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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
LABOMED, INC.
CULVER CITY,  CA,  US.
Initial Importer;   Remanufacturer;  
LABOMED, INC.
CULVER CITY,  CA ,  US.
LABONE, INC.
LENEXA,  KS,  US.
Specification Developer;   Repackager/Relabeller;  
LABONE, INC.
LENEXA,  KS ,  US.
LABOR BIOMEDICAL TECHNOLOGIES GMBH
AHRENSBURG,  GM.
Manufacturer;  
LABOR BIOMEDICAL TECHNOLOGIES GMBH
AHRENSBURG,  GM.
LABOR DIAGNOSTIKA NORD GMBH & CO. KG
NORDHORN,  GM.
Manufacturer;  
LABOR DIAGNOSTIKA NORD GMBH & CO. KG
NORDHORN,  GM.
LABORATOIRE BENOIST SARL
BELLEGARDE,  FR.
Unregistered Foreign Lister;  
LABORATOIRE BENOIST SARL
BELLEGARDE,  FR.
LABORATOIRE CHAUVIN
AUBENAS,  FR.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
LABORATOIRE GAMIDA
EAUBONNE,  FR.
Manufacturer;  
LABORATOIRE GAMIDA
EAUBONNE,  FR.
LABORATOIRE HRA PHARMA
PARIS,  FR.
Foreign Exporter;  
LABORATOIRE HRA PHARMA
PARIS,  FR.
LABORATOIRE MEDIX
HOUDAN,  FR.
Manufacturer;  
LABORATOIRE MEDIX
HOUDAN,  FR.
LABORATOIRE VILLANOVA
MONTPELLIER,  FR.
Manufacturer;  
LABORATOIRE VILLANOVA
MONTPELLIER,  FR.
LABORATOIRES BROTHIER, S.A.
FONTEVRAUD L'ABBAYE,  FR.
Contract Manufacturer;   Manufacturer;  
LABORATOIRES BROTHIER, S.A.
NANTERRE,  FR.
LABORATOIRES EURO-SILICONE
CERGY,  FR.
Unregistered Foreign Lister;  
LABORATOIRES EURO-SILICONE
CERGY,  FR.
LABORATOIRES GOEMAR S.A.
ST MALO,  FR.
Manufacturer;  
LABORATOIRES GOEMAR S.A.
ST MALO,  FR.
LABORATOIRES NYCOMED S.A.
PARIS, CEDEX 13,  FR.
Manufacturer;  
NYCOMED IMAGING A.S.
TORSHOV, OSLO,  NO.
LABORATOIRES PRODIMED
NEUILLY-EN-THELLE,  FR.
Manufacturer;  
LABORATOIRES C.C.D.
PARIS,  FR.
LABORATOIRES THERANOL-DEGLAUDE
BAGNEUX,  FR.
Unregistered Foreign Lister;  
LABORATOIRES THERANOL-DEGLAUDE
BAGNEUX,  FR.
LABORATOIRES URGO
DIJON,  FR.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LABORATOIRES URGO
CHENOVE,  FR.
LABORATORI PIAZZA S.N.C.
PARTILA IVA,  IT.
Manufacturer;  
DR. K INT'L TRADING CO., INC.
MONROVIA,  CA ,  US.
LABORATORIES MXM
VALLAURIS, PACA,  FR.
Contract Sterilizer;  
LABORATORIES MXM
VALLAURIS, PACA,  FR.
LABORATORIO DENTAL BRAVO
RIO PIEDRAS,  PR,  US.
Initial Importer;  
JOSE B BRAVO OTERO
RIO PIEDRAS,  PR ,  US.
LABORATORIO QUIROFANO S.A.
LIMA,AL,  PE.
Manufacturer;  
LABORATORIO QUIROFANO S.A.
LIMA,AL,  PE.
LABORATORIOS CLINIC, S.A. DE C.V.
QUERETARO, QRO.,  MX.
Manufacturer;  
LABORATORIOS CLINIC, S.A. DE C.V.
QUERETARO, QRO.,  MX.
LABORATORIOS DENTALES DE ZONA FRANCA, S.A.
CARTAGO,  CS.
Manufacturer;  
DENTALIUM DENTAL CERAMICS, INC.
NEWPORT BEACH,  CA ,  US.
LABORATORIOS GRIFOLS, S.A.
PARETS DEL VALLES, BARCELONA,  SP.
Manufacturer;  
LABORATORIOS GRIFOLS, S.A.
PARETS DEL VALLES, BARCELONA,  SP.
LABORATORIOS JALOMA, S.A. DE C.V.
GUADALAJARA, JALISCO,  MX.
Manufacturer;  
LABORATORIOS JALOMA, S.A. DE C.V.
GUADALAJARA, JALISCO,  MX.
LABORATORIOS LE ROY
COL. GRANZAS,  MX.
Unregistered Foreign Lister;  
LABORATORIOS LE ROY
COL. GRANZAS,  MX.
LABORATORIOS LE ROY SA DE CV
MEXICO CITY,  MX.
Contract Manufacturer;  
AMBRA LE ROY, LLC
CHARLOTTE,  NC ,  US.
LABORATORIOS RYMCO S.A.
BARRANQUILLA,  CO.
Manufacturer;  
LABORATORIOS RYMCO S.A.
BARRANQUILLA,  CO.
LABORATORIOS SANDERSON S.A.
SANTIAGO,  CI.
Manufacturer;  
LABORATORIOS SANDERSON S.A.
SANTIAGO,  CI.
LABORATORIOS SCANTIBODIES S.A. DE C.V.
TECATE, BAJA CALIFORNIA,  MX.
Contract Manufacturer;   Manufacturer;  
SCANTIBODIES LABORATORY, INC.
SANTEE,  CA ,  US.
LABORATORIOS SHERLEG COLOMBIA LIMITADA
BOGOTA DC,  CO.
Manufacturer;  
LABORATORIOS SHERLEG COLOMBIA LIMITADA
BOGOTA DC,  CO.
LABORATORY IMPLANT PRACTICE SYSTEMS, INC.
HALF MOON BAY,  CA,  US.
Manufacturer;   Specification Developer;  
LABORATORY IMPLANT PRACTICE SYSTEMS, INC.
HALF MOON BAY,  CA ,  US.
LABORATORY PM AG
ZUG,  SZ.
Manufacturer;   Specification Developer;  
LABORATORY PM AG
ZUG,  SZ.
LABORATORY SUPPLY CO.
LOUISVILLE,  KY,  US.
Initial Importer;  
LABORATORY SUPPLY CO.
LOUISVILLE,  KY ,  US.
LABORATORY TECHNOLOGIES, INC.
MAPLE PARK,  IL,  US.
Manufacturer;  
LABORATORY TECHNOLOGIES, INC.
ELBURN,  IL ,  US.
LABORIE MEDICAL TECH CORP
WILLISTON,  VT,  US.
Initial Importer;  
LABORIE MEDICAL TECH CORP
WILLISTON,  VT ,  US.
LABORIE MEDICAL TECH, INC.
MISSISSAUGA, ONTARIO,  CA.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LABORIE MEDICAL TECH, INC.
MISSISSAUGA, ONTARIO,  CA.
LABOSAN SRL
RIPALTA CREMASCA,  IT.
Manufacturer;  
LABOSAN SRL
RIPALTA CREMASCA,  IT.
LABOTECT LABOR-TECHNIK GOTTINGEN
GOTTINGEN,  GM.
Manufacturer;  
LABOTECT LABOR-TECHNIK GOTTINGEN
GOTTINGEN,  GM.
LABTICIAN OPHTHALMICS, INC.
OAKVILLE, ONTARIO,  CA.
Repackager/Relabeller;  
LABTICIAN OPHTHALMICS, INC.
OAKVILLE, ONTARIO,  CA.

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Last Modified: 29 April 2006
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