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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
(ADYD) ARTICULOS DENTALES Y DERIVADOS S.A.
TEPECOACUILCO, GRO, CP 40160,  MX.
Unregistered Foreign Lister;  
(ADYD) ARTICULOS DENTALES Y DERIVADOS S.A.
TEPECOACUILCO, GRO, CP 40160,  MX.
(MFG) TECH GROUP P.R. INC.
CIDRA,  PR,  US.
Contract Manufacturer;  
(MFG) TECH GROUP P.R. INC.
LIONVILLE,  PA ,  US.
000 FREZA
KAZAN,  RS.
Unregistered Foreign Lister;  
000 FREZA
KAZAN,  RS.
1 STEP DETECT ASSOCIATES
JEFFERSON HILLS,  PA,  US.
Initial Importer;  
1 STEP DETECT ASSOCIATES
JEFFERSON HILLS,  PA ,  US.
10/10 OPTICS
NEW YORK,  NY,  US.
Initial Importer;  
10/10 OPTICS
NEW YORK,  NY ,  US.
1073849 ONTARIO LIMITED O/A T.H.E. MEDICAL
BARRIE, ONTARIO,  CA.
Manufacturer;  
1073849 ONTARIO LIMITED O/A T.H.E. MEDICAL
BARRIE, ONTARIO,  CA.
123 EYEWEAR, INC.
OAKLAND,  CA,  US.
Initial Importer;  
123 EYEWEAR, INC.
OAKLAND,  CA ,  US.
1384563 ONTARIO LTD.
CORNWALL, ONTARIO,  CA.
Manufacturer;  
1384563 ONTARIO LTD.
CORNWALL, ONTARIO,  CA.
1496573 ONTARIO INC. O/A CN SPA MANUFACTURE OF CAN
NORTH YORK, ONTARIO,  CA.
Foreign Exporter;  
1496573 ONTARIO INC. O/A CN SPA MANUFACTURE OF CAN
NORTH YORK, ONTARIO,  CA.
1531506 ONTARIO, LTD.
ORILLIA, ONTARIO,  CA.
Foreign Exporter;   Manufacturer;  
1531506 ONTARIO, LTD.
ORILLIA, ONTARIO,  CA.
180S, LLC
BALTIMORE,  MD,  US.
Initial Importer;  
180S, LLC
BALTIMORE,  MD ,  US.
1888 MILLS, LLC
OAKBROOK TERR.,  IL,  US.
Initial Importer;  
1888 MILLS, LLC
OAKBROOK TERR.,  IL ,  US.
1976, LLC
SAN JUAN, CAPISTRANO,  CA,  US.
Specification Developer;  
1976, LLC
SAN JUAN, CAPISTRANO,  CA ,  US.
1ST EYE CARE DR. TIM P. KRET
FT. WORTH,  TX,  US.
Initial Importer;  
1ST EYE CARE DR. TIM P. KRET
FT. WORTH,  TX ,  US.
2 RN
MELBOURNE,  FL,  US.
Manufacturer;   Repackager/Relabeller;  
2 RN
MELBOURNE,  FL ,  US.
20/20 OPTICAL DISPENSATORY, INC.
PLANTATION,  FL,  US.
Initial Importer;  
20/20 OPTICAL DISPENSATORY, INC.
PLANTATION,  FL ,  US.
20/20 OPTICAL, INC.
NEW YORK CITY,  NY,  US.

20/20 OPTICAL, INC.
NEW YORK CITY,  NY ,  US.
200 CC
JACKSONVILLE,  FL,  US.
Initial Importer;  
200CC, INC.
JACKSONVILLE,  FL ,  US.
200 TOY (HK) LTD.
EAST KOWLOON,  HK.
Manufacturer;  
200 TOY, INC.
MILFORD,  MA ,  US.
2020 EYEWEAR, INC.
ROCKAWAY,  NY,  US.
Initial Importer;  
2020 EYEWEAR, INC.
ROCKAWAY,  NY ,  US.
210 INNOVATIONS, LLC
STONINGTON,  CT,  US.
Manufacturer;  
210 INNOVATIONS, LLC
STONINGTON,  CT ,  US.
21ST CENTECK MEDICAL, INC.
PENSACOLA,  FL,  US.
Initial Importer;  
21ST CENTECK MEDICAL, INC.
PENSACOLA,  FL ,  US.
21ST CENTURY SALES & MARKETING CO.
MISSION VIEJO,  CA,  US.
Initial Importer;  
GEORGE C LIU
MISSION VIEJO,  CA ,  US.
21ST CENTURY SCIENTIFIC, INC.
COEUR D' ALENE,  ID,  US.
Manufacturer;  
21ST CENTURY SCIENTIFIC, INC.
COEUR D' ALENE,  ID ,  US.
24K GOLD LENSCO
NEW YORK,  NY,  US.
Initial Importer;  
24K GOLD LENSCO
NEW YORK,  NY ,  US.
26 CALIFORNIA BAZAAR, INC.
VERNON,  CA,  US.
Initial Importer;  
26 CALIFORNIA BAZAAR, INC.
VERNON,  CA ,  US.
2966-1691 QUEBEC, INC.
BEAUPORT-QUEBEC,  CA.
Repackager/Relabeller;  
2966-1691 QUEBEC, INC.
BEAUPORT-QUEBEC,  CA.
2W INTL. CORP.
POMONA,  CA,  US.
Initial Importer;  
2W INTL. CORP.
POMONA,  CA ,  US.
3 A ELETTROMEDICALI
COLOMBARE DI SIRMIONE,  IT.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
3 A ELETTROMEDICALI
COLOMBARE DI SIRMIONE,  IT.
3 KITA HOME SHOPPING
MILWAUKEE,  WI,  US.
Initial Importer;  
3 KITA HOME SHOPPING
MILWAUKEE,  WI ,  US.
310 LLC
MELBOURNE,  FL,  US.
Manufacturer;  
310 LLC
MELBOURNE,  FL ,  US.
3742971 MAN LTD.
TEULON, MANITOBA,  CA.
Manufacturer;  
PREMIER CARE INDUSTRIES
TEULON, MANITOBA,  CA.
3A MEDES
GOYANG-SI, GYEONGGI-DO,  KS.
Manufacturer;  
3A MEDES
GOYANG-SI, GYEONGGI-DO,  KS.
3BY LTD.
TEFEN,  IS.
Contract Manufacturer;  
3BY LTD.
TEFEN,  IS.
3CPM CO., INC.
TOWSON,  MD,  US.
Specification Developer;  
3CPM CO., INC.
TOWSON,  MD ,  US.
3D LINE INTERNATIONAL S.R.L.
MILAN,  IT.
Contract Manufacturer;  
3D LINE INTERNATIONAL S.R.L.
MILAN,  IT.
3D LINE USA, INC.
RESTON,  VA,  US.
Initial Importer;   Repackager/Relabeller;  
3D LINE USA, INC.
RESTON,  VA ,  US.
3D MACHINING, INC.
RIVIERA BEACH,  FL,  US.
Contract Manufacturer;  
3D MACHINING, INC.
RIVIERA BEACH,  FL ,  US.
3D MED CO., LTD.
SEOUL,  KS.
Manufacturer;  
3D MED CO., LTD.
SEOUL,  KS.
3D MEDICAL CONCEPTS, LLC
PELHAM,  AL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;  
3D MEDICAL CONCEPTS, LLC
PELHAM,  AL ,  US.

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Last Modified: 29 April 2006
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