Medical Device Manufacturer · PL , Ozorkow

Htl-Strefa S.A

7 submissions · 7 cleared · Since 2015
7
Total
7
Cleared
0
Denied

Htl-Strefa S.A — FDA 510(k) Submissions

Htl-Strefa S.A has submitted 7 FDA 510(k) premarket notifications since 2015, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Needle, Hypodermic, Single Lumen, Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature . Use the specialty filter in the sidebar to narrow results.

7 devices
1–7 of 7
droplet? personal lancets
K250016 · QRK Single Use Only Blood... · General & Plastic Surgery
Jul 2025 179d
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
K220643 · FMK Single Use Only Blood... · General & Plastic Surgery
Jul 2022 126d
Droplet Pen Needle 30G & 33G
K202340 · FMI Needle, Hypodermic,... · General Hospital
Oct 2020 59d
Droplet Pen Needle 34G
K192082 · FMI Needle, Hypodermic,... · General Hospital
Apr 2020 263d
DROPLET PEN NEEDLE
K171982 · FMI Needle, Hypodermic,... · General Hospital
Mar 2018 264d
DropSafe Safety Pen Needle
K170988 · FMI Needle, Hypodermic,... · General Hospital
Dec 2017 253d
Droplet Pen Needles
K143437 · FMI Needle, Hypodermic,... · General Hospital
Jun 2015 206d
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