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

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SYNERMED PHOSPHORUS REAGENT KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MODIFICATION TO: INJECTABLE MIMIX

FDA 510(k)
FDA Class 2 ·Neurology

Diode Laser Therapy System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

FDA Adverse Event
Injury ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017

BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 13, 2013

HOMECHOICE CYCLER-REFURBISHED

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·December 2, 2010

INGENIO

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·April 26, 2018

BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

FDA Adverse Event
Injury ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024

BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

FDA Adverse Event
Malfunction ·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI, INC.·Product code EGS·May 12, 2015

NSK

FDA Adverse Event
Malfunction ·NAKANISHI INC.·Product code EGS·October 9, 2025

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·December 19, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·March 1, 2018

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·January 15, 2018

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·June 6, 2018

DA-800C5L

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·May 2, 2016

NSK

FDA Adverse Event
Injury ·NAKANISHI INC.·Product code EGS·April 26, 2018