Companion Medical, Inc.

FDA Regulatory Profile

Companion Medical, Inc. appears in FDA public data with 1 recall, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0741-2023, Class II) was initiated on November 8, 2022. Its most recent 510(k) clearance was granted on June 18, 2020.

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0741-2023Class IIInPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA, MMT-105ELGYNA, MMT-105ENovember 8, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K201337InPen SystemJune 18, 2020
K190487InPen Dose CalculatorFebruary 18, 2020
K192841InPen SystemFebruary 10, 2020
K181327InPen Dose CalculatorJuly 6, 2018
K160629InPenJuly 26, 2016