Who else makes this device?

Name: Magseed
Brand: Magseed

General & Plastic Surgery › SurgicalMarker, Radiographic, Implantable

Magseed

Magseed MagneticTissue Marker Length 12cm - Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed…

Registry build 21.09.26

Magseed MagneticTissue Marker Length 12cm – Magseed is a single-use sterile device composed of a magnetic marker (seed) preloaded in a delivery system. It is intended to be placed percutaneously into soft tissue to long-term mark a site intended for surgical removal. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance the marker is located and surgically removed with the target tissue.

1manufacturer

2catalogue numbers in this listing

3510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code NEU
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Magseed
Listed by	Endomagnetics Ltd, United Kingdom
FDA product code	NEU
Device type	Marker, Radiographic, Implantable
Device class	Class 2
Regulation	21 CFR 878.4300
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2023-06-20
Record revised	2026-01-27 (version 4)

Specifications

Specifications
MRI safety	MR Conditional
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Magseed
Catalogue number	Size	Per pack	Status
SM18-1-12US		10	In distribution
SM18-1-07US		10	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
HydroMARK	Devicor Medical Products, Inc.	75
Scout®	Merit Medical Systems, Inc.	68
Scout MD™	Merit Medical Systems, Inc.	46
SmartClip	Elucent Medical Inc.	37
BiomarC®	Carbon Medical Technologies, Inc.	25
HydroMARK Breast Biopsy Site Marker	Devicor Medical Products, Inc.	21
SecurMark	Hologic, Inc.	15
Gold Marker	Riverpoint Medical LLC	15
MammoStar™	Carbon Medical Technologies, Inc.	15
SecurMark for Atec	Hologic, Inc.	15
SenoMark® Ultra Breast Tissue Marker	Bard Peripheral Vascular, Inc.	14
TriMark	Hologic, Inc.	14

Showing 12 of 96. All products under Marker, Radiographic, Implantable

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K232865	2024-06-28
K222832	2023-01-21
K173587	2018-02-16

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2025-10-01	Class II	Process control	Potential for contamination with cotton fibers.	540 units
2025-10-01	Class II	Process control	Potential for contamination with cotton fibers.	1,760 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.