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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
ACUDERM, INC.
FT. LAUDERDALE,  FL,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ACUDERM, INC.
FT. LAUDERDALE,  FL ,  US.
ACUEITY, INC.
PALO ALTO,  CA,  US.
Specification Developer;  
ACUEITY, INC.
PALO ALTO,  CA ,  US.
ACUHEALTH PTY. LTD.
STEPNEY, SOUTH AUSTRALIA,  AS.
Manufacturer;  
ACUHEALTH PTY. LTD.
STEPNEY, SOUTH AUSTRALIA,  AS.
ACUITY ONE, LLC
SCOTTSDALE,  AZ,  US.
Initial Importer;   Repackager/Relabeller;  
ACUITY ONE, LLC
SCOTTSDALE,  AZ ,  US.
ACUITY OPTICAL MFY., LTD.
HONG KONG,  CH.
Manufacturer;  
ACUITY OPTICAL MFY., LTD.
HONG KONG,  CH.
ACUITY OPTICAL USA, INC.
TEMPE,  AZ,  US.
Initial Importer;  
ACUITY OPTICAL USA, INC.
TEMPE,  AZ ,  US.
ACULUX, INC.
NAPLES,  FL,  US.
Manufacturer;   Specification Developer;  
ACULUX, INC.
NAPLES,  FL ,  US.
ACUMAR TECHNOLOGY
PORTLAND,  OR,  US.
Manufacturer;  
ACUMAR TECHNOLOGY
PORTLAND,  OR ,  US.
ACU-MARKET
BOYNTON BEACH,  FL,  US.
Initial Importer;  
ACU-MARKET
BOYNTON BEACH,  FL ,  US.
ACUMART MEDICAL SUPPLIES, INC.
CITY OF INDUSTRY,  CA,  US.
Initial Importer;  
ACUMART MEDICAL SUPPLIES, INC.
CITY OF INDUSTRY,  CA ,  US.
ACUMED INSTRUMENTS CORP.
OAK PARK,  CA,  US.
Manufacturer;   Specification Developer;  
ACUMED INSTRUMENTS CORP.
OAK PARK,  CA ,  US.
ACUMED LLC
HILLSBORO,  OR,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ACUMED LLC
HILLSBORO,  OR ,  US.
ACUMED MEDICAL LTD.
ST. AUGUSTINE,  FL,  US.
Initial Importer;  
ACUMED MEDICAL SUPPLIES, LTD.
TORONTO, ONTARIO,  CA.
ACUMED MEDICAL SUPPLIES, LTD.
TORONTO, ONTARIO,  CA.
Repackager/Relabeller;  
ACUMED MEDICAL SUPPLIES, LTD.
TORONTO, ONTARIO,  CA.
ACUMED MEDICAL, USA
ST. LOUIS,  MO,  US.
Initial Importer;  
ACUMED MEDICAL SUPPLIES, LTD.
TORONTO, ONTARIO,  CA.
ACUMEDIA MANUFACTURERS, INC.
LANSING,  MI,  US.
Manufacturer;  
NEOGEN CORP.
LANSING,  MI ,  US.
ACUMEDIC LTD.
LONDON,  UK.
Unregistered Foreign Lister;  
ACUMEDIC LTD.
LONDON,  UK.
ACUMEN BRUSH INDUSTRY
CHOLBURI,  TH.
Unregistered Foreign Lister;  
ACUMEN BRUSH INDUSTRY CO.,LTD
TH.
ACUMEN BRUSH INDUSTRY CO.,LTD
TH.
Unregistered Foreign Lister;  
ACUMEN BRUSH INDUSTRY CO.,LTD
TH.
ACUMEN CO.,LTD.
TAIPEI HSIEN,TAIWAN,  CH.
Unregistered Foreign Lister;  
ACUMEN CO.,LTD.
TAIPEI HSIEN,TAIWAN,  CH.
ACUMEN HOUSEWARE INDUSTRY (NANNING) CO., LTD.
NANNING CITY, KWANGSI PROVINCE,  CH.
Manufacturer;  
ACUMEN HOUSEWARE INDUSTRY (NANNING) CO., LTD.
NANNING CITY, KWANGSI PROVINCE,  CH.
ACUMEN MEDICAL, INC.
SUNNYVALE,  CA,  US.
Manufacturer;  
ACUMEN MEDICAL, INC.
MOUNTAIN VIEW,  CA ,  US.
ACUMEN OPTICAL EYEWEAR
GOLDEN,  CO,  US.
Initial Importer;  
ACUMEN OPTICAL EYEWEAR
GOLDEN,  CO ,  US.
ACUMEN SURGICAL (PVT) LTD.
SIALKOT,  PK.
Manufacturer;  
ACUMEN SURGICAL (PVT) LTD.
SIALKOT,  PK.
ACUMEN, INC.
STERLING,  VA,  US.
Initial Importer;  
ACUMEN, INC.
STERLING,  VA ,  US.
ACUO TECHNOLOGIES
OAKDALE,  MN,  US.
Manufacturer;  
ACUO TECHNOLOGIES
OAKDALE,  MN ,  US.
ACUPAC PACKAGING, INC.
MAHWAH,  NJ,  US.
Contract Manufacturer;  
OUTSOURING SERVICES GROUP, INC.
WOODCLIFF LAKE,  NJ ,  US.
ACUPOINTOUCH, INC.
HOUSTON,  TX,  US.
Initial Importer;  
ACUPOINTOUCH, INC.
HOUSTON,  TX ,  US.
ACUPUNCTURE & HERBS RESEARCH
SAN DIEGO,  CA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ACUPUNCTURE & HERBS RESEARCH
SAN DIEGO,  CA ,  US.
ACUPUNCTURE FORUM CORP.
ROCKVILLE,  MD,  US.
Initial Importer;  
ACUPUNCTURE FORUM CORP.
ROCKVILLE,  MD ,  US.
ACUPUNCTURE SUPPLIES IMPORT CO.
CYPRESS,  CA,  US.
Initial Importer;  
ACUPUNCTURE SUPPLIES IMPORT CO.
CYPRESS,  CA ,  US.
ACUSTEP, INC.
SALINA,  KS,  US.
Manufacturer;  
ACUSTEP, INC.
SALINA,  KS ,  US.
ACUSUPPLY, INC.
HALLANDALE,  FL,  US.
Initial Importer;  
ACUSUPPLY, INC.
HALLANDALE,  FL ,  US.
ACUTE IDEAS CO. LTD.
TAIPEI,  TW.
Manufacturer;  
ACUTE IDEAS CO. LTD.
TAIPEI,  TW.
ACUTE INNOVATIONS LLC
HILLSBORO,  OR,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ACUTE INNOVATIONS LLC
HILLSBORO,  OR ,  US.
ACUTRONIC MEDICAL SYSTEMS AG
HIRZEL,  SZ.
Manufacturer;  
ACUTRONIC MEDICAL SYSTEMS AG
HIRZEL,  SZ.
ACUVISION LTD.
SOUTHAMPTON,  UK.
Specification Developer;  
ACUVISION LTD.
SOUTHAMPTON,  UK.
AD A NAME, INC.
MIDWAY,  KY,  US.
Initial Importer;  
AD A NAME, INC.
MIDWAY,  KY ,  US.
AD ELEKTRONIK GMBH
WETZLAR,  GM.
Manufacturer;   Specification Developer;  
AD ELEKTRONIK GMBH
WETZLAR,  GM.
AD OPTICS
MONTEREY PARK,  CA,  US.
Initial Importer;  
AD OPTICS
MONTEREY PARK,  CA ,  US.

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Last Modified: 29 April 2006
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