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

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SHIELD KYPHOPLASTY SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOLOY

FDA 510(k)
FDA Class 2 ·Dental

TOCO LITE, MODEL TD-01

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

RAD-57 PULSE CO-OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·July 26, 2023

LEGION CR

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code JWH·May 6, 2013

LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·September 16, 2014

FLOSEAL HEMOSTATIC MATRIX

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - HAYWARD·Product code LMF·May 18, 2011

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

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

ESHEATH INTRODUCER SHEATH

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

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 18, 2020

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2020

EDWARDS TRANSCATHETER TF SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 20, 2018

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 25, 2020

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2020

UNKNOWN EDWARDS LIFESCIENCES SHEATH

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

EDWARDS TRANSCATHETER ESHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPU·November 20, 2018

EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

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

UNKNOWN EDWARDS SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 15, 2019

UNKNOWN EDWARDS SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 21, 2019

UNKNOWN EDWARDS SHEATH

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 15, 2019