14 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Injection Screw
FDA 510(k)
FDA Class 2
·Orthopedic
The MetaNeb® System
FDA UDI
HILL-ROM SERVICES PTE. LTD.·00887761997127·
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
FDA 510(k)
FDA Class 2
·Dental
MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
FDA 510(k)
FDA Class 2
·Orthopedic
FUJIFILM BALLOON BS-4
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDA·January 14, 2021
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 15, 2014
ADVANTA 2 BED
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FNL·June 6, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·July 23, 2011
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code KRA·April 18, 2025
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
TRUWAVE, VAMP
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·March 20, 2025
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