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Cedars-Sinai Medical Center

FDA Regulatory Profile

Cedars-Sinai Medical Center has 0 FDA recalls, 9 inspections, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 14, 2025 · NAI
Latest 510(k)
Nov 3, 2017

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections9Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 14, 2025West Hollywood, CABiologicsNo Action Indicated (NAI)2073862
Aug 26, 2022West Hollywood, CABiologicsVoluntary Action Indicated (VAI)2073862
Feb 27, 2018West Hollywood, CABiologicsVoluntary Action Indicated (VAI)2073862
Mar 28, 2016West Hollywood, CABiologicsNo Action Indicated (NAI)2073862
Dec 7, 2015Los Angeles, CADevicesVoluntary Action Indicated (VAI)3000717534
Jul 14, 2014West Hollywood, CABiologicsNo Action Indicated (NAI)2073862
Dec 6, 2011West Hollywood, CABiologicsNo Action Indicated (NAI)2073862
Dec 17, 2010West Hollywood, CABiologicsNo Action Indicated (NAI)2073862
Sep 18, 2009West Hollywood, CABiologicsNo Action Indicated (NAI)2073862

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
K172609CSMC Cardiac SuiteNov 3, 2017
K141652CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWAREJul 22, 2014
K123433CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWAREFeb 26, 2013
K112474CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARESep 23, 2011
K100714CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01Apr 1, 2011

FDA data resources