7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Grreen X 12 (Model: PHT-75CHS)
FDA 510(k)
FDA Class 2
·Radiology
1717SCV, 1717SGV
FDA 510(k)
FDA Class 2
·Radiology
MANUKA FILL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·September 1, 2011
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·October 15, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022