Home › Device types › NEU
Marker, Radiographic, Implantable
FDA product code NEU · Class 2 · General, Plastic Surgery
653
Registered devices
1,888
Adverse events
15
Recalls
110
510(k) clearances
Devices with this code
SecurMark for ATEC — Hologic, Inc.HydroMark — DEVICOR MEDICAL PRODUCTS, INC.SCOUT® — MERIT MEDICAL SYSTEMS, INC.EnVisio — Elucent Medical, Inc.SCOUT® — MERIT MEDICAL SYSTEMS, INC.SCOUT CHECK® — MERIT MEDICAL SYSTEMS, INC.Beacon — Covidien LPMammotome MAMMOMARK 2 — DEVICOR MEDICAL PRODUCTS, INC.Sirius Pintuition — Sirius Medical Systems B.V.Mammotome MAMMOMARK — DEVICOR MEDICAL PRODUCTS, INC.Mammotome MAMMOMARK 2 — DEVICOR MEDICAL PRODUCTS, INC.Gold Marker — RIVERPOINT MEDICAL, LLCUltraClip® II Breast Tissue Marker — Bard Peripheral Vascular, Inc.GOLD MARKER — RIVERPOINT MEDICAL, LLCMammotome Hydromark — DEVICOR MEDICAL PRODUCTS, INC.SCOUT® — MERIT MEDICAL SYSTEMS, INC.SecurMark — Hologic, Inc.Tumark® Professional X for Eviva® Standard — SOMATEX Medical Technologies GmbHHydroMARK Plus — DEVICOR MEDICAL PRODUCTS, INC.SCOUT® — MERIT MEDICAL SYSTEMS, INC.Tumark Vision — SOMATEX Medical Technologies GmbHTraceIT Tissue Marker 1-UP — AUGMENIX, INC.SmartClip — Elucent Medical, Inc.HydroMARK Breast Biopsy Site Marker — DEVICOR MEDICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-27 | Merit Medical Systems, Inc. | The implantable clip may experience difficulties deploying, which could prevent the reflector from functioning as intended during use. |
| 2026-04-24 | Devicor Medical Products Inc | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| 2026-01-21 | Stryker Corporation | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tiss |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2024-11-18 | Elucent Medical Inc | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 oper |
| 2024-10-10 | Hologic, Inc | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, an |
| 2024-03-13 | Hologic, Inc | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, o |
| 2022-12-16 | Carbon Medical Technologies, Inc. | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, |
| 2022-08-09 | Hologic, Inc | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.