ClearanceBrief
Panels › Neurology › Product code QFX · Class 2

Diagnostic Neurosurgical Microscope Filter

Regulation 882.4950

2510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in QFX

Company510(k)sRecalls
Carl Zeiss Meditec, AG20
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)10
Leica Microsystems (Schweiz) AG10
Nico Corporation10
VPIX Medical, Inc.10
Decided510(k)Device and applicantCode
Oct 2, 2026K254030cCeLL405
VPIX Medical, Inc., KR
QFX
Jan 21, 2026K251286Affirm 400
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
QFX
Jun 28, 2024K240215BLUE 400; BLUE 400 S
Carl Zeiss Meditec, AG, DE
QFX
Mar 14, 2024K232567Myriad SPECTRA Light Source
Nico Corporation
QFX
Jul 22, 2022K211346BLUE 400
Carl Zeiss Meditec, AG, DE
QFX
Mar 28, 2019DEN180024Leica FL400
Leica Microsystems (Schweiz) AG, CH
QFX

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