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Ultimed, Inc.

FDA Regulatory Profile

Ultimed, Inc. has 0 FDA recalls, 4 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jan 20, 2015 · NAI
Latest 510(k)
Dec 16, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections4Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 20, 2015De Smet, SDDevicesNo Action Indicated (NAI)2183771
Aug 14, 2013De Smet, SDDevicesNo Action Indicated (NAI)2183771
Apr 5, 2012De Smet, SDDevicesNo Action Indicated (NAI)2183771
Apr 29, 2010De Smet, SDDevicesNo Action Indicated (NAI)2183771

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K213407UltiCare Disposable Pen NeedlesDec 16, 2021
K140949ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLEFeb 9, 2015
K100812ULTICARE DISPOSABLE PEN NEEDLESJun 3, 2010
K080600ULTIMED ULTICARE SAFETY SYRINGEJun 25, 2008
K081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINERJun 3, 2008
K062702ULTICARE DISPOSABLE SYRINGES AND NEEDLESNov 29, 2006
K050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2May 11, 2005
K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CCDec 30, 2003
K021983ULTI GUARD HOME INSULIN SYRINGE CONTAINERSep 16, 2002
K994230ULTICARE DISPOSABLE SYRINGEMar 24, 2000

FDA data resources