Flir Systems
Mccordsville, IN, US
Flir Systems appears in FDA device records in Mccordsville, IN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Flir Systems in 2004.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1223-2009 | MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infared laser pointer | MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products. | Terminated | ||
| Z-0937-2009 | MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infared laser for Laser Range Finding (LRF). | LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain