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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
ACHIEVIA DIRECT INC.
DAYTONA BEACH,  FL,  US.
Initial Importer;  
ACHIEVIA DIRECT INC.
DAYTONA BEACH,  FL ,  US.
ACI INTERNATIONAL, INC.
OLATHE,  KS,  US.
Initial Importer;  
ACI INTERNATIONAL, INC.
OLATHE,  KS ,  US.
ACI MEDICAL, INC.
SAN MARCOS,  CA,  US.
Manufacturer;  
ACI MEDICAL, INC.
SAN MARCOS,  CA ,  US.
ACIESHEALTH, INC.
BELLEFONTE,  PA,  US.
Initial Importer;   Specification Developer;  
ACIES INC.
CHICAGO,  IL ,  US.
ACIGI RELAXATION
MILPITAS,  CA,  US.
Initial Importer;  
ACIGI RELAXATION
MILPITAS,  CA ,  US.
ACIST MEDICAL SYSTEMS, INC.
EDEN PRAIRIE,  MN,  US.
Manufacturer;   Specification Developer;  
ACIST MEDICAL SYSTEMS, INC.
EDEN PRAIRIE,  MN ,  US.
ACK LABORATORIES, INC.
BRIDGEWATER,  NJ,  US.
Initial Importer;   Manufacturer;  
ACK LABORATORIES, INC.
BRIDGEWATER,  NJ ,  US.
ACKERMANN INSTRUMENTE GMBH
RIETHEIM, WEILHEIM,  GM.
Manufacturer;  
ACKERMANN INSTRUMENTE GMBH
RIETHEIM, WEILHEIM,  GM.
ACME ACCESSORIES, INC.
EL MONTE,  CA,  US.
Initial Importer;  
ACME ACCESSORIES, INC.
EL MONTE,  CA ,  US.
ACME INDUSTRIAL MAINTENANCE AND MACHINE, INC.
COLUMBIA CITY,  IN,  US.
Contract Manufacturer;  
ACME INDUSTRIAL MAINTENANCE AND MACHINE, INC.
COLUMBIA CITY,  IN ,  US.
ACME NORTHEAST, INC.
SALEM,  NH,  US.
Initial Importer;   Repackager/Relabeller;  
ACME NORTHEAST, INC.
SALEM,  NH ,  US.
ACME OF PRECISION SURGICAL CO., INC.
IRVINGTON,  NJ,  US.
Manufacturer;  
A. & P. SURGICAL CO., INC.
IRVINGTON,  NJ ,  US.
ACME PAD CORPORATION
BALTIMORE,  MD,  US.
Manufacturer;  
ACME PAD CORPORATION
BALTIMORE,  MD ,  US.
ACME SURGICAL INDUSTRIES (PVT) LTD.
SIALKOT, PUNJAB,  PK.
Manufacturer;  
ACME SURGICAL INDUSTRIES (PVT) LTD.
SIALKOT, PUNJAB,  PK.
ACME UNITED CORP.
FREMONT,  NC,  US.
Repackager/Relabeller;  
ACME UNITED CORP.
FAIRFIELD,  CT ,  US.
ACME-MONACO CORP.
NEW BRITAIN,  CT,  US.
Contract Manufacturer;  
ACME-MONACO CORP.
NEW BRITAIN,  CT ,  US.
ACME-MONACO CORP.
PRESQUE ISLE,  ME,  US.
Contract Manufacturer;  
ACME-MONACO CORP.
NEW BRITAIN,  CT ,  US.
ACMI CANADA INC.
WINDSOR, ONTARIO,  CA.
Manufacturer;  
GYRUS GROUP PLC
BERKSHIRE, WOKINGHAM,  UK.
ACMI CORPORATION
NORWALK,  OH,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
GYRUS GROUP PLC
BERKSHIRE, WOKINGHAM,  UK.
ACMI CORPORATION
RACINE,  WI,  US.
Initial Importer;   Manufacturer;   Repackager/Relabeller;  
GYRUS GROUP PLC
BERKSHIRE, WOKINGHAM,  UK.
ACMI CORPORATION
SOUTHBOROUGH,  MA,  US.
Specification Developer;  
GYRUS GROUP PLC
BERKSHIRE, WOKINGHAM,  UK.
ACMI CORPORATION
STAMFORD,  CT,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
GYRUS GROUP PLC
BERKSHIRE, WOKINGHAM,  UK.
ACMYCO INSTRUMENTS
SIALKOT-4,  PK.
Manufacturer;  
ACMYCO INSTRUMENTS
SIALKOT-4,  PK.
ACON BIOTECH (HANGZHOU) CO., LTD.
HANGZHOU, P.R.,  CH.
Manufacturer;  
ACON BIOTECH (HANGZHOU) CO., LTD.
HANGZHOU, ZHEJIANG, P.R.,  CH.
ACON LABORATORIES, INC.
SAN DIEGO,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;  
ACON LABORATORIES, INC.
SAN DIEGO,  CA ,  US.
ACOR ORTHOPAEDIC, INC.
CLEVELAND,  OH,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
ACOR ORTHOPAEDIC, INC.
CLEVELAND,  OH ,  US.
ACORN INTERNATIONAL GROUP, INC.
SUWANEE,  GA,  US.
Initial Importer;  
ACORN INTERNATIONAL GROUP, INC.
SUWANEE,  GA ,  US.
ACORN MEDICAL PRODUCTS, LTD.
RAMOT HASHAUIM,  IS.
Specification Developer;   Repackager/Relabeller;  
ACORN MEDICAL PRODUCTS, LTD.
RAMOT HASHAUIM,  IS.
ACORN MEDICAL PRODUCTS, LTD.
RAMOT, HASHAVIM,  IS.
Repackager/Relabeller;  
ACORN MEDICAL PRODUCTS, LTD.
RAMOT HASHAUIM,  IS.
ACOT PLASTICS (XIAMEN) CO., LTD.
HULI, XIAMEN, FUJIAN,  CH.
Contract Manufacturer;  
ACOT PLASTICS (XIAMEN) CO., LTD.
HULI, XIAMEN, FUJIAN,  CH.
ACP MEDICAL SUPPLIES, INC.
LONGWOOD,  FL,  US.
Initial Importer;  
ACP MEDICAL SUPPLIES, INC.
LONGWOOD,  FL ,  US.
ACQUAMED TECHNOLOGIES, INC.
BATAVIA,  IL,  US.
Initial Importer;   Specification Developer;  
ACQUAMED TECHNOLOGIES, INC.
BATAVIA,  IL ,  US.
ACRA CUT, INC.
ACTON,  MA,  US.
Manufacturer;  
ACRA CUT, INC.
ACTON,  MA ,  US.
ACRES, INC.
MANHATTAN,  KS,  US.
Initial Importer;  
ACRES, INC.
MANHATTAN,  KS ,  US.
ACRI.TEC GMBH
HENNIGSDORF,  GM.
Manufacturer;   Specification Developer;  
ACRI.TEC GMBH
HENNIGSDORF,  GM.
ACROMETRIX
BENICIA,  CA,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Specification Developer;  
ACROMETRIX
BENICIA,  CA ,  US.
ACRORAD CO., LTD.
URUMA, OKINAWA,  JA.
Manufacturer;  
ACRORAD CO., LTD.
URUMA, OKINAWA,  JA.
ACROSS MEDICAL DISPOSABLE CO., LTD.
ANQING, ANHUI PROVINCE,  CH.
Manufacturer;  
ACROSS MEDICAL DISPOSABLE CO., LTD.
ANQING, ANHUI PROVINCE,  CH.
ACRYDENTAL LABORATORIES, INC.
MAKATI CITY,  RP.
Manufacturer;  
ACRYDENTAL LABORATORIES, INC.
MAKATI CITY,  RP.
ACRYMED, INC.
PORTLAND,  OR,  US.
Initial Importer;   Manufacturer;   Specification Developer;   Repackager/Relabeller;  
ACRYMED, INC.
PORTLAND,  OR ,  US.

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Last Modified: 29 April 2006
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