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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
LUMENIS, INC.
SANTA CLARA,  CA,  US.
Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
LUMENIS LTD.
YOKNEAM,  IS.
LUMENIS, LTD.
YOKNEAM,  IS.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
LUMENIS LTD.
YOKNEAM,  IS.
LUMILIFE CORP.
BLOOMINGTON,  MN,  US.
Contract Manufacturer;  
LUMILIFE CORP.
BLOOMINGTON,  MN ,  US.
LUMINAUD, INC.
MENTOR,  OH,  US.
Manufacturer;  
LUMINAUD, INC.
MENTOR,  OH ,  US.
LUMINETX CORPORATION
MEMPHIS,  TN,  US.
Specification Developer;  
LUMINETX CORPORATION
MEMPHIS,  TN ,  US.
LUMINEX CORP.
AUSTIN,  TX,  US.
Contract Manufacturer;  
LUMINEX CORP.
AUSTIN,  TX ,  US.
LUMISCOPE CO., INC.
PISCATAWAY,  NJ,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
LUMISCOPE CO., INC.
EDISON,  NJ ,  US.
LUMITEX, INC.
STRONGSVILLE,  OH,  US.
Manufacturer;  
LUMITEX, INC.
STRONGSVILLE,  OH ,  US.
LUN CHEUNG ENT. LTD.
CHAI WAN,  HK.
Unregistered Foreign Lister;  
LUN CHEUNG ENT. LTD.
CHAI WAN,  HK.
LUNA FERTILITY INDICATOR, INC.
RICHMOND B.C.,  CA.
Manufacturer;  
LUNA FERTILITY INDICATOR, INC.
RICHMOND B.C.,  CA.
LUNAPADS INTL. PRODUCTS LTD.
VANCOUVER, B.C.,  CA.
Manufacturer;  
LUNAPADS INTL. PRODUCTS LTD.
VANCOUVER, B.C.,  CA.
LUNAX CORP.
BRIGHTON,  MI,  US.
Manufacturer;  
LUNAX CORP.
WEST BLOOMFIELD,  MI ,  US.
LUND DENTAL MFG.
ENCINO,  CA,  US.
Manufacturer;  
LUND DENTAL MFG.
ENCINO,  CA ,  US.
LUNDY INTERNATIONAL LTD.
MIDDX, LONDON,  UK.
Foreign Exporter;  
LUNDY INTERNATIONAL LTD.
MIDDX, LONDON,  UK.
LUNEAU GYNECOLOGIE SA
PRUNAY-LE-GILLON,  FR.
Manufacturer;  
LUNEAU GYNECOLOGIE SA
CHARTRES, CEDEX,  FR.
LUNEAU OPHTALMOLOGIE SA
PRUNAY-LE-GILLON,  FR.
Manufacturer;  
LUNEAU OPHTALMOLOGIE SA
CHARTRES, CEDEX,  FR.
LUNEAU SAS
PRUNAY-LE-GILLON,  FR.
Manufacturer;  
VISIONIX LTD.
JERUSALEM,  IS.
LUNETTERIE LEVET
CHAUX DU DOMBIEF,  FR.
Unregistered Foreign Lister;  
LUNETTERIE LEVET
CHAUX DU DOMBIEF,  FR.
LUNETTERIE LUCAL S.A.
MORBIER,  FR.
Unregistered Foreign Lister;  
LUNETTERIE LUCAL S.A.
MORBIER,  FR.
LUNETTERIE NEW LOOK, INC.
MONTREAL (QUEBEC),  CA.
Unregistered Foreign Lister;  
LUNETTERIE NEW LOOK, INC.
MONTREAL (QUEBEC),  CA.
LUNETTES DE PARIS, CORP.
MIAMI,  FL,  US.
Initial Importer;  
LUNETTES DE PARIS, CORP.
MIAMI,  FL ,  US.
LUNETTES FOLOMI S.A.
MOREZ,  FR.
Unregistered Foreign Lister;  
LUNETTES FOLOMI S.A.
MOREZ,  FR.
LUNETTES GRASSET ET ASSOCIES
OYONNAX,  FR.
Manufacturer;  
LUNETTES GRASSET ET ASSOCIES
OYONNAX,  FR.
LUNETTES INDUSTRIES
RAJKOT, GUJARAT,  IN.
Contract Manufacturer;  
LUNETTES INDUSTRIES
RAJKOT, GUJARAT,  IN.
LUNETTES JEAN FRANCOIS, INC.
KREMLIN-BICETRE,  FR.
Unregistered Foreign Lister;  
LUNETTES JEAN FRANCOIS, INC.
KREMLIN-BICETRE,  FR.
LUNETTES YVES COGAN S.A.
MOLINGES,  FR.
Manufacturer;  
LUNETTES YVES COGAN S.A.
MOLINGES,  FR.
LUNG PIN CONSTRUCTION CO., LTD.
TA LIAO HSIANG KAOHS,  TW.
Manufacturer;  
CHEN LIN HSIEN POU
TA LIAO HSIANG KAOHS,  TW.
LUNG PIN PLASTIC HARDWARE INDUSTRIES LTD.
ZHOU CITY, GUANG DONG PROVINCE,  CH.
Manufacturer;  
LUNG PIN PLASTIC HARDWARE INDUSTRIES LTD.
ZHOU CITY, GUANG DONG PROVINCE,  CH.
LUNG YEOU TRADING CO., LTD.
TAIPEI,  TW.
Manufacturer;  
LUNG YEOU TRADING CO., LTD.
TAIPEI,  TW.
LUNGYEN OPTICAL CORPORATION LIMITED
KOWLOON, HONG KONG,  CH.
Manufacturer;  
LUNGYEN OPTICAL CORPORATION LIMITED
KOWLOON, HONG KONG,  CH.
L'UNIQUE OPTIQUE
NEW YORK,  NY,  US.
Initial Importer;  
L'UNIQUE OPTIQUE
NEW YORK,  NY ,  US.
LUNOR-BRILLEN DESIGN U. VERTRIEBS GMBH
STUTTGART,  GM.
Manufacturer;  
LUNOR-BRILLEN DESIGN U. VERTRIEBS GMBH
STUTTGART,  GM.
LUOMANEN MEDICAL PRODUCTS
SPARTA,  NJ,  US.
Manufacturer;  
LUOMANEN MEDICAL PRODUCTS
SPARTA,  NJ ,  US.
LURE-EYES
BENTONVILLE,  AR,  US.
Initial Importer;   Repackager/Relabeller;  
LURE-EYES
BENTONVILLE,  AR ,  US.
LUROPAS
CALVENZANO (BG),  IT.
Manufacturer;  
LUROPAS
CALVENZANO (BG),  IT.
LUSTGARTEN MULTI-TECH INTERNATIONAL INC.
JUPITER,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
LUSTGARTEN MULTI-TECH INTL.
HOLLISTON,  MA ,  US.
LUSTGARTEN MULTI-TECH INTL.
HOLLISTON,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
LUSTGARTEN MULTI-TECH INTL.
HOLLISTON,  MA ,  US.
LUSYS LABORATORIES INC.
SAN DIEGO,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LUSYS LABORATORIES INC.
SAN DIEGO,  CA ,  US.
LUTH-ALL MEDICAL PRODUCTS, LLC
COSTA MESA,  CA,  US.
Specification Developer;  
LUTH-ALL MEDICAL PRODUCTS, LLC
COSTA MESA,  CA ,  US.
LUTHER NEEDLESAFE PRODUCTS, INC.
COSTA MESA,  CA,  US.
Specification Developer;  
LUTHER NEEDLESAFE PRODUCTS, INC.
COSTA MESA,  CA ,  US.

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Last Modified: 29 April 2006
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