NAJ
8 FDA 510(k) clearances · Product code
180 daysmedian time to decision
271 days90th percentile
8clearances measured
FDA profile
- Official device name
- Agents, Embolic, For Treatment Of Uterine Fibroids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Medical specialty
- Cardiovascular
- Flags
- Implant
- Adverse events (MAUDE)
- 2013: 9 · 2014: 15 · 2015: 16 · 2016: 14 · 2017: 11 · 2022: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Bearing nsPVA Express™ (K233813) | Merit Medical Systems, Inc. | 2023-12-21 |
| CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (K173871) | Suzhou Hengrui Callisyn Biomedical Co., Ltd. | 2018-09-17 |
| EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES (K133447) | Celonova Biosciences, Inc. | 2014-02-24 |
| BEARING NSPVA EMBOLIZATION PARTICLES (K130259) | Merit Medical Systems, Inc. | 2013-06-07 |
| CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 (K100663) | Boston Scientific Corporation | 2010-04-16 |
| COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES (K081768) | Cook Incorporated | 2008-12-23 |
| CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER (K030966) | Boston Scientific Corp | 2003-09-23 |
| EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION (K021397) | Biosphere Medical, Inc. | 2002-11-22 |
Track NAJ automatically
Every clearance here is in the API, with alerts when new ones post.