13 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Treace Medical Systems (TMC) Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257128152·30-40 MV FOR MEN SEL EW CLF STD TAN III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257129890·30-40 MV FOR MEN CLSC EW STD TAN III
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·November 21, 2001
PEDIATRIC AORTIC ROOT CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
Stone Retrieval Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·September 12, 2018
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
OPTISENSE
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
ACCU-CHEK ® SMARTVIEW TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2013
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·January 23, 2012
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·April 17, 2013