Home › Device types › NEU
Marker, Radiographic, Implantable
FDA product code NEU · Class 2 · General, Plastic Surgery
628
Registered devices
1,851
Adverse events
14
Recalls
110
510(k) clearances
Devices with this code
HydroMark — DEVICOR MEDICAL PRODUCTS, INC.Mammotome MAMMOMARK 2 — DEVICOR MEDICAL PRODUCTS, INC.HydroMark — DEVICOR MEDICAL PRODUCTS, INC.SmartClip — Elucent Medical, Inc.SecurMark for ATEC — Hologic, Inc.SmartClip — Elucent Medical, Inc.Tumark® Professional X for Eviva® Petite — SOMATEX Medical Technologies GmbHSCOUT® — MERIT MEDICAL SYSTEMS, INC.HydroMark — DEVICOR MEDICAL PRODUCTS, INC.Sentimag — ENDOMAGNETICS LTDSCOUT CHECK® — MERIT MEDICAL SYSTEMS, INC.TriMark — Hologic, Inc.SchurSign — SurgMark GmbHUltraClip® Dual Trigger Breast Tissue Marker — Bard Peripheral Vascular, Inc.SCOUT MD™ — MERIT MEDICAL SYSTEMS, INC.SCOUT® — MERIT MEDICAL SYSTEMS, INC.HydroMark — DEVICOR MEDICAL PRODUCTS, INC.BEACON — SCION MEDICAL TECHOLOGIES, LLCSmartClip — Elucent Medical, Inc.GOLD MARKER — RIVERPOINT MEDICAL, LLCMammotome CORMARK — DEVICOR MEDICAL PRODUCTS, INC.Mammotome HydroMARK — DEVICOR MEDICAL PRODUCTS, INC.HydroMARK — DEVICOR MEDICAL PRODUCTS, INC.BiomarC® — Carbon Medical Technologies, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2022-03-30 | Devicor Medical Products Inc | Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patie |
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