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 Carestream HealthLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Carestream Dental with 1 510(k) clearance, 1 device recall and 1 AI-enabled device. The most recent is a device recall dated Feb 15, 2021: Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage….
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.
| Feb 15, 2021 | Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of Class II · The mirror may become detached and fall from the unit | Device recalls |
| Sep 12, 2012 | CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWAREK122427 · LLZ | 510(k) clearances |
| Sep 2, 1998 | LOGICON CARIES DETECTORP980025 · Radiology | AI-enabled devices |
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
