7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HDL PRECIPATATING REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
F88 URE-SD/RD Flexible Ureteroscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODEL RZ PACEMAKER LEAD VARIOUS
FDA 510(k)
FDA Class 3
·Cardiovascular
LARGE NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 2, 2014
HEARTSTART MRX -EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 24, 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