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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 4 of 22
DeviceModel / ReferenceRegistriesClassStatus
Mastercast™ Pro 990044
FDA UDI
Class IIUnknown
Headrest - Timo size E MTTIMO2E
FDA UDI
Class IIActive
Universal Couchtop™ MTIL614115
FDA UDI
Class IIActive
ProForm™ Thermoplastic PRO330IM1832PT
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLWGB04C
EUDAMEDFDA UDI
Class IIActive
Individual Head Support MTIHS03
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPUID181332RD
EUDAMEDFDA UDI
Class IIActive
IPPS™ Overlay MTM3003
FDA UDI
Class IIActive
Vac-Lok™ Cushion MTVLARM01FC
FDA UDI
Class IIUnknown
Rails-only System MTSBRT050
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL3306
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 924392
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUCP301
FDA UDI
Class IIUnknown
Arm Support 106048
FDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUI1824VT
EUDAMEDFDA UDI
Class IIActive
Headrest MTTIMOBL
FDA UDI
Class IIUnknown
Fiducial Marker Kit MTNW887872
FDA UDI
Class IIActive
Alignment Block MTNW425200
FDA UDI
Class IUnknown
Headrest MTTIMODBB
FDA UDI
Class IIUnknown
Positioning Cushion 301001
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPUIR1832
FDA UDI
Class IIActive
Fiducial Marker Kit MTNW887870
EUDAMEDFDA UDI
Class IIActive
IPPS™ Couchtop MTIL3604
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 920044
FDA UDI
Class IIUnknown
Thermoplastic MTBBA1522S
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPUID181232
EUDAMEDFDA UDI
Class IIActive
MR Posi-S™ Adapter 301035
FDA UDI
Class IIActive
Combifix™ 151002
FDA UDI
Class IIUnknown
Feetfix™ Platform 302067
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPUI1832CL
EUDAMEDFDA UDI
Class IIActive
ProForm™ Pediatric Thermoplastic PRO430IM1832CL
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO331IM1832S
FDA UDI
Class IIActive
BPL Respiratory Belt MTSBRT015
EUDAMEDFDA UDI
Class IIActive
Vac-Lok Cushion MTVLA80C
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL604315
FDA UDI
Class IIUnknown
Thermoplastic Frame MTLTBP2
EUDAMEDFDA UDI
Class IIActive
Headrest MTTIMOE
FDA UDI
Class IIUnknown
Docking Station MTIL692012
FDA UDI
Class IIActive
Positioning Cushion 301004
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLARM02C
EUDAMEDFDA UDI
Class IIActive
Docking Station MTIL640010
FDA UDI
Class IIActive
HipFix® Thermoplastic MTHFX1822
FDA UDI
Class IIActive
Positioning Cushion 403024
FDA UDI
Class IIActive
ProForm™ Thermoplastic PRO330IM1832
EUDAMEDFDA UDI
Class IIActive
Proutra™ MT6XSM1.7.4
FDA UDI
Class IIActive
Rectangular Extension MTIL6601
FDA UDI
Class IIUnknown
Arm Support MT40011
FDA UDI
Class IIUnknown
Thermoplastic Frame 20CFHNPSUB1P
EUDAMEDFDA UDI
Class IIActive
IPPS™ Overlay MTM340530
FDA UDI
Class IIActive
Arm Support 106047
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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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.