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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 8 of 22
DeviceModel / ReferenceRegistriesClassStatus
IPPS™ Overlay MTIL6400
FDA UDI
Class IIUnknown
Positioning Cushion 301204
EUDAMEDFDA UDI
Class IIActive
Posifix® -1 Baseplate 101025
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLFBB01FC
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL6300
FDA UDI
Class IIUnknown
Interloc® Lok-Bar™ MTIL3051
FDA UDI
Class IIUnknown
trUpoint ARCH Replacement Kit MTHF225
FDA UDI
Class IIUnknown
Locators 109016
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLPLV03C
FDA UDI
Class IIUnknown
Iso-Point MTIAD100
FDA UDI
Class IActive
Arm Support 106023
FDA UDI
Class IIActive
IPPS™ Overlay MTIL3300
FDA UDI
Class IIActive
Universal Couchtop™ MTIL6840
FDA UDI
Class IIActive
Headrest MTTIMOD
FDA UDI
Class IIUnknown
Vac-Lok Vacuum Compressor MTVPEXK
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 940145
FDA UDI
Class IIUnknown
Pronumbra RT-4536-HH01R
FDA UDI
Class IIActive
Bolus MTCB410S
FDA UDI
Class IUnknown
Posicast® Thermoplastic 970031
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion VLH120C
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VL0017
EUDAMEDFDA UDI
Class IIActive
Thermoplastic Frame MTPLHA01
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUIW1824VT
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL6741
FDA UDI
Class IIActive
Wing Board™ MTWB08
EUDAMEDFDA UDI
Class IIActive
Vac-Lok Cushion MTVLJ20FC
FDA UDI
Class IIUnknown
C-Qual™ MT401
EUDAMEDFDA UDI
Class IIActive
Fixator™ MTCFHN006
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUIR1832CL
FDA UDI
Class IIActive
Rail Button MTSBRT034
FDA UDI
Class IIUnknown
Headrest - Timo Size F MTTIMO2F
EUDAMEDFDA UDI
Class IIActive
Posicast® Thermoplastic 900145
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL6301
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL604415
FDA UDI
Class IIActive
Encompass™ RT-B889KYSH
FDA UDI
Class IIActive
Headrest - Timo size C MTTIMO2C
FDA UDI
Class IIActive
Posicast Thermoplastic 940055
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLFBB02FC
FDA UDI
Class IIUnknown
Rails-only System MTSBRT059
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL6141
FDA UDI
Class IIActive
Chabner XRT Radiation Bra CRTBRA08
FDA UDI
Class IIUnknown
Interloc® Lok-Bar™ MTIL3351
FDA UDI
Class IIActive
Posicast Thermoplastic 950145
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL6501
FDA UDI
Class IIUnknown
Fiducial Marker Kit MTNW887810
FDA UDI
Class IIActive
Prone Face Cushion MTPFC02
EUDAMEDFDA UDI
Class IIActive
Baseplate MT20109
EUDAMEDFDA UDI
Class IIActive
Varian Interface MTIL6610
FDA UDI
Class IIUnknown
AccuForm™ Cushion MTACL4060
EUDAMEDFDA UDI
Class IIActive
Vac-Lok Cushion MTVLG35
FDA UDI
Class IIUnknown

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.