9 results
·
32ms
·
Sources: EU EUDAMED, US FDA
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
FDA 510(k)
FDA Class 1
·Microbiology
MODIFICATION TO CLEARFIL SE BOND
FDA 510(k)
FDA Class 2
·Dental
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
CONSTELLATION VISION SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 14, 2014
ALLURA XPER FD10/10
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code IZI·November 4, 2010
COULTER LH 750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·January 12, 2013
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021