7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTIMAX
FDA 510(k)
FDA Class 1
·General Hospital
VISION DIAGNOSTIC ULTRASONIC SCANNER
FDA 510(k)
FDA Class 2
·Radiology
HEMOGLOBIN ANALYZER
FDA 510(k)
FDA Class 2
·Hematology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·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