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

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ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

BIO-RAD PLATELIA TOXO IGM TMB

FDA 510(k)
FDA Class 2 ·Microbiology

FLEXIVIEW 8800 DIGITAL MOBILE IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015

FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015

ZOLL IVTM QUATTRO CATHETER

FDA Adverse Event
Death ·ZOLL CIRCULATION, INC.·Product code NCX·April 27, 2013

RECLAIM DIST REAMER EXTENSION

FDA Adverse Event
Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code LXH·September 16, 2014

ASR ACETABULAR CUPS 60

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 12, 2011

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

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

BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·September 19, 2019

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