29 results · 22ms · Sources: EU EUDAMED, US FDA

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AUTOMATED CORE BIOPSY DEVICE

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

Zirlux

FDA UDI
HENRY SCHEIN, INC.·00304040023549·ZIRLUX ACETAL MILLING DISC

Sigma

FDA UDI
ALPHATEC SPINE, INC.·00190376483467·FIXED BLADE ARM, 7.0", SIGMA ALIF

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 16, 2025

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 13, 2025

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0112000·Inserter, Universal Inline Fixed

Navagio

FDA UDI
Kalitec Direct LLC·B07330K0112100·Draw Rod, Universal Inline Fixed Inserter

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252161·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252178·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252185·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252123·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252109·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252116·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252154·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252130·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033251980·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252147·

SOFIA VERGARA

FDA UDI
FGX INTERNATIONAL INC.·00193033252192·

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·September 8, 2025

QUICK SET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 10, 2025