8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Biograph Vision.X and Biograph Vision.X Edge
FDA 510(k)
FDA Class 2
·Radiology
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981293581·No-Profile Interbody, 39mm x 30mm x 18mm, 33 Deg
CENTURION POCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·September 1, 2011
ZENITH AAA ENDOVASCULAR GRAFT GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 12, 2013
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024