FDA.reportPublic FDA data

Embolization particle, non-bioabsorbable

Definition
A sterile, 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
150
Last updated
2020-05-27 17:04:37

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00812636020662HydroPearlMicrovention, Inc.8HP2S11002020-05-14
10884450403058Embosphere®BIOSPHERE MEDICAL008844504030512019-12-02
10884450402945Embosphere®BIOSPHERE MEDICAL008844504029482019-10-31
10884450403133Embosphere®BIOSPHERE MEDICAL008844504031362019-09-10
10884450403423Embosphere®BIOSPHERE MEDICAL008844504034262019-06-17
10884450403454Embosphere®BIOSPHERE MEDICAL008844504034572019-04-09
10884450403553Embosphere®BIOSPHERE MEDICAL008844504035562019-04-03
10884450403867Embosphere®BIOSPHERE MEDICAL008844504038602019-04-03
10884450403928Embosphere®BIOSPHERE MEDICAL008844504039212019-04-03
10884450403409Embosphere®BIOSPHERE MEDICAL008844504034022019-03-29
10884450403430Embosphere®BIOSPHERE MEDICAL008844504034332019-03-29
10884450403157Embosphere®BIOSPHERE MEDICAL008844504031502019-03-25
10884450403201Embosphere®BIOSPHERE MEDICAL008844504032042019-03-25
05060116920055Bead Block 100-300BOSTON SCIENTIFIC CORPORATIONEB2S1032015-10-05
05060116920062Bead Block 300-500BOSTON SCIENTIFIC CORPORATIONEB2S3052015-10-05
05060116920079Bead Block 500-700BOSTON SCIENTIFIC CORPORATIONEB2S5072015-10-05
05060116920086Bead Block 700-900BOSTON SCIENTIFIC CORPORATIONEB2S7092015-10-05
05060116920093Bead Block 900-1200BOSTON SCIENTIFIC CORPORATIONEB2S9122015-10-05
05060116920185LC Bead 100-300BOSTON SCIENTIFIC CORPORATIONVE220GS2015-10-05
05060116920192LC Bead 300-500BOSTON SCIENTIFIC CORPORATIONVE420GS2015-10-05
05060116920208LC Bead 500-700BIOCOMPATIBLES UK LTDVE620GS2015-10-05
05060116920222LC Bead M1 70-150BOSTON SCIENTIFIC CORPORATIONVE020GS2015-10-05
05060116921151LC Bead LUMI 70 - 150BOSTON SCIENTIFIC CORPORATIONRO2L0012016-08-11
05060116921168LC Bead LUMI 100 - 300BIOCOMPATIBLES UK LTDRO2L1032016-08-11
05060116921205LC Bead LUMI 300 - 500BIOCOMPATIBLES UK LTDRO2L3052016-08-11
05060116921229LC Bead LUMI 40 - 90BOSTON SCIENTIFIC CORPORATIONRO2L0002017-03-21
00879397000074Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.111010-S12015-07-15
00879397000081Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.111020-S12015-07-15
00879397000098Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.113010-S12015-07-15
00879397000104Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.113020-S12015-07-15
00879397000111Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.10410-S12015-07-15
00879397000128Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.10420-S12015-07-15
00879397000135Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.10710-S12015-07-15
00879397000142Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.10720-S12015-07-15
00879397000241ONCOZENE Microspheres CELONOVA BIOSCIENCES, INC.10420-US12015-07-15
00879397000258ONCOZENE MicrospheresCELONOVA BIOSCIENCES, INC.10430-US12015-07-15
00879397000265ONCOZENE Microspheres CELONOVA BIOSCIENCES, INC.10720-US12015-07-15
00879397000272ONCOZENE Microspheres CELONOVA BIOSCIENCES, INC.10730-US12015-07-15
00879397000289ONCOZENE MicrospheresCELONOVA BIOSCIENCES, INC.11020-US12015-07-15
00879397000296ONCOZENE MicrospheresCELONOVA BIOSCIENCES, INC.11030-US12015-07-15
00879397001118Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.11010-S12015-07-15
00879397001125Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.11020-S12015-07-15
00879397002115Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.12010-S12015-07-15
00879397002122Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.12020-S12015-07-15
00879397003228Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.10410-S02015-07-15
00879397003235Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.10420-S02015-07-15
00879397003242Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.10710-S02015-07-15
00879397003259Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.10720-S02015-07-15
00879397003266Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.11010-S02015-07-15
00879397003273Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.11020-S02015-07-15
00879397003280Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.12010-S02015-07-15
00879397003297Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.12020-S02015-07-15
00879397003303Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.14010-S02015-07-15
00879397003310Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.14020-S02015-07-15
00879397003327Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.15010-S02015-07-15
00879397003334Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.15020-S02015-07-15
00879397003341Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.17010-S02015-07-15
00879397003358Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.17020-S02015-07-15
00879397003365Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.19010-S02015-07-15
00879397003372Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.19020-S02015-07-15
00879397003389Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.111010-S02015-07-15
00879397003396Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.111020-S02015-07-15
00879397003402Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.113010-S02015-07-15
00879397003419Embozene Microspheres (Opaque)CELONOVA BIOSCIENCES, INC.113020-S02015-07-15
00879397004119Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.14010-S12015-07-15
00879397004126Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.14020-S12015-07-15
00879397005116Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.15010-S12015-07-15
00879397005123Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.15020-S12015-07-15
00879397007110Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.17010-S12015-07-15
00879397007127Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.17020-S12015-07-15
00879397009114Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.19010-S12015-07-15
00879397009121Embozene Microspheres (Color-Advanced)CELONOVA BIOSCIENCES, INC.19020-S12015-07-15
10884450089221Embosphere®BIOSPHERE MEDICAL008844500892242015-10-30
10884450089238Embosphere®BIOSPHERE MEDICAL008844500892312016-09-24
10884450089245Embosphere®BIOSPHERE MEDICAL008844500892482015-10-30
10884450089252Embosphere®BIOSPHERE MEDICAL008844500892552016-09-24
10884450089269Embosphere®BIOSPHERE MEDICAL008844500892622015-10-31
10884450089276Embosphere®BIOSPHERE MEDICAL008844500892792016-09-24
10884450089283Embosphere®BIOSPHERE MEDICAL008844500892862015-10-31
10884450089290Embosphere®BIOSPHERE MEDICAL008844500892932016-09-20