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Medtec LLC

United States·US-MF-000002608

Last updated September 17, 2026

Information

Country
United States
Address
1401, 8th Street SE, Orange City, United States
Website
cqmedical.com
LinkedIn
—
Facebook
—
Phone
+17127378688
PRRC Contact
Alena Newgren
EUDAMED SRN
US-MF-000002608
FDA FEI Number
1000143606
DUNS Number
—

Catalogue (1098)

Page 17 of 22
DeviceModel / ReferenceRegistriesClassStatus
ProForm™ Thermoplastic PRO331IM1832CL
FDA UDI
Class IIActive
Alloy Melter MT801.5D
FDA UDI
Class IUnknown
Handle MTGBSUB1
EUDAMEDFDA UDI
Class IIActive
HipFix® Thermoplastic MTHFX18222.4S
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPU141.6
EUDAMEDFDA UDI
Class IIActive
Registration Film PRO340
EUDAMEDFDA UDI
Class IIActive
Headrest - Timo size D MTTIMO2D
EUDAMEDFDA UDI
Class IIActive
Wedge 107102
FDA UDI
Class IIActive
Vac-Lok Cushion MTVL27B
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPUR2.4
EUDAMEDFDA UDI
Class IIActive
Wing Board™ MTWB09
EUDAMEDFDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPSID29NR24
EUDAMEDFDA UDI
Class IIActive
AccuForm™ Cushion MTACL6060
EUDAMEDFDA UDI
Class IIActive
Combifix™ 151003
FDA UDI
Class IIUnknown
Posifix® -2 Baseplate 102021
EUDAMEDFDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPUD
EUDAMEDFDA UDI
Class IIActive
Grid Panel 20IL430104
FDA UDI
Class IIUnknown
Spacer 107103MR
FDA UDI
Class IIActive
Locators 663020
FDA UDI
Class IIUnknown
Chabner XRT Radiation Bra CRTBRA04
FDA UDI
Class IIUnknown
Thermoplastic Frame MTRFH3
EUDAMEDFDA UDI
Class IIActive
Belly Board 125012
FDA UDI
Class IIActive
Docking Station MTIL600812
FDA UDI
Class IIActive
Universal Couchtop™ MTIL6048
FDA UDI
Class IIActive
Thermoplastic MTRFI918
FDA UDI
Class IIActive
ProForm™ Thermoplastic PRO332
FDA UDI
Class IIUnknown
Guide Pins 109036
FDA UDI
Class IIUnknown
IPPS Overlay 20IL430035
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLJ20
FDA UDI
Class IIUnknown
Shim MTSHIM01S
EUDAMEDFDA UDI
Class IIActive
Combifix™ 151004MR
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL6340
FDA UDI
Class IIActive
Foot Extension MTIL3006001
FDA UDI
Class IIUnknown
Headrest MTTIMOAL
FDA UDI
Class IIUnknown
Mastercast™ Pro 990145
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLARM01FC
FDA UDI
Class IIActive
Protura 1.7.0 MT6XSM1.7.0
FDA UDI
Class IIUnknown
Arm Support 106015
FDA UDI
Class IIUnknown
Fiducial Markers MTNW887814
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPU1.6
EUDAMEDFDA UDI
Class IIActive
IPPS Couchtop MTIL6260
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPUR122.4
EUDAMEDFDA UDI
Class IIActive
Prodigy™ Lok-Bar™ MTIL3650
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLB40
EUDAMEDFDA UDI
Class IIActive
Arm Support MTTASL
FDA UDI
Class IIUnknown
Vac-Lok Cushion MTVL0017
FDA UDI
Class IIUnknown
Body Pro-Lok™ System MTSBRT400
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL6046
FDA UDI
Class IIActive
Overlay MTM300401
FDA UDI
Class IIActive
IPPS™ Overlay MTIL3019
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (14)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
May 12, 2020Z-2243-2020—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.

Apr 15, 2019Z-1837-2019—terminated

There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.

Nov 8, 2017Z-0671-2018—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.

Aug 10, 2017Z-3082-2017—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.

Aug 10, 2017Z-3083-2017—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.

Mar 31, 2016Z-1992-2016—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.

Aug 19, 2015Z-2763-2015—terminated

The wrist straps used for positioning the patient are too long

Dec 11, 2014Z-0989-2015—terminated

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

Dec 11, 2014Z-0990-2015—terminated

The product (wool wrist loop) was manufactured 7cm shorter than product specifications.

Jun 21, 2010Z-0394-2011—terminated

Under certain conditions, the extensions can become detached from the main body of the couch.

Jun 21, 2010Z-0395-2011—terminated

Under certain conditions, the extensions can become detached from the main body of the couch.

Jun 21, 2010Z-0396-2011—terminated

Under certain conditions, the extensions can become detached from the main body of the couch.

Aug 31, 2009Z-0124-2010—terminated

Some of the packages contain the incorrect mask style.

Mar 6, 2009Z-1721-2009—terminated

The silkscreened indexing scale was reversed.