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Eastman Kodak Company

United Statesfrom the FDA registration address FDA establishment FEI 3038430126

Devices
238
Registrations
FDA
FDA recalls
3

What Eastman Kodak Company makes

The company manufactures diagnostic imaging products, including dental X-ray film, radiographic film, and X-ray film processors such as the X-OMAT series, as well as intensifying screens for medical imaging. It also produces urine test kits for pregnancy and strep A detection, clinical chemistry slides for laboratory analysis, and medical imaging accessories like cassettes and printers. Additionally, the portfolio includes assay kits for hormone testing, such as prolactin, and specialized imaging reagents like Trophypan C.

The portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with regulatory submissions recorded in the FDA’s 510(k) database. These products are intended for use in medical diagnostics, imaging, and laboratory testing. The company is based in the United States.

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

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Company details

FDA FEI number
3038430126
Address
318 Technology Blvd., Rochester, NY, 14652

FDA recalls3

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

FDA recall records list 3 recalls initiated by EASTMAN KODAK COMPANY, the earliest on 2004-02-20 and the most recent on 2005-10-20. By recorded status: 3 terminated. The reasons filed fall into these groups: other reasons as filed. 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.

  • 2005

    • 20 Oct 2005 Z-0274-06 Unclassified (pre-2012) Terminated Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit. Distribution: DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7…
      Full distribution text DOMESTIC: 12 units shipped to 12 medical facilities in FL, KY, MI, NY, OH, PA, and SC. FOREIGN: 12 units shipped to 7 hospitals in China, 1 warehouse in China; 1in the possession of Chinese Customs (government); and 1 is in a warehouse in Russia.
      Submission number: K001341
    • 8 Apr 2005 Z-0817-05 Unclassified (pre-2012) Terminated Screens may be affected with image artifacts Distribution: There are 263 U.S. customers; 22 Canadian customers; 74 Japanese customers; 213 Greater Asian Region customers; 19 Latin…
      Full distribution text There are 263 U.S. customers; 22 Canadian customers; 74 Japanese customers; 213 Greater Asian Region customers; 19 Latin American customers; 306 Europe/Africa/ Middle East customers.
      Submission number: K925997

  • 2004

    • 20 Feb 2004 Z-0728-04 Unclassified (pre-2012) Terminated Defective component in overhead tube support balancer may cause the suspended load to fall. Distribution: Amsterdam, China and Kuwait. Submission number: K001341

This is an FDA establishment record. No EUDAMED registration is known for this company.