8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MODEL PV2000 VASCULAR MICROLABORATORY
FDA 510(k)
FDA Class 2
·Cardiovascular
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123175·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 150mm
Biograph mCT and mCT Flow PET/CT Scanners
FDA 510(k)
FDA Class 2
·Radiology
NORWOOD ABBEY CENTURION SES EPIKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·January 6, 2011
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·July 22, 2014
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024