11 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline ReNewal Reprocessed Compression Limb Sleeves
FDA 510(k)
FDA Class 2
·Cardiovascular
CHEETAH RELIANT
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEARPATH UPPER GI
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·January 14, 2022
COBAS INTEGRA 400 PLUS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JGS·February 16, 2012
ECHELON STEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·June 3, 2013
RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA·Product code KGE·June 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 26, 2024
ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020