8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
M.F.S. LOW AIR LOSS PULSATING BED
FDA 510(k)
FDA Class 2
·Physical Medicine
GYNECARE X-TRACT MORCELLATOR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code HET·June 8, 2006
IMPELLA CONTROLLER
FDA 510(k)
FDA Class 2
·Cardiovascular
AMES TDA ETHOSUXIMIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUADRA ASSURA DDQP+
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. (CRM-KISTA)·Product code NIK·July 7, 2015
DUROM ACETABULAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 12, 2014
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 9, 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