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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 11 of 22
DeviceModel / ReferenceRegistriesClassStatus
Universal Couchtop™ MTIL6043
FDA UDI
Class IIUnknown
Proutra™ MT6X200
FDA UDI
Class IIActive
Thorawedge™ 301080
EUDAMEDFDA UDI
Class IIActive
Vac-Lok Cushion MTVLH120C
FDA UDI
Class IIUnknown
ProForm™ Pediatric Thermoplastic PRO431IM1832CL
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion MTVLTYS02CX
FDA UDI
Class IIUnknown
Accessory Rail Locking Block MTARB002
FDA UDI
Class IIUnknown
Protura 206X120
FDA UDI
Class IIUnknown
Headrest - Timo size B with base MTTIMO2BL
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion VLPLV10C
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO330IM1832CL
EUDAMEDFDA UDI
Class IIActive
Protura 206X130
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLFBB01C
FDA UDI
Class IIUnknown
MR Posi-S™ Adapter with Backplate 301029
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301202
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Baseplate MT20104
EUDAMEDFDA UDI
Class IIActive
Eye Shield MTT45L
FDA UDI
Class IUnknown
Bolus MTCB415S
FDA UDI
Class IUnknown
Positioning Cushion 301008
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPU2.4
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO339IM1832CLN
FDA UDI
Class IIActive
Lateral Stabilizer MTIL630011
FDA UDI
Class IIUnknown
HipFix® Thermoplastic MTHFX1822S
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUNB
FDA UDI
Class IIUnknown
Rails-only System MTSBRT053
FDA UDI
Class IIUnknown
Head Extension MTM340505
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL674115
FDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUI2032
FDA UDI
Class IIUnknown
Chabner XRT Radiation Bra CRTBRA13
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL6002
FDA UDI
Class IIUnknown
Positioning Cushion 301054
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 920033
FDA UDI
Class IIUnknown
Thermoplastic MTAPS35
EUDAMEDFDA UDI
Class IIActive
Prodigy Lok-Bar 20IL430011
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL6140
FDA UDI
Class IIActive
Positioning Cushion 301018
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL3707
FDA UDI
Class IIActive
Pronumbra RT-4536KV-02
FDA UDI
Class IIActive
Vac-Lok™ Vacuum Compressor MTVPEXD
EUDAMEDFDA UDI
Class IIActive
HipFix® Thermoplastic MTPLHAI0203
EUDAMEDFDA UDI
Class IIActive
Foot-Lok Positioning Cushion MTAFS01
FDA UDI
Class IIUnknown
Docking Station MTIL3001100
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLG26FC
EUDAMEDFDA UDI
Class IIActive
Head Support CHS41
EUDAMEDFDA UDI
Class IIActive
Baseplate MT20110
FDA UDI
Class IIActive
Fiducial Markers MTNW887812
EUDAMEDFDA UDI
Class IIActive
Thermoplastic Frame MTRFH2
FDA UDI
Class IIUnknown
Arm Support MT40012
FDA UDI
Class IIUnknown
Wrist Support MT40017
EUDAMEDFDA UDI
Class IIActive
Interloc® Lok-Bar™ MTIL3152
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.