8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
FDA 510(k)
FDA Class 2
·Orthopedic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756389556·TOTAL JOINT PACK
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FOLFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·January 11, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 23, 2010
CURRENT VR RF
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 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