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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 15 of 22
DeviceModel / ReferenceRegistriesClassStatus
Elekta Unity QA Lok-Bar™ MTULB002
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLJ20C
EUDAMEDFDA UDI
Class IIActive
Solstice™ SRS Immobilization System CHS04
EUDAMEDFDA UDI
Class IIActive
Arm Support MT40015
EUDAMEDFDA UDI
Class IIActive
Base 20SR01SUB1
EUDAMEDFDA UDI
Class IIActive
Guide Pins 662010
FDA UDI
Class IIUnknown
Posirest 2 106419
FDA UDI
Class IIActive
Vac-Lok™ Cushion MTVLPLV02C
FDA UDI
Class IIUnknown
Positioning Cushion 301084
FDA UDI
Class IIUnknown
AccuForm™ Cushion MTACLTYPES2
FDA UDI
Class IIActive
ZENTEC™ Thermoplastic MTAPUID1824VT
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion VLPLV09FC
EUDAMEDFDA UDI
Class IIActive
Bolus MTCB305010S
FDA UDI
Class IUnknown
New Horizon Prone Breastboard MTHPBB100
EUDAMEDFDA UDI
Class IIActive
Uni-frame® Thermoplastic MTAPUIR2232
FDA UDI
Class IIUnknown
Phantom Mount MTIL604510
FDA UDI
Class IIActive
Body Pro-Lok™ System Lite MTSBRT001L
FDA UDI
Class IIActive
Vac-Lok™ Cushion MTVL04C
FDA UDI
Class IIUnknown
Couchtop Panel MTZXTZ44069CF
FDA UDI
Class IIUnknown
Auto-Lok Assembly MTSBRT033
FDA UDI
Class IIUnknown
Pronumbra RT-C878K
EUDAMEDFDA UDI
Class IIActive
IPPS™ Overlay MTIL3001
FDA UDI
Class IIUnknown
Headrest MT250SUB5
FDA UDI
Class IIUnknown
Chabner XRT Radiation Bra CRTBRA07
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL604115
FDA UDI
Class IIUnknown
Type-S™ Extension MTIL6605
FDA UDI
Class IIUnknown
IPPS™ Couchtop MTIL6100
FDA UDI
Class IIUnknown
Type-S™ Thermoplastic MTAPSID29NR32
EUDAMEDFDA UDI
Class IIActive
IPPS™ Couchtop MTIL3901
FDA UDI
Class IIUnknown
IPPS Overlay MTIL6561
FDA UDI
Class IIUnknown
Posifix® Headrest 305000BLK
FDA UDI
Class IIUnknown
Uni-frame® Thermoplastic MTAPU14
EUDAMEDFDA UDI
Class IIActive
Solstice™ Shoulder Thermoplastic MTAPSSPF
EUDAMEDFDA UDI
Class IIActive
Evolve Slant Board OAP200
EUDAMEDFDA UDI
Class IIActive
Align Fiducial Marker Kit MTNW887882
EUDAMEDFDA UDI
Class IIActive
Bolus MTCB465S
FDA UDI
Class IUnknown
IPPS™ Overlay MTIL331110
FDA UDI
Class IIUnknown
BioXmark 11210590
FDA UDI
Class IIActive
HipFix® Thermoplastic MTHFI1822
EUDAMEDFDA UDI
Class IIActive
Slide Guide Lok-Bar™ MTVL00853
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLARM02FC
EUDAMEDFDA UDI
Class IIActive
Shim MTSHIMS
EUDAMEDFDA UDI
Class IIActive
Head Extension MTM340405
FDA UDI
Class IIActive
IPPS™ Overlay MTIL6321
FDA UDI
Class IIActive
Feetfix™ Platform 302071
FDA UDI
Class IIUnknown
Vac-Lok™ Vacuum Compressor MTVPEXC
EUDAMEDFDA UDI
Class IIActive
Pronumbra RT-4536-NS50
FDA UDI
Class IIActive
Exact Lok-Bar™ MTVAR50
FDA UDI
Class IIUnknown
ProForm™ Thermoplastic PRO339IM1832
FDA UDI
Class IIActive
Posicast® Thermoplastic 910145
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.