8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIA-PACK TT3 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SeaSpine Spacer System - Redondo™
FDA UDI
Seaspine Orthopedics Corporation·10889981045296·Trial 30mm x 24mm x 19mm, Lordotic
APC FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
CLINICAL NEURO SYSTEMS CRANIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
APEX MONORAIL
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·December 22, 2010
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 30, 2013
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·July 15, 2014
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024