7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
COBAS READY URIC ACID REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SURGICAL PROBE
FDA 510(k)
FDA Class 1
·Orthopedic
EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)
FDA 510(k)
FDA Class 2
·Cardiovascular
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·June 13, 2014
LEFT HIP NECK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 28, 2012
TENDRIL ST
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020