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Elmed, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K010465DENSTATMay 14, 2001
K974793ELMED ESU 120 M/M DIGITALMarch 19, 1998
K953271ELMED RF-ALERTJanuary 18, 1996
K952110ELMED THERMO-FLUXAugust 14, 1995
K926517ELMED LBC 50-PNovember 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 DIGITALNovember 5, 1992
K905417ELMED PNEUMOMAT DIGITALJanuary 31, 1991
K881431SIEMENS STEREODYNATOR 828April 16, 1990
K875238SIEMENS NEUROTON 826 AND 827March 10, 1988
K872909SIEMENS SONODYNATOR 834, ULTRASOUND/STIMULATIONJanuary 13, 1988
K862589ULTRATHERM 808 IAugust 1, 1986
K862029SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNITJuly 16, 1986
K852034VITATRON MJanuary 3, 1986
K832589ELMED WMC 10 AND BC 50 M/MApril 23, 1984
K840321ENDODYNE DUALMarch 16, 1984
K832393ENCODYNE 4 & VACUFIX 4November 14, 1983
K810529DIRECT WRITING VECTORCARDIOGRAPHApril 23, 1981
K791279KOLPOSKOP KP20005September 17, 1979