36 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DRX 2000
FDA 510(k)
FDA Class 2
·Physical Medicine
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890102920·Zirlux Bite Ver Cyl NEng
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743489·LEVAMED ANKLE SUPPORT SILVER II
TraumaOne SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036275242·
TRAUMAONE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036182465·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023956·PADDLE SPREADER, 12MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102120·Shaver, Open 12mm
MINIMED QUICK SET INFUSION SET (SC1)
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 30, 2025
BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY
FDA 510(k)
FDA Class 2
·Radiology
XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
CADD
FDA UDI
ICU MEDICAL, INC.·10610586042669·
TRAXIS
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code MQP·November 30, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWQ·November 29, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWQ·November 29, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWQ·November 29, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code MQP·December 22, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code MQP·December 22, 2005
TRAXIS VUE
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code KWQ·March 8, 2006
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 25, 2025
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 6, 2025