510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MDSClass III

Sensor, Glucose, Invasive

Unknown
FDA source (opens on fda.gov)

MDS is the FDA product code for Sensor, Glucose, Invasive, a class III device type. FDA's definition for this code reads: "The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the...". As of , FDA records hold no 510(k) clearances under this code and 57 recalls.

Classification record

Product code
MDS
Device name
Sensor, Glucose, Invasive
FDA definition
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
57

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order