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

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STRYKER ARTHROSCOPE

FDA 510(k)
FDA Class 2 ·Orthopedic

ABX PENTRA 60C+ HEMATOLOGY ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM

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

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 6, 2013

DAILY ACTIVITY ASSIST DEVICES

FDA Adverse Event
UNKNOWN·Product code IKX·September 16, 2014

ACRYSOF RESTOR

FDA Adverse Event
Other ·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·April 20, 2011

UNKNOWN EDWARDS TRANSFEMORAL SHEATH

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

Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.

FDA Enforcement
Class I ·Terminated·Stryker Spine·August 28, 2013

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