Skip to content

Arizant Healthcare, Inc.

United StatesFDA applicant, unverified

Devices
6
FDA recalls
2

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Arizant Healthcare, Inc. makes

Arizant Healthcare, Inc. manufactures temperature management systems, including active warming devices for blood and irrigation fluids, as well as passive and active patient temperature monitoring solutions. These systems are designed for intraoperative and perioperative use to maintain or regulate patient body temperature during medical procedures.

The company’s portfolio consists of Class II medical devices, all of which are authorised via the FDA’s 510(k) clearance process. These devices are listed under the FDA’s regulatory framework and are intended for use in the United States.

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

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 2 recalls initiated by Arizant Healthcare, Inc., initiated on 2007-06-26. By recorded status: 2 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. 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.

  • 2007

    • 26 Jun 2007 Z-1183-2007 Unclassified (pre-2012) Terminated Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. Distribution: Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS,…
      Full distribution text Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.
      Submission number: K973741
    • 26 Jun 2007 Z-1184-2007 Unclassified (pre-2012) Terminated Incomplete seal on the product pouch; with the seal incomplete, the sterility of the product inside the pouch cannot be guaranteed. Distribution: Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS,…
      Full distribution text Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL., IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and countries of United Kingdom, France, Switzerland, Germany, India, Canada, Australia, Netherlands, Italy, Sweeden, South Korea, and Greece.
      Submission number: K973741

Frequently asked questions

How many devices does Arizant Healthcare, Inc. have in the registry?

The registry currently lists 6 devices for Arizant Healthcare, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Arizant Healthcare, Inc.'s devices?

Among its 6 most recently registered devices, Arizant Healthcare, Inc. has devices listed in FDA 510(k) (6 devices).

What risk classes do Arizant Healthcare, Inc.'s devices fall under?

Among its 6 most recently registered devices, the classes recorded for Arizant Healthcare, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Arizant Healthcare, Inc.?

FDA recall records list 2 recalls initiated by Arizant Healthcare, Inc., the most recent initiated on 26 Jun 2007. 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 Arizant Healthcare, Inc. in the registry?

The most recently registered devices listed for Arizant Healthcare, Inc. include BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM, 3M SPOTON TEMPERATURE MONITORING SYSTEM, RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM and RANGER IRRIGATION FLUID WARMING SYSTEM.

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