23 results · 42ms · Sources: EU EUDAMED, US FDA

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syngo.CT Lung CAD

FDA 510(k)
FDA Class 2 ·Radiology

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)

Edwards eSheath Introducer Set

FDA 510(k)
FDA Class 2 ·Cardiovascular

MS-ONE, MODEL MS-1

FDA 510(k)
FDA Class 2 ·Neurology

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 30, 2025

STERRAD 100NX STERILIZER

FDA Adverse Event
Malfunction ·JABIL·Product code MLR·October 17, 2008

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

OT ULTRALINK METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 2, 2013

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

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021