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Neitz Instruments Company, Ltd.

FDA Regulatory Profile

Neitz Instruments Company, Ltd. has 0 FDA recalls, 1 inspection, 24 510(k) clearances and 1 compliance action on record.

Latest inspection
May 19, 2023 · OAI
Latest 510(k)
Sep 30, 1997

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances24Nov 8, 2026File dated Nov 2, 2026Current
Inspections1Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 19, 2023Chiyoda, JapanDevicesOfficial Action Indicated (OAI)3002807701

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002807701Chiyoda, Japan1May 19, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K972440CATARACTSCREENER CT - SSep 30, 1997
K951341NEITZ SLIT LAMP SL-H2Jun 15, 1995
K951337FIBER HEAD LIGHT FH-300Jun 8, 1995
K950788OTOSCOPE A-34May 3, 1995
K951340NEITZ SLIT LAMP SL-H1Apr 10, 1995
K951338INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TVApr 7, 1995
K950789STREAK RETINOSCOPE RX-1Mar 28, 1995
K950793SPOT RETINOSCOPE RX-3SPMar 28, 1995
K950794STREAK RETINOSCOPE RX-RCMar 28, 1995
K950791STREAK RETINOSCOPE RX-3Mar 28, 1995
K950792STREAK RETINOSCOPE RX-3AMar 28, 1995
K950795STREAK RETINOSCOPE RX-RPMar 28, 1995
K950797HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134Mar 28, 1995
K950796HALOGEN DIAGNOSTIC SET BX A - 12345Mar 22, 1995
K950790STREAK RETINOSCOPE RX-2Mar 22, 1995
K942713NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-HAug 5, 1994
K942721NEITZ HALOGEN OPHTHALMOSCOPE BXA-13Aug 5, 1994
K942715NEITZ HALOGEN OPHTHALMOSCOPE BXA-RCAug 5, 1994
K942719NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JRAug 5, 1994
K942717NEITZ HALOGEN OPHTHALMOSCOPE BXA-13AAug 5, 1994

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.