30 results · 23ms · Sources: EU EUDAMED, 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