8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
FDA 510(k)
FDA Class 2
·Cardiovascular
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
FDA 510(k)
FDA Class 2
·Cardiovascular
KY-M280U SURGICAL CAMERA
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CONSULTA CRT-D
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014
CONSULTA
FDA Adverse Event
Malfunction
·MEDTRONIC S.A.·Product code NIK·October 12, 2010
PULSE-GENERATOR, PACEMAKER, EXTERNAL
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code DTE·December 10, 2012
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020