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Data / Medical devices / Diagnostic Neurosurgical Microscope Filter

Diagnostic Neurosurgical Microscope Filter (QFX): 5 FDA-registered makers in 4 countries

5 establishments in 4 countries are registered with the FDA to make Diagnostic Neurosurgical Microscope Filter (product code QFX, Class 2, 21 CFR 882.4950). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 2, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
QFX
Device class
2
Regulation
882.4950
Medical specialty
Neurology

Makers by country

CountryMakers
United States2
Germany1
Switzerland1
Singapore1

Makers of Diagnostic Neurosurgical Microscope Filter

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Carl Zeiss Meditec AG (oberkochen)OBERKOCHEN Baden-Wurttemberg, GermanyManufacturer2June 28, 2024000api.fda.gov
Leica Microsystems (schweiz) AGHEERBRUGG Sankt Gallen, SwitzerlandSpecification developer1March 28, 2019000api.fda.gov
Nico CorporationIndianapolis, IN, United StatesSpecification developer1March 14, 2024000api.fda.gov
Leica Instruments (singapore) Pte Ltd.SINGAPORE South West, SingaporeContract manufacturer0000api.fda.gov
RBC Development LLC dba RBC Medical Innovations dba Vantage MedTechOlathe, KS, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov

Updated October 2, 2026. 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.