9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60
FDA 510(k)
FDA Class 1
·Radiology
4874946
FDA Adverse Event
Malfunction
·June 26, 2015
TDXR 5-HIAA (URINE)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL
FDA 510(k)
FDA Class 1
·Clinical Toxicology
MENTOR MEMORYGEL XTRA BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·December 9, 2025
TDX/TDXFLX CANNABINOIDS REAGENT
FDA Adverse Event
Injury
·ABBOTT HEALTH PRODUCTS, INC.·Product code LDJ·November 8, 2006
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 25, 2014
AED10
FDA Adverse Event
Malfunction
·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·October 13, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 16, 2012