7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SPUNCRIT
FDA 510(k)
FDA Class 2
·Hematology
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
FDA 510(k)
FDA Class 2
·Neurology
MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·January 22, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 23, 2010
ACCENT SR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 10, 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