13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FLOWLOCK OXYGEN METER
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573023509·LIGHT BOND MED VISCOSITY SYRINGE W/FLUORIDE (5G)
AURADONICS
FDA UDI
AURADONICS INC.·00810033835933·LATEX ELASTICS 1/4" 3.5 oz. - NEON, 50 bags of ...
SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 21, 2019
SLIM ONEBODY SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 24, 2014
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·August 13, 2010
BD 20 ML SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 10, 2020
SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·July 11, 2019
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.
FDA Enforcement
Class II
·Terminated·Cook Inc.·July 1, 2015