7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT HE4 REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code OIU·February 6, 2026
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
DIACLEAR ULTRAFILTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEPUY ASR FEM IMPLANT SZ 43
FDA Adverse Event
Injury
·Product code KXA·May 6, 2013
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·September 16, 2014
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 16, 2011