92 results · 26ms · Sources: EU EUDAMED, US FDA

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InFill Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161121522590·Bridgeback Acetabular Reamer, Size 59mm

Acetabular Reamers

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039134·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973677·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970034·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970492·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970485·

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172973004·

DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

DIREXION? HI-FLO?

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