9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
IN-PROBE II URODYNAMIC SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TIBIAL NAIL, STANDARD 10X390 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·March 17, 2010
Modus Nav
FDA 510(k)
FDA Class 2
·Neurology
N-600X WITH SPD, OXIMAX N-600X
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK FLEX LV LEAD
FDA Adverse Event
Death
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code OJX·February 28, 2013
CARDIOVASCULAR PROCEDURE KIT
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·February 4, 2011
MITEK MILAGRO BIOCRYL RAPIDE 8X23MM INTERFERENCE SCREW
FDA Adverse Event
Injury
·DEPUY MITEK·Product code HWC·August 6, 2014
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·February 6, 2017
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024