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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
O.R. SURGICAL CO., INC.
GREENSBORO,  NC,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
O.R. SURGICAL CO., INC.
GREENSBORO,  NC ,  US.
O.S.T. LTD.
BETTENDORF,  IA,  US.
Manufacturer;  
O.S.T. LTD.
BETTENDORF,  IA ,  US.
O.T.C. PACKAGING, INC.
LITHIA SPRINGS,  GA,  US.
Initial Importer;   Repackager/Relabeller;  
O.T.C. PACKAGING, INC.
LITHIA SPRINGS,  GA ,  US.
O2 FIT
HAMPTON,  NH,  US.
Initial Importer;  
O2 FIT
HAMPTON,  NH ,  US.
OAESDIRECT
SHERRILLS FORD,  NC,  US.
Initial Importer;  
OAESDIRECT
SHERRILLS FORD,  NC ,  US.
OAK INTERNATIONAL CO.
TORRANCE,  CA,  US.
Initial Importer;  
OAK INTERNATIONAL CO.
TORRANCE,  CA ,  US.
OAK POINTE MEDICAL PRODUCTS, L.L.C.
TROY,  MI,  US.
Initial Importer;  
OAK POINTE MEDICAL PRODUCTS, L.L.C.
TROY,  MI ,  US.
OAK RIDGE MOLDED PRODUCTS, INC.
ALGONQUIN,  IL,  US.
Manufacturer;  
OAK RIDGE MOLDED PRODUCTS, INC.
ALGONQUIN,  IL ,  US.
OAK TECHNICAL, LLC
TULLAHOMA,  TN,  US.
Initial Importer;   Manufacturer;  
CHARTER FOODS, INC.
MORRISTOWN,  TN ,  US.
OAKFIELD INSTRUMENTS, LTD.
OXFORDSHIRE,  UK.
Manufacturer;  
OAKFIELD INSTRUMENTS, LTD.
WITNEY, OXFORDSHIRE,  UK.
OAKLEY, INC.
FOOTHILL RANCH,  CA,  US.
Manufacturer;  
OAKLEY, INC.
FOOTHILL RANCH,  CA ,  US.
OAKMONT PRECISION SERVICES, LLC
GORHAM,  ME,  US.
Contract Manufacturer;  
OAKMONT PRECISION SERVICES, LLC
GORHAM,  ME ,  US.
OAKWORKS, INC.
NEW FREEDOM,  PA,  US.
Manufacturer;  
OAKWORKS, INC.
NEW FREEDOM,  PA ,  US.
OAO TERMOPRIBOR
KLIN,  RS.
Manufacturer;  
OAO TERMOPRIBOR
KLIN,  RS.
OASIS CO.
LADERA HEIGHTS,  CA,  US.
Initial Importer;  
OASIS CO.
LADERA HEIGHTS,  CA ,  US.
OASIS MEDICAL, INC.
GLENDORA,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OASIS MEDICAL, INC.
GLENDORA,  CA ,  US.
OASIS RESEARCH, LLC.
GLENDORA,  CA,  US.
Manufacturer;  
OASIS RESEARCH, LLC.
GLENDORA,  CA ,  US.
OASIS VISCO, INC.
GLENDORA,  CA,  US.
Specification Developer;  
OASIS VISCO, INC.
GLENDORA,  CA ,  US.
OB INTL.
SAN BERNARDINO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
OB INTL.
SAN BERNARDINO,  CA ,  US.
OB SCIENTIFIC, INC.
GERMANTOWN,  WI,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
OB SCIENTIFIC, INC.
GERMANTOWN,  WI ,  US.
OBG PRODUCTS
VIENNA,  VA,  US.
Initial Importer;  
OBG PRODUCTS
VIENNA,  VA ,  US.
OBGYN DIRECT.COM, INC.
FARMINGDALE,  NY,  US.
Initial Importer;  
OBGYN DIRECT.COM, INC.
FARMINGDALE,  NY ,  US.
OBJECTIVISION PTY LTD.
EVELEIGH,  AS.
Foreign Exporter;   Manufacturer;   Specification Developer;  
OBJECTIVISION PTY LTD.
EVELEIGH,  AS.
O'BRIEN DEVELOPMENT COMPANY, LLC
WEST ENFIELD,  ME,  US.
Specification Developer;   Repackager/Relabeller;  
O'BRIEN DEVELOPMENT COMPANY, LLC
WEST ENFIELD,  ME ,  US.
OBSIDIAN DENTAL INC.
BEND,  OR,  US.
Manufacturer;  
OBSIDIAN DENTAL INC.
BEND,  OR ,  US.
OBSIDIAN MEDICAL TECHNOLOGY, INC.
DUBLIN,  CA,  US.
Manufacturer;   Remanufacturer;  
OBSIDIAN MEDICAL TECHNOLOGY, INC.
SPRING,  TX ,  US.
OBTECH MEDICAL GMBH
ZUG,  SZ.
Specification Developer;  
ETHICON ENDO-SURGERY, INC.
CINCINNATI,  OH ,  US.
OC SOL
MONTREAL-LA-CLUSE,  FR.
Contract Manufacturer;   Manufacturer;  
OC SOL
MONTREAL-LA-CLUSE,  FR.
OCCHIALERIA ARTIGIANA QUERESE, S.N.C.
QUERO,  IT.
Unregistered Foreign Lister;  
OCCHIALERIA ARTIGIANA QUERESE, S.N.C.
QUERO,  IT.
OCCHIALERIA FM SRL
DOMEGGE DI CADORE,  IT.
Contract Manufacturer;  
OCCHIALERIA FM SRL
DOMEGGE DI CADORE,  IT.
OCCHIALERIA MARTINI SNC
LOZZO DI CADORE-BELLUNO,  IT.
Manufacturer;  
OCCHIALERIA MARTINI
LOZZO DI CADORE-BELLUNO,  IT.
OCCHIALERIA SOLGIR SNC DI CEPPELLI GIORGIO & C.
MODENA,  IT.
Manufacturer;  
OCCHIALERIA SOLGIR SNC DI CEPPELLI GIORGIO & C.
MODENA,  IT.
OCCHIALERIA SOPRACOLLE SRL
PERAROLO DI CADORE,  IT.
Manufacturer;  
OCCHIALERIA SOPRACOLLE SRL
PERAROLO DI CADORE,  IT.
OCCHIALI COLOMBIA D.B.A. JOSE GABRIEL MEDINA
BOGOTA,  CO.
Foreign Exporter;  
OCCHIALI COLOMBIA D.B.A. JOSE GABRIEL MEDINA
BOGOTA,  CO.
OCCHIALI WEST INC.
NEWARK,  NJ,  US.
Initial Importer;  
OCCHIALI WEST INC.
NEWARK,  NJ ,  US.
OCCK, INC.
SALINA,  KS,  US.
Initial Importer;   Manufacturer;  
OCCK, INC.
SALINA,  KS ,  US.
OCCLUSION LABS, INC.
ST. LOUIS,  MO,  US.
Initial Importer;  
OCCLUSION LABS, INC.
ST. LOUIS,  MO ,  US.
OCCUPATIONAL HEARING SERVICES
SWARTHMORE,  PA,  US.
Specification Developer;  
OCCUPATIONAL HEARING SERVICES
SWARTHMORE,  PA ,  US.
OCEAN BLUE TECHNOLOGY, INC.
GAITHERSBURG,  MD,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
OCEAN BLUE TECHNOLOGY, INC.
GAITHERSBURG,  MD ,  US.
OCEAN BREEZE
STATEN ISLAND,  NY,  US.
Initial Importer;  
OCEAN BREEZE
STATEN ISLAND,  NY ,  US.

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Last Modified: 29 April 2006
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