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Hmd Biomedical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K212248GlucoLeader Enhance 2 Blood Glucose Monitoring SystemAugust 29, 2022
K182428GlucoLeader Enhance Blood Glucose Monitoring SystemMay 8, 2019
K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, GoMay 14, 2015
K131173FIA Blood Glucose Monitoring System (G2)September 18, 2014
K121433GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITFebruary 14, 2013
K113314PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEMNovember 9, 2012
K120064TEST, BLOOD GLUCOSE SYSTEMSeptember 5, 2012
K113307GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEMJuly 27, 2012
K072369EVOLUTION BLOOD GLUCOSE MONITORING SYSTEMMarch 21, 2008
K032985GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEMOctober 21, 2003
K023279GLUCOLEADER VALUEAugust 4, 2003