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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
KIRSIE PRODUCTS, INC.
NAPLES,  FL,  US.
Initial Importer;  
KIRSIE PRODUCTS, INC.
NAPLES,  FL ,  US.
KIRSTEN PIPE CO., INC.
SEATTLE,  WA,  US.
Contract Manufacturer;  
KIRSTEN PIPE CO., INC.
SEATTLE,  WA ,  US.
KIRWAN SURGICAL PRODUCTS, INC.
MARSHFIELD,  MA,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
KIRWAN SURGICAL PRODUCTS, INC.
MARSHFIELD,  MA ,  US.
KISCO DENTAL
WICHITA,  KS,  US.
Initial Importer;  
KISCO DENTAL
WICHITA,  KS ,  US.
KISCOMEDICA S.A.
SAINT PRIEST,  FR.
Manufacturer;  
KISCOMEDICA S.A.
SAINT PRIEST,  FR.
KISHIMOTO OPTICAL CO., LTD.
OSAKA-PRUF-584,  JA.
Manufacturer;  
KISHIMOTO OPTICAL CO., LTD.
OSAKA-PRUF-584,  JA.
KITAMURA CORP.
SIALKOT,  PK.
Unregistered Foreign Lister;  
KITAMURA CORP.
SIALKOT,  PK.
KITZ
HAMILTON, ONTARIO,  CA.
Unregistered Foreign Lister;  
KITZ
HAMILTON, ONTARIO,  CA.
KIWI SRL
DOMEGGE DI CADORE (BL),  IT.
Unregistered Foreign Lister;  
KIWI SRL
DOMEGGE DI CADORE (BL),  IT.
KJAERULFF REHABILITATION A/S
OTTERUP,  DA.
Foreign Exporter;   Manufacturer;   Repackager/Relabeller;  
KJAERULFF REHABILITATION A/S
OTTERUP,  DA.
KJI INDUSTRIAL CO., LTD.
GEUMJEONG-GU, BUSAN,  KS.
Manufacturer;  
KJI INDUSTRIAL CO., LTD.
GEUMJEONG-GU, BUSAN,  KS.
K-JUMP HEALTH CO., LTD.
TAIPEI HSIEN,  TW.
Manufacturer;  
K-JUMP HEALTH CO., LTD.
TAIPEI HSIEN,  TW.
KL DISTRIBUTING
PORT RICHEY,  FL,  US.
Initial Importer;   Manufacturer;  
KL DISTRIBUTING
PORT RICHEY,  FL ,  US.
KL GOLF CO.
ANAHEIM,  CA,  US.
Initial Importer;  
KL GOLF CO.
ANAHEIM,  CA ,  US.
KLAFSUN CORP
GASTONIA,  NC,  US.
Initial Importer;  
KLAFSUN CORP
GASTONIA,  NC ,  US.
KLANN, INC.
WAYNESBORO,  VA,  US.
Contract Manufacturer;  
KLANN, INC.
WAYNESBORO,  VA ,  US.
KLARITY MEDICAL & EQUIPMENT CO., LTD.
4TH RD., GETDD, GUANGZHOU,  CH.
Manufacturer;  
KLARITY MEDICAL & EQUIPMENT CO., LTD.
4TH RD., GETDD, GUANGZHOU,  CH.
KLASSIC IMPORTS, INC.
LOMBARD,  IL,  US.

KLASSIC IMPORTS, INC.
LOMBARD,  IL ,  US.
KLAUS GLASER GMBH
TUTTLINGEN,  GM.
Manufacturer;  
KLAUS GLASER GMBH
TUTTLINGEN,  GM.
KLAUS HUBER
TUTTLINGEN/NENDINGEN,  GM.
Manufacturer;  
KLAUS HUBER
TUTTLINGEN/NENDINGEN,  GM.
KLAUSZ DENTAL LABORATORIES LTD.
TORONTO, ONTARIO,  CA.
Manufacturer;  
KLAUSZ DENTAL LABORATORIES LTD.
TORONTO, ONTARIO,  CA.
KLEAN N KONSTANT DENTAL WATER COMPANY, LLC
BIRMINGHAM,  AL,  US.
Manufacturer;  
KLEAN N KONSTANT DENTAL WATER COMPANY, LLC
BIRMINGHAM,  AL ,  US.
KLEEN LAUNDRY & DRYCLEANING SERVICES, INC.
LEBANON,  NH,  US.
Manufacturer;  
KLEEN LAUNDRY & DRYCLEANING SERVICES, INC.
LEBANON,  NH ,  US.
KLEIN SURGICAL SYSTEMS, INC.
SAN ANTONIO,  TX,  US.
Initial Importer;  
KLEIN SURGICAL SYSTEMS, INC.
SAN ANTONIO,  TX ,  US.
KLENZ, LLC.
TRENTON,  NJ,  US.
Manufacturer;  
KLENZ, LLC.
TRENTON,  NJ ,  US.
KLH MEDICAL, INC.
NASSAU BAY,  TX,  US.
Initial Importer;   Repackager/Relabeller;  
KLH MEDICAL, INC.
NASSAU BAY,  TX ,  US.
KLI CORP.
CARMEL,  IN,  US.
Specification Developer;  
KLI CORP.
CARMEL,  IN ,  US.
KLIMAMED AG
KREUZLINGEN,  SZ.
Manufacturer;  
KLIMAMED AG
KREUZLINGEN,  SZ.
KLINGER EYE SHIELDS, INC.
SELMA,  AL,  US.
Manufacturer;  
KLINGER EYE SHIELDS, INC.
SELMA,  AL ,  US.
K-LINK (USA) INC.
ANAHEIM,  CA,  US.
Initial Importer;  
K-LINK (USA) INC.
ANAHEIM,  CA ,  US.
KLINTAN TRADING CO., LTD.
PU-TEU, CHIA-YI HSIEN,  TW.
Foreign Exporter;  
KLINTAN TRADING CO., LTD.
PU-TEU, CHIA-YI HSIEN,  TW.
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
IPOH, PERAK, DARUL RIDZUAN,  MY.
Manufacturer;  
KL-KEPONG RUBBER PRODUCTS SDN. BHD.
IPOH, PERAK, DARUL RIDZUAN,  MY.
KLM LABORATORIES, INC.
VALENCIA,  CA,  US.
Manufacturer;  
KLM LABORATORIES, INC.
VALENCIA,  CA ,  US.
KLOCKE OF AMERICA, INC.
FORT MYERS,  FL,  US.
Repackager/Relabeller;  
KLOCKE OF AMERICA, INC.
FORT MYERS,  FL ,  US.
KLOCKE VERPACKUNGS-SERVICE GMBH
WEINGARTEN/BADEN,  GM.
Repackager/Relabeller;  
KLOCKE VERPACKUNGS-SERVICE GMBH
WEINGARTEN/BADEN,  GM.
KLOEHN INSTRUMENT CO.
LAS VEGAS,  NV,  US.
Manufacturer;  
KLOEHN CO.
LAS VEGAS,  NV ,  US.
KLOSTERFRAU BERLIN GMBH
BERLIN,  GM.
Manufacturer;  
KLOSTERFRAU BERLIN GMBH
BERLIN,  GM.
KLS MARTIN GMBH + CO. KG
UMKIRCH,  GM.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
KLS MARTIN GMBH + CO. KG
UMKIRCH,  GM.
KLS-MARTIN L.P.
JACKSONVILLE,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
MUHLHEIM,  GM.
KLT TELECOM, INC.
FAIRFAX,  VA,  US.
Manufacturer;  
KLT TELECOM, INC.
FAIRFAX,  VA ,  US.

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Last Modified: 29 April 2006
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