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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
RMS CO.
MINNEAPOLIS,  MN,  US.
Contract Manufacturer;   Manufacturer;  
THE CRETEX COMPANIES, INC.
ELK RIVER,  MN ,  US.
RMS MEMPHIS
MEMPHIS,  TN,  US.
Contract Manufacturer;  
RMS CO.
MINNEAPOLIS,  MN ,  US.
RMS, INC.
APOLLO BEACH,  FL,  US.
Initial Importer;  
RMS, INC.
APOLLO BEACH,  FL ,  US.
RMSON SURGICO
PUJAB.,  PK.
Manufacturer;  
RMSON SURGICO
PUNJAB,  PK.
RNK PRODUCTS, INC.
BURNSVILLE,  MN,  US.
Manufacturer;  
RNK PRODUCTS, INC.
BURNSVILLE,  MN ,  US.
RO+TEN SRL
ARCORE (MI),  IT.
Unregistered Foreign Lister;  
RO+TEN SRL
ARCORE (MI),  IT.
ROADMASTER (HONG KONG) LIMITED
HONG KONG,  HK.
Manufacturer;  
PRAMARS COMPANY LIMITED
HONG KONG,  HK.
ROB TECHNOLOGY CO.
CHEONGWON-GUN, CHUNG-BUK,  KS.
Manufacturer;  
ROB TECHNOLOGY CO.
CHEONGWON-GUN, CHUNG-BUK,  KS.
ROB. HOPPE GMBH & CO.
SOLINGEN,  GM.
Manufacturer;  
ROB. HOPPE GMBH & CO.
SOLINGEN,  GM.
ROBBINS INSTRUMENTS, INC.
CHATHAM,  NJ,  US.
Initial Importer;   Repackager/Relabeller;  
ROBBINS INSTRUMENTS, INC.
CHATHAM,  NJ ,  US.
ROBELL RESEARCH, INC.
NEW YORK,  NY,  US.
Specification Developer;  
ROBELL RESEARCH, INC.
NEW YORK,  NY ,  US.
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
TAMPA,  FL,  US.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
ROBERT B. SCOTT OCULARISTS OF FLORIDA, INC.
TAMPA,  FL ,  US.
ROBERT CLERGERIE OF AMERICA, INC.
NEW YORK,  NY,  US.
Initial Importer;  
ROBERT CLERGERIE OF AMERICA, INC.
NEW YORK,  NY ,  US.
ROBERT E. DORAN
SAN JACINTO,  CA,  US.
Contract Manufacturer;   Manufacturer;  
ROBERT E. DORAN
SAN JACINTO,  CA ,  US.
ROBERT J. GULINER, CHARTERED
AVENTURA,  FL,  US.
Initial Importer;  
ROBERT J. GULINER, CHARTERED
AVENTURA,  FL ,  US.
ROBERT JOSEPH CRAIG SA DE CV
TLALNEPANTLA,  MX.
Manufacturer;  
ROBERT JOSEPH CRAIG SA DE CV
TLALNEPANTLA,  MX.
ROBERT L. JARRELL
ALBUQUERQUE,  NM,  US.
Initial Importer;  
ROBERT L. JARRELL
ALBUQUERQUE,  NM ,  US.
ROBERT MUELLER INSTRUMENTE
SPAICHINGEN,  GM.
Manufacturer;  
ROBERT MUELLER INSTRUMENTE
SPAICHINGEN,  GM.
ROBERT ZIELINSKI MEDICAL INSTRUMENTS
SAN BERNARDINO,  CA,  US.
Initial Importer;  
ROBERT ZIELINSKI
SAN BERNARDINO,  CA ,  US.
ROBERTO'S HEALTHCARE SUPPLIES, INC.
AIEA,  HI,  US.
Initial Importer;  
ROBERTO'S HEALTHCARE SUPPLIES, INC.
AIEA,  HI ,  US.
ROBERTS MEDICAL PRODUCTS, INC.
BOYERTOWN,  PA,  US.
Initial Importer;  
ROBERTS MEDICAL PRODUCTS, INC.
BOYERTOWN,  PA ,  US.
ROBERTS OXYGEN CO., INC.
GAITHERSBURG,  MD,  US.
Manufacturer;  
ROBERTS OXYGEN CO., INC.
ROCKVILLE,  MD ,  US.
ROBERTSON HARNESS
HENDERSON,  NV,  US.
Manufacturer;  
STELMOMORE, INC.
HENDERSON,  NV ,  US.
ROBI LTD.
NEW YORK,  NY,  US.
Initial Importer;  
ROBI LTD.
NEW YORK,  NY ,  US.
ROBIN INDUSTRIES FREDERICKSBURG FACILITY
FREDERICKSBURG,  OH,  US.
Contract Manufacturer;  
ROBIN INDUSTRIES
FREDERICKSBURG,  OH ,  US.
ROBIN MEDICAL, INC.
BALTIMORE,  MD,  US.
Initial Importer;   Specification Developer;  
ROBIN MEDICAL, INC.
BALTIMORE,  MD ,  US.
ROBIN RESEARCH LABORATORIES, INC.
WESTMOUNT, QUEBEC,  CA.
Unregistered Foreign Lister;  
ROBIN RESEARCH LABORATORIES, INC.
WESTMOUNT, QUEBEC,  CA.
ROBINSON AUDIOLOGY LABORATORIES
CENTERLINE,  MI,  US.
Manufacturer;  
ROBINSON AUDIOLOGY LABORATORIES
CENTERLINE,  MI ,  US.
ROBINSON HEALTHCARE LTD
WORKSOP,  UK.
Manufacturer;  
ROBINSON HEALTHCARE LTD
WORKSOP,  UK.
ROBMED MEDEX CORP.
RIO PIEDAS,  PR,  US.
Initial Importer;  
ROBMED MEDEX CORP.
RIO PIEDAS,  PR ,  US.
ROBODESIGN INTERNATIONAL, INC.
CARLSBAD,  CA,  US.
Contract Manufacturer;   Manufacturer;  
ROBODESIGN INTERNATIONAL, INC.
CARLSBAD,  CA ,  US.
ROBOMEDICA, INC.
IRVINE,  CA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
ROBOMEDICA, INC.
IRVINE,  CA ,  US.
ROBOZ SURGICAL INSTRUMENT CO., INC.
GAITHERSBURG,  MD,  US.
Initial Importer;  
ROBOZ SURGICAL INSTRUMENT CO., INC.
GAITHERSBURG,  MD ,  US.
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
HSIN-CHU CITY,  TW.
Manufacturer;  
ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
HSIN-CHU CITY,  TW.
ROCCO ORIGINALS, LTD.
SAN ANTONIO,  TX,  US.
Initial Importer;  
ROCCO ORIGINALS, LTD.
SAN ANTONIO,  TX ,  US.
ROCHE DIAGNOSTICS CORP.
PONCE,  PR,  US.
Manufacturer;  
CORANGE INTERNATIONAL LTD.
HAMILTON, HM HX,  BD.
ROCHE DIAGNOSTICS CORP.
GRAZ,  AU.
Manufacturer;  
ROCHE DIAGNOSTICS CORP.
GRAZ,  AU.
ROCHE DIAGNOSTICS CORP.
INDIANAPOLIS,  IN,  US.
Initial Importer;   Manufacturer;   Remanufacturer;   Specification Developer;   Repackager/Relabeller;  
ROCHE HOLDING, INC.
NUTLEY,  NJ ,  US.
ROCHE DIAGNOSTICS GMBH
MANNHEIM,  GM.
Manufacturer;   Specification Developer;  
CORANGE DEUTSCHLAND HOLDING GMBH
MANNHEIM,  GM.
ROCHE DIAGNOSTICS GMBH
MANNHEIM,  GM.
Manufacturer;  
CORANGE DEUTSCHLAND HOLDING GMBH
MANNHEIM,  GM.

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Last Modified: 29 April 2006
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