Data / Medical devices / Temporary Tissue Marker
Temporary Tissue Marker (PBY): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Temporary Tissue Marker (product code PBY, Class 2, 21 CFR 878.4300). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on November 9, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- PBY
- Device class
- 2
- Regulation
- 878.4300
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| Netherlands | 3 |
| United Kingdom | 2 |
Makers of Temporary Tissue Marker
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Endomagnetics Ltd | Cambridge Cambridgeshire, United Kingdom | Complaint file establishment, Specification developer | 2 | January 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Sirius Medical Systems B.V. | Eindhoven Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 1 | November 9, 2023 | 0 | 0 | 0 | api.fda.gov |
| Batenburg Applied Technologies | Rotterdam Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Technologies Ltd. | ASHFORD Kent, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VDL TBP Electronics | Dirksland Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 9, 2023. 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.