8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Venue
FDA 510(k)
FDA Class 2
·Radiology
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
FDA 510(k)
FDA Class 2
·Neurology
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GALAXY G3 MINI 1MM X 1CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
SCREWDRIVER HEX BALL END 3.5MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HXX·October 17, 2014
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
FDA Enforcement
Class II
·Completed·Vyaire Medical·December 13, 2023