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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
RESPIRONICS, INC.
YOUNGWOOD,  PA,  US.
Repackager/Relabeller;  
RESPIRONICS, INC.
MURRYSVILLE,  PA ,  US.
RESPITECH MEDICAL, INC.
LANCASTER,  PA,  US.
Initial Importer;  
RESPITECH MEDICAL, INC.
LANCASTER,  PA ,  US.
RESPOND INDUSTRIES, INC.
EWARDSVILLE,  KS,  US.
Repackager/Relabeller;  
CINTAS CORP.
CINCINNATI,  OH ,  US.
RESPONSE BIOMEDICAL CORP.
BURNABY, BRITISH COLUMBIA,  CA.
Manufacturer;  
RESPONSE BIOMEDICAL CORP.
BURNABY, BRITISH COLUMBIA,  CA.
RESPONSIVE PROVIDERS, INC.
HOUSTON,  TX,  US.
Initial Importer;  
RESPONSIVE PROVIDERS, INC.
HOUSTON,  TX ,  US.
RES-Q-TECH, N.A., INC.
HUMBLE,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
RES-Q-TECH, N.A., INC.
HUMBLE,  TX ,  US.
RESTORATION HARDWARE, INC.
CORTE MADERA,  CA,  US.
Initial Importer;  
RESTORATION HARDWARE, INC.
CORTE MADERA,  CA ,  US.
RESTORATIVE CARE OF AMERICA, INC.
ST. PETERSBURG,  FL,  US.
Manufacturer;  
RESTORATIVE CARE OF AMERICA, INC.
ST. PETERSBURG,  FL ,  US.
RESTORATIVE HEALTH SERVICES, INC.
NASHVILLE,  TN,  US.
Manufacturer;  
RESTORATIVE HEALTH SERVICES, INC.
NASHVILLE,  TN ,  US.
RESTORATIVE MEDICAL, INC.
BRANDENBURG,  KY,  US.
Contract Manufacturer;   Manufacturer;  
RESTORATIVE MEDICAL, INC.
BRANDENBURG,  KY ,  US.
RESTORATIVE THERAPIES INC.
BALTIMORE,  MD,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
RESTORATIVE THERAPIES INC.
BALTIMORE,  MD ,  US.
RESTORE MEDICAL INC.
ST PAUL,  MN,  US.
Manufacturer;  
RESTORE MEDICAL INC.
ST PAUL,  MN ,  US.
RESUMPTION ENT. CO.
HONG KONG,  HK.
Manufacturer;  
RESUMPTION ENT. CO.
HONG KONG,  HK.
RETAIL BRAND ALLIANCE INC.
ENFIELD,  CT,  US.
Initial Importer;  
RETAIL BRAND ALLIANCE INC.
ENFIELD,  CT ,  US.
RETAIL VENTURES SERVICES, INC.
COLUMBUS,  OH,  US.
Initial Importer;  
RETAIL VENTURES SERVICES, INC.
COLUMBUS,  OH ,  US.
RETRACTABLE TECHNOLOGIES, INC.
LITTLE ELM,  TX,  US.
Manufacturer;  
RETRACTABLE TECHNOLOGIES, INC.
LITTLE ELM,  TX ,  US.
RETRAX SAFETY SYSTEMS, INC.
MIAMI,  FL,  US.
Initial Importer;   Specification Developer;  
RETRAX SAFETY SYSTEMS, INC.
MIAMI,  FL ,  US.
RETROACTIVE BIOSCIENCE
WILDER,  KY,  US.
Manufacturer;   Specification Developer;  
40 J'S LLC
WILDER,  KY ,  US.
RETROFIT, LLC
EAST BRUNSWICK,  NJ,  US.
Specification Developer;  
RETROFIT, LLC
EAST BRUNSWICK,  NJ ,  US.
REVERT S.R.L.
BELLUNO,  IT.
Manufacturer;  
REVERT S.R.L.
BELLUNO,  IT.
REVIDERM AG
OBERHACHING/MUNICH,  GM.
Manufacturer;  
REVIDERM AG
OBERHACHING/MUNICH,  GM.
REVIVE SYSTEMS CORP.
LAKE GENEVA,  WI,  US.
Manufacturer;  
REVIVE SYSTEMS CORP.
LAKE GENEVA,  WI ,  US.
REVOLUTION EYEWEAR, INC.
SIMI VALLEY,  CA,  US.
Contract Manufacturer;  
REVOLUTION EYEWEAR, INC.
SIMI VALLEY,  CA ,  US.
REVOLUTION INTERNATIONAL LLC
TAMPA,  FL,  US.
Initial Importer;  
REVOLUTION INTERNATIONAL LLC
TAMPA,  FL ,  US.
REVUE INT'L. LLC.
SOUTH NORWALK,  CT,  US.
Initial Importer;  
REVUE INT'L. LLC.
SOUTH NORWALK,  CT ,  US.
REWINNER ENTERPRISE CO. LTD.
TAIPEI,  TW.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
REWINNER ENTERPRISE CO. LTD.
TAIPEI,  TW.
REWOOD CORP.
CAROL STREAM,  IL,  US.
Initial Importer;  
REWOOD CORP.
CAROL STREAM,  IL ,  US.
REX ENTERPRISES CO, LTD.
SAMPHRAN, NAKORN PATHOM,  TH.
Contract Manufacturer;  
REX ENTERPRISES CO, LTD.
SAMPHRAN, NAKORN PATHOM,  TH.
REX MEDICAL LP
CONSHOHOCKEN,  PA,  US.
Specification Developer;  
REX MEDICAL LP
CONSHOHOCKEN,  PA ,  US.
REX MEDICAL LTD.
PAPATOETOE, AUCKLAND,  NZ.
Unregistered Foreign Lister;  
REX MEDICAL LTD.
PAPATOETOE, AUCKLAND,  NZ.
REX METAL-CRAFT, INC.
INDIANAPOLIS,  IN,  US.
Manufacturer;  
REX METAL-CRAFT, INC.
INDIANAPOLIS,  IN ,  US.
REX PRODUCTS, INC.
SOUTH SAN FRANCISCO,  CA,  US.
Specification Developer;  
REX PRODUCTS, INC.
SOUTH SAN FRANCISCO,  CA ,  US.
REX ROUND RUBBER U.S.A.
RIO PIEDRAS,  PR,  US.
Initial Importer;   Repackager/Relabeller;  
REX ROUND RUBBER U.S.A.
RIO PIEDRAS,  PR ,  US.
REXITAL U.S., INC.
ROSWELL,  GA,  US.
Initial Importer;  
REXITAL U.S., INC.
ROSWELL,  GA ,  US.
REXTON (SUZHOU) HEARING SYSTEMS CO., LTD.
SUZHOU JIANG SU PROVINCE,  CH.
Manufacturer;  
A & M HEARING, LTD.
WEST SUSSEX,  UK.
REXTON, INC.
PLYMOUTH,  MN,  US.
Initial Importer;   Manufacturer;  
REXTON, INC.
PLYMOUTH,  MN ,  US.
REYTEK, SA DE C.V.
MERIDA, YUCATAN,  MX.
Contract Manufacturer;  
TRISTAR DENTAL LABORATORY, INC.
HOUSTON,  TX ,  US.
REZA RADMAND
CALABASAS,  CA,  US.
Specification Developer;  
REZA RADMAND
CALABASAS,  CA ,  US.
REZNIK INSTRUMENT, INC.
SKOKIE,  IL,  US.
Initial Importer;   Manufacturer;  
REZNIK INSTRUMENT, INC.
SKOKIE,  IL ,  US.
RF DESIGN, INC.
HOWELL,  MI,  US.
Manufacturer;  
RF DESIGN, INC.
HOWELL,  MI ,  US.

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Last Modified: 29 April 2006
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