7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Premia Spine XL Instruments
FDA 510(k)
FDA Class 2
·Neurology
ADVIA CHEMISTRY GLUCOSE HEXOKINASE_3 (GLUH_3) REAGENT, MODELS REF 05001429
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BIS CLICK SENSOR/CABLE
FDA 510(k)
FDA Class 2
·Neurology
ACCENT DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVAMEX·Product code FSA·June 26, 2013
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·July 29, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024