10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
AccelFix Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
QUART ARTERIAL FILTER WITH BIOLINE COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY
FDA 510(k)
FDA Class 2
·General Hospital
H 105700#TUBING SET
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015
HQV 32902#INTEGRATED ADULT PACK
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015
SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS
FDA Adverse Event
Injury
·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019
SYNCHRON LXI 725 SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 28, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013
SERVO VENTILATOR 300
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·July 21, 2008
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017