Rockwell Medical

FDA Filings

This page includes the latest FDA filings for Rockwell Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1835498
FEI Number3001236991
NameROCKWELL MEDICAL
Owner & OperatorROCKWELL MEDICAL TECHNOLOGIES, INC.
Contact Address30142 WIXOM RD. --
Wixom MI 48393 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address30142 WIXOM RD.
WIXOM, MI 48393 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number1954315
FEI Number3002970979
NameROCKWELL MEDICAL
Owner & OperatorROCKWELL MEDICAL TECHNOLOGIES, INC.
Contact Address30142 WIXOM RD. --
Wixom MI 48393 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address308 N Iowa Ave
WASHINGTON, IA 52353 US
Establishment TypeManufacture Medical Device

Registration Number1065847
FEI Number3003040753
NameROCKWELL MEDICAL
Owner & OperatorROCKWELL MEDICAL TECHNOLOGIES, INC.
Contact Address30142 WIXOM RD. --
Wixom MI 48393 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address604 High Tech Ct
GREER, SC 29650 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

Registration Number1652176
FEI Number3003463852
NameROCKWELL MEDICAL
Owner & OperatorROCKWELL MEDICAL TECHNOLOGIES, INC.
Contact Address30142 WIXOM RD. --
Wixom MI 48393 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4051 Freeport Pkwy Ste 100
GRAPEVINE, TX 76051 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device
Company
DeviceDate
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
CitraPure Acid Concentrates2016-11-07
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
CitraPure Acid Concentrates2016-11-07
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
CitraPure Acid Concentrates2016-11-07
ROCKWELL MEDICAL
Rockwell Medical CitraPure Acid Concetrate2016-10-20
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Dri-Sate Acid Concentrate Mixes2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Dri-Sate Acid Concentrate Mixes2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Dri-Sate Acid Concentrate Mixes2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Concentrate Solution for Acetate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Concentrate Solution for Acetate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Concentrate Solution for Acetate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Bicarbonate Solution Concentrates for Bicarbonate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Bicarbonate Solution Concentrates for Bicarbonate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Bicarbonate Solution Concentrates for Bicarbonate Dialysis2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Set, tubing, blood, with and without anti-regurgitation valv2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Set, tubing, blood, with and without anti-regurgitation valv2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Set, tubing, blood, with and without anti-regurgitation valv2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Citrapure Acid Concentrate2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Citrapure Acid Concentrate2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
Citrapure Acid Concentrate2010-10-06
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
DRI-SATE MIXER2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
DRI-SATE MIXER2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
DRI-SATE MIXER2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
DRI-SATE MIXER2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
DRI-SATE MIXER2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
BICARBONATE DIALYSATE CONCERTRATE2006-01-23
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
POWDERS2000-04-27
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
POWDERS2000-04-27
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
POWDERS2000-04-27
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
HEMODIALYSIS CONCENTRATE SOLUTIONS2000-04-27
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
HEMODIALYSIS CONCENTRATE SOLUTIONS2000-04-27
ROCKWELL MEDICAL [ROCKWELL MEDICAL TECHNOLOGIES, INC.]
HEMODIALYSIS CONCENTRATE SOLUTIONS2000-04-27

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