10 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Utepreva Endometrial Sampler (UP01)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ALICE 5
FDA 510(k)
FDA Class 2
·Neurology
THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
TERA HARZ CLEAR
FDA Adverse Event
Injury
·GRAPHY INC.·Product code NXC·June 16, 2025
SCD EXPRESS SLEEVE K/L MEDIUM
FDA Adverse Event
Other
·COVIDIEN·Product code JOW·August 26, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·July 22, 2013
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021