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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
KUMWOODENTAL CO., LTD.
YANG SAN CITY, GYEONGNAM,  KS.
Manufacturer;  
KUMWOODENTAL CO., LTD.
YANG SAN CITY, GYEONGNAM,  KS.
KUNAK ENTERPRISES, INC.
MIAMI,  FL,  US.
Initial Importer;  
KUNAK ENTERPRISES, INC.
MIAMI,  FL ,  US.
KUNDAN POLY PACK PVT. LTD.
DELHI,  IN.
Manufacturer;  
KUNDAN POLY PACK PVT. LTD.
DELHI,  IN.
KUNDT + CO. AG
ELGG,  SZ.
Manufacturer;  
KUNDT + CO. AG
ELGG,  SZ.
KUNG SHIN PLASTICS CO., LTD.
TAIPEI HSIEN,  TW.
Manufacturer;  
SAYKIA CORPORATION
TAIPEI HSIEN,  TW.
KUNHWA OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
KUNHWA OPTICAL CO.
DAEGU,  KS.
KUNNEX, INC.
HSIN CHUANG,  TW.
Unregistered Foreign Lister;  
KUNNEX, INC.
HSIN CHUANG,  TW.
KUNSHAN AIEDA NON-WOVEN PRODUCTS CO. LTD.
KUNSHAN, JIANGSU,  CH.
Manufacturer;  
KUNSHAN AIEDA NON-WOVEN PRODUCTS CO. LTD.
KUNSHAN, JIANGSU,  CH.
KUNSHAN DAIYO INDUSTRIES CO., LTD.
KUNSHAN, JIANGSU,  CH.
Manufacturer;  
KUSHAN DAIYO INDUSTRIES CO., LTD.
KUNSHAN, JIANGSU,  CH.
KUNSHAN DEYI PLASTIC CO., LTD.
KUNSHAN CITY, JIANGSU PROVINCE,  CH.
Manufacturer;  
KUNSHAN DEYI PLASTIC CO., LTD.
KUNSHAN CITY, JIANGSU PROVINCE,  CH.
KUNSHAN LIUERFENG PLASTIC ELECTRON COMPANY,LTD
KUNSHAN CITY, JIANGSU,  CH.
Manufacturer;  
YUH SHIUANS CO., LTD.
TAIPEI, SHIEN,  TW.
KUO & YANG INDUSTRIAL CO., LTD.
TAIPEI,  TW.
Manufacturer;  
KUO & YANG INDUSTRIAL CO., LTD.
TAIPEI,  TW.
KUO CHZNG (BVZ) CO., LTD.
TAIPEI,  TW.
Manufacturer;  
KUO CHZNG (BVZ) CO., LTD.
TAIPEI,  TW.
KUO JUN ELECTRICAL (SHENZHEN) CO., LTD.
SHENZHEN, GUANGDONG,  CH.
Manufacturer;  
GUAN HONG ENTERPRISE CO., LTD.
TAINAN,  TW.
KUPS INT'L., L.L.C.
CABIN JOHN,  MD,  US.
Initial Importer;  
KUPS INT'L., L.L.C.
CABIN JOHN,  MD ,  US.
KURARAY AMERICA, INC.
NEW YORK,  NY,  US.
Initial Importer;  
KURARAY AMERICA, INC.
NEW YORK,  NY ,  US.
KURARAY EUROPE GMBH
DUESSELDORF,,  GM.
Manufacturer;  
KURARAY EUROPE GMBH
DUESSELDORF,,  GM.
KURARAY MEDICAL KURASHIKI PLANT
KURASHIKI, OKAYAMA,  JA.
Manufacturer;  
KURARAY MEDICAL INC.
KURASHIKI, OKAYAMA,  JA.
KURKEL ENTERPRISES, LLC
BELLINGHAM,  WA,  US.
Initial Importer;  
KURKEL ENTERPRISES, LLC
BELLINGHAM,  WA ,  US.
KURON HEALTH PRODUCTS CORP.
SAN DIEGO,  CA,  US.
Repackager/Relabeller;  
KURON HEALTH PRODUCTS CORP.
SAN DIEGO,  CA ,  US.
KURT SEMRAU GMBH
TUTTLINGEN/WUERTEMBERG,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
RICHARD WOLF GMBH
KNITTLINGEN,  GM.
KURZ MEDICAL, INC.
IRVING,  TX,  US.
Initial Importer;  
HEINZ KURZ GMBH MEDIZINTECHNIK
DUSSLINGEN,  GM.
KUSA MARKET
WASHINGTON,  DC,  US.
Initial Importer;  
KIM SOOK
WASHINGTON,  DC ,  US.
KUSCHALL AG
WITTERSWIL,  SZ.
Manufacturer;  
INVACARE CORP.
ELYRIA,  OH ,  US.
KUSTOM REHAB, INC.
COHOES,  NY,  US.
Manufacturer;  
KUSTOM REHAB, INC.
COHOES,  NY ,  US.
KUWANA SEIKO CO., LTD.
KUWANA,  JA.
Contract Manufacturer;   Manufacturer;  
KUWANA SEIKO CO., LTD.
KUWANA,  JA.
KVALEBERG INDUSTRI A/S
STAVANGER,  NO.
Contract Manufacturer;   Repackager/Relabeller;  
OLA OLSEN EFTF. A/S
STAVANGER,  NO.
KWANG WON INDUSTRIAL CO.
DAEGU,  KS.
Manufacturer;  
KWANG WON INDUSTRIAL CO.
DAEGU,  KS.
KWANG WON OPTICAL CO., LTD.
DAEGU,  KS.
Manufacturer;  
KWANG WON OPTICAL CO., LTD.
DAEGU,  KS.
KWANG YANG MOTOR CO., LTD.
KAOHSIUNG,  TW.
Manufacturer;  
KWANG YANG MOTOR CO., LTD.
KAOHSIUNG,  TW.
KWICK TEST INC.
OWASSO,  OK,  US.
Repackager/Relabeller;  
KWICK TEST INC.
CERRITOS,  CA ,  US.
KWIK-ADJUST ANKLE SYSTEMS CANADA LTD.
ILE DES CHENES, MANITOBA,  CA.
Unregistered Foreign Lister;  
KWIK-ADJUST ANKLE SYSTEMS CANADA LTD.
ILE DES CHENES, MANITOBA,  CA.
KWOK LUEN PLASTIC MFG. CO., LTD.
QUARRY BAY,  HK.
Contract Manufacturer;  
KWOK LUEN PLASTIC MFG. CO., LTD.
QUARRY BAY,  HK.
KWOK LUEN PLASTICS (DONGGUAN), LTD.
DONGGUAN, GUANGDONG,  CH.
Unregistered Foreign Lister;  
KWOK LUEN PLASTICS (DONGGUAN), LTD.
DONGGUAN, GUANGDONG,  CH.
KWOK SHING IMPORT/EXPORT, INC.
SAN FRANCISCO,  CA,  US.
Initial Importer;  
KWOK SHING IMPORT/EXPORT, INC.
SAN FRANCISCO,  CA ,  US.
KWON WOO OPTICAL CO.
DAEGU,  KS.
Manufacturer;  
KWON WOO OPTICAL CO.
DAEGU,  KS.
KWONG SHING PLASTIC FTY
TUEN MUN,  HK.
Manufacturer;  
YEKO TRADING LTD.
CHEUNG SHA WAN,  HK.
KWONG TAI GLASSES WHOLESALE CO.
FO TAN SHATIN, NT,  CH.
Unregistered Foreign Lister;  
KWONG TAI GLASSES WHOLESALE CO.
FO TAN SHATIN, NT,  CH.
KWONNIE ELECTRICAL PRODUCTS LTD.
KOWLOON,  HK.
Manufacturer;  
KWONNIE ELECTRICAL PRODUCTS LTD.
KOWLOON,  HK.
KWS ELECTRONIC GMBH
TATTENHAUSEN,  GM.
Manufacturer;   Specification Developer;  
KWS ELECTRONIC GMBH
TATTENHAUSEN,  GM.

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Last Modified: 29 April 2006
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