Dignitana, Inc.

FDA Regulatory Profile

Dignitana, Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0825-2022, Class II) was initiated on November 5, 2021. Its most recent 510(k) clearance was granted on June 26, 2019.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0825-2022Class IIDigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp CoolingNovember 5, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K191166DigniCap DeltaJune 26, 2019
K170871DigniCap Scalp Cooling SystemJuly 3, 2017
DEN150010Dignitana AB DigniCap SystemDecember 8, 2015