7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
RESPIRONICS SLEEPEASY NASAL CPAP SYS
FDA 510(k)
FDA Class 2
·Anesthesiology
MODEL JY PACEMAKER LEAD - VARIOUS
FDA 510(k)
FDA Class 3
·Cardiovascular
Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
FDA 510(k)
FDA Class 2
·Neurology
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·June 2, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·November 23, 2012
PHILLIPS
FDA Adverse Event
Injury
·PHILLIPS HEALTHCARE·Product code HGM·September 20, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024