Eastman Kodak Company
Country not established 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.
Catalogue
Search and filter all 238 devicesShowing 1-50 of 238
Company details
- FDA FEI number
- 3038430126
- Address
- 318 Technology Blvd., Rochester, NY, 14652
FDA recalls
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.
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.
Full distribution text
- 8 Apr 2005 Z-0817-05 Unclassified (pre-2012) Terminated Screens may be affected with image artifacts
Full distribution text
- 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.
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.
Frequently asked questions
How many devices does EASTMAN KODAK COMPANY have in the registry?
The registry currently lists 238 devices for EASTMAN KODAK COMPANY. Devices recorded under merged duplicate company entries are counted once.
Which registries list EASTMAN KODAK COMPANY's devices?
Among its 50 most recently registered devices, EASTMAN KODAK COMPANY has devices listed in FDA 510(k) (50 devices).
What risk classes do EASTMAN KODAK COMPANY's devices fall under?
Among its 50 most recently registered devices, the classes recorded for EASTMAN KODAK COMPANY's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for EASTMAN KODAK COMPANY?
FDA recall records list 3 recalls initiated by EASTMAN KODAK COMPANY, the most recent initiated on 2005-10-20. 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 EASTMAN KODAK COMPANY in the registry?
The most recently registered devices listed for EASTMAN KODAK COMPANY include KODAK SURECELL HCG URINE TEST, MODIFICATION, KODAK EKTASPEED DENTAL X-RAY FILM, KODAK X-OMAT 3000 RA PROCESSOR and KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS.