7 results
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17ms
·
Sources: EU EUDAMED, US FDA
DERMGARD SYSTEM 800 AND 900
FDA 510(k)
FDA Class 2
·Physical Medicine
STIKSEP-T3 KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HemosIL Factor XII Deficient Plasma
FDA 510(k)
FDA Class 2
·Hematology
PUMP IN STYLE ADVANCED BREASTPUMP SHOULDER BAG
FDA Adverse Event
Other
·MEDELA, INC.·Product code HGX·October 13, 2010
ATLAS PLUS HF
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC. CRMD·Product code NIK·January 13, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·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