Graphic Controls Acquisition Corp

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Graphic Controls Acquisition Corp is a medical device manufacturer, with 785 devices listed in FDA GUDID and EUDAMED (FDA Class II, I and III) and 6 FDA recalls as of 12 Nov 2026.

Devices: 785
FDA recalls: 6

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries: FDA GUDID 785
EUDAMED 43

A device listed in two registries counts in both.
Device classes: FDA Class II 548
FDA Class I 168
FDA Class III 23
FDA recalls: 6 recalls matched by name
Identifiers: DUNS 002111896

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Graphic Controls Acquisition Corp makes

Graphic Controls Acquisition Corp manufactures electrocardiographic electrodes, recording paper, lead sets, and monitoring system modules for cardiac monitoring. They also produce cytotoxic waste containers, sharps containers, and analytical non-scalp cutaneous electrodes for clinical and laboratory use.

The company's devices span Class I, II, and III classifications and are listed in the FDA's Unique Device Identification (fda_udi) system.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue785

Newest first, rows 1-50 of 785

Search and filter all 785 devices

Rows 1-50 of 785

Showing 1-50 of 785

Company details

DUNS number: 002111896
Email: info@vermed.com
Phone: 1.800.669.6905

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by GRAPHIC CONTROLS ACQUISITION CORP, initiated on 2022-03-15. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 6
2023 0
2024 0
2025 0
2026 0

2022
- 15 Mar 2022 Z-0935-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685
- 15 Mar 2022 Z-0936-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685
- 15 Mar 2022 Z-0937-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685
- 15 Mar 2022 Z-0938-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685
- 15 Mar 2022 Z-0939-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685
- 15 Mar 2022 Z-0940-2022 Class II Terminated Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation. Distribution: US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN, NY, OK, VT. Submission number: K101685

Frequently asked questions

How many devices does GRAPHIC CONTROLS ACQUISITION CORP have in the registry?

The registry currently lists 785 devices for GRAPHIC CONTROLS ACQUISITION CORP. Devices recorded under merged duplicate company entries are counted once.

Which registries list GRAPHIC CONTROLS ACQUISITION CORP's devices?

Among its 50 most recently registered devices, GRAPHIC CONTROLS ACQUISITION CORP has devices listed in EUDAMED (3 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do GRAPHIC CONTROLS ACQUISITION CORP's devices fall under?

Among its 50 most recently registered devices, the classes recorded for GRAPHIC CONTROLS ACQUISITION CORP's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for GRAPHIC CONTROLS ACQUISITION CORP?

FDA recall records list 6 recalls initiated by GRAPHIC CONTROLS ACQUISITION CORP, the most recent initiated on 15 Mar 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from GRAPHIC CONTROLS ACQUISITION CORP in the registry?

The most recently registered devices listed for GRAPHIC CONTROLS ACQUISITION CORP include Nissha Medical Technologies O-4227-60, Nissha Medical Technologies O-5235-60, Nissha Medical Technologies Ultra 210HD Thermal Video Paper and MVAP Medical Supplies FT002.

Generated automatically from registry data and not verified by a human reviewer.