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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
STA-SOF BREAST COMPRESSOR-CLAMP
LOS ANGELES,  CA,  US.
Manufacturer;  
STA-SOF BREAST COMPRESSOR-CLAMP
LOS ANGELES,  CA ,  US.
STAT MEDICAL DEVICES, INC.
NORTH MIAMI,  FL,  US.
Initial Importer;   Specification Developer;  
STAT MEDICAL DEVICES, INC.
NORTH MIAMI,  FL ,  US.
STAT, DIV. DEROYAL INDUSTRIES, INC.
NEW TAZEWELL,  TN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DEROYAL INDUSTRIES, INC.
POWELL,  TN ,  US.
STATCHEM, INC
ORANGE,  CA,  US.
Specification Developer;  
STATCHEM, INC
ORANGE,  CA ,  US.
STATCO HEARING AID LABORATORY
NORTH LITTLE ROCK,  AR,  US.
Contract Manufacturer;   Manufacturer;  
STATCO HEARING AID LABORATORY
NORTH LITTLE ROCK,  AR ,  US.
STATCO HEARING LABORATORY
LITTLE ROCK,  AR,  US.
Manufacturer;  
STATCO HEARING LABORATORY
LITTLE ROCK,  AR ,  US.
STATCORP, INC.
JACKSONVILLE,  FL,  US.
Manufacturer;  
CAS MEDICAL SYSTEMS, INC.
BRANFORD,  CT ,  US.
STATE OPTICAL COMPANY OF MD., INC.
TAMPA,  FL,  US.
Initial Importer;  
STATE OPTICAL COMPANY OF MD., INC.
TAMPA,  FL ,  US.
STATE SURGICAL INSTRUMENTS CORP.
BLOOMING GLEN,  PA,  US.
Initial Importer;  
STATE SURGICAL INSTRUMENTS CORP.
BLOOMING GLEN,  PA ,  US.
STATENS SERUM INSTITUT
COPENHAGEN,  DA.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
STATENS SERUM INSTITUT
COPENHAGEN,  DA.
STATLAB MEDICAL PRODUCTS, INC.
LEWISVILLE,  TX,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
STATLAB MEDICAL PRODUCTS, INC.
LEWISVILLE,  TX ,  US.
STATLAB MEDICAL PRODUCTS, INC.
LEWISVILLE,  TX,  US.
Repackager/Relabeller;  
STATLAB MEDICAL PRODUCTS, INC.
LEWISVILLE,  TX ,  US.
STAT-LAB TECHNOLOGIES, INC.
FEDERAL WAY,  WA,  US.
Initial Importer;   Repackager/Relabeller;  
STAT-LAB TECHNOLOGIES, INC.
FEDERAL WAY,  WA ,  US.
STAVELEY SENSORS, INC.
EAST HARTFORD,  CT,  US.
Contract Manufacturer;  
STAVELEY SENSORS, INC.
EAST HARTFORD,  CT ,  US.
STAXI CORPORATION, LTD.
MISSISSAUGA, ONTARIO,  CA.
Manufacturer;  
STAXI CORPORATION, LTD.
MISSISSAUGA, ONTARIO,  CA.
STAYHAPPY
DENVER,  CO,  US.
Repackager/Relabeller;  
STAYHAPPY
DENVER,  CO ,  US.
STAYL-GMBH
ROSRATH,  GM.
Manufacturer;  
STAYL-GMBH
ROSRATH,  GM.
STB GROUP INTERNATIONAL, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
STB GROUP INTERNATIONAL, INC.
DELRAY BEACH,  FL ,  US.
STC PLASTICS, INC.
CHINO,  CA,  US.
Contract Manufacturer;  
STC PLASTICS, INC.
CHINO,  CA ,  US.
S-TCM ENTERPRISES, INC.
AUSTIN,  TX,  US.
Initial Importer;  
S-TCM ENTERPRISES, INC.
AUSTIN,  TX ,  US.
STCV - MOPTIC SARL
OYONNAX,  FR.
Unregistered Foreign Lister;  
STCV - MOPTIC SARL
OYONNAX,  FR.
STD MED, INC.
STOUGHTON,  MA,  US.
Contract Manufacturer;   Manufacturer;  
STD MED, INC.
STOUGHTON,  MA ,  US.
STD PHARMACEUTICAL PRODUCTS LTD.
HEREFORD,  UK.
Unregistered Foreign Lister;  
STD PHARMACEUTICAL PRODUCTS LTD.
HEREFORD,  UK.
STE NAVID INTL.
PARIS,  FR.
Manufacturer;  
STE NAVID INTL.
PARIS,  FR.
STEALTH PRODUCTS
BURNET,  TX,  US.
Manufacturer;  
STEALTH PRODUCTS
BURNET,  TX ,  US.
STEALTH SURGICAL, LLC
CULVER,  IN,  US.
Initial Importer;  
STEALTH SURGICAL, LLC
CULVER,  IN ,  US.
S-TEC OSAKA, INC.
OSAKA,  JA.
Foreign Exporter;  
S-TEC OSAKA, INC.
OSAKA,  JA.
STECO-SYSTEM-TECHNIK GMBH & CO. KG
HAMBURG,  GM.
Foreign Exporter;   Manufacturer;  
STECO-SYSTEM-TECHNIK GMBH & CO. KG
HAMBURG,  GM.
STEDIM S.A.
AUBAGNE CEDEX,  FR.
Contract Manufacturer;   Manufacturer;  
STEDIM S.A.
AUBAGNE CEDEX,  FR.
STEDIM, INC.
CONCORD,  CA,  US.
Initial Importer;   Manufacturer;  
STEDIM S.A.
AUBAGNE CEDEX,  FR.
STEEL TOP ENT.
SIALKOT,  PK.
Manufacturer;  
STEEL TOP ENT.
SIALKOT,  PK.
STEELCRAFT, INC.
MILLBURY,  MA,  US.
Manufacturer;  
STEELCRAFT, INC.
MILLBURY,  MA ,  US.
STEERING CORP.
TAIPEI,  TW.
Contract Manufacturer;  
STEERING CORP.
TAIPEI,  TW.
STEFAN HERMLE
GOSHEIM,  GM.
Manufacturer;  
STEFAN HERMLE
GOSHEIM,  GM.
STEGMAN LABORATORIES LLC
PHOENIX,  AZ,  US.
Repackager/Relabeller;  
STEGMAN LABORATORIES LLC
PHOENIX,  AZ ,  US.
STEIN DENTAL SUPPLIES INC.
BROOKLYN,  NY,  US.
Initial Importer;  
STEIN DENTAL SUPPLIES INC.
BROOKLYN,  NY ,  US.
STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK
HEIDELBERG,  GM.
Manufacturer;  
STEINBEIS GMBH & CO FUR TECHNOLOGIE-TRANSFER
STUTTGART,  GM.
STEINER LABORATORIES
EWA BEACH,  HI,  US.
Manufacturer;  
STEINER LABORATORIES
KAPOLEI,  HI ,  US.
STEINHART MEDIZINSYSTEME GMBH
VORSTETTEN,  GM.
Manufacturer;  
STEINHART MEDIZINSYSTEME GMBH
VORSTETTEN,  GM.
STEINMAN SERVICES, INC.
EDWARDSVILLE,  IL,  US.
Initial Importer;  
STEINMAN SERVICES, INC.
EDWARDSVILLE,  IL ,  US.

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Last Modified: 29 April 2006
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