Graphic Controls Acquisition Corporation
Medical device manufacturer in Buffalo, NY.
0510(k) clearances
0PMA approvals
6recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0940-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0939-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0938-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET 12 RT ADULT-US Model: 32028779 50602-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0937-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0936-2022 Class II | CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |
| Z-0935-2022 Class II | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-USInstructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG… | 03/15/2022Terminated |