510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Endomagnetics Ltd

Cambridge Cambridgeshire, GB

ENDOMAGNETICS LTD appears in FDA device records in Cambridge Cambridgeshire, GB. FDA records list 5 510(k) clearances between and , 11 PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
11
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Endomagnetics Ltd between 2016 and 2024. The busiest year on record is 2016, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Endomagnetics Ltd, by decision year
YearClearances
20161
20171
20181
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232865Magseed Pro Magnetic Marker SystemNEUSubstantially Equivalent
K222832Sentimag SystemNEUSubstantially Equivalent
K173587Magseed Magnetic Marker SysttemNEUSubstantially Equivalent
K163541Magseed Magnetic Marker SystemPBYSubstantially Equivalent
K153044Sentimag System, Sentimark Magnetic Marker SystermPBYSubstantially Equivalent

Registered establishments

FDA registered establishments for Endomagnetics Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30126444263012644426ENDOMAGNETICS LTD330 Cambridge Science Park, Cambridge Cambridgeshire CB4 0WN GB2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0317-2026Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. 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 System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.Potential for contamination with cotton fibers.Class IIOpen, Classified
Z-0316-2026Magseed 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 System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.Potential for contamination with cotton fibers.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain