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 Graphic ControlsLabelled 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 14, 2026, FDA's public records list Graphic Controls Acquisition Corporation with 6 device recalls. The most recent is a device recall dated Mar 15, 2022: CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US.
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 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
| Mar 15, 2022 | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-USClass II · Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables | Device recalls |
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
