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

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AI4CMR v1.0

FDA 510(k)
FDA Class 2 ·Radiology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772412501·PROTECT.LUMBOSTYLE BACK SUPPORT BLACK IV

VariAx

FDA UDI
Stryker GmbH·37613153067772·LOCKING PEGS

VEO® Lateral Interbody Fusion System

FDA UDI
Choice Spine, LP·00840996134675·LATERAL,7 IN BAYONETED ANG

BREAST BOLSTER

FDA 510(k)
FDA Class 2 ·Radiology

ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)

FDA 510(k)
FDA Class 2 ·Cardiovascular

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code DYB·April 11, 2025

INTROCAN SAFETY®

FDA Adverse Event
Malfunction ·B BRAUN MELSUNGEN AG·Product code FOZ·April 8, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·August 20, 2025

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 31, 2008

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 15, 2011

IMPAX CV REPORTING

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·July 8, 2013

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·November 28, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·April 7, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·November 26, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·March 20, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·July 12, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·April 29, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·April 15, 2025

OMNIPOD 5 PODS

FDA Adverse Event
Malfunction ·INSULET CORPORATION·Product code QFG·May 13, 2025