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Htl-Strefa S.A

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories3
Latest FDA decision2025-07-01
TypeNumberDevice NameCodeDateActions
510(k) K250016 droplet® personal lancetsQRK2025-07-01 View
510(k) K220643 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 LancetsFMK2022-07-08 View
510(k) K202340 Droplet Pen Needle 30G & 33GFMI2020-10-15 View
510(k) K192082 Droplet Pen Needle 34GFMI2020-04-21 View
510(k) K171982 DROPLET PEN NEEDLEFMI2018-03-21 View
510(k) K170988 DropSafe Safety Pen NeedleFMI2017-12-12 View
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