Establishment Registration & Device Listing

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</div> </div>  <div class="clearfloat"> - </div>      <span id="user_provided"> <style> .rl { color: #000000; width: 900px; float: right; margin: 0px 25px 0px 0px; } .rl-left { color: #000000; float: left; width: 610px; margin: 9px 30px 0px 0; } .rl-right { color: #000000; float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .rl-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #rl-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #rl-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #rl-form-title-left { font-size: 13px; font-weight: bold; } #rl-form-title-right { font-size: 11px; padding: 0px 0px 0px 300px; } #rl-results-table { table-layout:fixed; width: 610px; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #rl-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #rl-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #rl-results-table tr:nth-child(odd) { background-color: #f3f3f3; } .sort { float: right; margin-top: 5px;} .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } </style> <script type="text/javascript">  </script>  <div class="rl"> <div class="rl-left"> <div class="rl-intro"> <p>This database includes: <ul> <li>medical device manufacturers registered with FDA and</li> <li>medical devices listed with FDA</li> </ul> Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.<br> <p><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm" style="text-decoration:underline;">Learn More...</a></p> </p> </div> <div id="rl-form"> <FORM method="post" action="rl.cfm" name="Basic_Search" autocomplete="off"> <table align="center" width="100%" id="rl-form-title"> <tr> <td id="rl-form-title-left">Search Database</td> <td id="rl-form-title-right"><a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true"><img src="/scripts/cdrh/cfdocs/images/questionmark.gif"></a> <a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true">Help</a> <a href="https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download"><img src="/scripts/cdrh/cfdocs/images/download.gif"></a> <A HREF="https://www.fda.gov/medical-devices/device-registration-and-listing/establishment-registration-and-medical-device-listing-files-download">Download Files</A> </td> </tr> </table> <table bgcolor="#f9f9f3" width="100%" border=0 cellpadding="3" cellspacing="3" align="center" style="font-family: arial; color: #000000;"> <tr> <td> <table cellpadding="3" cellspacing="3"> <tr> <td><label for="EstablishmentName">Establishment<br>or Trade Name</label></td> <td><INPUT TYPE="text" NAME="establishmentName" ID="establishmentName" SIZE="20" MAXLENGTH="30" > </td> </tr> <tr> <td><label for="OwnerOperatorName">Owner/Operator<br>Name</label></td> <td><INPUT TYPE="text" NAME="OwnerOperatorName" ID="OwnerOperatorName" SIZE="20" MAXLENGTH="30" ></td> </tr> <tr> <td><label for="ProprietaryName">Proprietary<br>Name</label></td> <td> <INPUT TYPE="text" NAME="ProprietaryName" ID="ProprietaryName" SIZE="20" MAXLENGTH="30" > </td> </tr> <tr> <td><label for="ProductCode">Product<br>Code</label></td> <td> <INPUT TYPE="text" NAME="ProductCode" ID="ProductCode" SIZE="3" MAXLENGTH="3" > </td> </tr> <tr> <td> <label for="StateName">Establishment<br>State (U.S.)</label> </td> <td> <SELECT NAME="StateName"> <OPTION SELECTED> <option value="AL">ALABAMA</option> <option value="AK">ALASKA</option> <option value="AZ">ARIZONA</option> <option value="AR">ARKANSAS</option> <option value="CA">CALIFORNIA</option> <option value="CO">COLORADO</option> <option value="CT">CONNECTICUT</option> <option value="DE">DELAWARE</option> <option value="DC">DISTRICT OF COL</option> <option value="FL">FLORIDA</option> <option value="GA">GEORGIA</option> <option value="GU">GUAM</option> <option value="HI">HAWAII</option> <option value="ID">IDAHO</option> <option value="IL">ILLINOIS</option> <option value="IN">INDIANA</option> <option value="IA">IOWA</option> <option value="KS">KANSAS</option> <option value="KY">KENTUCKY</option> <option value="LA">LOUISIANA</option> <option value="ME">MAINE</option> <option value="MD">MARYLAND</option> <option value="MA">MASSACHUSETTS</option> <option value="MI">MICHIGAN</option> <option value="MN">MINNESOTA</option> <option value="MS">MISSISSIPPI</option> <option value="MO">MISSOURI</option> <option value="MT">MONTANA</option> <option value="NE">NEBRASKA</option> <option value="NV">NEVADA</option> <option value="NH">NEW HAMPSHIRE</option> <option value="NJ">NEW JERSEY</option> <option value="NM">NEW MEXICO</option> <option value="NY">NEW YORK</option> <option value="NC">NORTH CAROLINA</option> <option value="ND">NORTH DAKOTA</option> <option value="OH">OHIO</option> <option value="OK">OKLAHOMA</option> <option value="OR">OREGON</option> <option value="PA">PENNSYLVANIA</option> <option value="PR">PUERTO RICO</option> <option value="RI">RHODE ISLAND</option> <option value="SC">SOUTH CAROLINA</option> <option value="SD">SOUTH DAKOTA</option> <option value="TN">TENNESSEE</option> <option value="TX">TEXAS</option> <option value="UT">UTAH</option> <option value="VI">VIRGIN ISLANDS</option> <option value="VT">VERMONT</option> <option value="VA">VIRGINIA</option> <option value="WA">WASHINGTON</option> <option value="WV">WEST VIRGINIA</option> <option value="WI">WISCONSIN</option> <option value="WY">WYOMING</option> </SELECT> </td> </tr> </table> </td> <td> <table cellpadding="3" cellspacing="3"> <tr> <td><label for="RegistrationNumber">Registration<br>or FEI Number</label></td> <td><INPUT TYPE="text" NAME="RegistrationNumber" ID="RegistrationNumber" SIZE="20" MAXLENGTH="20"></td> </tr> <tr> <td><label for="OwnerOperatorNumber">Owner/Operator<br>Number</label></td> <td><INPUT TYPE="text" NAME="OwnerOperatorNumber" ID="OwnerOperatorNumber" SIZE="20" MAXLENGTH="20"></td> </tr> <tr> <td><label for="DeviceName">Classification<br>Device Name</label></td> <td> <INPUT TYPE="text" NAME="DeviceName" ID="DeviceName" SIZE="20" MAXLENGTH="30" > </td> </tr> <tr> <td align="left" nowrap> <label for="EstablishmentType">Establishment<br>Type</label> </td> <td> <SELECT NAME="EstablishmentType"> <OPTION SELECTED> <option value="11">Complaint File Estab</option> <option value="1">Contract Manufacture</option> <option value="2">Contract Sterilizer</option> <option value="3">Foreign Exporter</option> <option value="12">Foreign Private Labe</option> <option value="5">Manufacturer</option> <option value="6">Remanufacturer</option> <option value="7">Repackager/Relabeler</option> <option value="8">Reprocessor of Singl</option> <option value="9">Specification Develo</option> <option value="10">U.S. Manufacturer of</option> <option value="0" >Initial Distributor/Importer</option> </SELECT> </td> </tr> <tr> <td> <label for="CountryName">Establishment<br>Country *</label> </td> <td> <select name="CountryName"> <option selected></option> <option value="AF">AFGHANISTAN</option> <option value="QZ">AKROTIRI</option> <option value="AL">ALBANIA</option> <option value="DZ">ALGERIA</option> <option value="AS">AMERICAN SAMOA</option> <option value="AD">ANDORRA</option> <option value="AO">ANGOLA</option> <option value="AI">ANGUILLA</option> <option value="AQ">ANTARCTICA</option> <option value="AG">ANTIGUA & BARBUDA</option> <option value="AR">ARGENTINA</option> <option value="AM">ARMENIA</option> <option value="AW">ARUBA</option> <option value="XA">ASHMORE & CARTIER IS</option> <option value="AU">AUSTRALIA</option> <option value="AT">AUSTRIA</option> <option value="AZ">AZERBAIJAN</option> <option value="BS">BAHAMAS, THE</option> <option value="BH">BAHRAIN</option> <option value="XB">BAKER ISLAND</option> <option value="BD">BANGLADESH</option> <option value="BB">BARBADOS</option> <option value="QS">BASSAS DA INDIA</option> <option value="BY">BELARUS</option> <option value="BE">BELGIUM</option> <option value="BZ">BELIZE</option> <option value="BJ">BENIN</option> <option value="BM">BERMUDA</option> <option value="BT">BHUTAN</option> <option value="BO">BOLIVIA</option> <option value="BQ">BONAIRE, SINT EUSTAT</option> <option value="BA">BOSNIA & HERZEGOVINA</option> <option value="BW">BOTSWANA</option> <option value="BV">BOUVET ISLAND</option> <option value="BR">BRAZIL</option> <option value="IO">BRITISH INDIAN OCEAN</option> <option value="BN">BRUNEI</option> <option value="BG">BULGARIA</option> <option value="BF">BURKINA FASO</option> <option value="MM">BURMA</option> <option value="BI">BURUNDI</option> <option value="CV">CABO VERDE</option> <option value="KH">CAMBODIA</option> <option value="CM">CAMEROON</option> <option value="CA">CANADA</option> <option value="KY">CAYMAN ISLANDS</option> <option value="CF">CENTRAL AFRICAN REPU</option> <option value="TD">CHAD</option> <option value="CL">CHILE</option> <option value="CN">CHINA</option> <option value="CX">CHRISTMAS ISLAND</option> <option value="CP">CLIPPERTON ISLAND</option> <option value="CC">COCOS (KEELING) ISLA</option> <option value="CO">COLOMBIA</option> <option value="KM">COMOROS</option> <option value="CG">CONGO (BRAZZAVILLE)</option> <option value="CD">CONGO (KINSHASA)</option> <option value="CK">COOK ISLANDS</option> <option value="XC">CORAL SEA ISLANDS</option> <option value="CR">COSTA RICA</option> <option value="CI">CÔTE D'IVOIRE</option> <option value="HR">CROATIA</option> <option value="CU">CUBA</option> <option value="CW">CURAÇAO</option> <option value="CY">CYPRUS</option> <option value="CZ">CZECHIA</option> <option value="DK">DENMARK</option> <option value="XD">DHEKELIA</option> <option value="DG">DIEGO GARCIA</option> <option value="DJ">DJIBOUTI</option> <option value="DM">DOMINICA</option> <option value="DO">DOMINICAN REPUB</option> <option value="EC">ECUADOR</option> <option value="EG">EGYPT</option> <option value="SV">EL SALVADOR</option> <option value="A3">ENTITY 6</option> <option value="GQ">EQUATORIAL GUINEA</option> <option value="ER">ERITREA</option> <option value="EE">ESTONIA</option> <option value="SZ">ESWATINI</option> <option value="ET">ETHIOPIA</option> <option value="XE">EUROPA ISLAND</option> <option value="FK">FALKLAND ISLANDS (IS</option> <option value="FO">FAROE ISLANDS</option> <option value="FJ">FIJI</option> <option value="FI">FINLAND</option> <option value="FR">FRANCE</option> <option value="GF">FRENCH GUIANA</option> <option value="PF">FRENCH POLYNESIA</option> <option value="TF">FRENCH SOUTHERN & AN</option> <option value="GA">GABON</option> <option value="GM">GAMBIA, THE</option> <option value="XG">GAZA STRIP</option> <option value="GE">GEORGIA</option> <option value="DE">GERMANY</option> <option value="GH">GHANA</option> <option value="GI">GIBRALTAR</option> <option value="QX">GLORIOSO ISLANDS</option> <option value="GR">GREECE</option> <option value="GL">GREENLAND</option> <option value="GD">GRENADA</option> <option value="GP">GUADELOUPE</option> <option value="GU">GUAM</option> <option value="A2">GUANTANAMO BAY NAVAL</option> <option value="GT">GUATEMALA</option> <option value="GG">GUERNSEY</option> <option value="GN">GUINEA</option> <option value="GW">GUINEA-BISSAU</option> <option value="GY">GUYANA</option> <option value="HT">HAITI</option> <option value="HM">HEARD ISLAND & MCDON</option> <option value="HN">HONDURAS</option> <option value="HK">HONG KONG</option> <option value="XH">HOWLAND ISLAND</option> <option value="HU">HUNGARY</option> <option value="IS">ICELAND</option> <option value="IN">INDIA</option> <option value="ID">INDONESIA</option> <option value="IR">IRAN</option> <option value="IQ">IRAQ</option> <option value="IE">IRELAND</option> <option value="IM">ISLE OF MAN</option> <option value="IL">ISRAEL</option> <option value="IT">ITALY</option> <option value="JM">JAMAICA</option> <option value="XJ">JAN MAYEN</option> <option value="JP">JAPAN</option> <option value="XQ">JARVIS ISLAND</option> <option value="JE">JERSEY</option> <option value="XU">JOHNSTON ATOLL</option> <option value="JO">JORDAN</option> <option value="QU">JUAN DE NOVA ISLAND</option> <option value="KZ">KAZAKHSTAN</option> <option value="KE">KENYA</option> <option value="XM">KINGMAN REEF</option> <option value="KI">KIRIBATI</option> <option value="KP">KOREA, NORTH</option> <option value="KR">KOREA, SOUTH</option> <option value="XK">KOSOVO</option> <option value="KW">KUWAIT</option> <option value="KG">KYRGYZSTAN</option> <option value="LA">LAOS</option> <option value="LV">LATVIA</option> <option value="LB">LEBANON</option> <option value="LS">LESOTHO</option> <option value="LR">LIBERIA</option> <option value="LY">LIBYA</option> <option value="LI">LIECHTENSTEIN</option> <option value="LT">LITHUANIA</option> <option value="LU">LUXEMBOURG</option> <option value="MO">MACAU</option> <option value="MG">MADAGASCAR</option> <option value="MW">MALAWI</option> <option value="MY">MALAYSIA</option> <option value="MV">MALDIVES</option> <option value="ML">MALI</option> <option value="MT">MALTA</option> <option value="MH">MARSHALL ISLANDS</option> <option value="MQ">MARTINIQUE</option> <option value="MR">MAURITANIA</option> <option value="MU">MAURITIUS</option> <option value="YT">MAYOTTE</option> <option value="MX">MEXICO</option> <option value="FM">MICRONESIA, FEDERATE</option> <option value="QM">MIDWAY ISLANDS</option> <option value="MD">MOLDOVA</option> <option value="MC">MONACO</option> <option value="MN">MONGOLIA</option> <option value="ME">MONTENEGRO</option> <option value="MS">MONTSERRAT</option> <option value="MA">MOROCCO</option> <option value="MZ">MOZAMBIQUE</option> <option value="NA">NAMIBIA</option> <option value="NR">NAURU</option> <option value="XV">NAVASSA ISLAND</option> <option value="NP">NEPAL</option> <option value="NL">NETHERLANDS</option> <option value="NC">NEW CALEDONIA</option> <option value="NZ">NEW ZEALAND</option> <option value="NI">NICARAGUA</option> <option value="NE">NIGER</option> <option value="NG">NIGERIA</option> <option value="NU">NIUE</option> <option value="NF">NORFOLK ISLAND</option> <option value="MK">NORTH MACEDONIA</option> <option value="MP">NORTHERN MARIANA ISL</option> <option value="NO">NORWAY</option> <option value="OM">OMAN</option> <option value="PK">PAKISTAN</option> <option value="PW">PALAU</option> <option value="XL">PALMYRA ATOLL</option> <option value="PA">PANAMA</option> <option value="PG">PAPUA NEW GUINEA</option> <option value="XP">PARACEL ISLANDS</option> <option value="PY">PARAGUAY</option> <option value="PE">PERU</option> <option value="PH">PHILIPPINES</option> <option value="PN">PITCAIRN ISLANDS</option> <option value="PL">POLAND</option> <option value="PT">PORTUGAL</option> <option value="PR">PUERTO RICO</option> <option value="QA">QATAR</option> <option value="RE">REUNION</option> <option value="RO">ROMANIA</option> <option value="RU">RUSSIA</option> <option value="RW">RWANDA</option> <option value="BL">SAINT BARTHELEMY</option> <option value="SH">SAINT HELENA, ASCENS</option> <option value="KN">SAINT KITTS & NEVIS</option> <option value="LC">SAINT LUCIA</option> <option value="MF">SAINT MARTIN</option> <option value="PM">SAINT PIERRE & MIQUE</option> <option value="VC">SAINT VINCENT & THE </option> <option value="WS">SAMOA</option> <option value="SM">SAN MARINO</option> <option value="ST">SAO TOME & PRINCIPE</option> <option value="SA">SAUDI ARABIA</option> <option value="SN">SENEGAL</option> <option value="RS">SERBIA</option> <option value="SC">SEYCHELLES</option> <option value="SL">SIERRA LEONE</option> <option value="SG">SINGAPORE</option> <option value="SX">SINT MAARTEN</option> <option value="SK">SLOVAKIA</option> <option value="SI">SLOVENIA</option> <option value="SB">SOLOMON ISLANDS</option> <option value="SO">SOMALIA</option> <option value="ZA">SOUTH AFRICA</option> <option value="GS">SOUTH GEORGIA & SOUT</option> <option value="SS">SOUTH SUDAN</option> <option value="ES">SPAIN</option> <option value="XS">SPRATLY ISLANDS</option> <option value="LK">SRI LANKA</option> <option value="SD">SUDAN</option> <option value="SR">SURINAME</option> <option value="XR">SVALBARD</option> <option value="SE">SWEDEN</option> <option value="CH">SWITZERLAND</option> <option value="SY">SYRIA</option> <option value="TW">TAIWAN</option> <option value="TJ">TAJIKISTAN</option> <option value="TZ">TANZANIA</option> <option value="TH">THAILAND</option> <option value="TL">TIMOR-LESTE</option> <option value="TG">TOGO</option> <option value="TK">TOKELAU</option> <option value="TO">TONGA</option> <option value="TT">TRINIDAD & TOBAGO</option> <option value="XT">TROMELIN ISLAND</option> <option value="TN">TUNISIA</option> <option value="TR">TURKEY</option> <option value="TM">TURKMENISTAN</option> <option value="TC">TURKS & CAICOS ISLAN</option> <option value="TV">TUVALU</option> <option value="UG">UGANDA</option> <option value="UA">UKRAINE</option> <option value="AE">UNITED ARAB EMIRATES</option> <option value="GB">UNITED KINGDOM</option> <option value="US">UNITED STATES</option> <option value="UY">URUGUAY</option> <option value="UZ">UZBEKISTAN</option> <option value="VU">VANUATU</option> <option value="VA">VATICAN CITY</option> <option value="VE">VENEZUELA</option> <option value="VN">VIETNAM</option> <option value="VG">VIRGIN ISLANDS, BRIT</option> <option value="VI">VIRGIN ISLANDS, U.S.</option> <option value="QW">WAKE ISLAND</option> <option value="WF">WALLIS & FUTUNA</option> <option value="XW">WEST BANK</option> <option value="EH">WESTERN SAHARA</option> <option value="YE">YEMEN</option> <option value="ZM">ZAMBIA</option> <option value="ZW">ZIMBABWE</option> </select> </td> </tr> </table> </td> </tr> <tr> <td align="center" colspan="1"> </td> <td align="center"> </td> </tr> <tr> <td align="center" colspan="1"> <a href="./TextSearch.cfm" style="text-decoration:underline;">Quick Search</a>   </td> <td align="center"> <A style="text-decoration:underline;" href="javascript:doClear();" onfocus="window.status='Clear';return true;" onmouseover="window.status='Clear';return true;" onmouseout="window.status='';return true;">Clear Form</a>     <INPUT TYPE="submit" Name="Search" VALUE="Search">   </td> </tr> </table> </td> </tr> </table> </FORM> </td></tr></table> </div> <div> <p><span style="font-weight:bold;">Need to 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Updates are generally completed weekly by Monday evening.</p> <p>* Category includes Countries, States and Regions</p> </div> </div> <div class="rl-right"> <span style="font-weight: bold;">Other Databases</span> <ul style="margin:-5px;"> <li><a href="/scripts/cdrh/cfdocs/cfPMN/pmn.cfm" title="Database of new or significantly changed device information submitted by medical device manufacturers prior to commercial distribution.">510(k)s</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMN/denovo.cfm" title="Database of De Novos.">De Novo</a></li> <li><a href="/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm" title="Reports of adverse events involving medical devices.">Medical Device Reports (MAUDE)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/DTLS/rl_cert.cfm" title="This searchable database contains valid export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health.">CDRH Export Certificate Validation (CECV)</a></li> <li><a href="/scripts/cdrh/devicesatfda/readingroom.cfm" title="CDRH FOIA Electronic Reading Room.">CDRH FOIA Electronic Reading Room</a></li> <li><a href="/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm" title="Database of the most recent revision of Title 21 of the Code of Federal Regulations (CFR) from the Government Printing Office (GPO). 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This database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.">Radiation-Emitting Products</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/rh_res.cfm" title="Electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.">Radiation-Emitting Electronic Products Corrective Actions</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRES/res.cfm" title="Database of classified medical device recalls since November 1, 2002.">Recalls</a></li> <li><a href="/scripts/cdrh/cfdocs/cfStandards/search.cfm" title="Database of Recognized Consensus Standards with associated FDA, medical device and standards industry information.">Standards</a></li> <li><a href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm" title="The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls.">Total Product Life Cycle</a></li> <li><a href="/scripts/cdrh/cfdocs/cfAssem/assembler.cfm" title="Database of locations and identities of certified components of diagnostic x-ray systems for routine compliance testing at user facilities. 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