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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
KEEP TOP INTL., LTD.
KWAI CHUNG, N.T.,  HK.
Manufacturer;  
KEEP TOP INTL., LTD.
KWAI CHUNG, N.T.,  HK.
KEEPERS! INC.
PORTLAND,  OR,  US.
Manufacturer;  
KEEPERS! INC.
PORTLAND,  OR ,  US.
KEEPING HEALTHY, INC.
CHERRY HILL,  NJ,  US.
Repackager/Relabeller;  
KEEPING HEALTHY, INC.
CHERRY HILL,  NJ ,  US.
KEHR SURGICAL & ALLIED PRODUCTS
KANPUR, UP,  IN.
Manufacturer;  
KEHR SURGICAL & ALLIED PRODUCTS
KANPUR, UP,  IN.
KEHR USA
MIAMI,  FL,  US.
Initial Importer;  
KEHR USA
MIAMI,  FL ,  US.
KEIME, INC.
BOCA RATON,  FL,  US.
Initial Importer;  
KEIME, INC.
BOCA RATON,  FL ,  US.
KEISEI MEDICAL INDUSTRIAL CO., LTD.
TOKYO,  JA.
Manufacturer;  
KEISEI MEDICAL INDUSTRIAL CO., LTD.
TOKYO,  JA.
KELE INC.
ARCADIA,  CA,  US.
Initial Importer;  
KELE INC.
ARCADIA,  CA ,  US.
KELFRED OPTICAL LTD.
FO TAN, NEW TERRITORY,  HK.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
KELFRED OPTICAL LTD.
FO TAN, NEW TERRITORY,  HK.
KELLEHER MEDICAL, INC.
POWHATAN,  VA,  US.
Initial Importer;  
KELLEHER MEDICAL, INC.
POWHATAN,  VA ,  US.
KELLER ENGINEERING, INC.
TORRANCE,  CA,  US.
Contract Manufacturer;  
KELLER ENGINEERING, INC.
TORRANCE,  CA ,  US.
KELLER WHEELCHAIR LIFTS
LUZERNE,  PA,  US.
Initial Importer;  
KELLER WHEELCHAIR LIFTS
LUZERNE,  PA ,  US.
KELLEY COMMUNICATIONS GROUP, INC.
DUBLIN,  OH,  US.
Initial Importer;  
KELLEY COMMUNICATIONS GROUP, INC.
DUBLIN,  OH ,  US.
KELLEY DIRECT, INC.
GRAND PRAIRIE,  TX,  US.
Initial Importer;  
KELLEY DIRECT, INC.
GRAND PRAIRIE,  TX ,  US.
KELLS MEDICAL, INC.
BURR RIDGE,  IL,  US.
Initial Importer;   Repackager/Relabeller;  
KELLS MEDICAL, INC.
BURR RIDGE,  IL ,  US.
KELLY DENT SUPPLIES
SIALKOT, PUNJOB,  PK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KELLY DENT SUPPLIES
SIALKOT, PUNJOB,  PK.
KELLY HEARING AID
LAS VEGAS,  NV,  US.
Manufacturer;   Remanufacturer;  
KELLY HEARING AID
LAS VEGAS,  NV ,  US.
KELLY KINETICS, LLP
GREAT FALLS,  MT,  US.
Manufacturer;  
KELLY KINETICS, INC
GREAT FALLS,  MT ,  US.
KELMAR MEDICAL, LLC.
PACE,  FL,  US.
Specification Developer;  
KELMAR MEDICAL, LLC.
PACE,  FL ,  US.
KELMED, INC.
FAYETTEVILLE,  GA,  US.
Initial Importer;  
KELMED, INC.
FAYETTEVILLE,  GA ,  US.
KELVIN MA, MA WAI CHUN
FO TAN, SHATIN,  HK.
Unregistered Foreign Lister;  
KELVIN MA, MA WAI CHUN
FO TAN, SHATIN,  HK.
KEM ENTERPRISES,INC.
GRAND RAPIDS,  MI,  US.
Initial Importer;   Specification Developer;  
KEM ENT., INC.
GRAND RAPIDS,  MI ,  US.
KEM MEDICAL PRODUCTS CORP.
FARMINGDALE,  NY,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KEM MEDICAL PRODUCTS CORP.
FARMINGDALE,  NY ,  US.
KEMAC CO. LTD.
NAMDONG-GU, INCHON,  KS.
Unregistered Foreign Lister;  
KEMAC CO. LTD.
NAMDONG-GU, INCHON,  KS.
KEMCO SUPPLY
SAMMAMISH,  WA,  US.
Initial Importer;  
KEMCO SUPPLY
SAMMAMISH,  WA ,  US.
KEMDENT WORKS
WILTSHIRE, ENGLAND,  UK.
Unregistered Foreign Lister;  
KEMDENT WORKS
WILTSHIRE, ENGLAND,  UK.
KEMP LLC
WHITE PLAINS,  NY,  US.
Initial Importer;  
KEMP LLC
WHITE PLAINS,  NY ,  US.
KEMPF
SUNNYVALE,  CA,  US.
Manufacturer;  
KEMPF
SUNNYVALE,  CA ,  US.
KEN HILL INTL.
UGOKI SIALKOT PUNJAB,  PK.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KEN HILL INTL.
UGOKI SIALKOT PUNJAB,  PK.
KEN JOHNSON ASSOC.
ATLANTA,  GA,  US.
Specification Developer;  
KEN JOHNSON ASSOC.
ATLANTA,  GA ,  US.
KEN SOOPER VERTRIEBS GMBH
HAGEN,  GM.
Manufacturer;  
KEN SOOPER VERTRIEBS GMBH
HAGEN,  GM.
KENAD SG MEDICAL, INC.
MEMPHIS,  TN,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KENAD SG MEDICAL, INC.
MEMPHIS,  TN ,  US.
KENAN ENTERPRISE, INC.
MILPITAS,  CA,  US.
Initial Importer;  
KENAN ENTERPRISE, INC.
MILPITAS,  CA ,  US.
KENCAP
OFAQUIM,  IS.
Unregistered Foreign Lister;  
KENCAP
OFAQUIM,  IS.
KENCAP LTD.
GENEI-YEHUDA,  IS.
Manufacturer;  
KENCAP LTD.
GANEI-YAHUD,  IS.
KENCAP LTD.
OFAQUIM,  IS.
Unregistered Foreign Lister;  
KENCAP LTD.
OFAQUIM,  IS.
KENCO COMPANY
BEVERLY HILLS,  CA,  US.
Initial Importer;  
KENCO COMPANY
BEVERLY HILLS,  CA ,  US.
KEN-CREST CO.
POTTSTOWN,  PA,  US.
Contract Manufacturer;  
KEN-CREST SERVICES
PLYMOUTH MEETING,  PA ,  US.
KENDA AG, DENTAL MANUFACTURING
VADUZ/LIECHTENSTEIN,  LS.
Manufacturer;  
KENDA AG
VADUZ/LIECHTENSTEIN,  LS.
KENDAL KING GROUP
KANSAS CITY,  MO,  US.
Repackager/Relabeller;  
KENDAL KING GROUP
KANSAS CITY,  KS ,  US.

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Last Modified: 29 April 2006
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