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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: —
Email: [email protected]
Phone: +17127378688
PRRC Contact: Alena Newgren
EUDAMED SRN: US-MF-000002608
FDA FEI Number: 1000143606
DUNS Number: —

Catalogue (1098)

Page 12 of 22

Device	Model / Reference	Registries	Class	Status
C-Qual	MT40013	FDA UDI	Class II	Unknown
Prodigy™ 2 Head Extension	MTIL6617	FDA UDI	Class II	Active
Exact Lok-Bar™	MTVAR46	FDA UDI	Class II	Active
Universal Couchtop™	MTIL6026	FDA UDI	Class II	Active
Monarch™ Overhead Arm Positioner	OAP110	EUDAMEDFDA UDI	Class II	Active
Positioning Cushion	301005	FDA UDI	Class II	Unknown
Uni-frame® Thermoplastic	MTAPUW122.4	EUDAMEDFDA UDI	Class II	Active
Precise Bite™	MTCBPBITE	EUDAMEDFDA UDI	Class II	Active
RediFoam™	MTFA40B	FDA UDI	Class II	Active
Posicast® Thermoplastic	910030	FDA UDI	Class II	Unknown
Individual Head Support	MTIHS01	FDA UDI	Class II	Unknown
Positilt™ Baseplate	107020	FDA UDI	Class II	Unknown
ZENTEC™ Thermoplastic	MTAPSID2724VT	FDA UDI	Class II	Active
Posicast® Thermoplastic	770044	FDA UDI	Class II	Unknown
Body Pro-Lok™ System	MTSBRT001	FDA UDI	Class II	Active
Proutra™	MT6X400	FDA UDI	Class II	Active
Positioning Cushion	301075	FDA UDI	Class II	Unknown
Type-S™ Overlay	20CFHNSUB2	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Cushion	MTVLG40	FDA UDI	Class II	Unknown
Reference Lok-Bar™	20VAR00	FDA UDI	Class II	Active
Eye Shield	MTT45S	FDA UDI	Class I	Unknown
Head Bridge	MTM300005	FDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPUL2.4	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPUID2032	EUDAMEDFDA UDI	Class II	Active
ONEClamp (2)	BPL016	FDA UDI	Class II	Active
Vac-Lok™ Cushion	VLG35	EUDAMEDFDA UDI	Class II	Active
SRS Posifix® Extension	108020	FDA UDI	Class II	Active
Prodigy™ Lok-Bar™	MTIL3651	FDA UDI	Class II	Active
Type-S™ Extension	MTCFHNV	EUDAMEDFDA UDI	Class II	Active
Headrest - Timo size F with base	MTTIMO2FBB	EUDAMEDFDA UDI	Class II	Active
Bottom Stop	106029	FDA UDI	Class II	Unknown
HipFix® Thermoplastic	MTPLHA0201	EUDAMEDFDA UDI	Class II	Active
Solstice™ MR SRS Immobilization System	CHS18MR	FDA UDI	Class II	Unknown
Vac-Lok Cushion	MTVLF15	FDA UDI	Class II	Unknown
Encompass™	RT-B889KYSH-1	FDA UDI	Class II	Active
Protura 1.7.2	MT6XSM1.7.2	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTAPUID1832CL	EUDAMEDFDA UDI	Class II	Active
Posicast® Thermoplastic	920145	FDA UDI	Class II	Unknown
Coupled™ Fiducial Marker Kit	MTNW887712	FDA UDI	Class II	Active
Positioning Cushion	301030	EUDAMEDFDA UDI	Class II	Active
Combifix™ Baseplate	151014MR	EUDAMEDFDA UDI	Class II	Active
Shoulder Bridge 2	MTSBRT038	FDA UDI	Class II	Active
Universal Couchtop™	MTIL6044	FDA UDI	Class II	Active
Posifix® Headrest	301027	FDA UDI	Class II	Unknown
Vac-Lok™ Cushion	MTVLARM01	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTAPUID1824	EUDAMEDFDA UDI	Class II	Active
Chabner XRT Radiation Bra	CRTBRA11	FDA UDI	Class II	Unknown
Vac-Lok Cushion	MTVLG40C	FDA UDI	Class II	Unknown
Couchtop Panel	MTIL301002	FDA UDI	Class II	Unknown
Bolus	MTCB430S	FDA UDI	Class I	Unknown

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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.

Date	Recall No.	Class	Status	Reason
May 12, 2020	Z-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, 2019	Z-1837-2019	—	terminated	There is a potential for movement of the Solstice Tilting Head Fixation System during patient setup and/or treatment.
Nov 8, 2017	Z-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, 2017	Z-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, 2017	Z-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, 2016	Z-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, 2015	Z-2763-2015	—	terminated	The wrist straps used for positioning the patient are too long
Dec 11, 2014	Z-0989-2015	—	terminated	The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Dec 11, 2014	Z-0990-2015	—	terminated	The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Jun 21, 2010	Z-0394-2011	—	terminated	Under certain conditions, the extensions can become detached from the main body of the couch.
Jun 21, 2010	Z-0395-2011	—	terminated	Under certain conditions, the extensions can become detached from the main body of the couch.
Jun 21, 2010	Z-0396-2011	—	terminated	Under certain conditions, the extensions can become detached from the main body of the couch.
Aug 31, 2009	Z-0124-2010	—	terminated	Some of the packages contain the incorrect mask style.
Mar 6, 2009	Z-1721-2009	—	terminated	The silkscreened indexing scale was reversed.