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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 3 of 22

Device	Model / Reference	Registries	Class	Status
Positioning Cushion	301033	FDA UDI	Class II	Active
Vac-Lok™ Cushion	VLFBB01FC	EUDAMEDFDA UDI	Class II	Active
Shoulder Retractors	MTSR03	FDA UDI	Class I	Unknown
Vac-Lok™ Cushion	MTVLF15C	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTPT1000	FDA UDI	Class II	Active
IPPS™ Overlay	MTIL654115	FDA UDI	Class II	Active
Head Support	CHS40	EUDAMEDFDA UDI	Class II	Active
Protura	MT6XSM1.4.0	FDA UDI	Class II	Unknown
Multifix™ Baseplate	107063	FDA UDI	Class II	Active
Pronumbra	RT-4536-NS40	FDA UDI	Class II	Active
Monarch™ Thermoplastic Frame	OAP120	EUDAMEDFDA UDI	Class II	Active
Bridge Adapter	MTIL6615	FDA UDI	Class II	Active
Wedge	107102MR	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPS3.2	EUDAMEDFDA UDI	Class II	Active
Thermoplastic Adapter	MTM3011	FDA UDI	Class II	Unknown
Feetfix™ MR Platform	302071MR	EUDAMEDFDA UDI	Class II	Active
PinnPoint™ Lok-Bar™	MTIL5052	FDA UDI	Class II	Unknown
Grid Panel	20IL430003	FDA UDI	Class II	Unknown
Combifix™ Baseplate	151014	FDA UDI	Class II	Unknown
Vac-Lok™ Cushion	VLF15	EUDAMEDFDA UDI	Class II	Active
Bolus	MTCB420S	FDA UDI	Class I	Unknown
Vac-Lok™ Cushion	VLE225	EUDAMEDFDA UDI	Class II	Active
Head Extension	MTIL301005	FDA UDI	Class II	Unknown
Universal Couchtop™	MTIL604615	FDA UDI	Class II	Active
Eye Shield	MTT45M	FDA UDI	Class I	Unknown
Uni-frame® Thermoplastic	MTVRTW	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic Frame	20CFHNSUB1P	EUDAMEDFDA UDI	Class II	Active
Positioning Cushion	301001BLK	FDA UDI	Class II	Unknown
Posicast® Thermoplastic	930030	EUDAMEDFDA UDI	Class II	Active
Helping Hands ™	MTVLHH150	EUDAMEDFDA UDI	Class II	Active
AccuForm™ Cushion	MTACL14242	EUDAMEDFDA UDI	Class II	Active
Posifix® -4 Baseplate	104021	FDA UDI	Class II	Active
Combifix™	151004	FDA UDI	Class II	Unknown
ProForm™ Pediatric Thermoplastic	PRO430IM1832SG	EUDAMEDFDA UDI	Class II	Active
IPPS™ Couchtop	MTIL6060	FDA UDI	Class II	Unknown
HipFix® Thermoplastic	MTPLHA0202	EUDAMEDFDA UDI	Class II	Active
Mastercast™ Pro	991145	FDA UDI	Class II	Unknown
GE MR Posifix® Baseplate	101027	EUDAMEDFDA UDI	Class II	Active
Interloc® Lok-Bar™	MTIL3453	FDA UDI	Class II	Unknown
Rectangular Extension	MTIL6604	FDA UDI	Class II	Unknown
C-Qual™	MT40014	FDA UDI	Class II	Unknown
IPPS™ Overlay	MTIL3502	FDA UDI	Class II	Unknown
Vac-Lok™ Cushion	MTVL0011	FDA UDI	Class II	Unknown
Evolve Bottom Board	OAP210	EUDAMEDFDA UDI	Class II	Active
Solstice™ Shoulder Thermoplastic	MTAPSSTS	EUDAMEDFDA UDI	Class II	Active
AccuForm™ Cushion	MTACL1520	EUDAMEDFDA UDI	Class II	Active
Belly Board Flat Cushion	301101	FDA UDI	Class II	Active
Headrest	MTTIMOEBB	FDA UDI	Class II	Unknown
Thermoplastic	MTRFI9182.4	FDA UDI	Class II	Active
Headrest	MTTIMODL	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.