11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Drakon and Sequre® Microcatheters
FDA 510(k)
FDA Class 2
·Cardiovascular
BD BBL™ Sensi-Disc™ Nitrofurantoin 300 µg
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902312933·BD BBL™ Sensi-Disc™ Nitrofurantoin 300 µg
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022441·600 micron core/730 micron OD Luer Lock Diode L...
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
FDA 510(k)
FDA Class 1
·General Hospital
Ureterorenoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 30, 2026
OPTILITE® FREELITE® KAPPA FREE KIT
FDA Adverse Event
Injury
·THE BINDING SITE LIMITED·Product code DFH·March 31, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 1, 2011
LANTUS SOLO STAR ULTRA FINE NEEDLE
FDA Adverse Event
Malfunction
·CANAMCARE·Product code FMI·July 11, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022