Htl-Strefa S.A

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K250016droplet® personal lancetsJuly 1, 2025
K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus SafetyJuly 8, 2022
K202340Droplet Pen Needle 30G & 33GOctober 15, 2020
K192082Droplet Pen Needle 34GApril 21, 2020
K171982DROPLET PEN NEEDLEMarch 21, 2018
K170988DropSafe Safety Pen NeedleDecember 12, 2017
K143437Droplet Pen NeedlesJune 25, 2015