Panels › General, Plastic Surgery › Product code PBY · Class 2
Temporary Tissue Marker
Regulation 878.4300
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PBY
| Company | 510(k)s | Recalls |
|---|---|---|
| Sirius Medical Systems B.V. | 3 | 0 |
| Endomagnetics Ltd., | 2 | 0 |
| Cianna Medical | 1 | 0 |
| Health Beacons, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 2023 | K223682 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit Sirius Medical Systems B.V., NL | PBY |
| Oct 19, 2022 | K222643 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit Sirius Medical Systems B.V., NL | PBY |
| Feb 24, 2021 | K200734 | Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit Sirius Medical Systems B.V., NL | PBY |
| Apr 28, 2017 | K163667 | RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System Health Beacons, Inc. | PBY |
| Jan 13, 2017 | K163541 | Magseed Magnetic Marker System Endomagnetics Ltd.,, GB | PBY |
| Mar 2, 2016 | K153044 | Sentimag System, Sentimark Magnetic Marker Systerm Endomagnetics Ltd.,, GB | PBY |
| Feb 4, 2013 | K120804 | CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM Cianna Medical | PBY |
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