11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Barrx SB RFA Endoscopic Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
FDA 510(k)
FDA Class 2
·Cardiovascular
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
FDA 510(k)
FDA Class 2
·Orthopedic
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·August 22, 2011
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 26, 2019
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014
TWINFIX FT HA RC 4.5
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY MANSFIELD MANUFACTURE·Product code MAI·July 23, 2011
AMPLATZER SEPTAL OCCLUDER
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code MLV·June 17, 2013
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
LUCAS 3 CHEST COMPRESSION SYSTEM
FDA Adverse Event
Death
·JOLIFE AB - 3005445717·Product code DRM·February 6, 2024
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018