International Medical Devices Database

Manufacturer Address
Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
8 Events

8 devices in the database

Device Recall Optiflux F180NR Dialyzer

Model / Serial
Lot Number: 10AU04011, Exp 01/13.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
Optiflux¿ F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404. || Designed for single use acute and chronic hemodialysis.

Device Recall Fresenius FDS08 Dialysate Delivery Machine

Model / Serial
Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to 5404 customers throughout the US and the world.
Product Description
Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA

Device Recall Fresenius FDS08 Dialysate Delivery Machine

Model / Serial
Catalog Numbers G047-80101 and RTLG047-80101
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to 5404 customers throughout the US and the world.
Product Description
Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA

Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines

Model / Serial
Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to 5404 customers throughout the US and the world.
Product Description
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA

Device Recall Fresenius FDS08 Dialysate Delivery Machine

Model / Serial
Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to 5404 customers throughout the US and the world.
Product Description
Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA

3 more

3 manufacturers with a similar name

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Fresenius Medical Care North America

Manufacturer Address
Fresenius Medical Care North America, 95 Hayden Avenue, Lexington MA 02421-7942
Source
USFDA

Fresenius Medical Care North America

Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
DH

Fresenius Medical Care North America

Manufacturer Address
Fresenius Medical Care North America, 95 Hayden Ave, Lexington MA 02421-7942
Source
USFDA

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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