Moor Instruments Ltd.
Wilmington, DE, US
MOOR INSTRUMENTS LTD. appears in FDA device records in Wilmington, DE. FDA records list 14 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for Moor Instruments Ltd. between 1991 and 2016. The busiest year on record is 2007, with 3. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| 2003 | 1 |
| 2007 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K132163 | MOORLDLS-BI LASER DOPPLER BURNS IMAGER | DPT | Substantially Equivalent | |
| K122943 | MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER | DPT | Substantially Equivalent | |
| K112826 | NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR | MUD | Substantially Equivalent | |
| K102433 | MOORVMS-PRES PRESSURE CUFF CONTROLLER | DPW | Substantially Equivalent | |
| K083082 | MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS | GEX | Substantially Equivalent | |
| K060976 | MOORLD12-B1 LASER DOPPLER BURNS IMAGER | DPT | Substantially Equivalent | |
| K063586 | MOORFLPI FULL-FIELD LASER PERFUSION IMAGER | DPT | Substantially Equivalent | |
| K063561 | MOORLDLS LASER DOPPLER LINE SCANNER | DPT | Substantially Equivalent | |
| K032841 | MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR | DPT | Substantially Equivalent | |
| K011070 | DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR | GEX | Substantially Equivalent | |
| K980383 | MOOORLDI LASER DOPPLER IMAGER | DPT | Substantially Equivalent | |
| K905233 | MOOR LASER BLOOD FLOW MONITOR MBF3D | GEX | Substantially Equivalent | |
| K905232 | MOOR LASER BLOOD FLOW MONITOR MBF3 | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043564 | 1000279065 | MOOR INSTRUMENTS LTD. | MILLWEY, AXMINSTER Devon EX135HU GB | 2026 | |
| 3001434565 | 3001434565 | MOOR INSTRUMENTS, INC. | 501 Silverside Rd, Wilmington, DE 19809 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain