 |
12/15/2014 |
Prelude PF Patellae |
BIOMET INC. |
JARED COOPER |
| K143697 |
12/24/2014 |
Biomet Proximal Humerus Plating System |
Biomet Manufacturing |
Julie Largent |
| K143503 |
12/10/2014 |
BioMonitor |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K143705 |
12/29/2014 |
NeedleCam HD Visualization System |
BIOVISION TECHNOLOGIES, LLC |
DAVID SANSO |
| K143668 |
12/24/2014 |
Navio |
BLUE BELT TECHNOLOGIES, INC. |
RICHARD G CONFER |
| K143587 |
12/18/2014 |
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire |
BOSTON SCIENTIFIC CORPORATION |
NIKKI M WAHLBERG |
| K143643 |
12/22/2014 |
Brainscope Ahead 200 |
BRAINSCOPE COMPANY, INC. |
Michael E Singer |
| K143559 |
12/16/2014 |
XP1000 RF |
BTL INDUSTRIES, INC |
Jan Zarsky |
| K143743 |
12/31/2014 |
ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH |
C.R. Bard Inc. |
FELICIA RULEY |
| K143522 |
12/12/2014 |
Presto Inflation Device |
C.R. BARD, INC. |
TIMOTHY WADE |
| K143490 |
12/08/2014 |
VERTA Corpectomy Cage |
CAMBER SPINE |
Daniel A. Pontecorvo |
| K143718 |
12/29/2014 |
Mammography Color Display DP-M3010 |
CANON INC. |
MASAKI TAMURA |
| K143496 |
12/09/2014 |
Piccolo Composite Plate System |
CarboFix Orthopedics Ltd. |
Yael Rubin |
| K143714 |
12/29/2014 |
Powerheart G5 AED |
CARDIAC SCIENCE CORPORATION |
Kathleen Roberts |
| K143432 |
12/01/2014 |
Cardio-TriTest |
CARDIO-PHOENIX INC. |
MARC BISNAIRE |
| K143675 |
12/24/2014 |
FORE-SIGHT Elite Absolute Tissue Oximeter |
CAS MEDICAL SYSTEMS, INC. |
Ron Jeffrey |
| K143473 |
12/05/2014 |
Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles |
CAYENNE MEDICAL, INC |
Shima Hashemian |
| K143599 |
12/18/2014 |
Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 |
Chemtron Biotech, Inc. |
Jane Zhang |
| K143758 |
12/31/2014 |
PerioType Rapid |
CLINICAL HOUSE EUROPE GMBH |
Judi Weissinger |
| K143725 |
12/29/2014 |
Consensus Knee System Modular Tibial Baseplate |
Consensus Orthopedics, Inc |
Matthew M Hills |
| K143650 |
12/23/2014 |
CooperSurgical Advincula Delineator Uterine Manipulator |
Cooper Surgical Inc. |
James Keller |
| K143506 |
12/10/2014 |
BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL |
COVIDIEN |
TIMOTHY HOLWICK |
| K143644 |
12/22/2014 |
Premium Surgiclip?; Endo Clip?; AcuClip? |
COVIDIEN |
Michael Koczocik |
| K143598 |
12/18/2014 |
Lapro-Clip Auto Suture Reusable Long Clip Applier |
Covidien LLC |
Rebecca Magnanimo |
| K143654 |
12/23/2014 |
Valleylab LS10 Generator |
COVIDIEN LLC |
DONALD HENTON |
| K143520 |
12/12/2014 |
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) |
CROSSTEX |
Michael G Nolan |
| K143625 |
12/22/2014 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K143530 |
12/12/2014 |
Aespire View |
Datex-Ohmeda, Inc. |
Michelle Huettner |
| K143679 |
12/24/2014 |
Nuance FLOW |
Den-Mat Holdings, LLC |
Helen Ragus |
| K143475 |
12/05/2014 |
VAPR Tripolar Suction Electrode |
Depuy Mitek |
Susan Kagan |
| K143660 |
12/23/2014 |
Milagro / Milagro Advance Interference Screw |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Yayoi Fujimaki |
| K143677 |
12/24/2014 |
DeVilbiss Intellipap2/DeVilbiss BLUE |
DeVilbiss Healthcare, LLC |
Betty Miller |
| DEN140038 |
12/15/2014 |
Dexcom Share Direct Secondary Displays |
DEXCOM, INC. |
Andrew K Balo |
| K143494 |
12/09/2014 |
ADX6000 Portable X-Ray System; iRayA6 |
DEXCOWIN CO., LTD |
Ryu Seung-Bum |
| K143586 |
12/18/2014 |
FACT Medical Imaging Sysytem |
Dexin Medical Imaging Technology Co., Ltd. |
Wang Yu |
| K143470 |
12/05/2014 |
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set |
DIAZYME LABORATORIES |
Abhijit Datta |
| K143551 |
12/15/2014 |
Compex Wireless USA |
DJO, LLC |
GINA FLORES |
| K143716 |
12/29/2014 |
DSM Biomedical DPR Cable |
DSM BIOMEDICAL |
Lori Burns |
| K143430 |
12/01/2014 |
SmartTENS |
EASYMED INSTRUMENT CO., LTD. |
Jeffery Wu(Tingjie Wu) |
| K143499 |
12/10/2014 |
eCligner |
eClear International Co., Ltd. |
Tae Weon Kim |
| K143695 |
12/24/2014 |
CENTRAL MONITORING SYSTEM |
EDAN INSTRUMENTS INC |
QUEENA CHEN |
| K143690 |
12/24/2014 |
EksoÖ (version 1.1) and Ekso GTÖ (version 1.2) |
EKSO BIONICS, INC. |
JOHN TUGWELL |
| K143645 |
12/22/2014 |
EsophyX« Z Fastener Delivery Device |
ENDOGASTRIC SOLUTIONS, INC. |
DARREN CROW |
| K143557 |
12/15/2014 |
SupaScoota Motorized vehicle |
EUROGREEN INTERNATIONAL INC |
DAVID HSIEH |
| K143659 |
12/23/2014 |
Equinoxe Mega Prosthesis |
EXACTECH, INC. |
Thomas McNamara |
| K143576 |
12/17/2014 |
Exactech Ambassador |
EXACTECH, INC. |
DAWN DAVISSON |
| K143666 |
12/23/2014 |
Noblex Long Pulse Alexandrite Laser |
FINEMEC CO.,LTD. |
GHUN HEE LEE |
| K143646 |
12/22/2014 |
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit |
Fisher & Paykel Healthcare Ltd |
Elizabeth Goldstein |
| K143484 |
12/08/2014 |
BioZorb Marker |
FOCAL THERAPEUTICS |
George Hermann |
| K143651 |
12/23/2014 |
Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack |
FOCUS DIAGNOSTICS, INC. |
Sharon Young |
| K143723 |
12/29/2014 |
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro |
FOTONA D.D. |
STOJAN TROST |
| K143556 |
12/15/2014 |
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
MARY MOORE |
| K143732 |
12/29/2014 |
FUJIFILM Endoscope Models EC-600HL and EC-600LS |
FUJIFILM Medical Systems U.S.A., Inc. |
Mary Moore |
| K143721 |
12/29/2014 |
PRCT2 |
FX SOLUTIONS |
JEAN JACQUES MARTIN |
| K143564 |
12/16/2014 |
Visual-ICE Cryoablation System, Software Revision 1.3.1 |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K143570 |
12/17/2014 |
WIRION |
GARDIA MEDICAL |
OHAD HAAS |
| K143667 |
12/23/2014 |
GC KommonBase |
GC Orthodontics America Inc. |
Tom Macari |
| K143452 |
12/02/2014 |
LOGIQ P9, LOGIQ P7 |
GE HEALTHCARE |
BRYAN BEHN |
| K143676 |
12/24/2014 |
B40i Patient Monitor |
GE HEALTHCARE FINLAND OY |
JOEL KENT |
| K143574 |
12/17/2014 |
Melodi Prime Breast Pump |
Genadyne Biotechnologies, Inc. |
Chien Ming GOH |
| K143726 |
12/29/2014 |
XLR8 PLUS (XLR8+) |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING GOH |
| K143591 |
12/18/2014 |
Dorsal Appliance |
GERGENS ORTHODONTIC LAB |
Chris Morrison |
| K143438 |
12/02/2014 |
Flowtron ACS900 |
Getinge (Suzhou) Co., Ltd |
Lenda Hou |
| K143633 |
12/22/2014 |
CREO Stabilization System |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K143578 |
12/17/2014 |
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K143527 |
12/12/2014 |
IPM Wound Gel Bio, IPM Derm Gel Bio |
GLYCOBIOSCIENCES, INC |
Kevin Drizen |
| K143670 |
12/24/2014 |
ICS CHARTR EP 200 WITH VEMP |
GN OTOMETRICS A/S |
ANDERS RASMUSSEN |
| K143734 |
12/30/2014 |
Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K143735 |
12/30/2014 |
Digital Automatic Blood Pressure Monitor MD2300 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K143733 |
12/30/2014 |
Digital Automatic Wrist Blood Pressure Monitor MD2400 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K143497 |
12/09/2014 |
Safety Auto-Disable Syrine with Needle (Auto-Lock) |
GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD |
HU YIHAN |
| K143535 |
12/15/2014 |
CR3 Keyless Split Sample Cup Secobarbital- Methadone |
GUANGZHOU WONDFO BIOTECH CO., LTD. |
Ben Chen |
| K143656 |
12/23/2014 |
StarCeram« Z-Nature, StarCeram« Z-Smile |
H.C. Starck Ceramics GmbH |
Alexandra Krausch |
| K143539 |
12/15/2014 |
Dental Implant OKTAGON Bone Level |
Hager & Meisinger GmbH |
Wiebke Stolten |
| K143537 |
12/15/2014 |
Sirius Starmobile tiara |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
| K143737 |
12/30/2014 |
EM25 - glute toning device |
HIVOX BIOTEK, INC. |
CLYTIE CHIOU |
| K143594 |
12/18/2014 |
VaPro Pocket |
Hollister Incorporated |
Jeanne Lee |
| K143612 |
12/19/2014 |
LifeCare PCA Infusion System |
Hospira, Inc |
Tom Gutierrez |
| K143437 |
12/01/2014 |
Droplet Pen Needles |
HTL-STREFA S.A. |
Aleksandra Prazmowska-Wilanowska |
| K143431 |
12/01/2014 |
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) |
i-codi Co., Ltd |
Yoo Hwan Park |
| K143736 |
12/30/2014 |
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA |
IMMCO DIAGNOSTICS, INC. |
Kevin Lawson |
| K143500 |
12/10/2014 |
Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set |
Immunalysis Corporation |
Joseph Ginete |
| K143502 |
12/10/2014 |
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K143731 |
12/29/2014 |
IMPLANET Spine System (ISS) |
IMPLANET S.A. |
Regis Le Couedic |
| K143759 |
12/31/2014 |
JAZZ System |
IMPLANET S.A. |
REGIS LE COUEDIC |
| K143563 |
12/16/2014 |
Infusion Aspiration Catheter System |
Inari Medical, Inc. |
Eben Gordon |
| DEN140039 |
12/15/2014 |
NOVA View Automated Fluorescense Microscope |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K143754 |
12/31/2014 |
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
| K143663 |
12/23/2014 |
MiroCam Capsule Endoscope System |
INTROMEDIC CO., LTD |
Jinyoung Lee |
| K143738 |
12/30/2014 |
DSS Sinusplasty Balloon Catheter |
Intuit Medical Products, LLC |
Jack Griffis |
| K143436 |
12/01/2014 |
InvisionECG System |
InvisionHeart Inc. |
Michael Wurst |
| K143513 |
12/11/2014 |
ZIO SR ECG Monitoring Service |
iRhythm Technologies, Inc. |
Rich Laguna |
| K143605 |
12/19/2014 |
Nutraseb Facial Cream |
ISDIN Corp |
STEVE SMITH |
| K143575 |
12/17/2014 |
Accu-Dent XD Tray, Accu-Dent XD Syringe |
IVOCLAR VIVADENT, INC. |
Donna Marie Hartnett |
| DEN140040 |
12/23/2014 |
Nautilus BrainPulse 1000 |
JAN MEDICAL, INC. |
Paul Lovoi |
| K143730 |
12/29/2014 |
GBR System |
JEIL MEDICAL CORPORATION |
HYEROUNG LEE |
| K143465 |
12/04/2014 |
MASTERmatic LUX |
Kaltenbach & Voigt Gmbh |
Stefan Trampler |
| K143640 |
12/22/2014 |
KSEA CMOS Camera System (C-cam) |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
Susie S Chen |
| K143439 |
12/02/2014 |
KATANA Zirconia |
KURARAY NORITAKE DENTAL, INC. |
Michio Takigawa |
| K143487 |
12/08/2014 |
Lifelines iEEG |
KVIKNA EHF |
Gardar Thorvardsson |
| K143454 |
12/03/2014 |
Pruitt F3-S Carotid Shunt |
LeMaitre Vascular, Inc |
Xiang Zhang |
| K143498 |
12/10/2014 |
LifeGlobal Global HP |
LifeGlobal Group, LLC |
MICHAEL D CECCHI |
| K143509 |
12/11/2014 |
MasterSL femoral stem |
LIMACORPORATE S.P.A. |
STEPHEN J PEOPLES |
| K143531 |
12/12/2014 |
Rapid Therapy System |
MAGSTIM COMPANY LIMITED |
Charles Hounsell |
| K143635 |
12/22/2014 |
KINETIS Total Knee System |
MAKO SURGICAL |
JONATHAN REEVES |
| K143752 |
12/31/2014 |
Total Knee Application (TKA) |
MAKO SURGICAL CORP. |
JONATHAN REEVES |
| K143567 |
12/16/2014 |
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for l |
MARVAO MEDICAL DEVICES, LTD. |
CHRISTOPHER DAVEY |
| K143453 |
12/03/2014 |
Mpact Double Mobility System |
Medacta International |
Adam Gross |
| K143662 |
12/23/2014 |
Bissinger Monopolar Forceps and Cables |
MEDAGENT, INC |
Franz Menean |
| K143669 |
12/24/2014 |
MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter |
MEDGYN PRODUCTS, INC. |
AMAR AGADI |
| K143688 |
12/24/2014 |
ASFORA ANTERIOR CERVICAL PLATE SYSTEM |
MEDICAL DESIGNS, LLC |
KRISTI VONDRA |
| K143615 |
12/19/2014 |
Antistatic Compact Space Chamber |
MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED |
MAGGIE OH |
| K143485 |
12/08/2014 |
iGuide 2.1 |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K143447 |
12/02/2014 |
Dilapan-S |
Medicem Technology s.r.o. |
Adam Vlcek |
| K143634 |
12/22/2014 |
MUSE System |
MEDIGUS LTD. |
SHARON KANETY DERESH |
| K143693 |
12/24/2014 |
MEDLINE SHARPS CONTAINERS |
MEDLINE INDUSTRIES, INC. |
Matt Clausen |
| K143529 |
12/12/2014 |
UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer |
MEDLINE INDUSTRIES, INC. |
JENNIFER MASON |
| K143711 |
12/29/2014 |
Reaxon Plus |
MEDOVENT GMBH |
THOMAS FREIER |
| K143480 |
12/08/2014 |
Euphora Rapid Exchange Balloon Dilatation Catheter |
MEDTRONIC INC. |
John Kilmartin |
| K143569 |
12/16/2014 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
GREGORY MASCHEK |
| K143628 |
12/22/2014 |
Navigated Vertex Select Instruments |
MEDTRONIC SOFAMOR DANEK USA, INC |
Tejas Patel |
| K143471 |
12/05/2014 |
VERTEX Reconstruction System |
Medtronic Sofamor Danek USA, Inc |
Lee Grant |
| K143583 |
12/18/2014 |
Cathivex ?GV filter units |
MERCK MILLIPORE LTD. |
CHRIS PARR |
| K143429 |
12/01/2014 |
Passage Hemostasis Valve |
MERIT MEDICAL SYSTEMS, INC. |
MARK MULLANEY |
| K143426 |
12/01/2014 |
Wound Matrix TF |
MIROMATRIX MEDICAL INC. |
Jeff Ross |
| K143457 |
12/03/2014 |
NeuroBlate System |
MONTERIS MEDICAL, INC. |
Brooke Ren |
| K143622 |
12/22/2014 |
dynaMX Compression Staple |
MX Orthopedics, Corp. |
Howard L. Schrayer |
| K143653 |
12/23/2014 |
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) |
NANOSPHERE, INC |
Noah Lermer |
| K143706 |
12/29/2014 |
FortiBridge Anterior Cervical Plate System |
Nanovis Spine LLC |
Matthew Hedrick |
| K143433 |
12/01/2014 |
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm |
Natus Manufacturing Limited |
Michael Galvin |
| K143440 |
12/02/2014 |
Natus Quantum |
NATUS MEDICAL INCORPORATED |
SANJAY MEHTA |
| K143607 |
12/19/2014 |
I-Portal NOTC, VNG and VOG |
NEURO KINETICS, INC. |
J. Howison Schroeder |
| K143458 |
12/04/2014 |
Neurosplint |
Neurospectrum LLC |
David Kernan |
| K143507 |
12/10/2014 |
NFANT Feeding Solution |
NFANT Labs, LLC |
Lou Malice |
| K143703 |
12/29/2014 |
NICAL SMART MICRO CR system for intraoral dental images |
NICAL SPA |
ROBERTO NICCOLUCCI |
| K143678 |
12/24/2014 |
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory |
NINEPOINT MEDICAL, INC. |
SCOTT BLOOD |
| K143608 |
12/19/2014 |
NovaCross Microcatheter |
Nitiloop Ltd. |
Michael A Daniel |
| K143523 |
12/12/2014 |
Airlock osteosynthesis plate system |
NOVASTEP |
Gilles AUDIC |
| K143684 |
12/24/2014 |
NuVasive Reline System |
NUVASIVE INCORPORATED |
OLGA LEWIS |
| K143641 |
12/22/2014 |
NuVasive NVM5 System |
NuVasive, Incorporated |
Jeremy Markovich |
| K143579 |
12/18/2014 |
NuVasive Sterilization Trays |
NuVasive, Incorporated |
Olga Lewis |
| K143595 |
12/18/2014 |
NuVasive(R) CCX-L Interbody System |
NuVasive, Incorporated |
Cynthia Adams |
| K143561 |
12/16/2014 |
ELM PTA Balloon Dilatation Catheter |
O'CONNELL REGULATORY CONSULTANTS, INC. |
Maureen O'Connell |
| K143590 |
12/18/2014 |
Alevicyn SG Antipruritic Gel |
OCULUS INNOVATIVE SCIENCES |
Brian W Martin |
| K143609 |
12/19/2014 |
Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
MARY ANNE PATELLA |
| K143463 |
12/04/2014 |
IS4/DF4 Port Plug |
Oscor Inc. |
Dorit Segal |
| K143572 |
12/17/2014 |
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK |
Osteomed Implantes, LTDA |
Niderdani Ragonha |
| K143596 |
12/18/2014 |
MINIARS SCREWS |
OVERMED SRL. |
DAVIDE PIZZAMIGLIO |
| K143696 |
12/24/2014 |
Spirit |
PELTON & CRANE |
Frank Ray |
| K143727 |
12/29/2014 |
PENTAX Medical EKP-i5010 Video Processor with EB Family |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K143606 |
12/19/2014 |
MultiBand SENSE |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Jan van de Kerkhof |
| K143488 |
12/08/2014 |
InFill Graft Delivery System |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K143435 |
12/01/2014 |
Planmed Verity |
PLANMED OY |
Lars Moring |
| K143477 |
12/05/2014 |
Nitrile Patient Examination gloves, Powderfree, Blue color |
PRIMUS GLOVES PVT LIMITED |
JOSE PAUL M |
| K143515 |
12/11/2014 |
Inclusive« Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants |
PRISMATIK DENTALCRAFT, INC. |
Brandon Shepard |
| K143533 |
12/12/2014 |
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE |
PROSIDYAN, INC. |
CHARANPREET S BAGGA |
| K143514 |
12/11/2014 |
Panther StereoSeed |
PROWESS, INC. |
Rachel Scarano |
| K143468 |
12/04/2014 |
QbCheck |
QBTECH AB |
Hans Bostrom |
| K143474 |
12/05/2014 |
Artemis Hand Held Imaging System |
QUEST MEDICAL IMAGING |
MARTIN HEUVELMANS |
| K143753 |
12/31/2014 |
Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio |
Rayence Co., Ltd |
Kevin Kim |
| K143671 |
12/23/2014 |
Propeller Model 2014-D Sensor |
Reciprocal Labs |
David Hubanks |
| K143511 |
12/11/2014 |
K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant |
RECKITT BENCKISER |
ELIZABETH TORRE |
| K143532 |
12/12/2014 |
Durex Silicone |
Reckitt Benckiser LLC |
Elizabeth Torre |
| K143466 |
12/04/2014 |
Hemogrip Patch |
REMEDIUM TECHNOLOGIES, INC. |
JOHN GUSTIN |
| K143647 |
12/22/2014 |
Renovis Surgical Hip Replacement System |
Renovis Surgical Technologies, Inc. |
Anthony DeBenedictis |
| K143603 |
12/18/2014 |
Darlinghurst Vented, Darlinghurst NV-AAV |
RESMED LTD. |
Jean-Nicholas Boudaud |
| K143623 |
12/22/2014 |
Narval Brux |
RESMED SAS |
Larissa D'Andrea |
| K143582 |
12/18/2014 |
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL |
RESORBA MEDICAL GMBH |
KARL JOSEF BECK |
| K143584 |
12/18/2014 |
PGA RESORBA, PGA RESOQUICK, GLYCOLON |
RESORBA MEDICAL GMBH |
KARL JOSEF BECK |
| K143694 |
12/24/2014 |
Rhondium One-Visit-Crown(OVC) |
Rhondium, Ltd. |
Greer Fricker |
| K143481 |
12/08/2014 |
IntellaMap Orion High Resolution Mapping Catheter |
RHYTHMIA MEDICAL, INC |
FRANK JURCZAK |
| K143476 |
12/05/2014 |
Digi-One |
RIMED LTD. |
AHAVA STEIN |
| K143446 |
12/02/2014 |
Accu-Chek FlexLink Plus infusion set |
Roche Diagnostics GmbH |
Alexander Ruegner |
| K143691 |
12/24/2014 |
LDLC3 LDL-Cholesterol Gen.3 |
Roche Diagnostics Operations (RDO) |
Noel B Mencias |
| K143534 |
12/12/2014 |
Elecsys CA-125 II assay |
ROCHE PROFESSIONAL DIAGNOSTICS |
LINDA MCCAMMACK |
| K143744 |
12/31/2014 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
GRACE LI |
| K143700 |
12/24/2014 |
CPAP Cannulaide |
Salter Labs |
Aurelia Brownridge |
| K143673 |
12/24/2014 |
CMOS Video Nasopharyngoscope System |
Schoelly Fiberoptic Gmbh |
Dr. Sandra Baumann |
| K143483 |
12/08/2014 |
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING |
SEBIA |
Karen Anderson |
| K143585 |
12/18/2014 |
Electric Breast Pump |
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD |
Jun Deng |
| K143472 |
12/05/2014 |
TE7 Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K143655 |
12/23/2014 |
SICAT OPTIMOTION |
SICAT GMBH & CO. KG |
MANFRED BREUER |
| K143720 |
12/29/2014 |
Dimension Vista MMB Assay |
Siemens Healthcare Diagnostics |
Kathleen Dray-Lyons |
| K143639 |
12/22/2014 |
IMMULITE 2000 CEA Calibration Verification Material |
Siemens Healthcare Diagnostics |
Asha Gartland |
| K143504 |
12/10/2014 |
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material |
Siemens Healthcare Diagnostics Inc. |
Sara Kastrup |
| K143687 |
12/24/2014 |
ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Fatima Pacheco |
| K143680 |
12/24/2014 |
ADVIA Centaur IgE Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Fatima Pacheco |
| K143636 |
12/22/2014 |
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Donna Velasquez |
| K143493 |
12/09/2014 |
SignosRT Bladder Ultrasound System |
Signostics Ltd |
Stewart Bartlett |
| K143459 |
12/04/2014 |
Silk Road Acccess Catheter |
SILK ROAD MEDICAL, INC |
RICHARD M RUEDY |
| K143624 |
12/22/2014 |
Headless Compression Screw System |
SKELETAL DYNAMICS, LLC |
Ana M. Escagedo |
| K143512 |
12/11/2014 |
ActiSpec Activity Monitor |
SLEEP MODUS, INC. |
STANFORD P HUDSON |
| K143739 |
12/30/2014 |
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA |
SMITH & NEPHEW, INC. |
JEFF SPRAGUE |
| K143448 |
12/02/2014 |
Sonendo GentleWave System |
Sonendo, Inc. |
JENNY FAM |
| K143601 |
12/18/2014 |
U-Lite |
Sonoscanner SARL |
Bruno Richard |
| K143751 |
12/31/2014 |
Visi Mobile Monitoring System |
Sotera Wireless, Inc. |
Eben Gordon |
| K143683 |
12/24/2014 |
APEX-DL Spine System |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K143562 |
12/16/2014 |
Reprocessed Cordless Ultrasonic Dissection Device |
STERILMED, INC. |
Nicole Boser |
| K143661 |
12/23/2014 |
DirectInject |
STRYKER |
Nathan VanSweden |
| K143597 |
12/18/2014 |
Navigated XIA 4.5 Polyaxial Screwdriver |
STRYKER CORPORATE |
BECKY DITTY |
| K143616 |
12/19/2014 |
AccuLIF TL and PL Cage |
STRYKER CORPORATION |
Aakash Jain |
| K143546 |
12/15/2014 |
Imbibe Aspirating XIA Taps |
Stryker Corporation |
Soraya King |
| K143540 |
12/15/2014 |
Stryker MIS Attachments and Cutting Accessories |
STRYKER CORPORATION |
Mairead Twomey |
| K143588 |
12/18/2014 |
Surefire Infusion System 021 |
SUREFIRE MEDICAL, INC |
Lynne Aronson |
| K143728 |
12/29/2014 |
Minhua Disposable Blood Pressure Cuff |
SUZHOU MINHUA MEDICAL APPARATUS |
Ji Dong Yang |
| K143444 |
12/02/2014 |
SynePure Wound Cleanser |
Synedgen Inc. |
Shenda Baker |
| K143589 |
12/18/2014 |
GEM Flow COUPLER Device and System |
Synovis Life Technologies, Inc. |
Jodi Jorgenson |
| K143577 |
12/17/2014 |
XW-100 Automated Hematology Analyzer, XW QC CHECK |
SYSMEX AMERICA, INC. |
Peter Shearstone |
| K143467 |
12/04/2014 |
FORA GD43 Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
C. W. CHEN |
| K143692 |
12/24/2014 |
GranOSTM - beta tricalcium phosphate synthetic bone granules |
TCM ASSOCIATES LTD |
IAIN ALLIGAN |
| K143581 |
12/18/2014 |
Arrow Epidural Catheter Kit |
Teleflex Medical, Inc. |
Angela Bouse |
| K143469 |
12/05/2014 |
SOFTECH Plus ETCO2 Cannula |
TELEFLEX MEDICAL, INC. |
Brian Gall |
| K143445 |
12/02/2014 |
Tellos ISQ Buddy |
Tellos Medical AB |
Anders Petersson |
| K143592 |
12/18/2014 |
GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC |
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY |
Kenneth A. Bertram |
| K143526 |
12/12/2014 |
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) |
Thermo Fisher Scientfic |
Cynthia Knapp |
| K143479 |
12/08/2014 |
Bluefin Interbody System |
Tides Medical |
J. Doug Payne |
| K143552 |
12/15/2014 |
Simpliciti Shoulder System |
TORNIER, INC. |
Loucinda Bjorklund |
| K143717 |
12/29/2014 |
Treace Medical Concepts(TMC) Plating System |
Treace Medical Concepts, INc. |
Joe Ferguson |
| K143548 |
12/15/2014 |
TRUE METRIX GO Self Monitoring Blood Glucose System |
Trividia Health, Inc. |
Beth Foster |
| K143631 |
12/22/2014 |
Benefix Interspinous Fixation System |
U & I Corporation |
Young-Geun Kim |
| K143629 |
12/22/2014 |
U&U Bowie-Dick Test Pack |
U&U MEDICAL TECHNOLOGY CO., LTD |
GARFIELD WANG |
| K143637 |
12/22/2014 |
U&U Sterilization Pouch and Roll |
U&U Medical Technology Co.,Ltd |
Garfield Wang |
| K143664 |
12/23/2014 |
HeartSee |
UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON |
K Lance Gould |
| K143424 |
12/01/2014 |
UTAH CVX-RIPE |
UTAH MEDICAL PRODUCTS, INC. |
Ben Shirley |
| K143652 |
12/23/2014 |
Vector PTA Balloon Dilatation Catheter |
Vector Corporation LLC |
Jay Sturm |
| K143554 |
12/15/2014 |
Venus Legacy CX |
Venus Concept Ltd. |
Orit Ron Edoute |
| K143685 |
12/24/2014 |
Hedgehog Cervical Interbody Fusion Device |
Vertera, Inc. |
Stephen Laffoon |
| K143617 |
12/19/2014 |
AquaC UNO H |
VIVONIC GMBH |
Andreas Hessberger |
| K143549 |
12/15/2014 |
Vivorte Trabexus |
VIVORTE, INC |
ROBERT BURDEN |
| K143547 |
12/15/2014 |
Vivorte Trabexus EB |
VIVORTE, INC |
Robert Burden |
| K143486 |
12/08/2014 |
Ufi Gel hard C |
VOCO GMBH |
M.Th. Plaumann |
| K143701 |
12/24/2014 |
EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K143704 |
12/29/2014 |
Advanced Air System |
W & H Dentalwerk Buermoos GmbH |
Anja Lindner |
| K143724 |
12/29/2014 |
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
Gordana Pozvek |
| K143460 |
12/04/2014 |
Cannulated Screw System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Tara Conrad |
| K143741 |
12/31/2014 |
Lipofina Laser System |
YOLO MEDICAL, INC. |
Robert J Krznaric |
| K143528 |
12/12/2014 |
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System |
ZIMMER DENTAL INC. |
CHRISTINA BOYDSTON |
| K143505 |
12/10/2014 |
Zimmer Patient-Specific Abutment, Internal Hex, Titanium |
Zimmer Dental, Inc. |
Christina Boydston |
| K143626 |
12/22/2014 |
inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele |
Zimmer Spine, Inc. |
Donna M. Semlak |
| K143618 |
12/19/2014 |
Kirschner Wires, Steinmann Pins |
ZIMMER, INC. |
PATRICK MCCULLAGH |
