Clark Research and Development, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What Clark Research and Development, Inc. makes
Clark Research and Development, Inc. manufactures the Clark Tut Image Processing System, a device used for analyzing and processing radiographic images, and the Clark Precision Block Cutter with cooling, designed for precise tissue or sample preparation in laboratory settings.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Clark Tut Image Processing System Ref K954589
Regimes: 510(k) Registry: 510(k)Clark Precision Block Cutter, Cooling Ref K842615
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Clark Research and Development, Inc., initiated on 2007-01-19. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use and 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.
2007
- 19 Jan 2007 Z-0550-2007 Unclassified (pre-2012) Terminated Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
- 19 Jan 2007 Z-0551-2007 Unclassified (pre-2012) Terminated Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
- 19 Jan 2007 Z-0552-2007 Unclassified (pre-2012) Terminated Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
- 19 Jan 2007 Z-0553-2007 Unclassified (pre-2012) Terminated Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Frequently asked questions
How many devices does Clark Research and Development, Inc. have in the registry?
The registry currently lists 2 devices for Clark Research and Development, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clark Research and Development, Inc.'s devices?
Among its 2 most recently registered devices, Clark Research and Development, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Clark Research and Development, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Clark Research and Development, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Clark Research and Development, Inc.?
FDA recall records list 4 recalls initiated by Clark Research and Development, Inc., the most recent initiated on 19 Jan 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 Clark Research and Development, Inc. in the registry?
The most recently registered devices listed for Clark Research and Development, Inc. include CLARK TUT IMAGE PROCESSING SYSTEM and CLARK PRECISION BLOCK CUTTER, COOLING.