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

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VIVIX-S 1417N

FDA 510(k)
FDA Class 2 ·Radiology

BIOMET HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304256811·

Biomet® Hip System

FDA UDI
Biomet Orthopedics, LLC·00887868310812·

Sklar

FDA UDI
SKLAR CORPORATION·10649111402159·SIMS TC UTER SCISS 9 INCHES CV BL/BL

REGUIS SIGMA

FDA 510(k)
FDA Class 2 ·Radiology

CITRIC ACID 20% SOLUTION, MODEL 329

FDA 510(k)
FDA Unclassified ·Unknown

DIREXION? HI-FLO?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 11, 2025

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QKP·January 19, 2022

BINAXNOW COVID-19 SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 27, 2021

DIREXION HI-FLO FATHOM-16 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 13, 2025

DIREXION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·August 19, 2025

DIREXION? TRANSEND?-14 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·January 26, 2026

DIREXION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 2, 2025

DIREXION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 16, 2025

DIREXION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 21, 2025

DIREXION? HI-FLO?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 24, 2026

DIREXION? TRANSEND?-14 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 10, 2025

DIREXION? HI-FLO? FATHOM?-16 SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·April 23, 2025

DIREXION TRANSEND-14 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 31, 2025

DIREXION? FATHOM?-16 SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·July 8, 2025