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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
DENTSPLY SANKIN K.K.
TOKYO,  JA.
Manufacturer;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENTSPLY TULSA DENTAL
JOHNSON CITY,  TN,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DENTSPLY INTERNATIONAL
YORK,  PA ,  US.
DENT-TECHNIK
SIALKOT, PUNJAB,  PK.
Manufacturer;  
DENT-TECHNIK
SIALKOT, PUNJAB,  PK.
DENT-TEK LABORATORIES
BURLINGAME,  CA,  US.
Initial Importer;  
DENT-TEK LABORATORIES
BURLINGAME,  CA ,  US.
DENTURE DYNAMIC'S, INC.
KEIZER,  OR,  US.
Repackager/Relabeller;  
DENTURE DYNAMIC'S, INC.
KEIZER,  OR ,  US.
DENTUSA LABORATORY
SHANGHAI,  CH.
Manufacturer;  
DENTUSA LABORATORY
SHANGHAI,  CH.
DENVER BIOMEDICAL, INC.
GOLDEN,  CO,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DENVER BIOMEDICAL, INC.
GOLDEN,  CO ,  US.
DENVER OPTIC OCULAR PROSTHETIC CO., INC.
ENGLEWOOD,  CO,  US.
Manufacturer;  
DENVER OPTIC OCULAR PROSTHETIC CO., INC.
ENGLEWOOD,  CO ,  US.
DENVU TECNOLOGIES INC.
DORVAL, QUEBEC,  CA.
Manufacturer;  
DENVU TECNOLOGIES INC.
DORVAL, QUEBEC,  CA.
DENX ADVANCED DENTAL SYSTEMS
JERUSALEM, AL,  IS.
Manufacturer;  
DENX ADVANCED DENTAL SYSTEMS
JERUSALEM,  IS.
DENX AMERICA INC.
BOYNTON BEACH,  FL,  US.
Initial Importer;  
DENX ADVANCED DENTAL SYSTEMS
JERUSALEM,  IS.
DE'O TECH
ILSAN-GU, KYUNGKI-DO,  KS.
Manufacturer;  
DE'O TECH
ILSAN-GU, KYUNGKI-DO,  KS.
DEO VOLENTE ORTHOPAEDICS, LLC
WARSAW,  IN,  US.
Specification Developer;  
DEO VOLENTE ORTHOPAEDICS, LLC
WARSAW,  IN ,  US.
DEONE, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Repackager/Relabeller;  
PEGGY CHEONG
SAN DIEGO,  CA ,  US.
DEPALT INC.
PLANO,  TX,  US.
Specification Developer;  
DEPALT INC.
PLANO,  TX ,  US.
DEPARTMENT OF RADIATION ONCOLOGY
LOS ANGELES,  CA,  US.
Manufacturer;  
UNIVERSITY OF SOUTHERN CALIFORNIA
LOS ANGELES,  CA ,  US.
DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER
PORTLAND,  OR,  US.
Manufacturer;  
DEPARTMENT OF VETERANS AFFAIRS
PORTLAND,  OR ,  US.
DEPENDABLE FIRST AID SUPPLY
GLEN BURNIE,  MD,  US.
Initial Importer;  
DEPENDABLE FIRST AID SUPPLY
GLEN BURNIE,  MD ,  US.
DEPENDICARE HOME HEALTH, INC.
BROADVIEW,  IL,  US.
Repackager/Relabeller;  
DEPENDICARE HOME HEALTH, INC.
BROADVIEW,  IL ,  US.
DEPILASE GROUP LTD.
LONDON,  UK.
Manufacturer;  
DEPILASE GROUP LTD.
LONDON,  UK.
DEPILASE ITALIA
MOGLIANO VENETO, TREVISO,  IT.
Manufacturer;  
DEPILASE GROUP LTD.
LONDON,  UK.
DEPROCO, INC.
NEW CASTLE,  DE,  US.
Initial Importer;  
DEPROCO, INC.
NEW CASTLE,  DE ,  US.
DEPT.OF MEDICAL PHYSICS & BIOMEDICAL ENGINEERING,
SALSIBURY,  UK.
Manufacturer;  
DEPT.OF MEDICAL PHYSICS & BIOMEDICAL ENGINEERING,
SALSIBURY,  UK.
DEPUY (IRELAND) LTD.
CORK,  EI.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY ACE S.A.'R.L.
LE LOCLE,  SZ.
Manufacturer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY BRIDGEWATER
BRIDGEWATER,  MA,  US.
Repackager/Relabeller;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY CMW
BLACKPOOL, LANCASHIRE,  UK.
Manufacturer;   Specification Developer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY FRANCE S.A.S.
CHAUMONT,  FR.
Manufacturer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY FRANCE S.A.S.-SAINT PRIEST
SAINT PRIEST CEDEX,  FR.
Specification Developer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY INTL., LTD.
LEEDS,  UK.
Manufacturer;   Specification Developer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
BRIDGEWATER,  MA,  US.
Initial Importer;   Manufacturer;  
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
RAYNAHM,  MA ,  US.
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
RAYNHAM,  MA,  US.
Manufacturer;   Specification Developer;  
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
RAYNAHM,  MA ,  US.
DEPUY ORTHOPAEDICS, INC.
WARSAW,  IN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY SPINE SARL
LELOCLE,  SZ.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
DEPUY SPINE SARL
LELOCLE,  SZ.
DEPUY SPINE, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
DEPUY SPINE, INC.
RAYNHAM,  MA ,  US.
DEPUY SPINE, INC.
RAYNHAM,  MA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DEPUY SPINE, INC.
RAYNHAM,  MA ,  US.
DEPUY-NEW BEDFORD
NEW BEDFORD,  MA,  US.
Manufacturer;   Specification Developer;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEPUY-RAYNHAM
RAYNHAM,  MA,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
DEPUY, INC.
WARSAW,  IN ,  US.
DEQING IDEAL MEDICAL DRESSING INDUSTRIES CO. LTD.
DEQING, ZHEJIANG PROV.,  CH.
Manufacturer;  
DEQING IDEAL MEDICAL DRESSING INDUSTRIES CO. LTD.
DEQING, ZHEJIANG PROV.,  CH.
DER VINCI GROUP INTERNATIONAL, INC.
LIVINGSTON,  TX,  US.
Initial Importer;   Specification Developer;  
DER VINCI GROUP INTERNATIONAL, INC.
LIVINGSTON,  TX ,  US.

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Last Modified: 29 April 2006
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