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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
ZAHNFABRIK PHILIPPINES, INC.
TAGUIG METRO MANILA,  RP.
Manufacturer;  
ZAHNFABRIK BAD NAUHEIM GMBH & CO. LUXOR KG
BAD NAUHEIM,  GM.
ZAHNWERKSTATT TRAUB GMBH
ALBSTADT,  GM.
Manufacturer;  
ZAHNWERKSTATT TRAUB GMBH
ALBSTADT,  GM.
ZAIDO
GARFIELD,  NJ,  US.
Initial Importer;  
I.B.F. INDUSTRIA BRASILEIRA DE FILMES
RIO DE JANEIRO,  BR.
ZAIN'S MEDICAL IMAGE
SIALKOT,  PK.
Manufacturer;  
ZAIN'S MEDICAL IMAGE
SIALKOT,  PK.
ZAITA ASSOC., INC.
MONTGOMERY,  NY,  US.

ZAITA ASSOC., INC.
WASHINGTONVILLE,  NY ,  US.
ZAMILCO INTL., INC.
ALBERTSON,  NY,  US.
Initial Importer;  
ZAMILCO INTL., INC.
ALBERTSON,  NY ,  US.
ZAN MESSGERATE GMBH
OBERTHULBA,  GM.
Manufacturer;  
ZAN MESSGERATE GMBH
OBERTHULBA,  GM.
ZANDER IVF, INC.
VERO BEACH,  FL,  US.
Initial Importer;  
ZANDER SCIENTIFIC, INC.
VERO BEACH,  FL ,  US.
ZANDER MEDICAL SUPPLIES, INC.
VERO BEACH,  FL,  US.
Initial Importer;  
ZANDER MEDICAL SUPPLIES, INC.
VERO BEACH,  FL ,  US.
ZAP LASERS, LLC
PLEASANT HILL,  CA,  US.
Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ZAP LASERS, LLC
PLEASANT HILL,  CA ,  US.
ZAPTRON (HK) LIMITED
SHEUNG WAN, HONG KONG, SAR,  CH.
Foreign Exporter;  
ZAPTRON (HK) LIMITED
SHEUNG WAN, HONG KONG, SAR,  CH.
ZARA USA INC.
NEW YORK,  NY,  US.
Initial Importer;  
ZARA USA INC.
NEW YORK,  NY ,  US.
ZARGIS MEDICAL CORP.
PRINCETON,  NJ,  US.
Manufacturer;   Specification Developer;  
ZARGIS MEDICAL CORP.
PRINCETON,  NJ ,  US.
ZARMAN SURGICAL SUPPLY, INC.
LONG ISLAND CITY,  NY,  US.
Initial Importer;  
ZARMAN SURGICAL SUPPLY, INC.
LONG ISLAND CITY,  NY ,  US.
ZASCO QUALITY INSTRUMENTS, INC.
BAYONNE,  NJ,  US.
Initial Importer;  
ZASCO QUALITY INSTRUMENTS, INC.
BAYONNE,  NJ ,  US.
ZASSI MEDICAL EVOLUTIONS
FERNANDINA BEACH,  FL,  US.
Contract Manufacturer;   Manufacturer;   Specification Developer;  
ZASSI MEDICAL EVOLUTIONS, INC.
FERNANDINA BEACH,  FL ,  US.
ZASSI MEDICAL EVOLUTIONS, INC.
ST. LOUIS,  MO,  US.
Specification Developer;  
ZASSI MEDICAL EVOLUTIONS, INC.
FERNANDINA BEACH,  FL ,  US.
ZAT ENT., INC.
VERNON,  CA,  US.
Initial Importer;  
ZAT ENT., INC.
VERNON,  CA ,  US.
ZAVOS DIAGNOSTIC LABORATORIES, INC.
LEXINGTON,  KY,  US.
Initial Importer;   Specification Developer;   Repackager/Relabeller;  
ZAVOS BIOTECH LABORATORIES, INC.
LEXINGTON,  KY ,  US.
ZEBRA TECHNOLOGIES CORP.
VERNON HILLS,  IL,  US.
Contract Manufacturer;  
ZEBRA TECHNOLOGIES CORP.
VERNON HILLS,  IL ,  US.
ZEBRIS MEDICAL GMBH
ISNY, BADEN-WURTTEMBERG,  GM.
Manufacturer;  
ZEBRIS MEDICAL GMBH
ISNY, BADEN-WURTTEMBERG,  GM.
ZEDIN INSTRUMENTE
DUERBHEIM,  GM.
Manufacturer;  
ZEDIN INSTRUMENTE
DUERBHEIM,  GM.
ZEE MANAGEMENT CO., INC.
EL MONTE,  CA,  US.
Initial Importer;  
ZEE MANAGEMENT CO., INC.
EL MONTE,  CA ,  US.
ZEE MEDICAL, INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;   Repackager/Relabeller;  
ZEE MEDICAL, INC.
IRVINE,  CA ,  US.
ZEFON INTL.
OCALA,  FL,  US.
Manufacturer;  
ZEFON INTL.
OCALA,  FL ,  US.
ZEISIN INDUSTRIAL CO., LTD.
TOWN TAINAN,  TW.
Manufacturer;  
ZEISIN INDUSTRIAL CO., LTD.
TOWN TAINAN,  TW.
ZELO CO.
HSIN-TIEN CITY,  TW.
Unregistered Foreign Lister;  
ZELO CO.
HSIN-TIEN CITY,  TW.
ZENITH MEDICAL, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
ZENITH MEDICAL, INC.
SAN DIEGO,  CA ,  US.
ZENITH POINT MANUFACTURING
NEWBURY PARK,  CA,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ZENITH POINT MANUFACTURING
NEWBURY PARK,  CA ,  US.
ZENITH SOUND INC.
PARK RIDGE,  IL,  US.
Contract Manufacturer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ZENITH SOUND INC.
PARK RIDGE,  IL ,  US.
ZENITH/OMNI HEARING INSTRUMENTS, INC.
NEW HAVEN,  CT,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ZENITH/OMNI HEARING INSTRUMENTS, INC.
NEW HAVEN,  CT ,  US.
ZENMI CO., LTD.
KAINAN CITY, WAKAYAMA PREF.,  JA.
Unregistered Foreign Lister;  
ZENMI CO., LTD.
KAINAN CITY, WAKAYAMA PREF.,  JA.
ZENNI OPTICAL
SAN RAFAEL,  CA,  US.
Initial Importer;  
ZENNI OPTICAL
SAN RAFAEL,  CA ,  US.
ZENS MFG., INC.
MILWAUKEE,  WI,  US.
Manufacturer;  
ZENS MFG., INC.
MILWAUKEE,  WI ,  US.
ZENTEK INTERNATIONAL INC
KANGMAN-KU, SEOUL,  KS.
Manufacturer;  
ZENTEK INTERNATIONAL INC
KANGMAN-KU, SEOUL,  KS.
ZEPF MEDICAL INSTRUMENTS GMBH
SEITINGEN-OBERFLACHT,  GM.
Manufacturer;  
ZEPF MEDICAL INSTRUMENTS GMBH
SEITINGEN-OBERFLACHT,  GM.
ZEPTOMETRIX CORPORATION
BUFFALO,  NY,  US.
Contract Manufacturer;  
ZEPTOMETRIX CORPORATION
BUFFALO,  NY ,  US.
ZER HITECH
JERUSALEM,  IS.
Contract Manufacturer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ZER HITECH
JERUSALEM,  IS.
ZEROSMOKE USA LLC
WEST MILFORD,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
ZEROSMOKE USA LLC
WEST MILFORD,  NJ ,  US.
ZEROWET, INC.
PALOS VERDES PENINSULA,  CA,  US.
Specification Developer;  
ZEROWET, INC.
PALOS VERDES PENINSULA,  CA ,  US.

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Last Modified: 29 April 2006
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