7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CPR YANKAUER
FDA 510(k)
FDA Class 2
·General Hospital
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter
FDA 510(k)
FDA Class 2
·Neurology
SPARC SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 8, 2013
INRATIO2
FDA Adverse Event
Other
·ALERE SAN DIEGO, INC.·Product code GJS·January 5, 2011
NATURALYTE
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 15, 2014
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024