18 results · 27ms · Sources: EU EUDAMED, US FDA

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Mini Sterilizable Tray

FDA 510(k)
FDA Class 2 ·General Hospital

NXSTAGE THERAPY SYSTEM

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

WEHRS INCUS-STAPES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

EDWARDS ESHEATH+ INTRODUCER SET

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·April 28, 2022

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·March 12, 2026

TF SHEATH UNKNOWN

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES·Product code DYB·July 18, 2023

UNKNOWN EDWARDS LIFESCIENCES SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 12, 2025

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES LLC·Product code NPT·December 5, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 29, 2025

COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

RIATA

FDA Adverse Event
ST. JUDE MEDICAL·Product code LWS·June 26, 2013

ON-Q PUMP

FDA Adverse Event
Injury ·I-FLOW CORP.·Product code MEB·August 8, 2011

ESHEATH INTRODUCER SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·December 17, 2021

UNKNOWN EDWARDS LIFESCIENCES SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYB·May 30, 2024

UNKNOWN EDWARDS INTRODUCER SHEATH SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023

EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022

UNKNOWN EDWARDS INTRODUCER SHEATH SET

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·June 21, 2023

EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 20, 2022