| UniPearls® Embolic Microspheres (K252812) | Suzhou Haowei Medical Technology Co., Ltd. | 2026-07-31 |
| OBSIDIO Conformable Embolic (K261488) | Boston Scientific Corporation | 2026-07-24 |
| Concerto Versa™ Detachable Coil (K261866) | Medtronic, Inc. | 2026-06-24 |
| HARBOR Occlusion Device (K260635) | Nuvascular, Inc. | 2026-06-12 |
| LOBO Vascular Occlusion System (K260508) | Okami Medical, Inc. | 2026-04-10 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| Tembo Embolic System (K253677) | Instylla, Inc. | 2025-12-15 |
| OBSIDIO™ Conformable Embolic (M0013972101010) (K253376) | Boston Scientific Corporation | 2025-10-30 |
| Polyvinyl Alcohol Embolic Microspheres (K250209) | Canyon Medical, Inc. | 2025-09-23 |
| HARBOR Occlusion Device (K250133) | Nuvascular, Inc. | 2025-07-09 |
| Prestige Coil System (Prestige Packing Line Extension) (K251383) | Balt USA, LLC | 2025-05-30 |
| Embosphere Microspheres (K250971) | Biosphere Medical, S.A. | 2025-05-16 |
| Nitinol Enhanced Device (NED) (K250276) | Embolization, Inc. | 2025-05-15 |
| Ruby XL System (K250079) | Penumbra, Inc. | 2025-03-14 |
| Embozene Color-Advanced Microspheres (K242608) | Varian Medical Systems, Inc. | 2025-01-17 |
| TEMBO Embolic System (K240873) | Instylla, Inc. | 2024-12-16 |
| ONCOZENE Microspheres (K242794) | Varian Medical Systems, Inc. | 2024-10-16 |
| OBSIDIO™ Conformable Embolic (K242507) | Boston Scientific | 2024-10-03 |
| Sunsphere (K232934) | Hangzhou Yangshun Medical Technology Co.,Ltd | 2024-05-30 |
| Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) (K240261) | Merit Medical Systems, Inc. | 2024-05-02 |
| Easi-Vue® embolic microspheres System (K234123) | Abk Biomedical, Inc. | 2024-02-13 |
| UniPearls® Embolic Microspheres (K231554) | Suzhou Haowei Medical Technology Co., Ltd. | 2023-11-14 |
| EMBOLD™ Soft Detachable Coil System (K230706) | Boston Scientific Corporation | 2023-06-27 |
| AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) (K223050) | MicroVention, Inc. | 2022-12-21 |
| Easi-Vue embolic microspheres System (K220567) | Abk Biomedical, Inc. | 2022-09-07 |
| GEM (K213385) | Obsidio, Inc. | 2022-07-01 |
| LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) (K220383) | Okami Medical | 2022-04-29 |
| EMBOLD Fibered Detachable Coil System (K213398) | Boston Scientific Corporation | 2022-04-12 |
| Prestige Coil System (K220699) | Bait USA, LLC | 2022-04-08 |
| Solus Gold Embolization Device (K213200) | Artio Medical, Inc. | 2022-03-21 |
| Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS (K212057) | Artventive Medical Group, Inc. | 2022-03-01 |
| Merit Siege Vascular Plug (K212817) | Merit Medical System, Inc. | 2021-12-15 |
| HRSpheres Narrow-Size Embolic Microspheres (K210562) | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2021-10-01 |
| Concerto Versa, Detachable Coil (K202850) | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 2021-02-09 |
| LOBO Vascular Occlusion System (model LOBO-5) (K203025) | Okami Medical | 2020-11-05 |
| AZUR Vascular Plug (K191680) | MicroVention, Inc. | 2020-03-20 |
| EMBA Hourglass Peripheral Embolization Device (PED) (K200083) | Embolic Acceleration, LLC | 2020-02-14 |
| The Caterpillar and Caterpillar Micro Arterial Embolization Devices (K191532) | C.R. Bard, Inc. | 2020-02-04 |
| Torpedo Gelatin Foam (K192480) | Biosphere Medical, S.A. | 2019-11-21 |
| Okami Medical LOBO Vascular Occlusion System (K192083) | Okami Medical | 2019-10-30 |
| EmboCube Embolization Gelatin (K183120) | Biosphere Medical, S.A. | 2019-08-06 |
| Torpedo Gelatin Foam (K183578) | Biosphere Medical, S.A. | 2019-06-18 |
| IMPEDE-FX Embolization Plug (K182390) | Shape Memory Medical | 2019-05-23 |
| Dr. Amplatz Micro Plug (K182944) | Ka Medical, LLC | 2019-04-17 |
| EmboCube Embolization Gelatin (K181021) | Biosphere Medical, S.A. | 2018-09-27 |
| Embosphere Microspheres (K181300) | Biosphere Medical, S.A. | 2018-07-16 |
| IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm (K181051) | Shape Memory Medical | 2018-06-22 |
| Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume (K173891) | Vascular Solutions, Inc. | 2018-01-19 |
| Gel-Bead (K171946) | Vascular Solutions, Inc. | 2017-10-25 |
| QuadraSphere Microspheres (K172372) | Biosphere Medical, S.A. | 2017-09-06 |
| EMBA Hourglass Peripheral Embolization Device (K171845) | Emba Medical Limited | 2017-08-18 |
| AZUR CX Detachable 18 Peripheral Coil System (K162524) | MicroVention, Inc. | 2017-03-03 |
| LC Bead LUMI (K162373) | Biocompatibles UK Limited | 2016-12-16 |
| Hilal Embolization MicroCoils (K160219) | Cook Incorporated | 2016-08-03 |
| Nester Embolization Coils, Tornado Embolization Coils (K153778) | Cook Incorporated | 2016-05-19 |
| Bead Block (K150876) | Biocompatibles UK , Ltd. | 2016-03-07 |
| HydroPearl Microspheres, HydroPearl Microspheres (K150870) | MicroVention, Inc. | 2015-12-21 |
| MReye Embolization Coils (K150931) | Cook Incorporated | 2015-12-18 |
| MReye Flipper Detachable Embolization Coil and Delivery System (K150964) | Cook Incorporated | 2015-12-18 |
| LC Bead LUMI (K152157) | Biocompatibles UK , Ltd. | 2015-12-11 |
| QuadraSphere Microspheres (K153102) | Biosphere Medical, S.A. | 2015-11-23 |
| Endoluminal Occlusion System-EOS (K150402) | Artventive Medical Group, Inc. | 2015-09-25 |
| AZUR CX Detachable 35 Coils (K151358) | MicroVention, Inc. | 2015-09-25 |
| LifePearl Microshperes (K150958) | MicroVention, Inc. | 2015-09-17 |
| QuadraSphere Microspheres (K151187) | Biosphere Medical, S.A. | 2015-07-27 |
| Retracta Detachable Embolization Coil (K151676) | Cook Incorporated | 2015-07-22 |
| Reverse Medical Micro Vascular Plug System (K150108) | Reverse Medical Corporation | 2015-04-22 |
| ENDOLUMINAL OCCLUSION SYSTEM (EOS) (K133924) | Artventive Medical Group, Inc. | 2014-12-03 |
| MEDUSA VASCULAR PLUG, (K140796) | Endoshape, Inc. | 2014-12-02 |
| Gel-Block 10X embolization pledgets (K143038) | Vascular Solutions, Inc. | 2014-11-20 |
| IDC INTERLOCKING DETACHABLE COIL (K141378) | Boston Scientific Corporation | 2014-10-08 |
| EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES (K141209) | Celonova Biosciences, Inc. | 2014-08-07 |
| REVERSE MEDICAL MICRO VASCULAR PLUG SYSTEM (K141313) | Reverse Medical Corporation | 2014-06-18 |
| GEL-BEAD EMBOLIZATION SPHERES (K133237) | Vascular Solutions, Inc. | 2014-04-25 |
| AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K133626) | MicroVention, Inc. | 2013-12-20 |
| REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K133282) | Reverse Medical Corporation | 2013-11-27 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K133208) | Boston Scientific Corp | 2013-11-14 |
| AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35 (K132083) | MicroVention, Inc. | 2013-10-28 |
| MEDUSA VASCULAR PLUG (K123696) | Endoshape, Inc. | 2013-10-25 |
| EMBOZENE MICROSPHERES (K132675) | Celonova Biosciences, Inc. | 2013-10-03 |
| INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM (K132578) | Boston Scientific Corp | 2013-09-13 |
| REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM (K123803) | Reverse Medical Corporation | 2013-07-02 |
| AZUR PUSHABLE 18 & 35 SYSTEM (K130577) | MicroVention, Inc. | 2013-06-17 |
| ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE (K130307) | Celonova Biosciences, Inc. | 2013-03-04 |
| RETRACTA DETACHABLE EMBOLIZATION COIL (K123712) | Cook Incorporated | 2013-01-03 |
| AZUR CX DETACHABLE 18 (K123384) | MicroVention, Inc. | 2012-11-28 |
| AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 (K122543) | MicroVention, Inc. | 2012-11-28 |
| AZUR DETACHABLE 35 (K122316) | MicroVention, Inc. | 2012-08-29 |
| AMPLATZER VASCULAR PLUG 4 (K113658) | Aga Medical Corp. | 2012-06-12 |
| GEL-BLOCK EMBOLIZATION PLEDGETS (K113266) | Vascular Solutions, Inc. | 2012-05-14 |
| INZONE DETACHMENT SYSTEM (K120816) | Stryker | 2012-04-17 |
| AZUR DETACHABLE 18 (K120630) | MicroVention, Inc. | 2012-03-28 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K113651) | Boston Scientific Corporation | 2012-01-11 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K112103) | Boston Scientific Corp | 2011-08-12 |
| AZUR DETACHABLE 35 PLATINUM COIL SYSTEM (K111307) | MicroVention, Inc. | 2011-06-15 |
| INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM (K110295) | Boston Scientific Corp | 2011-03-03 |
| INTERLOCK FIBERED IDC OCCLUSION SYSTEM (K102912) | Boston Scientific | 2011-03-03 |
| COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL (K102714) | Boston Scientific Corp | 2011-02-11 |
| MICROPLEX COIL SYSTEM- COSMOS (K102365) | MicroVention, Inc. | 2010-11-18 |
| ACTA VESSEL OCCLUSION SYSTEM (VOS) (K091952) | Nfocus Neuromedical, Inc. | 2010-09-10 |