Company · PL
Htl-Strefa S.A
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2025 | K250016 | droplet® personal lancets Htl-Strefa S.A, PL | QRK |
| Jul 8, 2022 | K220643 | DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet ME Htl-Strefa S.A, PL | FMK |
| Jan 7, 2022 | K211716 | DropSafe Safety Pen Needles Htl Strefa SA, PL | FMI |
| Oct 15, 2020 | K202340 | Droplet Pen Needle 30G & 33G Htl-Strefa S.A, PL | FMI |
| Apr 21, 2020 | K192082 | Droplet Pen Needle 34G Htl-Strefa S.A, PL | FMI |
| Mar 21, 2018 | K171982 | DROPLET PEN NEEDLE Htl-Strefa S.A, PL | FMI |
| Dec 12, 2017 | K170988 | DropSafe Safety Pen Needle Htl-Strefa S.A, PL | FMI |
| Jun 25, 2015 | K143437 | Droplet Pen Needles Htl-Strefa S.A, PL | FMI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||