Medical Device Manufacturer · US , Ocean , NJ

Hmd Biomedical, Inc.

10 submissions · 10 cleared · Since 2003
10
Total
10
Cleared
0
Denied

Hmd Biomedical, Inc. — FDA 510(k) Submissions

Hmd Biomedical, Inc. has submitted 10 FDA 510(k) premarket notifications since 2003, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Glucose Dehydrogenase, Glucose . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
GlucoLeader Enhance 2 Blood Glucose Monitoring System
K212248 · NBW System, Test, Blood... · Chemistry
Aug 2022 406d
GlucoLeader Enhance Blood Glucose Monitoring System
K182428 · NBW System, Test, Blood... · Chemistry
May 2019 244d
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
K140150 · NBW System, Test, Blood... · Chemistry
May 2015 477d
FIA Blood Glucose Monitoring System (G2)
K131173 · NBW System, Test, Blood... · Chemistry
Sep 2014 511d
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS
K121433 · LFR Glucose Dehydrogenase,... · Chemistry
Feb 2013 276d
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K113314 · LFR Glucose Dehydrogenase,... · Chemistry
Nov 2012 366d
TEST, BLOOD GLUCOSE SYSTEM
K120064 · NBW System, Test, Blood... · Chemistry
Sep 2012 240d
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM
K113307 · LFR Glucose Dehydrogenase,... · Chemistry
Jul 2012 262d
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
K032985 · NBW System, Test, Blood... · Chemistry
Oct 2003 27d
GLUCOLEADER VALUE
K023279 · NBW System, Test, Blood... · Chemistry
Aug 2003 307d
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