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MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Phonak

FDA UDI
Phonak AG·07613275086131·Phonak Naída Q70-UP (blue transparent)

INSET 30

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·October 30, 2025

INSET 30

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031764·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031689·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031672·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031719·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031726·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031733·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031665·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031702·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031658·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031696·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031740·

READERS.COM

FDA UDI
FGX INTERNATIONAL INC.·00192304031757·

SP5-1Ns Ultrasonic Probe(FDA)

FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415925918·

INSET 30

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025

INSET 30

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 17, 2025

SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924

FDA 510(k)
FDA Class 2 ·Cardiovascular