Data / Medical devices / United Kingdom / Moor Instruments Ltd.

Moor Instruments Ltd.: FDA-registered device maker in AXMINSTER Devon, United Kingdom, 9 510(k) clearances

Name: Moor Instruments Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Moor Instruments Ltd. is registered with the FDA (registration 8043564) in AXMINSTER Devon, United Kingdom. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 12, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8043564
FEI number: 1000279065
Address: Millwey, AXMINSTER Devon, United Kingdom, EX135HU
Owner or operator: MOOR INSTRUMENTS LTD. (9002394)
Roles: Complaint file establishment, Manufacturer
First device listed: December 13, 2007
Registered through: 2026
Brand names listed: moorFLPI, moorFLPI2, moorLDI2, moorLDI2-BI, moorLDLS, moorLDLS-BI, moorVMS-LDF1, moorVMS-LDF2 and more

Devices it lists

Device	Product code	Class	Role	Source
Flowmeter, Blood, Cardiovascular	DPW	2	Manufacturer	accessdata.fda.gov
Oximeter, Tissue Saturation	MUD	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Probe, Blood-Flow, Extravascular	DPT	2	Complaint file establishment, 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
May 12, 2016	K152749	moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imager	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
January 29, 2014	K132163	MOORLDLS-BI LASER DOPPLER BURNS IMAGER	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
January 3, 2013	K122943	MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
October 10, 2012	K112826	NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR	MUD	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
November 18, 2010	K102433	MOORVMS-PRES PRESSURE CUFF CONTROLLER	DPW	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
January 13, 2009	K083082	MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS	GEX	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
March 27, 2007	K060976	MOORLD12-B1 LASER DOPPLER BURNS IMAGER	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
January 25, 2007	K063586	MOORFLPI FULL-FIELD LASER PERFUSION IMAGER	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov
January 19, 2007	K063561	MOORLDLS LASER DOPPLER LINE SCANNER	DPT	Substantially Equivalent	Moor Instruments, Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 12, 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.