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 Smith & NephewLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Blue Belt Technologies with 22 510(k) clearances and 3 device recalls. The most recent is a 510(k) clearance dated Mar 26, 2026: REAL INTELLIGENCE™ CORI™.
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.
| Mar 26, 2026 | REAL INTELLIGENCE™ CORI™K260601 · OLO | 510(k) clearances |
| Dec 5, 2025 | REAL INTELLIGENCE™ CORI™ XT (CORI XT)K252841 · OLO | 510(k) clearances |
| Jun 25, 2025 | CORIOGRAPH Pre-Op Planning and Modeling ServicesK250921 · PBF | 510(k) clearances |
| Nov 15, 2024 | CORIOGRAPH Pre-Op Planning and Modeling ServicesK242272 · | 510(k) clearances |
| May 7, 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist the surgeon in providing software-defined spatial Class II · CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cau | Device recalls |
| Mar 18, 2024 | Real Intelligence™ CORI™K240139 · OLO | 510(k) clearances |
| Nov 13, 2023 | CORI REAL INTELLIGENCE Robotic Drill, Product No. ROB10013 and ROB10013SClass II · Possibility that the user is unable to resolve drill disconnection error messages. | Device recalls |
| Sep 7, 2023 | Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299Class II · CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range o | Device recalls |
| Aug 1, 2023 | REAL INTELLIGENCE™ CORI™K231963 · OLO | 510(k) clearances |
| Aug 19, 2022 | REAL INTELLIGENCE CORIK221224 · OLO | 510(k) clearances |
| Jul 27, 2022 | Real Intelligence CoriK220958 · 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
