8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Temporis, Irix Plus
FDA 510(k)
FDA Class 2
·Dental
Epi-Stop Nasal Gel/epistaxis pack
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
BD TUBERCULIN SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 27, 2020
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVZ·August 30, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·November 7, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020