8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ISO-GARD MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
Z-SERIES MODULAR TOTAL HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC·Product code KWP·December 18, 2014
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·July 22, 2015
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·December 1, 2010
TURON SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·July 14, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024