8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DNA Appliance
FDA 510(k)
FDA Class 2
·Dental
ETHICON LINX® Esophagus Sizing Tool
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2025
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 19, 2008
PARIETEX UGYTEX PP ANTERIOR KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code FTL·August 29, 2011
STEALTHSTATION S7 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 18, 2013
OEC 9800 Systems with 9-inch Image Intensifier
FDA Enforcement
Class II
·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023