NEU
- 产品代码
- NEU
- 器械名称
- Marker, Radiographic, Implantable
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.4300
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 17 件
- 其中 Summary 已存档
- 15 份，可直接下载
- FDA 历史累计 510(k)
- 110 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（17 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253761 | 2026-01-23 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly… | FDA |
| K253888 | 2025-12-31 | Stryker Endoscopy | MOLLI 2 System | |
| K252892 | 2025-12-19 | Merit Medical Systems, Inc. | SCOUT MD Surgical Guidance System | |
| K251989 | 2025-12-12 | Breast-Med, Inc. | VizMark Preloaded Tissue Marker Device (VM-0001) | |
| K251748 | 2025-07-23 | Carbon Medical Technologies, Inc. | MammoSTAR Biopsy Site Identifier | |
| K243642 | 2025-03-24 | Bard Peripheral Vascular, Inc. | UltraCor Twirl Breast Tissue Marker | |
| K233639 | 2024-12-20 | Elucent Medical, Inc. | SmartClip Secure Soft Tissue Marker | |
| K240429 | 2024-11-07 | Inrad, Inc. | Trilogy Tissue Marker | |
| K234149 | 2024-09-26 | Molli Surgical, Inc. | MOLLI 2 System | |
| K240042 | 2024-09-25 | Molli Surgical, Inc. | MOLLI 2 System | |
| K241762 | 2024-09-16 | View Point Medical | OneMark | |
| K240527 | 2024-07-10 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Hummingbi… | FDA |
| K232865 | 2024-06-28 | Endomagnetics Ltd., | Magseed Pro Magnetic Marker System | |
| K231468 | 2024-02-12 | Merit Medical System, Inc. | SCOUT MD Surgical Guidance System | |
| K230836 | 2024-01-23 | Surgmark GmbH | SchurSign Tissue Marker | |
| K232615 | 2024-01-12 | Devicor Medical Products, Inc. | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape))… | |
| K231579 | 2023-10-26 | Molli Surgical, Inc. | MOLLI 2 |
FDA 官方分类页： NEU
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。