8 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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N-IMMUNOGLOBULIN LIGHT CHAIN KIT
FDA 510(k)
FDA Class 2
·Immunology
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515225824·Heidbrink Elevator #1 Straight
ENDODRAPE(TM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FUJIFILM 600 Series Endoscope EG-600WR v2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EVEREST BICOAG MACRO JAW FORCEPS 5MM X 45 CM
FDA Adverse Event
Malfunction
·GYRUS/ACMI·Product code GEI·June 13, 2014
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC.·Product code GEI·October 20, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025