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