FDA 510(k) Premarket Notification K091762: DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration

MEDTRONIC XOMED, INC. Registration: 1045254 View Registration

ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration

INTELLIGENT HEARING SYSTEMS CORP. Registration: 1052723 View Registration

PRIZM MEDICAL, INC. Registration: 1055808 View Registration

REMINGTON MEDICAL, INC. Registration: 1056553 View Registration

DeRoyal Industries, Inc. Registration: 1060680 View Registration

LifeSync Corporation Registration: 1063285 View Registration

RHYTHMLINK INTERNATIONAL, LLC Registration: 1067162 View Registration

Conmed Corporation Registration: 1223925 View Registration

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies Registration: 1317188 View Registration

CONMED CORPORATION Registration: 1320894 View Registration

MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration

SOMATICS, LLC Registration: 1420295 View Registration

Cardinal Health 200, LLC Registration: 1423537 View Registration

Sterigenics US LLC Registration: 1423662 View Registration

Omron Healthcare, Inc. Registration: 1450057 View Registration

WillowWood Global LLC Registration: 1522166 View Registration

Sterigenics US, LLC Registration: 1526534 View Registration

PAIN MANAGEMENT TECHNOLOGIES Registration: 1528161 View Registration

ELECTRO-CAP INTL., INC. Registration: 1626185 View Registration

RS MEDICAL Registration: 1644243 View Registration

COMPUMEDICS USA, INC. Registration: 1650946 View Registration

CLEARLAKE-TECH INC Registration: 1721293 View Registration

ACCELERATED CARE PLUS CORP. Registration: 1911273 View Registration

Cardinal Health Registration: 1921846 View Registration

KATECHO LLC Registration: 1930027 View Registration

Geodis Logistics Registration: 2000004234 View Registration

METTLER ELECTRONICS CORP. Registration: 2013558 View Registration

THE ELECTRODE STORE Registration: 2022388 View Registration

Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration

AXELGAARD MFG. CO., LTD. Registration: 2025066 View Registration

GEREONICS, INC. Registration: 2025694 View Registration

ALPHATEC SPINE, INC. Registration: 2027467 View Registration

R & D MEDICAL PRODUCTS, INC. Registration: 2031094 View Registration

NIHON KOHDEN AMERICA, INC. Registration: 2080783 View Registration

DIAGNOSTIC GROUP LLC Registration: 2113281 View Registration

PEPIN MFG., INC. Registration: 2132556 View Registration

Innovize Registration: 2135339 View Registration

Cardinal Health Registration: 2183164 View Registration

MINDRAY DS USA, Inc. Registration: 2221819 View Registration

NEUROTRON MEDICAL Registration: 2245302 View Registration

Covidien Registration: 2936999 View Registration

NORTH COAST MEDICAL, INC. Registration: 2939821 View Registration

SUZHOU ENNOVA ELECTRONIC TECHNOLOGY CO LTD Registration: 3000947648 View Registration

OMRON (DALIAN) CO., LTD. (PLANT 1) Registration: 3001373226 View Registration

DAEHAN MEDICAL SYSTEMS CO.,LTD Registration: 3002893037 View Registration

ASIATIC FIBER CORPORATION Registration: 3002923871 View Registration

FIAB SPA Registration: 3003072803 View Registration

TENSCARE LTD. Registration: 3003446042 View Registration

Electrostim Medical Services, Inc. Registration: 3003573572 View Registration

WANDY RUBBER INDUSTRIAL CO., LTD Registration: 3003749270 View Registration

Xian Friendship Medical Electronics Co., Ltd. Registration: 3003851073 View Registration

HI-DOW INTERNATIONAL INC. Registration: 3003895865 View Registration

EDAN INSTRUMENTS, INC. Registration: 3003971136 View Registration

AMBU SDN.BHD. Registration: 3004040397 View Registration

GEMORE TECHNOLOGY CO., LTD. Registration: 3004146401 View Registration

Industrial Vallera de Mexicali, S. A. de C. V. Registration: 3004415095 View Registration

INFINITE BIOMEDICAL TECHNOLOGIES, LLC Registration: 3004426795 View Registration

BIOWAVE CORPORATION Registration: 3004558433 View Registration

INCEREB LTD Registration: 3004695199 View Registration

EVERLIFE MEDICAL EQUIPMENT CO., LTD. Registration: 3004753827 View Registration

InterX Technologies Registration: 3004786509 View Registration

AVAZZIA, INC. Registration: 3004839404 View Registration

MEDICO ELECTRODES INTERNATIONAL LTD Registration: 3004903538 View Registration

GLOBAL INTERCONNECT, INC. Registration: 3004920696 View Registration

Shenzhen Dongdixin Technology Co., Ltd. Registration: 3005170249 View Registration

Otto Bock Healthcare Products GmbH Registration: 3005190268 View Registration

JOMEL SEAMS REASONABLE LLC Registration: 3005463575 View Registration

INSPIRSTAR, INC. Registration: 3005511941 View Registration

BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Registration: 3005569927 View Registration

SPES MEDICA S.P.A Registration: 3005581220 View Registration

Natus Manufacturing Limited Registration: 3005581270 View Registration

FAMIDOC TECHNOLOGY CO., LTD Registration: 3005621440 View Registration

SHENZHEN ZIFOUND INFONET TECHNOLOGY CO., LTD. Registration: 3005663471 View Registration

SVTRONICS, INC. Registration: 3005698910 View Registration

G.TEC MEDICAL ENGINEERING GMBH Registration: 3005713796 View Registration

KONAN MEDICAL USA, INC. Registration: 3005955744 View Registration

NEUROVIRTUAL USA, INC. Registration: 3006125362 View Registration

DOMINO S.R.L. Registration: 3006153348 View Registration

FISHER WALLACE LABORATORIES Inc Registration: 3006258094 View Registration

BSG Corp Registration: 3006315274 View Registration

TONE-A-MATIC INTERNATIONAL, INC. Registration: 3006551156 View Registration

Top-rank Health Care Co.,Ltd. Registration: 3006626283 View Registration

SHENZHEN MED-LINK ELECTRONICS TECH CO.,LTD Registration: 3006636961 View Registration

PINE MOON ELECTRONICS CO., LTD. Registration: 3006697681 View Registration

Well-Life Healthcare Limited Registration: 3006850006 View Registration

RITM OKB ZAO Registration: 3007028037 View Registration

CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD. Registration: 3007048259 View Registration

DJO FRANCE SAS Registration: 3007502541 View Registration

Shenzhen Mindray Bio-Medical Electronics Co.,LTD Registration: 3007603826 View Registration

GYMMAX TECHNOLOGY SHENZHEN CO., LTD Registration: 3007689716 View Registration

WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD Registration: 3007710601 View Registration

VGH SOLUTIONS INC Registration: 3007731000 View Registration

BAISHENG MEDICAL CO.,LTD. Registration: 3007748793 View Registration

HOSMED INC. Registration: 3007836437 View Registration

G.TEC MEDICAL ENGINEERING GMBH Registration: 3008008477 View Registration

DRTV Asia LTD Registration: 3008048783 View Registration

GMDASZ MANUFACTURING CO., LTD. Registration: 3008197884 View Registration

CELESTICA ELECTRONICS (S) PTE LTD. Registration: 3008202779 View Registration

HI-TECH PRODUCTS DE MEXICO S.A. DE C.V. Registration: 3008255748 View Registration

AMPCARE, LLC Registration: 3008273892 View Registration

MORGAN NEWTON COMPANY Registration: 3008312728 View Registration

CHOICEMMED AMERICA CORPORATION Registration: 3008507279 View Registration

Axiobionics, LLC, Center for Neuroprosthetics Registration: 3008525454 View Registration

NEUROWAVE SYSTEMS INC. Registration: 3008657519 View Registration

SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. Registration: 3008716327 View Registration

Handelshaus Dittmann GmbH Registration: 3008729899 View Registration

Ives EEG Solutions Registration: 3008806011 View Registration

TECHNOMED ASIA, PT. Registration: 3008892509 View Registration

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Registration: 3009156722 View Registration

UPS SUPPLY CHAIN SOLUTIONS, INC. Registration: 3009171251 View Registration

DYMEDIX DIAGNOSTICS INC Registration: 3009351773 View Registration

EAGLE ELECTRODE MANUFACTURING, LLC Registration: 3009492424 View Registration

EDAN Diagnostics, Inc. Registration: 3009499478 View Registration

Cathay Manufacturing Corp. Registration: 3009555600 View Registration

STERIPACK USA (LIMITED) LLC Registration: 3009656988 View Registration

MASIMO CORPORATION Registration: 3009831876 View Registration

ACTEGY LTD. Registration: 3010078417 View Registration

GUANGZHOU XINBO ELECTRONIC CO., LTD Registration: 3010097863 View Registration

HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED Registration: 3010402752 View Registration

HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD Registration: 3010417025 View Registration

WUHAN GREENTEK PTY LTD. Registration: 3010515191 View Registration

Coapt LLC Registration: 3010605876 View Registration

Natus Neurology Incorporated Registration: 3010611950 View Registration

BIO PROTECH YANTAI INC Registration: 3010805941 View Registration

HONG KONG MEDSOURCING LIMITED Registration: 3010852191 View Registration

BEAR DOWN BRANDS, LLC Registration: 3011077581 View Registration

VIVE Health LLC Registration: 3011191255 View Registration

EVERYWAY4ALL Registration: 3011267903 View Registration

VONCARE MEDICAL DEVICE CO LTD Registration: 3011307234 View Registration

DGS Diagnostics Sp. z o.o Registration: 3011310592 View Registration

MASIMO CORPORATION Registration: 3011353843 View Registration

NEUROMETRIX, INC. Registration: 3011412151 View Registration

Motive Health, Inc. Registration: 3011466827 View Registration

SPES MEDICA S.P.A Registration: 3011534533 View Registration

FIDELTRONIK POLAND SP. Z O.O. Registration: 3011766844 View Registration

SHENZHEN KONMED TECHNOLOGY CO., LTD Registration: 3011905669 View Registration

SMART RECOVERY TECHNOLOGIES LLC Registration: 3012176966 View Registration

COMPASS HEALTH BRANDS (CORPORATE OFFICE) Registration: 3012316249 View Registration

COLUMBIA SCIENTIFIC DEVELOPMENT, LLC Registration: 3012321270 View Registration

Therabody, Inc. Registration: 3012386142 View Registration

SANICURE BV Registration: 3012494290 View Registration

TAIZHOU CHENGUANG IMPORT AND EXPORT TRADING CO., LTD. Registration: 3012680643 View Registration

EASY HEALTHCARE CORPORATION Registration: 3012725363 View Registration

ETEKCITY CORPORATION Registration: 3012840029 View Registration

ASCENTRON, INC. Registration: 3013069546 View Registration

VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration

THERAGEN, INC. Registration: 3013378804 View Registration

MED-LINKET CORP Registration: 3013426279 View Registration

Amphenol Cable and Interconnect Technologies Asia Pacific Ltd. Registration: 3013500228 View Registration

CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration

Amphenol Medical Technologies (Dongguan) Co., Ltd. Registration: 3013596024 View Registration

SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD Registration: 3013671142 View Registration

CERIBELL, INC. Registration: 3013671918 View Registration

WAVI CO Registration: 3013757456 View Registration

SHENZHEN YUWEN E-COMMERCE CO., LTD. Registration: 3013957847 View Registration

BIOSERENITY MEDICAL DEVICES GROUP Registration: 3014027738 View Registration

SHENZHEN ROUNDWHALE TECHNOLOGY CO. LTD. Registration: 3014314933 View Registration

WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration

FASHIONABLE, INC. Registration: 3014647250 View Registration

WAT MEDICAL TECHNOLOGY INC. Registration: 3014649088 View Registration

SHAOXING DL HEALTHCARE CO., LTD. Registration: 3014659326 View Registration

EPITEL Registration: 3014692331 View Registration

DONG GUAN OU KANG ELECTRONICS CO.,LTD Registration: 3015060202 View Registration

SHAOXING YINGTUO HEALTHCARE CO.,LTD. Registration: 3015429360 View Registration

SHENZHEN BESTPAD TECHNOLOGY DEVELOPMENT CO., LTD Registration: 3015531976 View Registration

CGX, LLC Registration: 3015614098 View Registration

Industrial Vallera de Mexicali, S.A. de C.V. (Terra) Registration: 3016674095 View Registration

Nihon Kohden Corporation - Eastern Japan Logistics Center Registration: 3016852448 View Registration

VOMA ECZA DEPOSU MEDIKAL URUNLER SAN. TIC. A.S. Registration: 3017210488 View Registration

DJO, LLC Registration: 3017264244 View Registration

DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD Registration: 3017450375 View Registration

SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD. Registration: 3017619536 View Registration

Hugh Steeper Ltd DBA SteeperUSA Registration: 3017697481 View Registration

ETEKCITY COMPANY LIMITED Registration: 3017887928 View Registration

SHENZHEN HUAYAN E-COMMERCE CO., LTD. Registration: 3017953405 View Registration

Zeto EU Kft. Registration: 3017970307 View Registration

BIONIT LABS S.R.L. Registration: 3018070844 View Registration

Medtronic Engineering and Innovation Center (MEIC) Registration: 3018094310 View Registration

OXILINE LLC Registration: 3018940143 View Registration

Masimo Corporation Registration: 3019388613 View Registration

Verity Medical Ltd (Ireland) Registration: 3019822804 View Registration

SHENZHEN DELIDUO MEDICAL TECHNOLOGY CO., LTD Registration: 3019865183 View Registration

Alphatec Spine, Inc. Registration: 3019878714 View Registration

CADWELL INDUSTRIES, INC. Registration: 3020018 View Registration

QUANTALX NEUROSCIENCE Registration: 3020494684 View Registration

PAMEL D.O.O. Registration: 3021192567 View Registration

COMEPA INDUSTRIES LIMITED Registration: 3021602003 View Registration

ZETO, INC. Registration: 3021826057 View Registration

NXTSTIM, LLC Registration: 3022631685 View Registration

BIOANA Registration: 3022954003 View Registration

LEAD-LOK, INC. d.b.a Nissha Medical Technologies Registration: 3023164 View Registration

BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD. Registration: 3023237645 View Registration

Therabody Australia Pty. Ltd. Registration: 3023613474 View Registration

IMEDISYNC INC. Registration: 3023707151 View Registration

PASCALL SYSTEMS INC Registration: 3024892936 View Registration

HI TECH ELECTRONIC MANUFACTURING CORPORATION Registration: 3025186177 View Registration

VESYNC (SINGAPORE) PTE.LTD. Registration: 3026753375 View Registration

Masimo Medical Technologies (Malaysia) SDN BHD Registration: 3027256461 View Registration

AXION USA LLC Registration: 3027329006 View Registration

ALLIANCE NEURODIAGNOSTICS, LLC, D/B/A STRATUS Registration: 3027532607 View Registration

DYNAPULSE MEDICAL LLC Registration: 3027718340 View Registration

BEAR DOWN BRANDS, LLC CHINO WAREHOUSE Registration: 3028172072 View Registration

MULLAN MEDICAL (VIETNAM) LIMITED COMPANY Registration: 3029973920 View Registration

IMEX, LLC Registration: 3030151584 View Registration

ADP HEALTH LIMITED Registration: 3030597665 View Registration

BOI(VIETNAM) Company Ltd Registration: 3030978471 View Registration

KRENERB, LLC Registration: 3031464228 View Registration

SEACOMP DISPLAYS Registration: 3033509895 View Registration

MYOCENE Registration: 3036833452 View Registration

SHENZHEN JIANTUO ELECTRONICS CO., LTD Registration: 3038195193 View Registration

PRAYWISE TECHNOLOGY (DONGGUAN) CO., LTD Registration: 3042268484 View Registration

UAN Healthcare Limited Registration: 3043013796 View Registration

ZAPALIGN LLC Registration: 3043226252 View Registration

Drive Northpoint, LLC Registration: 3044563261 View Registration

ZIMMER MEDIZINSYSTEME GMBH Registration: 8010720 View Registration

LEONHARD LANG GMBH Registration: 8020045 View Registration

AMG MEDICAL INC. Registration: 8022077 View Registration

C.M.P. CANADIAN MEDICAL PRODUCTS INC. Registration: 8022189 View Registration

CHANGE HEALTHCARE CANADA COMPANY Registration: 8022257 View Registration

VALENTINE INTL. LTD. Registration: 8022890 View Registration

NIHON KOHDEN TOMIOKA PRODUCTION CENTER Registration: 8030229 View Registration

OMRON HEALTHCARE CO., LTD. Registration: 8030245 View Registration

ORIDION MEDICAL 1987 LTD. Registration: 8044004 View Registration

GE HEALTHCARE FINLAND OY Registration: 9610105 View Registration

Ambu A/S Registration: 9610691 View Registration

HIVOX BIOTEK INC. Registration: 9611558 View Registration

HUGH STEEPER LTD Registration: 9612243 View Registration

NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) Registration: 9612330 View Registration

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH Registration: 9612389 View Registration

COMPUMEDICS LIMITED Registration: 9613619 View Registration

DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V. Registration: 9616086 View Registration

Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH Registration: 9616494 View Registration

EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Registration: 9616877 View Registration

ZMI ELECTRONICS LTD. Registration: 9617486 View Registration

Nicolay GMBH Registration: 9681377 View Registration

Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) Registration: 9681860 View Registration

INTERACOUSTICS A/S Registration: 9710051 View Registration

TECHNOMED EUROPE Registration: 9710376 View Registration

HOME CARE TECHNOLOGY CO., LTD. Registration: 9710580 View Registration

BIO PROTECH, INC. Registration: 9710582 View Registration

GE MEDICAL SYSTEMS (CHINA) CO., LTD. Registration: 9710602 View Registration

DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE

Submission Details & Decision

Related Establishments / Registrations

Public Record Disclaimer