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.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Graphic Controls and its 1 subsidiaries with 55 510(k) clearances and 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, Graphic Controls and its 1 subsidiaries
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 |
| Nov 13, 1998 | MEDI-TRACE 4103 NEONATAL ELECTRODEK981964 · DRX | 510(k) clearances |
| Nov 5, 1998 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK983287 · MKJ | 510(k) clearances |
| Jul 14, 1998 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K974730 · KXO | 510(k) clearances |
| May 12, 1998 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK980857 · MKJ | 510(k) clearances |
| Aug 27, 1997 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK972970 · MKJ | 510(k) clearances |
| Mar 27, 1997 | POINT OF USE II SHARPS-A-GATORK964387 · MMK | 510(k) clearances |
| Jan 22, 1997 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)K964279 · KXO | 510(k) clearances |
| Nov 19, 1996 | MEDI-TRACE 5700 RESTING ECG ELECTRODEK963151 · DRX | 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
