7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MICROWAVE OVEN 2M9810
FDA 510(k)Mini Cannulated Headed and Headless Screw Set
FDA 510(k)
FDA Class 2
·Orthopedic
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 21, 2012
REPLY
FDA Adverse Event
Malfunction
·SORIN BIOMEDICA CRM S.R.L.·Product code NVZ·October 15, 2010
CRANIOFIX 2 TITANIUM CLAMP 20MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GXN·February 19, 2014
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