Skip to content

Millipore Corp.

United StatesFDA applicant, unverified

Devices
33
FDA recalls
8

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Millipore Corp. makes

Millipore Corp. manufactures syringe filters (e.g., MILLEX VV, GV, HV), liquid chromatography systems and accessories (e.g., SEP-PAK cartridges, high-pressure liquid chromatography systems), and diagnostic assay kits (e.g., Light Diagnostics HSV typing, Immunozyme E. histolytica antigens). Their portfolio also includes single-use filter units, electrochemical detectors, and data integration modules for analytical instruments.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with submissions recorded via 510(k) and PMA pathways. Products are listed in the FDA registry, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue33

Newest first, rows 1-33 of 33

Search and filter all 33 devices
Skip device list

Rows 1-33 of 33

FDA recalls8

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 8 recalls initiated by Millipore Corp., the earliest on 2004-01-26 and the most recent on 2009-11-25. By recorded status: 8 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2009

    • 25 Nov 2009 Z-1044-2010 Unclassified (pre-2012) Terminated Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter. Distribution: Worldwide Distribution -- United States, Japan and Hungary. Submission number: K023892

  • 2008

    • 24 Nov 2008 Z-0953-2009 Unclassified (pre-2012) Terminated Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. Distribution: Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA,…
      Full distribution text Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
      Submission number: K974302
    • 24 Nov 2008 Z-0954-2009 Unclassified (pre-2012) Terminated Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B. Distribution: Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA,…
      Full distribution text Worldwide Distribution -- USA including states of AL, CA, CO, CT, FL, ID, IL, KS, MA, MI, MS, NM, NY, OH, OK, OR, PA, SD, TX, UT, VA, VT, WA, WV, and WI and countries of Canada, Mexico, Italy, Belgium,Germany, France, Spain, and United Kingdom.
      Submission number: K974302

  • 2004

    • 26 Jan 2004 Z-0573-04 Unclassified (pre-2012) Terminated Lack of assurance of sterility Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
    • 26 Jan 2004 Z-0574-04 Unclassified (pre-2012) Terminated Lack of assurance of sterility Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
    • 26 Jan 2004 Z-0575-04 Unclassified (pre-2012) Terminated Lack of assurance of sterility Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
    • 26 Jan 2004 Z-0576-04 Unclassified (pre-2012) Terminated Lack of assurance of sterility Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
    • 26 Jan 2004 Z-0577-04 Unclassified (pre-2012) Terminated Lack of assurance of sterility Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada

Frequently asked questions

How many devices does Millipore Corp. have in the registry?

The registry currently lists 33 devices for Millipore Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Millipore Corp.'s devices?

Among its 33 most recently registered devices, Millipore Corp. has devices listed in FDA 510(k) (32 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Millipore Corp.'s devices fall under?

Among its 33 most recently registered devices, the classes recorded for Millipore Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Millipore Corp.?

FDA recall records list 8 recalls initiated by Millipore Corp., the most recent initiated on 25 Nov 2009. 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 Millipore Corp. in the registry?

The most recently registered devices listed for Millipore Corp. include MILLEX VV, GV, AND HV SYRINGE FILTER UNITS, WATERS 740 DATA MODULE-PLOTTER INTEGRATOR, WATERS(TM) 996 PDA and LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT.

Generated automatically from registry data and not verified by a human reviewer.