Medical device makerLabelled 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 Carbon Medical Technologies with 18 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Mar 31, 2026: InjecSURE Injection 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.
| Mar 31, 2026 | InjecSURE Injection SystemK253598 · FBK | 510(k) clearances |
| Jul 23, 2025 | MammoSTAR Biopsy Site IdentifierK251748 · NEU | 510(k) clearances |
| Jul 26, 2024 | BiomarC EX Fiducial Marker System, Catalog Number 040165Class III · This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient. | Device recalls |
| Dec 16, 2022 | Mammotome MammoStar Biopsy Site Identified, REF STAR1401Class II · The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, | Device recalls |
| Jun 10, 2021 | Fiducial MarkerK211590 · IYE | 510(k) clearances |
| Jul 29, 2019 | BiomarC Fiducial MarkerK191797 · IYE | 510(k) clearances |
| Aug 23, 2017 | Endoscopic Injection NeedleK172227 · FBK | 510(k) clearances |
| May 13, 2014 | BIOMARC COAXIAL NEEDLEK133148 · FBK | 510(k) clearances |
| Feb 28, 2014 | BIOMARC FIDUCIAL MARKERK132064 · IYE | 510(k) clearances |
| Dec 20, 2013 | BIOMARC FIDUCIAL MARKERK132708 · NEU | 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
