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Syntermed, Inc.

FDA Regulatory Profile

Syntermed, Inc. has 0 FDA recalls, 4 inspections, 14 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 11, 2022 · NAI
Latest 510(k)
Mar 30, 2023

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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) clearances14Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 11, 2022Atlanta, GADevicesNo Action Indicated (NAI)3003079232
May 23, 2018Atlanta, GADevicesNo Action Indicated (NAI)3003079232
Nov 30, 2012Atlanta, GADevicesNo Action Indicated (NAI)3003079232
Mar 22, 2010Atlanta, GADevicesVoluntary Action Indicated (VAI)3003079232

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
K223422Emory Cardiac Toolbox 4.3Mar 30, 2023
K180077NeuroQ 3.8Aug 16, 2018
K130902EMORY CARDIAC TOOLBOX 3.2Jun 14, 2013
K130451NEUROQ 3.6May 17, 2013
K123646EMORY CARDIAC TOOLBOX 4.0Feb 22, 2013
K072307QUANTITATIVE NEUROQ 3.0Mar 14, 2008
K071503SYSTEM, TOMOGRAPHY, COMPUTED EMISSIONJul 26, 2007
K070089SYNTERMED LIVEMar 2, 2007
K042258BP-SPECT V1.OOct 4, 2004
K041022NEUROQ - PET DPJun 17, 2004
K040141EMORY CARDIAC TOOLBOX VERSION 2.6Jan 30, 2004
K020300NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)Apr 23, 2002
K014033EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERSFeb 22, 2002
K001276MEDICAL IMAGE MERGE (MIM)Jul 17, 2000

FDA data resources