FDA.reportPublic FDA data

Embolization particle, non-bioabsorbable

Definition
A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
GUDID devices
214
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850042341049Easi-Vue embolic microspheres SystemABK Biomedical IncorporatedRefill Syringe 50 micron2022-10-24
00850042341056Easi-Vue embolic microspheres SystemABK Biomedical IncorporatedRefill Syringe 100 micron2022-10-24
00850042341063Easi-Vue embolic microspheres SystemABK Biomedical IncorporatedRefill Syringe 150 micron2022-10-24
00850042341094Easi-Vue embolic microspheres SystemABK Biomedical IncorporatedEVD1002024-03-12
00850042341100Easi-Vue embolic microspheres SystemABK Biomedical IncorporatedEVD1502024-03-12
00884450089224Embosphere®BIOSPHERE MEDICAL008844500892242015-10-30
00884450089231Embosphere®BIOSPHERE MEDICAL008844500892312016-09-24
00884450089248Embosphere®BIOSPHERE MEDICAL008844500892482015-10-30
00884450089255Embosphere®BIOSPHERE MEDICAL008844500892552016-09-24
00884450089262Embosphere®BIOSPHERE MEDICAL008844500892622015-10-31
00884450089279Embosphere®BIOSPHERE MEDICAL008844500892792016-09-24
00884450089286Embosphere®BIOSPHERE MEDICAL008844500892862015-10-31
00884450089293Embosphere®BIOSPHERE MEDICAL008844500892932016-09-20
00884450089309Embosphere®BIOSPHERE MEDICAL008844500893092015-10-30
00884450089316Embosphere®BIOSPHERE MEDICAL008844500893162015-10-30
00884450089323Embosphere®BIOSPHERE MEDICAL008844500893232015-10-30
00884450089330Embosphere®BIOSPHERE MEDICAL008844500893302016-09-24
00884450096147EmboGold®BIOSPHERE MEDICAL008844500961472016-09-24
00884450097021EmboGold®BIOSPHERE MEDICAL008844500970212015-10-31
00884450098424Embosphere®BIOSPHERE MEDICAL008844500984242015-10-30
00884450098561Embosphere®BIOSPHERE MEDICAL008844500985612015-10-30
00884450100516EmboGold®BIOSPHERE MEDICAL008844501005162015-10-31
00884450103395EmboGold®BIOSPHERE MEDICAL008844501033952015-10-30
00884450104750Embosphere®BIOSPHERE MEDICAL008844501047502015-10-31
00884450106051Embosphere®BIOSPHERE MEDICAL008844501060512015-10-30
00884450106099QuadraSphere®BIOSPHERE MEDICAL008844501060992015-10-31
00884450106419EmboGold®BIOSPHERE MEDICAL008844501064192015-10-31
00884450109519Embosphere®BIOSPHERE MEDICAL008844501095192015-10-31
00884450109854Embosphere®BIOSPHERE MEDICAL008844501098542015-10-30
00884450110294EmboGold®BIOSPHERE MEDICAL008844501102942015-10-31
00884450110621Embosphere®BIOSPHERE MEDICAL008844501106212015-10-31
00884450112854EmboGold®BIOSPHERE MEDICAL008844501128542015-10-30
00884450113875QuadraSphere®BIOSPHERE MEDICAL008844501138752015-10-30
00884450114223Embosphere®BIOSPHERE MEDICAL008844501142232015-10-31
00884450115169Embosphere®BIOSPHERE MEDICAL008844501151692015-10-30
00884450116296Embosphere®BIOSPHERE MEDICAL008844501162962015-10-30
00884450116715Embosphere®BIOSPHERE MEDICAL008844501167152015-10-31
00884450118191EmboGold®BIOSPHERE MEDICAL008844501181912015-10-31
00884450118467QuadraSphere®BIOSPHERE MEDICAL008844501184672015-10-31
00884450118566EmboGold®BIOSPHERE MEDICAL008844501185662015-10-30
00884450118948QuadraSphere®BIOSPHERE MEDICAL008844501189482015-10-30
00884450119761EmboGold®BIOSPHERE MEDICAL008844501197612015-10-30
00884450122396EmboGold®BIOSPHERE MEDICAL008844501223962015-10-30
00884450123317Bearing nsPVA®Merit Medical Systems, Inc.008844501233172015-10-31
00884450123324Bearing nsPVA®Merit Medical Systems, Inc.008844501233242015-10-31
00884450123331Bearing nsPVA®Merit Medical Systems, Inc.008844501233312015-10-30
00884450123348Bearing nsPVA®Merit Medical Systems, Inc.008844501233482015-10-31
00884450123355Bearing nsPVA®Merit Medical Systems, Inc.008844501233552015-10-30
00884450123362Bearing nsPVA®Merit Medical Systems, Inc.008844501233622015-10-31
00884450123379Bearing nsPVA®Merit Medical Systems, Inc.008844501233792015-10-30
00884450275160QuadraSphere®BIOSPHERE MEDICAL008844502751602016-04-13
00884450275177QuadraSphere®BIOSPHERE MEDICAL008844502751772016-08-22
00884450275184QuadraSphere®BIOSPHERE MEDICAL008844502751842016-09-24
00884450275191QuadraSphere®BIOSPHERE MEDICAL008844502751912016-09-24
00884450299432Embosphere®BIOSPHERE MEDICAL008844502994322022-09-20
00884450299449Embosphere Pro™BIOSPHERE MEDICAL008844502994492017-10-16
00884450299494QuadraSphere Q2™BIOSPHERE MEDICAL008844502994942017-12-18
00884450402948Embosphere®BIOSPHERE MEDICAL008844504029482019-10-31
00884450403051Embosphere®BIOSPHERE MEDICAL008844504030512019-12-02
00884450403136Embosphere®BIOSPHERE MEDICAL008844504031362019-09-10
00884450403150Embosphere®BIOSPHERE MEDICAL008844504031502019-03-25
00884450403174Embosphere®BIOSPHERE MEDICAL008844504031742019-03-13
00884450403204Embosphere®BIOSPHERE MEDICAL008844504032042019-03-25
00884450403402Embosphere®BIOSPHERE MEDICAL008844504034022019-03-29
00884450403426Embosphere®BIOSPHERE MEDICAL008844504034262019-06-17
00884450403433Embosphere®BIOSPHERE MEDICAL008844504034332019-03-29
00884450403440Embosphere®BIOSPHERE MEDICAL008844504034402019-03-08
00884450403457Embosphere®BIOSPHERE MEDICAL008844504034572019-04-09
00884450403464Embosphere®BIOSPHERE MEDICAL008844504034642019-03-08
00884450403556Embosphere®BIOSPHERE MEDICAL008844504035562019-04-03
00884450403716Embosphere®BIOSPHERE MEDICAL008844504037162022-10-01
00884450403730Embosphere®BIOSPHERE MEDICAL008844504037302019-02-28
00884450403822Embosphere®BIOSPHERE MEDICAL008844504038222022-10-01
00884450403860Embosphere®BIOSPHERE MEDICAL008844504038602019-04-03
00884450403921Embosphere®BIOSPHERE MEDICAL008844504039212019-04-03
08714729743958Contour™BOSTON SCIENTIFIC CORPORATIONM00176001202015-09-24
08714729743965Contour™BOSTON SCIENTIFIC CORPORATIONM00176001502015-09-24
08714729743972Contour™BOSTON SCIENTIFIC CORPORATIONM00176002202015-09-24
08714729743989Contour™BOSTON SCIENTIFIC CORPORATIONM00176002502015-09-24
08714729743996Contour™BOSTON SCIENTIFIC CORPORATIONM00176003202015-09-24