ClearanceBrief
Panels › Cardiovascular › Product code KRD · Class 2

Device, Vascular, For Promoting Embolization

Regulation 870.3300

8510(k)s in 12 months (133 all time)
1recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in KRD

Company510(k)sRecalls
MicroVention, Inc.188
Cook Incorporated135
Boston Scientific161
Biosphere Medical, Inc.100
Aga Medical Corp.41
Okami Medical50
Vascular Solutions, Inc.50
Biocompatibles UK , Ltd.40
Celonova Biosciences, Inc.40
Reverse Medical Corporation40
Decided510(k)Device and applicantCode
Oct 6, 2026K262798LOBO Vascular Occlusion System
Okami Medical, Inc.
KRD
Jul 31, 2026K252812UniPearls® Embolic Microspheres
Suzhou Haowei Medical Technology Co., Ltd., CN
KRD
Jul 24, 2026K261488OBSIDIO Conformable Embolic
Boston Scientific Corporation
KRD
Jun 24, 2026K261866Concerto Versa™ Detachable Coil
Medtronic, Inc.
KRD
Jun 12, 2026K260635HARBOR Occlusion Device
Nuvascular, Inc.
KRD
Apr 10, 2026K260508LOBO Vascular Occlusion System
Okami Medical, Inc.
KRD
Jan 14, 2026K253511Concerto Versa™ Detachable Coil
Medtronic, Inc.
KRD
Dec 15, 2025K253677Tembo Embolic System
Instylla, Inc.
KRD
Oct 30, 2025K253376OBSIDIO™ Conformable Embolic (M0013972101010)
Boston Scientific Corporation
KRD
Sep 23, 2025K250209Polyvinyl Alcohol Embolic Microspheres
Canyon Medical, Inc., CN
KRD
Jul 9, 2025K250133HARBOR Occlusion Device
Nuvascular, Inc.
KRD
May 30, 2025K251383Prestige Coil System (Prestige Packing Line Extension)
Balt USA, LLC
KRD
May 16, 2025K250971Embosphere Microspheres
Biosphere Medical, S.A., FR
KRD
May 15, 2025K250276Nitinol Enhanced Device (NED)
Embolization, Inc.
KRD
Mar 14, 2025K250079Ruby XL System
Penumbra, Inc.
KRD
Jan 17, 2025K242608Embozene Color-Advanced Microspheres
Varian Medical Systems, Inc.
KRD
Dec 16, 2024K240873TEMBO Embolic System
Instylla, Inc.
KRD
Oct 16, 2024K242794ONCOZENE Microspheres
Varian Medical Systems, Inc.
KRD
Oct 3, 2024K242507OBSIDIO™ Conformable Embolic
Boston Scientific
KRD
May 30, 2024K232934Sunsphere
Hangzhou Yangshun Medical Technology Co.,Ltd, CN
KRD
May 2, 2024K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)
Merit Medical Systems, Inc.
KRD
Feb 13, 2024K234123Easi-Vue® embolic microspheres System
Abk Biomedical, Inc., CA
KRD
Nov 14, 2023K231554UniPearls® Embolic Microspheres
Suzhou Haowei Medical Technology Co., Ltd., CN
KRD
Jun 27, 2023K230706EMBOLD™ Soft Detachable Coil System
Boston Scientific Corporation
KRD
Dec 21, 2022K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)
MicroVention, Inc.
KRD
Sep 7, 2022K220567Easi-Vue embolic microspheres System
Abk Biomedical, Inc., CA
KRD
Jul 1, 2022K213385GEM
Obsidio, Inc.
KRD
Apr 29, 2022K220383LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9)
Okami Medical
KRD
Apr 12, 2022K213398EMBOLD Fibered Detachable Coil System
Boston Scientific Corporation
KRD
Apr 8, 2022K220699Prestige Coil System
Bait USA, LLC
KRD
Mar 21, 2022K213200Solus Gold Embolization Device
Artio Medical, Inc.
KRD
Mar 1, 2022K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
Artventive Medical Group, Inc.
KRD
Dec 15, 2021K212817Merit Siege Vascular Plug
Merit Medical System, Inc.
KRD
Oct 1, 2021K210562HRSpheres Narrow-Size Embolic Microspheres
Suzhou Hengrui Hongyuan Medical Co., Ltd., CN
KRD
Feb 9, 2021K202850Concerto Versa, Detachable Coil
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
KRD
Nov 5, 2020K203025LOBO Vascular Occlusion System (model LOBO-5)
Okami Medical
KRD
Mar 20, 2020K191680AZUR Vascular Plug
MicroVention, Inc.
KRD
Feb 14, 2020K200083EMBA Hourglass Peripheral Embolization Device (PED)
Embolic Acceleration, LLC
KRD
Feb 4, 2020K191532The Caterpillar and Caterpillar Micro Arterial Embolization Devices
C.R. Bard, Inc., IE
KRD
Nov 21, 2019K192480Torpedo Gelatin Foam
Biosphere Medical, S.A., FR
KRD
Oct 30, 2019K192083Okami Medical LOBO Vascular Occlusion System
Okami Medical
KRD
Aug 6, 2019K183120EmboCube Embolization Gelatin
Biosphere Medical, S.A., FR
KRD
Jun 18, 2019K183578Torpedo Gelatin Foam
Biosphere Medical, S.A., FR
KRD
May 23, 2019K182390IMPEDE-FX Embolization Plug
Shape Memory Medical
KRD
Apr 17, 2019K182944Dr. Amplatz Micro Plug
Ka Medical, LLC
KRD
Sep 27, 2018K181021EmboCube Embolization Gelatin
Biosphere Medical, S.A., FR
KRD
Jul 16, 2018K181300Embosphere Microspheres
Biosphere Medical, S.A., FR
KRD
Jun 22, 2018K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
Shape Memory Medical
KRD
Jan 19, 2018K173891Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
Vascular Solutions, Inc.
KRD
Oct 25, 2017K171946Gel-Bead
Vascular Solutions, Inc.
KRD

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