FDA 510(k) Applications for Medical Device Product Code "PBY"

FDA 510(k) Number Applicant Device Name Decision Date
K120804 CIANNA MEDICAL CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM 02/04/2013
K163541 ENDOMAGNETICS LTD Magseed Magnetic Marker System 01/13/2017
K153044 ENDOMAGNETICS LTD. Sentimag System, Sentimark Magnetic Marker Systerm 03/02/2016
K163667 HEALTH BEACONS, INC. RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) 04/28/2017
K200734 Sirius Medical Systems B.V. Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit 02/24/2021
K222643 Sirius Medical Systems B.V. Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit 10/19/2022


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact