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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
DR. HOPF GMBH & CO. KG
LANGENHAGEN,  GM.
Manufacturer;  
DR. HOPF GMBH & CO. KG
LANGENHAGEN,  GM.
DR. IHDE DENTAL GMBH
ECHING, MUNCHEN,  GM.
Unregistered Foreign Lister;  
DR. IHDE DENTAL GMBH
ECHING, MUNCHEN,  GM.
DR. ING. H.C.F. PORSCHE AG
LUDWIGSBURG,  GM.
Repackager/Relabeller;  
DR. ING. H.C.F. PORSCHE AG
LUDWIGSBURG,  GM.
DR. J.H. MCLEAN MEDICINE CO.
LEVITTOWN,  NY,  US.
Initial Importer;  
DR. J.H. MCLEAN MEDICINE CO.
LEVITTOWN,  NY ,  US.
DR. JAMES ZIMMERMAN
DEPTFORD,  NJ,  US.
Initial Importer;  
DR. JAMES ZIMMERMAN
DEPTFORD,  NJ ,  US.
DR. JAPAN CO., LTD.
TOKYO,  JA.
Manufacturer;  
DR. JAPAN CO., LTD.
TOKYO,  JA.
DR. JEAN BAUSCH KG.
COLOGNE,  GM.
Manufacturer;  
PETER BAUSCH
COLOGNE,  GM.
DR. JOHNSTON'S BACKMAGIC
CANNINGTON, ONTARIO,  CA.
Unregistered Foreign Lister;  
DR. JOHNSTON'S BACKMAGIC
CANNINGTON, ONTARIO,  CA.
DR. K INT'L TRADING CO., INC.
MONROVIA,  CA,  US.
Initial Importer;  
DR. K INT'L TRADING CO., INC.
MONROVIA,  CA ,  US.
DR. K. HONLE MEDIZINTECHNIK GMBH
MARTINSRIED,  GM.
Unregistered Foreign Lister;  
DR. K. HONLE MEDIZINTECHNIK GMBH
MARTINSRIED,  GM.
DR. KERN USA, INC.
INDIANAPOLIS,  IN,  US.
Initial Importer;  
DR. KERN USA, INC.
INDIANAPOLIS,  IN ,  US.
DR. KOH & COMPANY
DALLAS,  TX,  US.
Initial Importer;  
DR. KOH & COMPANY
DALLAS,  TX ,  US.
DR. LEE CO., LTD.
SEOCHEON-GUN, CHUNGNAM,  KS.
Manufacturer;  
DR. LEE CO., LTD.
SEOCHEON-GUN, CHUNGNAM,  KS.
DR. LEE CO., LTD.
LOS ANGELES,  CA,  US.
Initial Importer;   Specification Developer;  
DR. LEE CO., LTD.
LOS ANGELES,  CA ,  US.
DR. LEN'S MEDICAL PRODUCTS LLC
LAFAYETTE HILL,  PA,  US.
Initial Importer;   Manufacturer;   Specification Developer;  
BLADSS TEC LLC
ERDENHEIM,  PA ,  US.
DR. LEONARD'S HEALTHCARE CORP.
EDISON,  NJ,  US.
Initial Importer;  
DR. LEONARD'S HEALTHCARE CORP.
EDISON,  NJ ,  US.
DR. M. STEVEN KHOURY
CARO,  MI,  US.
Manufacturer;  
DR. M. STEVEN KHOURY
CARO,  MI ,  US.
DR. MACH GMBH & CO.
D-85560 EBERSBERG,  GM.
Unregistered Foreign Lister;  
DR. MACH GMBH & CO.
D-85560 EBERSBERG,  GM.
DR. MACH GMBH & CO. MEDIZINTECHNIK
EBERSBERG, BAVARIA,  GM.
Manufacturer;  
DR. MACH GMBH & CO. MEDIZINTECHNIK
EBERSBERG, BAVARIA,  GM.
DR. MANN PHARMA
BERLIN,  GM.
Manufacturer;  
BAUSCH & LOMB, INC.
ROCHESTER,  NY ,  US.
DR. OCMAN VINDEL SERRANO
PLAYA DE ARO,GIRONA,  SP.
Unregistered Foreign Lister;  
DR. OCMAN VINDEL SERRANO
PLAYA DE ARO,GIRONA,  SP.
DR. PAUL H. CARTWRIGHT
MARION,  NC,  US.
Manufacturer;  
DR. PAUL H. CARTWRIGHT
FOREST CITY,  NC ,  US.
DR. PRODUCTS, L.L.C.
EUSTIS,  FL,  US.
Repackager/Relabeller;  
DR. PRODUCTS, L.L.C.
EUSTIS,  FL ,  US.
DR. R.G. GRAVES
VICTORIA, BRITISH COLUMBIA,  CA.
Manufacturer;  
DR. R.G. GRAVES
VICTORIA, BRITISH COLUMBIA,  CA.
DR. REZA S. MOHAJER
ENCINO,  CA,  US.
Specification Developer;  
DR. REZA S. MOHAJER
ENCINO,  CA ,  US.
DR. ROBERT MAMES
GAINESVILLE,  FL,  US.
Initial Importer;  
DR. ROBERT MAMES
GAINESVILLE,  FL ,  US.
DR. ROTH'S FOOTCARE PRODUCTS L.L.C.
COSTA MESA,  CA,  US.
Specification Developer;  
DR. ROTH'S FOOTCARE PRODUCTS L.L.C.
COSTA MESA,  CA ,  US.
DR. SABHARWAL'S MANUFACTURING LABS, LTD.
KANPUR, UTTAR PRADESH,  IN.
Contract Manufacturer;   Manufacturer;  
DR. SABHARWAL'S MANUFACTURING LABS, LTD.
KANPUR, UTTAR PRADESH,  IN.
DR. SABHARWAL'S MEDICALS PVT, LTD.
KANPUR, UTTAR PRADESH,  IN.
Contract Manufacturer;   Manufacturer;  
DR. SABHARWAL'S MEDICALS PVT, LTD.
KANPUR, UTTAR PRADESH,  IN.
DR. SABIA'S SCOLIOMETER
MANCHESTER,  NJ,  US.
Initial Importer;  
DR. SABIA'S SCOLIOMETER
MANCHESTER,  NJ ,  US.
DR. STANLEY J DENMARK
NEW YORK CITY,  NY,  US.
Specification Developer;  
DR. STANLEY J DENMARK
NEW YORK CITY,  NY ,  US.
DR. SYSTEMS, INC.
SAN DIEGO,  CA,  US.
Manufacturer;  
DR. SYSTEMS, INC.
SAN DIEGO,  CA ,  US.
DR. THEISS NATURWAREN GMBH
HOMBURG, SAARLAND,  GM.
Foreign Exporter;   Manufacturer;  
DR. THEISS NATURWAREN GMBH
HOMBURG, SAARLAND,  GM.
DR. THOMAS COLEMAN
PUTNEY,  VT,  US.
Specification Developer;  
DR. THOMAS COLEMAN
PUTNEY,  VT ,  US.
DR. TUNG'S PRODUCTS
KANEOHE,  HI,  US.
Initial Importer;   Specification Developer;  
DR. TUNG'S PRODUCTS
KANEOHE,  HI ,  US.
DR. TWINKLE
ENCINO,  CA,  US.
Initial Importer;  
DR. TWINKLE
ENCINO,  CA ,  US.
DR. WALSER DENTAL G.M.B.H.
RADOLFZELL,  GM.
Manufacturer;  
DR. WALSER DENTAL G.M.B.H.
RADOLFZELL,  GM.
DR. WILLIAM CAI, ACUPUNCTURIST, PC
NEW YORK,  NY,  US.
Initial Importer;  
DR. WILLIAM CAI, ACUPUNCTURIST, PC
NEW YORK,  NY ,  US.
DR. ZEN, INC.
HEATHROW,  FL,  US.
Initial Importer;   Contract Manufacturer;  
DR. ZEN, INC.
HEATHROW,  FL ,  US.
DRAEGER MEDICAL AG & CO. KG
LUEBECK,  GM.
Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
DRAEGER MEDICAL AG & CO. KG
LUEBECK,  GM.

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Last Modified: 29 April 2006
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