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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 18 of 22
DeviceModel / ReferenceRegistriesClassStatus
Vac-Lok™ Cushion VLPLV01FC
EUDAMEDFDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPSID27NR32
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUW2.4
EUDAMEDFDA UDI
Class IIActive
Respiratory Belt BPL002
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 760145
FDA UDI
Class IIUnknown
Elekta Unity Lok-Bar™ MTULB003
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLWGB03
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL6041
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL604015
FDA UDI
Class IIActive
Headrest MTTIMOA
FDA UDI
Class IIUnknown
Shoulder Retractors 20SR01SUB2
EUDAMEDFDA UDI
Class IIActive
Spacer 107103
FDA UDI
Class IIActive
Posifix® Extension MTIL6606
FDA UDI
Class IIUnknown
Posifix® Headrest 301234
EUDAMEDFDA UDI
Class IIActive
Posicast® Thermoplastic 770030
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 910044
FDA UDI
Class IIUnknown
Fiducial Markers MTNW887805
FDA UDI
Class IIActive
IPPS™ Couchtop MTIL3605
FDA UDI
Class IIUnknown
Clamp MTSBRT257
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301024
EUDAMEDFDA UDI
Class IIActive
Docking Station MTIL630312
FDA UDI
Class IIActive
Nasion Cushion MTHF016
EUDAMEDFDA UDI
Class IIActive
Chabner XRT Radiation Bra CRTBRA12
FDA UDI
Class IIUnknown
Rectangular Extension MTIL6660
FDA UDI
Class IIActive
IPPS™ Couchtop MTIL3015
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPUID1832CLRD
EUDAMEDFDA UDI
Class IIActive
Guide Pins 109013
FDA UDI
Class IIUnknown
Type-S™ Thermplastic MTAPUD002
EUDAMEDFDA UDI
Class IIActive
ONEPlatform™ BPL003
EUDAMEDFDA UDI
Class IIActive
Mastercast™ Pro 990045
FDA UDI
Class IIUnknown
Body Pro-Lok™ Bridge MTSBRT039
FDA UDI
Class IIActive
IPPS™ Overlay MTIL331105
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLB40FC
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLPLV03C
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVLPLV02
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion MTVL06C
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VL04
FDA UDI
Class IIUnknown
Posicast® Thermoplastic 904392
FDA UDI
Class IIUnknown
Positioning Cushion 301203
EUDAMEDFDA UDI
Class IIActive
PinnPoint™ Lok-Bar™ MTIL5053
FDA UDI
Class IIUnknown
Bath Liner MTCBPLLG
EUDAMEDFDA UDI
Class IIActive
SnapFrame™ Type-S™ Thermoplastic MTAPUDMP
FDA UDI
Class IIUnknown
Solstice™ Thermoplastic Frame MTAPCID1832SG
FDA UDI
Class IIActive
Vac-Lok Cushion MTVL0008
FDA UDI
Class IIUnknown
Positioning Cushion 301002
FDA UDI
Class IIUnknown
C-Qual M™ MTM400
EUDAMEDFDA UDI
Class IIActive
Combifix™ 151005MR
EUDAMEDFDA UDI
Class IIActive
HipFix® Thermoplastic MTHFI18222.4
EUDAMEDFDA UDI
Class IIActive
Coupled™ Fiducial Marker Kit MTNW887711
FDA UDI
Class IIActive
CT Simulation Laser QA Device MTTG66
FDA UDI
Class IActive

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.