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Elmed, Inc.

FDA Regulatory Profile

Elmed, Inc. has 0 FDA recalls, 6 inspections, 27 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 17, 2023 · VAI
Latest 510(k)
Mar 22, 2019

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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) clearances27Oct 4, 2026Not statedCurrent
Inspections6Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 17, 2023Glendale Heights, ILDevicesVoluntary Action Indicated (VAI)1412854
Apr 12, 2019Glendale Heights, ILDevicesNo Action Indicated (NAI)1412854
Sep 21, 2016Glendale Heights, ILDevicesNo Action Indicated (NAI)1412854
Aug 12, 2014Glendale Heights, ILDevicesNo Action Indicated (NAI)1412854
Mar 7, 2011Glendale Heights, ILDevicesNo Action Indicated (NAI)1412854
Jun 17, 2009Glendale Heights, ILDevicesNo Action Indicated (NAI)1412854

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
K181173ELMED Laparoscopic Instruments and AccessoriesMar 22, 2019
K010465DENSTATMay 14, 2001
K974793ELMED ESU 120 M/M DIGITALMar 19, 1998
K953271ELMED RF-ALERTJan 18, 1996
K952110ELMED THERMO-FLUXAug 14, 1995
K926517ELMED LBC 50-PNov 15, 1994
K932938ELMED ESU 300 M/M AND DIGITALMay 2, 1994
K921770ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/MMay 17, 1993
K915731ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITALNov 5, 1992
K905417ELMED PNEUMOMAT DIGITALJan 31, 1991
K881431SIEMENS STEREODYNATOR 828Apr 16, 1990
K875238SIEMENS NEUROTON 826 AND 827Mar 10, 1988
K872909SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATIONJan 13, 1988
K862589ULTRATHERM 808 IAug 1, 1986
K862029SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNITJul 16, 1986
K852034VITATRON MJan 3, 1986
K832589ELMED WMC 10 AND BC 50 M/MApr 23, 1984
K840321ENDODYNE DUALMar 16, 1984
K832393ENCODYNE 4 & VACUFIX 4Nov 14, 1983
K810529DIRECT WRITING VECTORCARDIOGRAPHApr 23, 1981

FDA data resources