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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
ONYX MEDICAL CORP.
MEMPHIS,  TN,  US.
Contract Manufacturer;  
ONYX MEDICAL CORP.
MEMPHIS,  TN ,  US.
ONYX MEDICAL INC.
SAUSALITO,  CA,  US.
Specification Developer;  
ONYX MEDICAL INC.
SAUSALITO,  CA ,  US.
OOGLE'S, INC.
FRISCO,  TX,  US.
Specification Developer;  
OOGLE'S, INC.
FRISCO,  TX ,  US.
OOLITT ADVANTAGE, INC.
TAMPA,  FL,  US.
Initial Importer;  
OOLITT ADVANTAGE, INC.
TAMPA,  FL ,  US.
OOLTEWAH MFG., INC.
OOLTEWAH,  TN,  US.
Contract Manufacturer;   Manufacturer;  
OOLTEWAH MFG., INC.
OOLTEWAH,  TN ,  US.
OON CORP. RESOURCES
SEREMBAN,  MY.
Manufacturer;  
OON CORP. RESOURCES
SEREMBAN,  MY.
OOO" MILLENIUM PHARMA
MOSCOW,  RS.
Manufacturer;  
OOO" MILLENIUM PHARMA
MOSCOW,  RS.
OOO"DELTA-TERM"
MOSCOW,  RS.
Foreign Exporter;   Manufacturer;  
OOO"DELTA-TERM"
MOSCOW,  RS.
OP COUTURE BRILLEN GMBH
PASSAU,  GM.
Manufacturer;  
OP COUTURE BRILLEN GMBH
PASSAU,  GM.
OPAL-LITE, INC.
SOUTH EL MONTE,  CA,  US.
Manufacturer;  
OPAL-LITE, INC.
SOUTH EL MONTE,  CA ,  US.
OPAP, INC.
CAPITOLA,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;  
OPAP, INC.
CAPITOLA,  CA ,  US.
OP-D-OP VISOR SHIELDS, INC.
ROSEVILLE,  CA,  US.
Manufacturer;  
OP-D-OP VISOR SHIELDS, INC.
ROSEVILLE,  CA ,  US.
OPED AG, ORTHOPADISCHE PRODUKTE
STEINHAUSEN,  SZ.
Foreign Exporter;   Manufacturer;  
OPED AG, ORTHOPADISCHE PRODUKTE
STEINHAUSEN,  SZ.
OPED INC.
FRAMINGHAM,  MA,  US.
Initial Importer;   Repackager/Relabeller;  
OPED AG, ORTHOPADISCHE PRODUKTE
STEINHAUSEN,  SZ.
OPEN ENTERPRISES
SAN FRANCISCO,  CA,  US.
Initial Importer;  
OPEN ENTERPRISES
SAN FRANCISCO,  CA ,  US.
OPEN KITCHENS, INC.
CHICAGO,  IL,  US.
Manufacturer;  
OPEN KITCHENS, INC.
CHICAGO,  IL ,  US.
OPEN MED TECHNOLOGIES CORPORATION
WOBURN,  MA,  US.
Manufacturer;  
OPEN MED TECHNOLOGIES CORPORATION
WOBURN,  MA ,  US.
OPEN TRADE, S.A.
BUENOS AIRES,  AR.
Manufacturer;  
OPEN TRADE, S.A.
BUENOS AIRES,  AR.
OPERA OPTICAL
CINCINNATI,  OH,  US.
Manufacturer;  
OPERA OPTICAL
CINCINNATI,  OH ,  US.
OPERMAN, INC.
ROCKVILLE,  MD,  US.
Initial Importer;  
OPERMAN, INC.
ROCKVILLE,  MD ,  US.
OPEX
ST PAUL,  FR.
Manufacturer;  
PRIMOPTIC
MACAU,  CH.
OPGAL OPTRONIC INDUSTRIES
KARMIEL,  IS.
Manufacturer;   Specification Developer;  
OPGAL OPTRONIC INDUSTRIES
KARMIEL,  IS.
OPHL. DIFFUSION DES LUNETTES
ISSY LES MOULINEAUX,  FR.
Manufacturer;  
OPHL. DIFFUSION DES LUNETTES
ISSY LES MOULINEAUX,  FR.
OPHTEC BV
GRONINGEN,  NL.
Manufacturer;  
OPHTEC BV
GRONINGEN,  NL.
OPHTEC USA, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
OPHTEC BV
GRONINGEN,  NL.
OPHTECHNICS, INC.
CARSON CITY,  NV,  US.
Initial Importer;  
OPHTECHNICS, INC.
CARSON CITY,  NV ,  US.
OPHTHALMED LLC
ROSWELL,  GA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
OPHTHALMED LLC
ROSWELL,  GA ,  US.
OPHTHALMIC GROUP WORLDWIDE, INC.
ST. PETERSBURG,  FL,  US.
Initial Importer;  
OPHTHALMIC GROUP WORLDWIDE, INC.
ST. PETERSBURG,  FL ,  US.
OPHTHALMIC IMAGING SYSTEMS
SACRAMENTO,  CA,  US.
Manufacturer;  
OPHTHALMIC IMAGING SYSTEMS
SACRAMENTO,  CA ,  US.
OPHTHALMIC INNOVATIONS INTL., INC.
ONTARIO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
OPHTHALMIC INNOVATIONS INTL., INC.
ONTARIO,  CA ,  US.
OPHTHALMIC INSTRUMENTS, INC.
TUSTIN,  CA,  US.
Initial Importer;  
OPHTHALMIC INSTRUMENTS, INC.
TUSTIN,  CA ,  US.
OPHTHALMIC INTL.
FOUNTAIN HILLS,  AZ,  US.
Manufacturer;  
OPHTHALMIC INTL.
FOUNTAIN HILLS,  AZ ,  US.
OPHTHALMIC SUPPORT SYSTEMS OF CHICAGO, INC.
CHICAGO,  IL,  US.
Repackager/Relabeller;  
OPHTHALMIC SUPPORT SYSTEMS OF CHICAGO, INC.
CHICAGO,  IL ,  US.
OPHTHALMIC SURGICAL LLC
GROSSE TETE,  LA,  US.
Repackager/Relabeller;  
OPHTHALMIC SURGICAL LLC
GROSSE TETE,  LA ,  US.
OPHTHALMIC TECHNOLOGIES, INC.
DOWNSVIEW, ONTARIO,  CA.
Manufacturer;  
OPHTHALMIC TECHNOLOGIES, INC.
DOWNSVIEW, ONTARIO,  CA.
OPHTHALMIC TECHNOLOGIES, INC.
RIDGEWOOD,  NJ,  US.
Initial Importer;  
OPHTHALMIC TECHNOLOGIES, INC.
DOWNSVIEW, ONTARIO,  CA.
OPHTHONIX INC.
SAN DIEGO,  CA,  US.
Manufacturer;   Specification Developer;  
OPHTHONIX INC.
SAN DIEGO,  CA ,  US.
OPHTIMED INSTRUMENTS
CAGUAS,  PR,  US.
Initial Importer;  
OPHTIMED INSTRUMENTS
CAGUAS,  PR ,  US.
OPI, INC.
COLUMBIA CITY,  IN,  US.
Contract Manufacturer;  
OPI, INC.
COLUMBIA CITY,  IN ,  US.
OP-MARKS, INC.
BOGART,  GA,  US.
Manufacturer;  
OP-MARKS, INC.
BOGART,  GA ,  US.

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Last Modified: 29 April 2006
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