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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
SINGAPORE,  SN.
Contract Manufacturer;  
LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
SINGAPORE,  SN.
LEICA MICROSYSTEMS CMS GMBH
MANNHEIM,  GM.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MICROSYSTEMS CMS GMBH
WETZLAR,  GM.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MICROSYSTEMS INC.
EXTON,  PA,  US.
Initial Importer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MICROSYSTEMS NUSSLOCH GMBH
NUSSLOCH,  GM.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MICROSYSTEMS, INC.
ALLENDALE,  NJ,  US.
Initial Importer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MICROSYSTEMS, INC.
BANNOCKBURN,  IL,  US.
Initial Importer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEICA MIKROSYSTEME GMBH
VIENNA,  AU.
Manufacturer;  
DANAHER CORPORATION
WASHINGTON,  DC ,  US.
LEIGHTON FLEXOMETER
SPOKANE,  WA,  US.
Repackager/Relabeller;  
LEIGHTON FLEXOMETER
SPOKANE,  WA ,  US.
LEIHOP INDUSTRIES LTD.
NORTH POINT, HONG KONG,  HK.
Manufacturer;  
LEIHOP INDUSTRIES LTD.
NORTH POINT, HONG KONG,  HK.
LEINA-WERKE GMBH
WINDECK, NRW,  GM.
Contract Manufacturer;  
LEINA-WERKE GMBH
WINDECK, NRW,  GM.
LEISEGANG FEINMECHANIK-OPTIK GMBH
BERLIN,  GM.
Manufacturer;  
COOPERSURGICAL, INC.
TRUMBULL,  CT ,  US.
LEISTER PROCESS TECHNOLOGIES
SARNEN,  SZ.
Manufacturer;  
LEISTER PROCESS TECHNOLOGIES
SARNEN,  SZ.
LEISURE SYSTEMS INTERNATIONAL, LTD.
SOUTHAM, WARWICKSHIRE,  UK.
Manufacturer;  
LEISURE SYSTEMS INTERNATIONAL, LTD.
SOUTHAM, WARWICKSHIRE,  UK.
LEISURE TIME PRODUCTS
FORT COLLINS,  CO,  US.
Initial Importer;  
LEISURE TIME PRODUCTS
FORT COLLINS,  CO ,  US.
LEISURE TIME PRODUCTS & DESIGN CORP.
AVON,  OH,  US.
Manufacturer;  
LEISURE TIME PRODUCTS & DESIGN CORP.
AVON,  OH ,  US.
LELE JIA MEDICAL TECHNOLOGY LTD.
BEIJING,  CH.
Contract Manufacturer;  
LELE JIA MEDICAL TECHNOLOGY LTD.
BEIJING,  CH.
LEM SRL.
DAVERIO (VARESE),  IT.
Manufacturer;  
LEM SRL.
DAVERIO (VARESE),  IT.
LEMAITRE VASCULAR
PHOENIX,  AZ,  US.
Manufacturer;  
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA ,  US.
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA ,  US.
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA,  US.
Manufacturer;  
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA ,  US.
LEMAITRE VASCULAR, INC.
ST. PETERSBURG,  FL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LEMAITRE VASCULAR, INC.
BURLINGTON,  MA ,  US.
LEMANS CORP.
JANESVILLE,  WI,  US.
Initial Importer;  
LEMANS CORP.
JANESVILLE,  WI ,  US.
LEMARE MEDICAL, INC.
MIAMI,  FL,  US.
Initial Importer;  
LEMARE MEDICAL, INC.
MIAMI,  FL ,  US.
LEMBRAN LTD.
ASHKELON,  IS.
Manufacturer;  
LEMBRAN LTD.
ASHKELON,  IS.
LEMCO ENT., INC.
ARDMORE,  OK,  US.
Contract Sterilizer;  
LEMCO ENT., INC.
ARDMORE,  OK ,  US.
LEMER-PAX
CARQUEFOU, CEDEX,  FR.
Manufacturer;  
LEMER-PAX
CARQUEFOU, CEDEX,  FR.
LENACO CORP.
SOUTH SAN FRANCISCO,  CA,  US.
Specification Developer;  
LENACO CORP.
SOUTH SAN FRANCISCO,  CA ,  US.
LENDELL MFG., INC.
ST. CHARLES,  MI,  US.
Contract Manufacturer;   Manufacturer;  
LENDELL MFG., INC.
ST. CHARLES,  MI ,  US.
L'ENFANT EYE CENTER
WASHINGTON,  DC,  US.
Initial Importer;  
L'ENFANT EYE CENTER
WASHINGTON,  DC ,  US.
LENJOY MEDICAL ENGINEERING, INC.
GARDENA,  CA,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
LENJOY MEDICAL ENGINEERING, INC.
GARDENA,  CA ,  US.
LENOX-MACLAREN SURGICAL CORP.
LOUISVILLE,  CO,  US.
Manufacturer;  
LENOX-MACLAREN SURGICAL CORP.
LOUISVILLE,  CO ,  US.
LENS DEPOT, INC.
EAST BRUNSWICK,  NJ,  US.
Initial Importer;  
LENS DEPOT, INC.
EAST BRUNSWICK,  NJ ,  US.
LENS DESIGN OPTICAL
HUNTINGTON PARK,  CA,  US.
Initial Importer;  
LENS DESIGN OPTICAL
HUNTINGTON PARK,  CA ,  US.
LENS DYNAMICS, INC.
GOLDEN,  CO,  US.
Manufacturer;   Specification Developer;  
LENS DYNAMICS, INC.
GOLDEN,  CO ,  US.
LENS.COM, INC.
LOUISIANA,  MO,  US.
Initial Importer;  
LENS.COM, INC.
LOUISIANA,  MO ,  US.
LENSCARE LTD.
MEVASERET ZION,  IS.
Manufacturer;  
BIOSCIENCE TECHNOLOGY LABORATORIES LTD.
MEVASERET ZION,  IS.
LENSCRAFTERS, INC.
MCDONOUGH,  GA,  US.
Initial Importer;  
LENSCRAFTERS, INC.
MASON,  OH ,  US.
LENSCRAFTERS, INC.
MASON,  OH,  US.
Initial Importer;  
LENSCRAFTERS,INC.
MASON,  OH ,  US.
LENSTEC BARBADOS, INC.
CHRIST CHURCH,  BB.
Manufacturer;  
LENSTEC, INC.
ST. PETERSBURG,  FL ,  US.

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Last Modified: 29 April 2006
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