7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Navilas Laser System 577sl (156691)
FDA 510(k)
FDA Class 2
·Ophthalmic
Actreen Mini Intermittent Urinary Catheters
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASAHI TORNUS SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
BD ULTRA FINE SHORT INSULIN PEN NEEDLE
FDA Adverse Event
Injury
·BD·Product code FMI·November 6, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·September 16, 2011
GENERATOR AQM 115V
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY, LLC·Product code MUL·July 29, 2013
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
FDA Enforcement
Class II
·Terminated·Diagnostica Stago, Inc.·March 21, 2018