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

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CPR LIFE MASK COMPACT BARRIER

FDA 510(k)
FDA Class 2 ·Anesthesiology

PANOSOL II UVA-218

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

KODAK EKTACHEM HDL CHOLESTEROL KIT

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

MAINFRAME 8253001 NIM RESPONSE 3.0

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code ETN·November 7, 2013

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·June 3, 2015

MAINFRAME 8253001 NIM RESPONSE 3.0

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code ETN·December 16, 2013

CARELINK

FDA Adverse Event
Malfunction ·RICE CREEK MFG·Product code DXY·February 11, 2013

MEDISENSE OPTIUM

FDA Adverse Event
Malfunction ·Product code NBW·January 10, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 24, 2014

NIM® 3.0 MAINFRAME

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code ETN·January 14, 2015

ENDOTRACH TUBE 8229507 CONTACT EMG 7MM

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ETN·January 7, 2014

NIM® EMG ELECTRODE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GXZ·January 27, 2017

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code ETN·July 1, 2016

NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code ETN·December 8, 2016

NIM® EMG ELECTRODE

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code GXZ·February 13, 2017

Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024