24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Blood Administration Set
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V
Accufit
FDA UDI
Ortho Organizers, Inc.·00190707185183·AccuFit™ Molar Band UL7 - 33.5
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551068297·BRW/CRW-sEEG KIT: 2103-36, 2103-95 (QTY 2), 210...
Radius Plate PROlock II
FDA UDI
I.T.S. GmbH·09120047296912·Radius Plate PROlock II, Wide, 5-Hole, Right
SLENDERTONE FLEX, MODEL, 512
FDA 510(k)
FDA Class 2
·Physical Medicine
CERAMIC BRACKETS
FDA 510(k)
FDA Class 2
·Dental
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·September 29, 2022
OPTI-FREE MULTI-ACTION SOLUTION
FDA Adverse Event
Injury
·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·August 9, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 29, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013
Prism 3000S and 3000XP Gamma Camera Systems, Models N210060 and N210335.
FDA Recall
Terminated
·Philips Medical Systems Inc·Product code KPS·January 23, 2003
XVWEB
FDA Adverse Event
Injury
·PLANET DDS·Product code LLZ·March 13, 2025
SECOND OPINION
FDA Adverse Event
Injury
·PEARL INC.·Product code MYN·March 13, 2025
BD 30GA 1/2IN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·December 10, 2021
BD MICROLANCE¿3 NEEDLES 30 G
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·June 3, 2022
BD MICROLANCE¿ 3 NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·July 15, 2022
BD MICROLANCE 3 HYPODERMIC NEEDLES 30GX0.5"
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·February 1, 2022
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21035-3, 21036-3.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026