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

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Arthrex Corkscrew FT

FDA 510(k)
FDA Class 2 ·Orthopedic

Dandy Clear Aligners

FDA UDI
Orthly, Inc.·00860006891206·

DEFLEX ACRILATO

FDA 510(k)
FDA Class 2 ·Dental

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

BD¿ SYRINGE LUER-LOK¿ CONVENIENCE TRAY

FDA Adverse Event
Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMF·April 24, 2018

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

ALTRUA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 24, 2011

FORTEC BARE HOLMIUM FIBERS

FDA Adverse Event
Malfunction ·TRIMEDYNE, INC.·Product code GEX·June 17, 2013

COOK® MULTI-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·May 10, 2019

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 21, 2020

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·August 19, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·October 15, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·December 10, 2019

COOK® SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Injury ·COOK INC·Product code GEX·November 4, 2022

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·March 3, 2020

COOK SINGLE-USE HOLMIUM LASER FIBER

FDA Adverse Event
Malfunction ·COOK INC·Product code GEX·February 13, 2020

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

FDA Enforcement
Class II ·Ongoing·Medtronic Inc.·November 29, 2017