15 results · 19ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Orthopedic

SOFTVIEW, MODEL 2.01

FDA 510(k)
FDA Class 2 ·Radiology

SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004

FDA 510(k)
FDA Class 2 ·General Hospital

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·May 12, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 15, 2025

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 29, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 17, 2026

ULTRA 2 MONORAIL CUTTING BALLOON

FDA Adverse Event
Injury ·BSC LETTERKENNY·Product code LIT·October 2, 2008

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 18, 2013

ADVIA CENTAUR XP HBSAG ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LOM·August 4, 2011

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·January 30, 2026

INTELLAMAP ORION?

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·April 1, 2026

INTELLAMAP ORION

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·November 21, 2024

INTELLAMAP ORION?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·February 26, 2026

INTELLAMAP ORION

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DRF·December 12, 2024