FDA 510(k) Applications Submitted by JAY MANSOUR

FDA 510(k) Number Submission Date Device Name Applicant
K030081 01/09/2003 CSF400 AND CSF600 INMED LTDA.
K030466 02/12/2003 HANDYDOP ELCAT, GMBH
K020478 02/13/2002 ELECTROMEDICARIN 900 ELECTROMEDICARIN, S.A.
K110509 02/22/2011 EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K020749 03/07/2002 DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K020750 03/07/2002 DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K080661 03/10/2008 MODELS TENS 7000, EMS 7500 AND TWIN STIM KOALATY PRODUCTS, INC.
K040691 03/17/2004 INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D WIN-US TECHNOLOGY CO., LTD.
K030887 03/21/2003 LEKTROGEL, MODEL LK3001 INMED LTDA.
K030889 03/21/2003 ULTRAEKOGEL MODELS EK 2000 & EK 2001 INMED LTDA.
K080853 03/26/2008 DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM GENEXEL-SEIN, INC.
K021012 03/29/2002 LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM QUALITY MEDICAL SOLUSIONS LLC
K050807 03/30/2005 20G SMA LASER FIBER, MODEL LF100 OPHTHALMED LLC
K061175 04/27/2006 CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES SOTA PRECISION OPTICS, INC.
K051126 05/03/2005 CARDIOSCOPE SONOPLUS 3000 PULSONIC AG, MEDICAL TECHNOLOGY
K031463 05/08/2003 MARINA MEDICAL SILICONE PESSARY MARINA MEDICAL INSTRUMENTS, INC.
K091424 05/13/2009 OSTA MAXIGRO AND REGIGRO OSTA TECHNOLOGIES
K041308 05/17/2004 REMOTENURSE PATIENT MONITORING SYSTEM WEBVMC, LLC
K041311 05/17/2004 TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) TIGER MEDICAL PRODUCTS LTD
K021696 05/22/2002 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 OPHTHALMED LLC
K081537 06/02/2008 CFS FLEXIBLE COMFORT AND FLEXIBLE SYSTEMS
K071523 06/04/2007 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 GENEXEL-SEIN, INC.
K021876 06/07/2002 MAS WITH OR WITHOUT SYRINGE MARINA MEDICAL INSTRUMENTS, INC.
K092061 07/08/2009 FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 GENEXEL MEDICAL INSTRUMENT INC
K071951 07/16/2007 COMFY SERIES: EV-804, EV-805 & EV-806 EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K112074 07/20/2011 EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K122206 07/25/2012 GARAVENTA X3 INCLINED PLATFORM LIFT GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT]
K042014 07/27/2004 DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 SEIN ELECTRONICS CO., LTD.
K032341 07/29/2003 INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 SOTA PRECISION OPTICS, INC.
K052108 08/03/2005 SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 SEIN ELECTRONICS CO., LTD.
K042138 08/09/2004 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 SEIN ELECTRONICS CO., LTD.
K032517 08/14/2003 MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE MEDSAFE TECHNOLOGIES LLC.
K012819 08/23/2001 SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
K032612 08/25/2003 IR FOREHEAD THERMOMETER, MODEL HV-T36 ORIENTAL INSPIRATION LTD
K023034 09/12/2002 CARDIOTOUCH-3000 BIONET COMPANY LTD
K023082 09/17/2002 BABYCARE BIONET COMPANY LTD
K042534 09/17/2004 MARINA MEDICAL FINGER PROTECTORS MARINA MEDICAL INSTRUMENTS, INC.
K032927 09/22/2003 FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR SEIN ELECTRONICS CO., LTD.
K033164 09/30/2003 ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM DR. LEN'S MEDICAL PRODUCTS LLC
K142830 09/30/2014 Ophthalmed Bending Laser Probes OPHTHALMED LLC
K093105 10/01/2009 VISTEO OWANDY
K083008 10/08/2008 COOLSKIN ELBIO CO., LTD
K063110 10/11/2006 CST61 HIGH SPEED TURBINE HANDPIECE SHANGHAI DENTAL INSTRUMENT FACTORY
K013437 10/17/2001 SF SH CATHETER, MODEL R65-945 A & A MEDICAL, INC.
K013491 10/22/2001 HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 A & A MEDICAL, INC.
K013560 10/26/2001 SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT
K023725 11/06/2002 HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 MARINA MEDICAL INSTRUMENTS, INC.
K033544 11/10/2003 ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K083302 11/10/2008 LIFECARE ELECTRODES EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
K023823 11/15/2002 EASYCUP ZER HITECH
K053225 11/17/2005 CELLU M6 KEYMODULE I LPG ONE, INC
K063526 11/22/2006 A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER A-M SYSTEMS, INC.
K014112 12/14/2001 SATARI LATEX PATIENT EXAMINATION POWDERED GLOVE SINGLE SIDE POLYMER COATED, NON STERILE, 200 MG OR LESS OF TOTAL WATER E SIAM SEMPERMED CORP. LTD.
K014110 12/14/2001 SATARI POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) POLYMER COATED WHIT SIAM SEMPERMED CORP. LTD.
K083756 12/17/2008 GUARDIAN 150 ELECTRODE SELECTIVE MED COMPONENTS, INC.
K103719 12/21/2010 LIFECARE CONDUCTIVE GARMENTS EVERYWAY MEDICAL INSTRUMENTS CO., LTD.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact