Hmd Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: GlucoLeader Enhance 2 Blood Glucose Monitoring System, GlucoLeader Enhance Blood Glucose Monitoring System, Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hmd Biomedical, Inc. Chemistry ✕
10 devices
Cleared
Aug 29, 2022
GlucoLeader Enhance 2 Blood Glucose Monitoring System
Chemistry
406d
Cleared
May 08, 2019
GlucoLeader Enhance Blood Glucose Monitoring System
Chemistry
244d
Cleared
May 14, 2015
Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood...
Chemistry
477d
Cleared
Sep 18, 2014
FIA Blood Glucose Monitoring System (G2)
Chemistry
511d
Cleared
Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT...
Chemistry
276d
Cleared
Nov 09, 2012
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
Chemistry
366d
Cleared
Sep 05, 2012
TEST, BLOOD GLUCOSE SYSTEM
Chemistry
240d
Cleared
Jul 27, 2012
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
Chemistry
262d
Cleared
Oct 21, 2003
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
Chemistry
27d
Cleared
Aug 04, 2003
GLUCOLEADER VALUE
Chemistry
307d