Nds Surgical Imaging

FDA Regulatory Profile

Nds Surgical Imaging has 0 FDA recalls, 6 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 13, 2026 · NAI
Latest 510(k)
Oct 19, 2022

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections6Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 13, 2026Sarasota, FLDevicesNo Action Indicated (NAI)3003301977
Mar 25, 2015Sarasota, FLDevicesNo Action Indicated (NAI)3003301977
Aug 17, 2012Sarasota, FLDevicesNo Action Indicated (NAI)3003301977
Apr 20, 2012Sarasota, FLDevicesNo Action Indicated (NAI)3003301977
Jul 21, 2010Sarasota, FLDevicesNo Action Indicated (NAI)3003301977
Aug 18, 2009Sarasota, FLDevicesNo Action Indicated (NAI)3003301977

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.

Recent 510(k) Clearances

K-NumberDeviceDate
K222890RADIANCE ULTRA 32 4K ZEROWIRE DUOOct 19, 2022
K170598ZeroWire MobileApr 7, 2017
K161228Radiance Ultra Series ZeroWire EmbeddedMay 26, 2016
K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nov 6, 2015
K133609THE DOME S6CFeb 28, 2014
K132770DOME S10Jan 30, 2014
K131115ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIREJun 7, 2013
K120709THE DOME GX4MP COLOR NONITORApr 6, 2012
K100195NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY…Apr 21, 2010
K080320PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300Feb 21, 2008