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Owen Mumford, Ltd.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories4
Latest FDA decision2023-06-30
TypeNumberDevice NameCodeDateActions
510(k) K223854 Unistik® ShieldLock, Unistik VacuFlipJKA2023-06-30 View
510(k) K231124 Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)FMK2023-06-27 View
510(k) K222168 Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and ToddlerFMK2022-11-03 View
510(k) K222303 Unistik® ProFMK2022-10-25 View
510(k) K221613 Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsQRL2022-10-03 View
510(k) K222111 Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30GFMK2022-09-07 View
510(k) K221126 Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancetsFMK2022-08-12 View
510(k) K210399 Unifine SafeControlFMI2021-09-17 View
510(k) K173881 Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GFMI2018-07-11 View
510(k) K152339 Unifine Pentips/ Unifine Pentips PlusFMI2016-06-24 View
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