Owen Mumford, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K223854Unistik® ShieldLock, Unistik VacuFlipJune 30, 2023
K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)June 27, 2023
K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik HNovember 3, 2022
K222303Unistik® ProOctober 25, 2022
K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet LancetsOctober 3, 2022
K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30GSeptember 7, 2022
K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; August 12, 2022
K210399Unifine SafeControlSeptember 17, 2021
K173881Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30GJuly 11, 2018
K152339Unifine Pentips/ Unifine Pentips PlusJune 24, 2016
K122837AUTOJECT 2 FOR GLASSY SYRINGEOctober 15, 2012
K011951EZ SYRINGEAugust 2, 2001
K000482MODIFICATION TO AUTOJECT MINIMarch 6, 2000