Medtec LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000002608 FEI 1000143606
Medtec LLC is a medical device manufacturer based in the United States, with 1,214 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I) and 14 FDA recalls as of 12 Nov 2026.
- Devices
- 1,214
- Registrations
- EUDAMEDFDA
- FDA recalls
- 14
Registry facts
- Registries
- FDA GUDID 1,165
- EUDAMED 601
- FDA 510(k) 49
- Device classes
- FDA Class II 1,164
- FDA Class I 43
- EU Class I 7
- Top EMDN categories
- FDA recalls
- Sites and related companies
- CEpartner4U authorised representative
- Identifiers
- EUDAMED SRN US-MF-000002608
- FDA FEI 1000143606
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- CEpartner4UNL
What Medtec LLC makes
Medtec LLC manufactures patient positioning solutions for medical imaging, including thermoplastic mould materials like Type-S™ and Solstice™, vacuum-mould systems such as Vac-Lok™, and foam mould kits for customised support. Their portfolio also includes immobilisation systems like the Posifix® Overlay and Posifix® Extension, as well as radiological accessories such as headrests, breast positioners, and whole-body positioners. Implantable image markers and marker placement needles are used to enhance radiographic precision during procedures.
The company’s devices are classified under Class I and Class II regulatory categories, with listings in the EUDAMED database and the FDA’s UDI system. Medtec LLC is based in the United States.
Catalogue
Search and filter all 1,214 devicesShowing 1-50 of 1,214
Company details
- EUDAMED SRN
- US-MF-000002608
- FDA FEI number
- 1000143606
- EU VAT number
- .
- EUDAMED status
- Active
- EUDAMED registered name
- Medtec LLC
- EUDAMED abbreviated name
- CQ Medical
- Registered address
- 1401, 8th Street SE, 51041, Orange City, United States
- Website
- cqmedical.com
- linkedin.com/company/cqmedical
- facebook.com/CQMedical
- Phone
- +17127378688
- PRRC contact
- Alena Newgren
FDA recalls
FDA recall records list 14 recalls initiated by Medtec LLC, the earliest on 2009-03-06 and the most recent on 2020-05-12. By recorded status: 14 terminated. The reasons filed fall into these groups: software or firmware, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 3
- 2018 0
- 2019 1
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2020
- 12 May 2020 Z-2243-2020 Class II Terminated Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
Full distribution text
- 12 May 2020 Z-2243-2020 Class II Terminated Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
2019
- 15 Apr 2019 Z-1837-2019 Class II Terminated There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Full distribution text
- 15 Apr 2019 Z-1837-2019 Class II Terminated There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
2017
- 8 Nov 2017 Z-0671-2018 Class II Terminated When an error message remains displayed and is not cleared in the Protura software with the Elekta pedestal coordinates, moving the pedestal could cause the Protura software to not update with the pedestal location and buffers the pedestal movement history.
- 10 Aug 2017 Z-3082-2017 Class II Terminated Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
Full distribution text
- 10 Aug 2017 Z-3083-2017 Class II Terminated Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
Full distribution text
2016
- 31 Mar 2016 Z-1992-2016 Class II Terminated When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
2015
- 19 Aug 2015 Z-2763-2015 Class II Terminated The wrist straps used for positioning the patient are too long
Full distribution text
- 19 Aug 2015 Z-2763-2015 Class II Terminated The wrist straps used for positioning the patient are too long
2014
- 11 Dec 2014 Z-0989-2015 Class II Terminated The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Full distribution text
- 11 Dec 2014 Z-0990-2015 Class II Terminated The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Full distribution text
- 11 Dec 2014 Z-0989-2015 Class II Terminated The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
2010
- 21 Jun 2010 Z-0394-2011 Unclassified (pre-2012) Terminated Under certain conditions, the extensions can become detached from the main body of the couch.
Full distribution text
- 21 Jun 2010 Z-0394-2011 Unclassified (pre-2012) Terminated Under certain conditions, the extensions can become detached from the main body of the couch.
Show all 14 recalls
2010
- 21 Jun 2010 Z-0395-2011 Unclassified (pre-2012) Terminated Under certain conditions, the extensions can become detached from the main body of the couch.
Full distribution text
- 21 Jun 2010 Z-0396-2011 Unclassified (pre-2012) Terminated Under certain conditions, the extensions can become detached from the main body of the couch.
Full distribution text
- 21 Jun 2010 Z-0395-2011 Unclassified (pre-2012) Terminated Under certain conditions, the extensions can become detached from the main body of the couch.
2009
- 31 Aug 2009 Z-0124-2010 Unclassified (pre-2012) Terminated Some of the packages contain the incorrect mask style.
- 6 Mar 2009 Z-1721-2009 Unclassified (pre-2012) Terminated The silkscreened indexing scale was reversed.
Full distribution text
Frequently asked questions
How many devices does Medtec LLC have in the registry?
The registry currently lists 1214 devices for Medtec LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtec LLC's devices?
Among its 50 most recently registered devices, Medtec LLC has devices listed in EUDAMED (26 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medtec LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Medtec LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medtec LLC?
FDA recall records list 14 recalls initiated by Medtec LLC, the most recent initiated on 12 May 2020. 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 Medtec LLC in the registry?
The most recently registered devices listed for Medtec LLC include Alta Indexing Bar MTWBL007, SECUREFOAM, SMALL BKRT-5036, Large SecureFoam BKRT-5038 and Medium SecureFoam BKRT-5037.