Medical Device Manufacturer · US , Lake Forest , IL

Hospira, Inc. - FDA 510(k) Cleared Devices

45 submissions · 44 cleared · Since 2004

Recent clearances: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module, Hospira Extension Set, Hospira Primary Set, Hospira Sapphire Sets

45
Total
44
Cleared
0
Denied

Hospira, Inc. was an American global pharmaceutical and medical device company headquartered in Lake Forest, Illinois. The company specialized in generic injectable pharmaceuticals and integrated infusion therapy systems for hospitals and alternate care settings.

Hospira maintains an FDA 510(k) regulatory record of 44 cleared devices from 45 total submissions between 2004 and 2017. The company's primary focus was General Hospital devices, which comprised the majority of its submissions. Notable cleared products include the Plum 360 Infusion System, extension sets, administration sets, and blood administration products designed for acute-care hospital environments.

Hospira was acquired by Pfizer in September 2015. The medical devices portion was subsequently sold to ICU Medical. This regulatory record represents the company's historical FDA 510(k) clearance activity and should be treated as a historical reference.

Explore the complete list of device names, product codes, and clearance dates in the database to review Hospira's full regulatory submission history.

Regulatory submissions have been managed by Icu Medical, Inc., Underwriters Laboratories, Inc. and Intertek Testing Services.

FDA 510(k) Regulatory Record - Hospira, Inc.

45 devices
1-12 of 45

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