Data / Medical devices / United Kingdom / Endomagnetics Ltd

Endomagnetics Ltd: FDA-registered device maker in Cambridge Cambridgeshire, United Kingdom, 5 510(k) clearances and 1 PMA approval

Name: Endomagnetics Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Endomagnetics Ltd is registered with the FDA (registration 3012644426) in Cambridge Cambridgeshire, United Kingdom. It lists 3 device types. The FDA files 5 510(k) clearances and 1 PMA approval under its listings, the newest dated June 28, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012644426
Address: 330 Cambridge Science Park Milton Road, Cambridge Cambridgeshire, United Kingdom, CB4 0WN
Owner or operator: HOLOGIC, INC. (9007676)
Roles: Complaint file establishment, Specification developer
First device listed: December 8, 2025
Registered through: 2027
Brand names listed: Magseed, Magseed Pro, Magtrace, Sentimag Cart

Devices it lists

Device	Product code	Class	Role	Source
Lymph Node Location System During Sentinel Biopsy Procedure	PUV	3	Complaint file establishment, Specification developer	accessdata.fda.gov
Marker, Radiographic, Implantable	NEU	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Temporary Tissue Marker	PBY	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 28, 2024	K232865	Magseed Pro Magnetic Marker System	NEU	Substantially Equivalent	Endomagnetics Ltd.,	accessdata.fda.gov
January 21, 2023	K222832	Sentimag System	NEU	Substantially Equivalent	Endomagnetics Ltd.,	accessdata.fda.gov
February 16, 2018	K173587	Magseed Magnetic Marker Systtem	NEU	Substantially Equivalent	Endomagnetics Ltd.,	accessdata.fda.gov
January 13, 2017	K163541	Magseed Magnetic Marker System	PBY	Substantially Equivalent	Endomagnetics Ltd.,	accessdata.fda.gov
March 2, 2016	K153044	Sentimag System, Sentimark Magnetic Marker Systerm	PBY	Substantially Equivalent	Endomagnetics Ltd.,	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
July 24, 2018	P160053	MagtraceTM and Sentimag(R) Magnetic Locatization System	PUV	10	May 18, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 1, 2025	97680	Class II	Ongoing	Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery	Potential for contamination with cotton fibers.	accessdata.fda.gov

Compare with other makers

Updated May 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.