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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 1 of 22
DeviceModel / ReferenceRegistriesClassStatus
305001 305001
EUDAMED
Class IActive
107101mr 107101MR
EUDAMED
Class IActive
Rails-only System MTSBRT052
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLARM02FC
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPSID2724
EUDAMEDFDA UDI
Class IIActive
Respiratory Belt MTSBRT004
FDA UDI
Class IIUnknown
Body Pro-Lok™ Patient Transfer System MTSBRT011
FDA UDI
Class IIUnknown
Alloy Melter MT803D
FDA UDI
Class IUnknown
Fiducial Markers MTNW887855
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 402525
FDA UDI
Class IIActive
Marker Placement Needle MTNW887358
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop Extension Latch Mount Subassembly MTIL666010
FDA UDI
Class IIUnknown
Bolus MTCB455S
FDA UDI
Class IUnknown
Type-S™ Thermoplastic MTAPS2.4
FDA UDI
Class IIUnknown
Positioning Cushion 301005BLK
FDA UDI
Class IIUnknown
Positioning Cushion 402820
FDA UDI
Class IIActive
Posifix® Overlay 108072
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Vacuum Compressor MTVPEXG
EUDAMEDFDA UDI
Class IIActive
Solstice™ Thermoplastic Frame MTAPCIN1832
EUDAMEDFDA UDI
Class IIActive
Body Pro-Lok™ System Lite MTSBRT410
FDA UDI
Class IIUnknown
Foot Extension MTIL3006002
FDA UDI
Class IIActive
Posifix® Extension MTIL6671
FDA UDI
Class IIActive
Vac-Lok™ Cushion VL71FC
EUDAMEDFDA UDI
Class IIActive
Type-S™ Overlay 20CFHNSUB7
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301008A
EUDAMEDFDA UDI
Class IIActive
Posicast® Thermoplastic 770020
FDA UDI
Class IIUnknown
ProForm™ Pediatric Thermoplastic PRO431IM1832SG
FDA UDI
Class IIActive
ProForm™ Treatment Overlay PRO300
FDA UDI
Class IIActive
Positioning Cushion 301002BLK
FDA UDI
Class IIUnknown
Protura 206XPIPS3
FDA UDI
Class IIUnknown
Grid Extension MTIL6663
FDA UDI
Class IIActive
Respiratory Plate Cushion Kit BPL120
FDA UDI
Class IIActive
Fixator™ Shoulder Cups MTCFHN006SUB6
EUDAMEDFDA UDI
Class IIActive
Headrest MTLTBPIAT
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPUID2232
EUDAMEDFDA UDI
Class IIActive
Thermoplastic Frame MTAPUR1
EUDAMEDFDA UDI
Class IIActive
IPPS™ Overlay MTIL6302
FDA UDI
Class IIUnknown
Lateral Stabilizer MTIL600311
FDA UDI
Class IIUnknown
Iso-Align™ MTIAD1
FDA UDI
Class IActive
Gas Strut MTRHGS01
EUDAMEDFDA UDI
Class IIActive
Mastercast™ Pro 990030
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPUI1824
FDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPUID181432
EUDAMEDFDA UDI
Class IIActive
Headrest MTTIMOB
FDA UDI
Class IIUnknown
IPPS™ Overlay MTIL3706
FDA UDI
Class IIActive
Uni-frame® Baseplate MT20100
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLTYS01CX
EUDAMEDFDA UDI
Class IIActive
Fiducial Marker Kit MTNW887853
EUDAMEDFDA UDI
Class IIActive
Posifix® Headrest 301027A
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLPLV02FC
EUDAMEDFDA UDI
Class IIActive

Related Companies

Authorised Representatives

Importers

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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.