ClearanceBrief
Product code PQF ยท Class 3

Sensor, Glucose, Invasive, Non-Adjunctive

0510(k)s in 12 months (0 all time)
0recalls in 12 months (4 all time)
0recalls that name a 510(k)
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Top companies in PQF

Company510(k)sRecalls
Tandem Diabetes Care Inc03
Dexcom Inc01
DateFirm and productCodeLinked 510(k)
Sep 26, 2022Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Open, Classified
PQFNone listed
Sep 26, 2022Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Open, Classified
PQFNone listed
Jun 10, 2022Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Open, Classified
PQFNone listed
Feb 3, 2020Dexcom Inc
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in perso
Terminated
PQFNone listed

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