11 results · 25ms · Sources: EU EUDAMED, US FDA

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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