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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 14 of 22
DeviceModel / ReferenceRegistriesClassStatus
Positioning Cushion 400006
FDA UDI
Class IIActive
Type-S Overlay 108071
FDA UDI
Class IIUnknown
ProForm™ Thermoplastic PRO331IM1832
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion VLF15FC
EUDAMEDFDA UDI
Class IIActive
Vac-Lok™ Cushion VLFBB01
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301077
FDA UDI
Class IIActive
Headrest MTTIMOC
FDA UDI
Class IIUnknown
Headrest MTSILVER2A
EUDAMEDFDA UDI
Class IIActive
Gas Strut MTRHGS60
FDA UDI
Class IIUnknown
Wedge 107101
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLARM01
EUDAMEDFDA UDI
Class IIActive
Feetfix™ 2 301066
FDA UDI
Class IIUnknown
ProForm™ Thermoplastic PRO3391832SGN
FDA UDI
Class IIActive
Individual Head Support MTIHS02
FDA UDI
Class IIUnknown
trUpoint ARCH™ MTHF01
FDA UDI
Class IIActive
Vac-Lok™ Cushion VLB40C
EUDAMEDFDA UDI
Class IIActive
Shim MTSHIMT
EUDAMEDFDA UDI
Class IIActive
Headrest - Timo size F with base MTTIMO2FL
EUDAMEDFDA UDI
Class IIActive
Evolve Type-S™ Locating Bar OAP226
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL604215
FDA UDI
Class IIActive
ZENTEC™ Thermoplastic MTAPSID2732VT
FDA UDI
Class IIActive
Body Pro-Lok™ System MTSBRT420
FDA UDI
Class IIActive
BrachyGel Vaginal Hydrogel Packing System RT-5300
FDA UDI
Class IIActive
Waterbath MTRH1500EX
EUDAMEDFDA UDI
Class IActive
Respiratory Pump and Gauge BPL009
FDA UDI
Class IIActive
Type-S™ Thermoplastic MTVRT20
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301090
FDA UDI
Class IIActive
Latch 20IL340310
FDA UDI
Class IIUnknown
Arm Support 106024
FDA UDI
Class IIActive
Respiratory Belt Adapter MTIL6620
FDA UDI
Class IIActive
Posicast® Thermoplastic 772044
EUDAMEDFDA UDI
Class IIActive
Wedge and Spacer Set 107106MR
EUDAMEDFDA UDI
Class IIActive
Positioning Cushion 301085
EUDAMEDFDA UDI
Class IIActive
Wedge and Spacer Set 107106
FDA UDI
Class IIActive
Waterbath MTRH1500
FDA UDI
Class IActive
Posifix® Headrest 305000
FDA UDI
Class IIUnknown
Vac-Lok Cushion MTVLTYS01CX
FDA UDI
Class IIUnknown
IPPS Overlay MTM3402
FDA UDI
Class IIUnknown
Posifix® Extension MTIL6608
FDA UDI
Class IIUnknown
HipFix® Baseplate MTPLVCMR
FDA UDI
Class IIUnknown
Posterior Panel MTIL310001
FDA UDI
Class IIUnknown
Lok-Bar™ MTSBRT264
FDA UDI
Class IIActive
Proutra™ MT6X200R
FDA UDI
Class IIActive
Fiducial Marker Kit MTNW887825
EUDAMEDFDA UDI
Class IIActive
Universal Couchtop™ MTIL6540
FDA UDI
Class IIActive
Type-S™ Overlay 108073
FDA UDI
Class IIActive
Type-S™ Thermoplastic MTAPUID2024
EUDAMEDFDA UDI
Class IIActive
Alloy Melter MT801.5DEX
FDA UDI
Class IUnknown
Type-S™ Thermoplastic MTAPSI2932
FDA UDI
Class IIUnknown
Head Coil Support MTM300405
FDA UDI
Class IIActive

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.