Fresenius Hemocare, Inc.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Fresenius Hemocare, Inc. makes
Fresenius Hemocare, Inc. manufactures the Prosorba Column, a device used for blood purification in patients with severe metabolic disorders, such as urea cycle disorders or ammonia toxicity. This device employs adsorption technology to remove excess ammonia from the bloodstream during therapeutic apheresis procedures.
The company’s portfolio is regulated under Class III devices in the U.S., requiring Premarket Approval (PMA) through the FDA. The Prosorba Column is listed in the FDA’s PMA registry, reflecting its authorised status for commercial distribution in the United States.
Catalogue
Prosorba Column Ref P850020
PMA, withdrawn PMA
FDA recalls
2003
- 11 Jul 2003 Z-1086-03 Unclassified (pre-2012) Terminated No package insert
- 21 Jan 2003 Z-0906-03 Unclassified (pre-2012) Terminated Sterility may be compromised
Full distribution text
FDA establishments
- Fresenius Hemocare GmbH Friedberg Hesse · DE FEI 3004634229
Frequently asked questions
How many devices does Fresenius Hemocare, Inc. have in the registry?
The registry currently lists 1 device for Fresenius Hemocare, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fresenius Hemocare, Inc.'s devices?
Among its 1 most recently registered device, Fresenius Hemocare, Inc. has devices listed in FDA PMA (1 device).
What risk classes do Fresenius Hemocare, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Fresenius Hemocare, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Fresenius Hemocare, Inc.?
FDA recall records list 2 recalls initiated by Fresenius Hemocare, Inc., the most recent initiated on 2003-07-11. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fresenius Hemocare, Inc. in the registry?
The most recently registered devices listed for Fresenius Hemocare, Inc. include PROSORBA COLUMN.
Which FDA establishments are linked to Fresenius Hemocare, Inc.?
1 FDA establishment is linked to Fresenius Hemocare, Inc. in the registry; they are listed on the company page.