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10815212026987 525-620

by Izi Medical Products LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

25 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10815212026987 UDI-DI Date15 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

25 recalls · FDA

  • 25 recalls, same reason

    • Terminated Z-1587-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1581-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1582-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1600-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1584-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1601-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1578-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1580-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1591-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1590-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1595-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1594-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1593-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1596-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1598-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1592-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1589-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1585-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1579-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1602-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1583-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K022074
    • Terminated Z-1599-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1588-2014 FDA Class II initiated 24 Apr 2014 on shared 510(k) K022074
    • Terminated Z-1597-2014 FDA Class II initiated 24 Apr 2014
    • Terminated Z-1586-2014 FDA Class II initiated 24 Apr 2014

    Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
10815212026987
Generic Name
Radiological image marker, noninvasive, single-use
Model / Reference
525-620
Primary DI / UDI-DI
10815212026987
510(k) Number
FDA Product Code
HAW
GMDN Term
Radiological image marker, noninvasive, single-use
Device Class
Class II
Regulation Number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K022074)

Show all (12)

Other devices from Izi Medical Products LLC

See all devices from Izi Medical Products LLC →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No