Data / Medical devices / United Kingdom / Research Instruments Ltd
Research Instruments Ltd: FDA-registered device maker in Falmouth Cornwall, United Kingdom, 3 510(k) clearances
Research Instruments Ltd is registered with the FDA (registration 3004871219) in Falmouth Cornwall, United Kingdom. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 18, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004871219
- FEI number
- 3003751666
- Address
- Bickland Industrial Park, Falmouth Cornwall, United Kingdom, TR11 4TA
- Owner or operator
- Research Instruments Ltd (9034672)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- April 13, 2007
- Registered through
- 2026
- Brand names listed
- EZ, Incubators, Integra 3 Micromanipulator, RI WItness, Saturn 5, Wallace® Aspiration Pump (WAPV1)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Assisted Reproduction | MQG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessory, Assisted Reproduction, Exempt | PUB | 2 | Contract manufacturer | accessdata.fda.gov |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | 2 | Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Assisted Reproduction Laser | MRX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2016 | K160504 | RI Witness Embryology Heated Plate | MQG | Substantially Equivalent | Research Instruments Limited | accessdata.fda.gov |
| February 18, 2015 | K141434 | SATURN 5 LASER | MRX | Substantially Equivalent | Research Instruments , Ltd. | accessdata.fda.gov |
| November 22, 2000 | K003142 | MICROMANIPULATOR | MQJ | Substantially Equivalent | Research Instruments , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 11, 2016 | 73581 | Class II | Terminated | Integra 3; Model Numbers: 6-54-100, 6-54-110, 6-54-150, 6-54-160 Product Usage: The Rl TDU500 Micromanipulator for Assisted Reproduction is used to accurately position microtools under a microscope for the techniques of | The units have been fitted with a potentially faulty power supply cable. | accessdata.fda.gov |
Compare with other makers
- All makers of Microtools, Assisted Reproduction (Pipettes)
- All makers of Accessory, Assisted Reproduction
- All makers of Micromanipulators And Microinjectors, Assisted Reproduction
- All makers of Accessory, Assisted Reproduction, Exempt
- All makers of System, Assisted Reproduction Laser
Updated July 18, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.