158 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Raider Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
K133532
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·February 2, 2021
AUTOREADER 2
FDA 510(k)
FDA Class 2
·Microbiology
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 16, 2026
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 17, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 23, 2011
COYOTE? ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·October 15, 2014
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·April 3, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 23, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026
PANEL PHOENIX NMIC-312
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 19, 2026