Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of R2 TechnologyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list R2 Technologies, Inc. with 3 510(k) clearances. The most recent is a 510(k) clearance dated Nov 10, 2022: Dermal Cooling System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 10, 2022 | Dermal Cooling SystemK213294 · QPZ | 510(k) clearances |
| Aug 5, 2021 | R2 Dermabrasion Tip (for Dermal Cooling System)K203006 · QPZ | 510(k) clearances |
| Sep 24, 2020 | Dermal Cooling SystemK201260 · GEH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
