Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Medtech with 12 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Jul 20, 2023: ROSA ONE Brain Application.
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.
| Jul 20, 2023 | ROSA ONE Brain ApplicationK231103 · HAW | 510(k) clearances |
| May 4, 2022 | ROSA ONE Brain applicationK214065 · HAW | 510(k) clearances |
| Sep 22, 2021 | ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides tClass I · The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate pla | Device recalls |
| May 29, 2020 | ROSA ONE Brain applicationK200511 · HAW | 510(k) clearances |
| Jan 6, 2020 | ROSA Brain 3.0 Application-BrainClass II · Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly | Device recalls |
| Jan 6, 2020 | ROSA One 3.1 Brain ApplicationClass II · Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly | Device recalls |
| Oct 29, 2019 | ROSA ONE Spine applicationK192173 · OLO | 510(k) clearances |
| Sep 10, 2019 | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. SClass I · The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the as | Device recalls |
| Mar 22, 2019 | ROSA ONE Spine applicationK182848 · OLO | 510(k) clearances |
| Feb 7, 2019 | ROSA ONE Brain ApplicationK182417 · HAW | 510(k) clearances |
| May 8, 2018 | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intenClass II · Replacement of units lacking an updated device approval. | Device recalls |
| Mar 28, 2018 | ROSA BRAIN (v3.0.0.5)K172444 · HAW | 510(k) clearances |
| Jan 4, 2016 | ROSA SpineK151511 · OLO | 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
