11 results
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19ms
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Sources: EU EUDAMED, US FDA
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE
FDA 510(k)
FDA Class 2
·General Hospital
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209108558·KIT, M-FAK - CUSTOM
Rochester
FDA UDI
Advantage Medical Electronics, LLC·00849593025324·DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 23 GA, 7...
300 Series Facebow
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746150753·FACEBOW LOOP STYLE SHORT OUTER BOW 045 SIZE 5 1...
Megasystem C
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575383511·Stem Components,Push-through, for total femur r...
AMPCO SKIN SCRUB TRAY
FDA 510(k)
FDA Class 1
·General Hospital
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
FDA 510(k)
FDA Class 2
·Physical Medicine
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
SPINBRUSH REPLACEMENT HEADS
FDA Adverse Event
Malfunction
·CHURCH & DWIGHT CO., INC.·Product code JEQ·November 13, 2012
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·September 29, 2010
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