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

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Arthrex iBalance TKA System

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (Cocaine)

FDA UDI
Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161121522520·Bridgeback Acetabular Reamer, Size 52mm

Acetabular Reamers

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215039066·

CONTRAST MEDIA TRANSFER SETS

FDA 510(k)
FDA Class 2 ·General Hospital

DMP PIT & FISSURE SEALANT

FDA 510(k)
FDA Class 2 ·Dental

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·June 20, 2017

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·August 1, 2017

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

BD NEXIVA

FDA Adverse Event
Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 13, 2024

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

VIRTUOSO DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 23, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·October 21, 2024

840 VENTILATOR

FDA Adverse Event
Injury ·COVIDIEN·Product code CBK·June 26, 2017

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 29, 2024

COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·March 28, 2024

COOK CVC SINGLE LUMEN CENTRAL VENOUS CATHETER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FOZ·December 28, 2023