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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 6 of 22
DeviceModel / ReferenceRegistriesClassStatus
HipFix® Baseplate MTPLVC04
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VL0018
EUDAMEDFDA UDI
Class IIActive
Headrest MTSILVER2E
EUDAMEDFDA UDI
Class IIActive
Protura MT6XSM1.6.0
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLARM02
FDA UDI
Class IIUnknown
Clamp MTSBRT020
EUDAMEDFDA UDI
Class IIActive
Thermoplastic Adapter MTM3010
FDA UDI
Class IIUnknown
Respiratory Plate MTSBRT003
EUDAMEDFDA UDI
Class IIActive
IPPS™ Couchtop MTIL301004
FDA UDI
Class IIUnknown
IPPS™ Overlay MTM3001
FDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPUD2.4
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUI1832
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL684015
FDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPSI2724
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL6029
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLF15C
EUDAMEDFDA UDI
Class IIActive
Low Kneefix™ 2 301048
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLE225C
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO339IM1832N
FDA UDI
Class IIActive
C-Qual M™ MTM410
FDA UDI
Class IIUnknown
Bra Extender CRTEXT01
FDA UDI
Class IIUnknown
Marker Placement Needle MTNW887351
FDA UDI
Class IIActive
Posifix® Extension 108010
EUDAMEDFDA UDI
Class IIActive
Attachment Bar 600251
FDA UDI
Class IIUnknown
Overlay MTM6508
FDA UDI
Class IIActive
IPPS™ Couchtop MTIL3009
FDA UDI
Class IIUnknown
Proutra™ MT6X300
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLJ20FC
FDA UDI
Class IIActive
SnapFrame™ Type-S™ Thermoplastic MTAPUDMPSG
FDA UDI
Class IIUnknown
Positioning Cushion 301055
FDA UDI
Class IIActive
Body Pro-Lok™ Patient Transfer Base MTSBRT012
FDA UDI
Class IIUnknown
Headrest MT250SUB11
EUDAMEDFDA UDI
Class IIActive
Pronumbra RT-C889K
EUDAMEDFDA UDI
Class IIActive
IPPS™ Overlay MTIL3404
FDA UDI
Class IIActive
Bolus MTCB405S
FDA UDI
Class IUnknown
Precise Bite™ MTCBPBITETD
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO331IM1832CLN
FDA UDI
Class IIActive
Universal Couchtop™ MTIL6045
FDA UDI
Class IIActive
Thermoplastic MTAPSX24362.4
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VL14C25
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion MTVLG40FC
FDA UDI
Class IIUnknown
Align Fiducial Marker Kit MTNW887881
EUDAMEDFDA UDI
Class IIActive
Fiducial Marker Kit MTNW887873
EUDAMEDFDA UDI
Class IIActive
Elekta Unity Lok-Bar™ MTULB001
FDA UDI
Class IIActive
Vac-Lok Cushion MTVLPLV08
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLH90C
EUDAMEDFDA UDI
Class IIActive
Posicast® Thermoplastic 930055
EUDAMEDFDA UDI
Class IIActive
Wrist Support MTTWS2S
FDA UDI
Class IIActive
Posicast® Thermoplastic 940030
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL3403
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

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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.