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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
KENTEC MEDICAL, INC.
IRVINE,  CA,  US.
Specification Developer;  
KENTEC MEDICAL, INC.
IRVINE,  CA ,  US.
KENTEK CORPORATION
PITTSFIELD,  NH,  US.
Initial Importer;   Manufacturer;  
KENTEK CORPORATION
PITTSFIELD,  NH ,  US.
KENTRON HEALTH CARE, INC.
SPRINGFIELD,  TN,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
KENTRON HEALTH CARE, INC.
SPRINGFIELD,  TN ,  US.
KENTUCKY TEXTILES
PARIS,  KY,  US.
Repackager/Relabeller;  
KENTUCKY TEXTILES
PARIS,  KY ,  US.
KENYON INDUSTRIES, INC.
RINGWOOD,  NJ,  US.
Initial Importer;  
KENYON INDUSTRIES, INC.
RINGWOOD,  NJ ,  US.
KENZMEDICO CO. LTD.
KODAMAGUN, SAITAMA PREF.,  JA.
Manufacturer;  
KENZMEDICO CO. LTD.
KODAMAGUN, SAITAMA PREF.,  JA.
KEOMED, INC.
MINNETONKA,  MN,  US.

KEOMED, INC.
MINNETONKA,  MN ,  US.
KEOSAN CO., LTD.
KWANGJU-SI, KYUNGGI-DO,  KS.
Manufacturer;  
KEOSAN CO., LTD.
KWANGJU-SI, KYUNGGI-DO,  KS.
KEOYOUNG INC.
GYEONGGI-DO,  KS.
Manufacturer;  
KEOYOUNG INC.
GYEONGGI-DO,  KS.
KEOYOUNG IND. CO., LTD.
SEOUL,  KS.
Manufacturer;  
KEOYOUNG IND. CO., LTD.
SEOUL,  KS.
KER, S.A. DE C.V.
MONTERREY, N.L.,  MX.
Unregistered Foreign Lister;  
KER, S.A. DE C.V.
MONTERREY, N.L.,  MX.
KERA TECHNOLOGY, S.L.
MADRID,  SP.
Unregistered Foreign Lister;  
KERA TECHNOLOGY, S.L.
MADRID,  SP.
KERAGENIX, INC.
DIAMOND SPRINGS,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KERAGENIX, INC.
DIAMOND SPRINGS,  CA ,  US.
KERALA RUBBER & RECLAIMS, LTD.
COCHIN,  IN.
Manufacturer;  
KERALA RUBBER & RECLAIMS, LTD.
COCHIN,  IN.
KERBER APPLIED RESEARCH, INC.
ONTARIO,  CA.
Manufacturer;  
J.L. BLOSSER, INC.
LIBERTY,  MO ,  US.
KERBEROS PROXIMAL SOLUTIONS, INC.
CUPERTINO,  CA,  US.
Manufacturer;  
KERBEROS PROXIMAL SOLUTIONS
CUPERTINO,  CA ,  US.
KERLARDAN ASSOC., INC.
SCARBOROUGH, ONTARIO,  CA.
Manufacturer;  
KERLARDAN ASSOC., INC.
SCARBOROUGH, ONTARIO,  CA.
KERMA MEDICAL PRODUCTS, INC.
PORTSMOUTH,  VA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KERMA MEDICAL PRODUCTS, INC.
PORTSMOUTH,  VA ,  US.
KERNCO DENTAL SUPPLY, INC.
REINHOLDS,  PA,  US.
Initial Importer;  
KERNCO DENTAL SUPPLY, INC.
REINHOLDS,  PA ,  US.
KERNEL SYSTEMS
SINGAPORE,  SN.
Manufacturer;  
KERNEL SYSTEMS
SINGAPORE,  SN.
KERO
ROMANSHORN,  SZ.
Unregistered Foreign Lister;  
KERO
ROMANSHORN,  SZ.
KERR CORP.
ROMULUS,  MI,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
KERR CORPORATION
MIDDLETON,  WI,  US.
Manufacturer;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
KERR CORPORATION
ORANGE,  CA,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
KERRHAWE SA
BIOGGIO,  SZ.
Manufacturer;  
SYBRON DENTAL SPECIALTIES, INC.
NEWPORT BEACH,  CA ,  US.
KERRY'S MEDICAL, INC.
WEST SACRAMENTO,  CA,  US.
Initial Importer;  
KERRY'S MEDICAL, INC.
WEST SACRAMENTO,  CA ,  US.
KESAIR TECHNOLOGIES, LLC
KENNESAW,  GA,  US.
Manufacturer;  
KESAIR TECHNOLOGIES, LLC
KENNESAW,  GA ,  US.
KESSINGTON MACHINE PRODUCTS, INC.
ELKHART,  IN,  US.
Contract Manufacturer;  
KESSINGTON MACHINE PRODUCTS, INC.
ELKHART,  IN ,  US.
KETOCONCEPTS, LLC
SCOTTSDALE,  AZ,  US.
Initial Importer;   Repackager/Relabeller;  
KETOCONCEPTS, LLC
SCOTTSDALE,  AZ ,  US.
KETOGENICS INC
JOHNSTOWN,  PA,  US.
Initial Importer;  
KETOGENICS INC
JOHNSTOWN,  PA ,  US.
KEUM KOK INDUSTRIAL CO.
DAEGU,  KS.
Manufacturer;  
KEUM KOK INDUSTRIAL CO.
DAEGU,  KS.
KEVIN MCNAMEE, D.C., INC.
CANOGA PARK,  CA,  US.
Initial Importer;  
KEVIN MCNAMEE, D.C., INC.
CANOGA PARK,  CA ,  US.
KEVIN O. BOLAND
BETHESDA,  MD,  US.
Specification Developer;  
KEVIN O. BOLAND
BETHESDA,  MD ,  US.
KEWANEE HOSPITAL HOME MEDICAL EQUIPMENT
KEWANEE,  IL,  US.
Initial Importer;  
KEWANEE HOSPITAL HOME MEDICAL EQUIPMENT
KEWANEE,  IL ,  US.
KEY ELECTRONICS, INC.
NEW ALBANY,  IN,  US.
Contract Manufacturer;  
KEY ELECTRONICS, INC.
NEW ALBANY,  IN ,  US.
KEY INSTRUMENTS
TREVOSE,  PA,  US.
Manufacturer;  
WORLD WIDE PLASTICS, INC.
TREVOSE,  PA ,  US.
KEY MEDICAL PRODUCTS CO.
ROUND ROCK,  TX,  US.
Initial Importer;   Manufacturer;  
KEY MEDICAL PRODUCTS CO.
ROUND ROCK,  TX ,  US.
KEY MEDICAL SERVICES, INC.
CHICAGO,  IL,  US.
Specification Developer;  
KEY MEDICAL SERVICES, INC.
CHICAGO,  IL ,  US.
KEY OPTICAL EUROPE S.R.L.
BARBERINO DI MUGELLO,  IT.
Remanufacturer;  
KEY OPTICAL EUROPE S.R.L.
BARBERINO DI MUGELLO,  IT.
KEY STAR ENTERPRISE CO., LTD.
TAIPEI,  TW.
Manufacturer;  
KEY STAR ENTERPRISE CO., LTD.
TAIPEI,  TW.

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Last Modified: 29 April 2006
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