11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ADVIA Centaur Cortisol (COR)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AccuQuest
FDA UDI
Bernafon AG·05711584089460·AQ CO1 MNR T, 2.4G NFM DPB MSIL ACCUQ
TORNIER BIOFIBER SCAFFOLD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERIOPHIL BIPHASIC
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 22, 2025
MYSPINE STANDARD DRILL GUIDE T07
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019
REFLEX HYBRID THREE-LEVEL PLATE, SIZE 51MM
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code KWQ·October 8, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2013
CARESCAPE MONITOR B850
FDA Adverse Event
Malfunction
·GE HEALTHCARE·Product code MHX·July 20, 2011
VENT RES TR SAL-RIC ST BA
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·December 18, 2023
Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
FDA Enforcement
Class I
·Ongoing·Abbott Vascular·May 25, 2022