9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARGYLE SALEM SUMP TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ORTHOSOURCE
FDA UDI
ORTHOSOURCE·D9118101560·Unilateral Expansion 5mm
AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER,
FDA 510(k)
FDA Class 2
·Cardiovascular
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
THE M-COR MODULAR HIP SYSTEMS
FDA Adverse Event
Malfunction
·MIPRO US, INC·Product code LPH·January 23, 2015
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 25, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·October 12, 2007
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code NVZ·October 31, 2012
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