10 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ORTHOPHOS XG
FDA UDI
SIRONA Dental Systems GmbH·E27659638500·ORTHOPHOS XG 3D ready
N/A
FDA UDI
MEDTRONIC NAVIGATION, INC.·00763000055561·ACC 963-850 FIGHTER INSERT/REMOVAL TOOL
N/A
FDA UDI
MEDTRONIC NAVIGATION, INC.·00681490917025·ACC 963-850 FIGHTER INSERT/REMOVAL TOOL
PHILIPS 45 SERIES
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
DRESSING, FIRST AID, FIELD, VARIOUS SIZES
FDA 510(k)
FDA Unclassified
·Unknown
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·February 15, 2013
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code LOX·December 22, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014
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