11 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DVS (OPTION 01)
FDA 510(k)
FDA Class 2
·Radiology
Transfer Set
FDA UDI
Fresenius Kabi AG·04250273756081·For transition of irrigation solution.
URIC ACID REAGENT
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code KNK·April 15, 2011
PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
FDA 510(k)
FDA Class 1
·Dental
Zenition 50
FDA 510(k)
FDA Class 2
·Radiology
ENDEAVOR SPRINT RX
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·June 19, 2014
PSI KIT: 8.5 FR
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code KGZ·October 15, 2010
VITROS CHEMISTRY PRODUCTS PHYT SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DIP·December 21, 2012
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
SmartPath to dStream for 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017