7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CHURCHILL-HE VENTED IV SET
FDA 510(k)
FDA Class 2
·General Hospital
SENTRY SIGNAL ENURESIS ALARM SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E
FDA 510(k)
FDA Class 1
·Pathology
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 6, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·December 3, 2012
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·October 19, 2016