8 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Indigo Aspiration System - Lightning Flash
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALIX ADVANCE
FDA UDI
Medos International Sàrl·10886705027781·HEALIX ADVANCE ANCHOR OPEN HARD BONE KIT Open I...
Protective Face Mask for Medical Use
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVEON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2014
INTELLIFILL I.V.
FDA Adverse Event
Other
·BAZA SYSTEMS DEVELOPMENT CENTER·Product code NEP·August 18, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 12, 2013
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021