17 results · 31ms · Sources: EU EUDAMED, US FDA

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EchoSure Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

BD SAFETY-LOK

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·December 3, 2024

REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

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

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·October 6, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·March 13, 2026

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·January 13, 2026

BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·December 12, 2019

6600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 21, 2014

LIFEVEST WCD 3100 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORP·Product code MVK·June 29, 2011

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025

REZUM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 18, 2025