7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCOTTS TAP WATER SUBSTITUTE
FDA 510(k)
FDA Class 1
·Pathology
EndoTool SubQ
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·November 21, 2012
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·March 13, 2014
SPECTRA
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·September 20, 2010
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024