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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 5 of 22
DeviceModel / ReferenceRegistriesClassStatus
Protura MT6XSM1.6.1
FDA UDI
Class IIUnknown
Vac-Lok Cushion MTVLBRB01C
FDA UDI
Class IIUnknown
Vac-Lok™ Cushion VLFBB01C
FDA UDI
Class IIActive
IPPS™ Overlay MTIL4101
FDA UDI
Class IIUnknown
ProForm™ Thermoplastic PRO339IM1832CL
FDA UDI
Class IIActive
IPPS Overlay MTIL6361
FDA UDI
Class IIUnknown
Attachment Bar 151020
FDA UDI
Class IIUnknown
Universal Couchtop™ MTIL6841
FDA UDI
Class IIActive
Fiducial Markers MTNW887852
FDA UDI
Class IIUnknown
Adjustable Backrest MTIL7116
FDA UDI
Class IIActive
C-Qual™ MT402
EUDAMEDFDA UDI
Class IIActive
O.D.I. Checking Tool MTIAD16
FDA UDI
Class IUnknown
Posicast® Thermoplastic 770033
FDA UDI
Class IIUnknown
IPPS™ Overlay MTM3406
FDA UDI
Class IIActive
Universal Couchtop™ MTIL6342
FDA UDI
Class IIActive
AccuForm™ Cushion MTACL2045
EUDAMEDFDA UDI
Class IIActive
Patient Hand Grip MTSBRT0051
EUDAMEDFDA UDI
Class IIActive
Accessory Rail MTIL6630
FDA UDI
Class IIActive
IPPS Overlay MTIL6161
FDA UDI
Class IIUnknown
Posifix® Extension MTIL6672
FDA UDI
Class IIActive
Swivel Clamp MT201SC
EUDAMEDFDA UDI
Class IIActive
Chabner XRT Radiation Bra CRTBRA03
FDA UDI
Class IIUnknown
Pronumbra RT-C876K
EUDAMEDFDA UDI
Class IIActive
Pediatric Registration Film PRO440
EUDAMEDFDA UDI
Class IIActive
Body Pro-Lok ONE™ Respiratory Belt BPL028
FDA UDI
Class IIActive
Universal Couchtop™ MTIL6341
FDA UDI
Class IIActive
Vac-Lok™ Cushion MTVL71FC
FDA UDI
Class IIUnknown
Thermoplastic MTRFX9182.4
EUDAMEDFDA UDI
Class IIActive
Type-S™ Extension MTIL6607
FDA UDI
Class IIUnknown
Arm Support 106011
FDA UDI
Class IIUnknown
IPPS™ Couchtop MTIL6120
FDA UDI
Class IIActive
Headrest MTTIMOFL
FDA UDI
Class IIUnknown
AccuForm™ Cushion MTACL2035
EUDAMEDFDA UDI
Class IIActive
ONEBridge™ BPL001
EUDAMEDFDA UDI
Class IIActive
ProForm™ Thermoplastic PRO339IM1832S
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLARM01C
EUDAMEDFDA UDI
Class IIActive
Vac-Lok Cushion MTVLJ20C
FDA UDI
Class IIUnknown
Positioning Cushion 301003BLK
FDA UDI
Class IIUnknown
Arm Support 106025
FDA UDI
Class IIActive
Fixing Knob 302069
FDA UDI
Class IIUnknown
IPPS™ Overlay MTM3401
FDA UDI
Class IIUnknown
Fiducial Marker Kit MTNW887860
EUDAMEDFDA UDI
Class IIActive
Headrest MTSILVER2F
EUDAMEDFDA UDI
Class IIActive
Fiducial Marker Kit MTNW887837
EUDAMEDFDA UDI
Class IIActive
Posicast® Thermoplastic 900030
FDA UDI
Class IIUnknown
Handle MTGBSUB3
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion MTVL37
FDA UDI
Class IIUnknown
Body Pro-Lok™ Bridge MTSBRT007
FDA UDI
Class IIActive
Fiducial Markers MTNW887808
EUDAMEDFDA UDI
Class IIActive
Hip Stop MT350302
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.