30 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MENTOR STERILE SALINE MAMMARY VOLUME SIZERS
FDA 510(k)
FDA Unclassified
·Unknown
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890107090·Zirlux Multi-Unit Abutment 2.5 mmH compatible w...
EsCom 100 B1 Syringe
FDA UDI
Spident Co., Ltd.·08809262955262·
Single Use Biliary Stent V
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170185779·Single Use Biliary Stent V
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100090·Dilator Sleeve, Screwdriver
INSET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 3, 2025
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
FDA 510(k)
FDA Class 2
·Orthopedic
KOKO PEAK KP; KOKO PEAK KP+
FDA 510(k)
FDA Class 2
·Anesthesiology
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025
INSET I
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 4, 2025
BD INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·April 10, 2024
INSYTE AUTOGUARD IV CATHETER, 20G
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2024
INSYTE AUTOGUARD IV CATHETER, 18G
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2024
INSYTE AUTOGUARD IV CATHETER, 22G
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2024
INSYTE AUTOGUARD IV CATHETER, 20G
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 30, 2024
BIPAP SYNCHRONY ST
FDA Adverse Event
Death
·RESPIRONICS INC·Product code MNS·November 21, 2008
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 26, 2025
INSYTE AUTOGUARD IV CATHETER, 20G
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 15, 2024