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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
DATCARD SYSTEMS, INC.
IRVINE,  CA,  US.
Manufacturer;  
DATCARD SYSTEMS, INC.
IRVINE,  CA ,  US.
DA-TECH CORP.
IVYLAND,  PA,  US.
Contract Manufacturer;  
DA-TECH CORP.
IVYLAND,  PA ,  US.
DATEX-OHMEDA, INC.
MADISON,  WI,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
DATEX-OHMEDA, INC.
MIAMI,  FL,  US.
Initial Importer;  
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
MILWAUKEE,  WI ,  US.
DATOYO (NINGBO) CO., LTD.
NINGBO,  CH.
Contract Manufacturer;  
DATOYO (NINGBO) CO., LTD.
NINGBO,  CH.
DATRAN CORP.
NEW HAVEN,  CT,  US.
Contract Manufacturer;   Manufacturer;  
DATRAN CORP.
NEW HAVEN,  CT ,  US.
DATREND SYSTEMS, INC.
RICHMOND, BRITISH COLUMBIA,  CA.
Contract Manufacturer;   Manufacturer;  
DATREND SYSTEMS, INC.
RICHMOND, BRITISH COLUMBIA,  CA.
DATREX, INC.
MIAMI,  FL,  US.
Initial Importer;  
L.E. WEST LTD
LONDON,  UK.
DATRIX
ESCONDIDO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
DATRIX
ESCONDIDO,  CA ,  US.
DATRON PRODUCTS CO., LTD.
TAIPEI,  TW.
Manufacturer;  
COOLER KING CORP.
DUARTE,  CA ,  US.
DATT MEDIPRODUCTS, LTD.
SOHNA, GURGAON, HARYANA,  IN.
Manufacturer;  
DATT MEDIPRODUCTS, LTD.
NEW DELHI,  IN.
DAUM CORP.
CHICAGO,  IL,  US.
Initial Importer;  
MRI DEVICES DAUM GMBH
SCHWERIN,  GM.
DAVAL LTD.
CREVILLENTE ALICANTE,  SP.
Manufacturer;   Specification Developer;  
DAVAL LTD.
CREVILLENTE ALICANTE,  SP.
DAVENPORT INTERNATIONAL ENTERPRISES INC.
IRVINE,  CA,  US.
Initial Importer;  
DAVENPORT INTERNATIONAL ENTERPRISES INC.
IRVINE,  CA ,  US.
DAVE'S WHEELCHAIR, INC.
HYDE PARK,  NY,  US.
Specification Developer;  
DAVE'S WHEELCHAIR, INC.
HYDE PARK,  NY ,  US.
DAVID & YOUNG CO., INC.
NEW YORK,  NY,  US.
Initial Importer;  
DAVID & YOUNG CO., INC.
NEW YORK,  NY ,  US.
DAVID BIOTECH LTD.
SHANTOU GUANGDONG,  CH.
Manufacturer;  
DAVID BIOTECH LTD.
SHANTOU GUANGDONG,  CH.
DAVID CLARK COMPANY, INC.
WORCESTER,  MA,  US.
Manufacturer;  
DAVID CLARK COMPANY, INC.
WORCESTER,  MA ,  US.
DAVID J. SLUTSKY MD
TORRANCE,  CA,  US.
Specification Developer;  
DAVID J. SLUTSKY MD
TORRANCE,  CA ,  US.
DAVID M. HARVEY
ROME,  NY,  US.
Initial Importer;  
DAVID M. HARVEY
ROME,  NY ,  US.
DAVID MEDICAL PRODUCTS (SUZHOU) CO., LTD.
JIANGSU PROVINCE,  CH.
Manufacturer;  
DAVID MEDICAL PRODUCTS (SUZHOU) CO., LTD.
JIANGSU PROVINCE,  CH.
DAVID OPTICIANS
POTOMAC,  MD,  US.
Initial Importer;  
DAVID OPTICIANS
POTOMAC,  MD ,  US.
DAVID PACKARD COMPANY, INC.
OXFORD,  MA,  US.
Contract Manufacturer;  
DAVID PACKARD COMPANY, INC.
OXFORD,  MA ,  US.
DAVID SCOTT CO.
FRAMINGHAM,  MA,  US.
Manufacturer;  
ROBERT H. KAPLAN ASSOC., INC.
FRAMINGHAM,  MA ,  US.
DAVID STEELE ENT., INC.
NEWPORT BEACH,  CA,  US.
Initial Importer;  
DAVID STEELE ENT., INC.
NEWPORT BEACH,  CA ,  US.
DAVID STUBBS DENTAL LABS, INC.
CEDAR HILL,  TX,  US.
Repackager/Relabeller;  
DAVID STUBBS DENTAL LABS, INC.
CEDAR HILL,  TX ,  US.
DAVID WEST
MIRAMAR,  FL,  US.
Initial Importer;  
DAVID WEST
MIRAMAR,  FL ,  US.
DAVINCI CORP.
SEOUL,  KS.
Manufacturer;  
YOON, KWAN EUK
ANYAN, KYUNGKI-DO,  KS.
DAVINCI DENTAL STUDIOS, INC.
WEST HILLS,  CA,  US.
Initial Importer;   Reprocessor of single-use devices;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DAVINCI DENTAL STUDIOS, INC.
WEST HILLS,  CA ,  US.
DAVIS AND GECK CARIBE, LTD.
SANTO DOMINGO,  DR.
Manufacturer;  
UNITED STATES SURGICAL
NORWALK,  CT ,  US.
DAVIS CERVICAL TRACTION PILLOW CO.
MEXICO,  MO,  US.
Specification Developer;  
DAVIS CERVICAL TRACTION PILLOW CO.
MEXICO,  MO ,  US.
DAVIS DENTAL LABS
WYOMING,  MI,  US.
Initial Importer;   Manufacturer;  
SENTAGE CORPORATION
MINNEAPOLIS,  MN ,  US.
DAVIS DENTAL SUPPLY
NORTH HOLLYWOOD,  CA,  US.
Initial Importer;  
ODONTORIUM PRODUCTS, INC.
NORTH HOLLYWOOD,  CA ,  US.
DAVIS LEAD APRON CO.
HOUSTON,  TX,  US.
Manufacturer;  
DAVIS LEAD APRON CO.
HOUSTON,  TX ,  US.
DAVIS MEDICAL SUPPLY CO., INC.
PASADENA,  TX,  US.
Initial Importer;  
DAVIS MEDICAL SUPPLY CO., INC.
PASADENA,  TX ,  US.
DAVIS SCHOTTLANDER & DAVIS, LTD.
LETCHWORTH, HERTS.,  UK.
Foreign Exporter;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DAVIS SCHOTTLANDER & DAVIS, LTD.
LETCHWORTH, HERTS.,  UK.
DAVIS VISION, INC.
PLAINVIEW,  NY,  US.
Initial Importer;  
DAVIS VISION, INC.
PLAINVIEW,  NY ,  US.
DAVIS-LOBDELL INSTRUMENT, INC.
ST. PAUL,  MN,  US.
Initial Importer;  
DAVIS-LOBDELL INSTRUMENT, INC.
ST. PAUL,  MN ,  US.
DAVISMADE, INC.
BURTON,  MI,  US.
Manufacturer;  
DAVISMADE, INC.
BURTON,  MI ,  US.
DAVOL INC., SUB. C.R. BARD, INC.
CRANSTON,  RI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
C.R. BARD, INC.
MURRAY HILL,  NJ ,  US.

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Last Modified: 29 April 2006
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