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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 2 of 22

Device	Model / Reference	Registries	Class	Status
Solstat™ Immobilization System	CHS05	EUDAMEDFDA UDI	Class II	Active
ZENTEC™ Thermoplastic	MTAPUID1832VT	EUDAMEDFDA UDI	Class II	Active
Clam-Lok™ Cushion	VLSBRT202FC	EUDAMEDFDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPUR142.4	FDA UDI	Class II	Unknown
IPPS Overlay	MTIL6360	FDA UDI	Class II	Unknown
Vac-Lok™ Cushion	MTVLF15FC	FDA UDI	Class II	Unknown
Vac-Lok™ Vacuum Compressor	MTVPEXA	EUDAMEDFDA UDI	Class II	Active
Prodigy™ 2 Lok-Bar™	MTIL6057	FDA UDI	Class II	Unknown
IPPS™ Couchtop	MTIL6101	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTAPSI29NR32	FDA UDI	Class II	Unknown
Solstat™ Immobilization System	CHS06	EUDAMEDFDA UDI	Class II	Active
Positioning Cushion	301023	EUDAMEDFDA UDI	Class II	Active
IPPS™ Couchtop	MTIL3600	FDA UDI	Class II	Active
Belly Board MRI	126000	FDA UDI	Class II	Active
Breastboard	MT350N	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic Frame	20CFHNSUB1C	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTAPSD001	EUDAMEDFDA UDI	Class II	Active
Posicast® Thermoplastic	772145	EUDAMEDFDA UDI	Class II	Active
Universal Couchtop™	MTIL6742	FDA UDI	Class II	Active
Posicast® Thermoplastic	914392	FDA UDI	Class II	Unknown
Universal Couchtop™	MTIL614215	FDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPUIR2032	FDA UDI	Class II	Unknown
Positioning Cushion	301201	EUDAMEDFDA UDI	Class II	Active
Chabner XRT Radiation Bra	CRTBRA10	FDA UDI	Class II	Unknown
Pronumbra	RT-4536-01	FDA UDI	Class II	Active
Posicast Thermoplastic	950030	FDA UDI	Class II	Unknown
Positioning Cushion	402848	FDA UDI	Class II	Active
Attachment Bar	109017	FDA UDI	Class II	Unknown
Clamp	20SBRT0601	FDA UDI	Class II	Unknown
Vac-Lok Cushion	MTVLE2.25C	FDA UDI	Class II	Unknown
ONEFit	RT-4800-C0	EUDAMEDFDA UDI	Class II	Active
Posifix® -2 Baseplate	102011	FDA UDI	Class II	Unknown
IPPS™ Couchtop	MTIL6200	FDA UDI	Class II	Unknown
Solstice™ Thermoplastic Frame	MTAPCID1832	EUDAMEDFDA UDI	Class II	Active
Docking Station	MTIL630212	FDA UDI	Class II	Active
ONEBridge™	RT-4800-B3	EUDAMEDFDA UDI	Class II	Active
Precise Bite™	MTCBPBITES	EUDAMEDFDA UDI	Class II	Active
Headrest	MTLTBPIAT01	EUDAMEDFDA UDI	Class II	Active
IPPS™ Couchtop	MTIL6021	FDA UDI	Class II	Unknown
Proutra™	MT6XSM1.7.3	FDA UDI	Class II	Active
Thermoplastic	MTAPS25	EUDAMEDFDA UDI	Class II	Active
HipFix® Thermoplastic	MTHFX18222.4	EUDAMEDFDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPU122.4	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Cushion	VLG35C	EUDAMEDFDA UDI	Class II	Active
Adapter Plate Box Label	MT350400	FDA UDI	Class II	Unknown
Bolus	MTCB404005S	FDA UDI	Class I	Active
Interloc® Lok-Bar™	MTIL3850	FDA UDI	Class II	Active
Rail Mount Lok-Bar™	MTIL1000	FDA UDI	Class II	Unknown
RediFoam™	MTFA39B	FDA UDI	Class II	Active
IPPS™ Couchtop	MTIL6000	FDA UDI	Class II	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.