8 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BLUE PLASTIC EYE SHIELD
FDA 510(k)
FDA Class 1
·Ophthalmic
UniTip Catheter
FDA UDI
Unisensor AG·07640172973776·
NEIA-FERRITIN ENZYMEIMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
STERILE DRESSING PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FREESTYLE HANDS-FREE BREASTPUMP
FDA Adverse Event
Other
·MEDELA, INC·Product code HGX·October 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 30, 2014
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·Product code NIQ·December 19, 2012
Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025