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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
ISCON SURGICALS, LTD.
JODHPUR,  IN.
Manufacturer;  
ISCON SURGICALS, LTD.
JODHPUR,  IN.
ISCON SURGICALS, LTD.
JODHPUR,  IN.
Manufacturer;  
ISCON SURGICALS, LTD.
JODHPUR,  IN.
ISCREEN, LLC.
MEMPHIS,  TN,  US.
Specification Developer;  
ISCREEN, LLC.
MEMPHIS,  TN ,  US.
I-SENS, INC.
SEOUL,  KS.
Contract Manufacturer;  
I-SENS, INC.
SEOUL,  KS.
ISHAQ TOWEL FACTORY
KARACHI,  PK.
Unregistered Foreign Lister;  
ISHAQ TOWEL FACTORY
KARACHI,  PK.
ISHIHARA OPTICAL COMPANY.
SABAE, FUKUI,  JA.
Manufacturer;  
ISHIHARA OPTICAL COMPANY.
SABAE, FUKUI,  JA.
ISHWARI PRASAD & SONS (P) LTD.
BOMBAY,  IN.
Repackager/Relabeller;  
ISHWARI PRASAD & SONS (P) LTD.
BOMBAY,  IN.
ISIS
LONDON,  UK.
Unregistered Foreign Lister;  
ISIS
LONDON,  UK.
ISIS MEDICAL TECHNOLOGIES, LTD.
EAST SUSSEX,  UK.
Unregistered Foreign Lister;  
ISIS MEDICAL TECHNOLOGIES, LTD.
EAST SUSSEX,  UK.
ISIS OPTRONICS GMBH
MANNHEIM,  GM.
Unregistered Foreign Lister;  
ISIS OPTRONICS GMBH
MANNHEIM,  GM.
ISLAND BIOSURGICAL, LLC.
MERCER ISLAND,  WA,  US.
Specification Developer;  
ISLAND BIOSURGICAL, LLC.
MERCER ISLAND,  WA ,  US.
ISLAND DENTAL SUPPLY CO., INC.
ARLINGTON,  TX,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
CINCINNATI,  OH,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
HAYWARD,  CA,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
LAKE MARY,  FL,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
LAS VEGAS,  NV,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
MIDVALE,  UT,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
RENO,  NV,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
ROSEVILLE,  CA,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
SAN DIEGO,  CA,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY CO., INC.
VALDOSTA,  GA,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY, INC.
JACKSONVILLE,  FL,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY, INC.
LAWRENCEVILLE,  GA,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND DENTAL SUPPLY, INC.
PLAINVIEW,  NY,  US.
Initial Importer;  
ISLAND DENTAL SUPPLY CO., INC.
JERICHO,  NY ,  US.
ISLAND IMPORT & EXPORT CO.
FRIDLEY,  MN,  US.
Initial Importer;   Repackager/Relabeller;  
ISLAND IMPORT & EXPORT CO.
FRIDLEY,  MN ,  US.
ISM SOUTH EAST ASIA PTE LTD.
SN.
Unregistered Foreign Lister;  
ISM SOUTH EAST ASIA PTE LTD.
SN.
ISMAIL JEE
SIALKOT,  PK.
Manufacturer;  
ISMAIL JEE
SIALKOT,  PK.
ISOAID, L.L.C.
PORT RICHEY,  FL,  US.
Manufacturer;  
ISOAID, L.L.C.
PORT RICHEY,  FL ,  US.
ISOCOMFORTER, INC.
PALM CITY,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ISOCOMFORTER, INC.
PALM CITY,  FL ,  US.
ISODIAGNOSTIKA, INC.
EDMONTON, ALBERTA,  CA.
Manufacturer;   Specification Developer;  
ISOTECHNIKA, INC.
EDMONTON, AB,  CA.
ISOHELIX LTD.
LONDON,  UK.
Foreign Exporter;   Specification Developer;  
ISOHELIX LTD.
LONDON,  UK.
ISOLA A/S
GOTHENBURG,  SW.
Unregistered Foreign Lister;  
ISOLA A/S
GOTHENBURG,  SW.
ISOLUX LLC
NAPLES,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
LUXTEL LLC
DANVERS,  MA ,  US.
ISOMED, S.L.
MADRID,  SP.
Specification Developer;   Repackager/Relabeller;  
ISOMED, S.L.
MADRID,  SP.
ISOMED,INC.
PORTLAND,  OR,  US.
Initial Importer;   Specification Developer;  
ISOMED,INC.
PORTLAND,  OR ,  US.
ISOMEDIX CORP.
WHITBY, ONTARIO,  CA.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC
EL PASO,  TX,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC
GROVEPORT,  OH,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC.
NORTHBOROUGH,  MA,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.
ISOMEDIX OPERATIONS INC.
SANDY,  UT,  US.
Contract Sterilizer;  
STERIS CORPORATION
MENTOR,  OH ,  US.

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Last Modified: 29 April 2006
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