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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 19 of 22

Device	Model / Reference	Registries	Class	Status
ProForm™ Thermoplastic	PRO3311832SGN	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Cushion	MTVL04	FDA UDI	Class II	Unknown
Bite Cup	MTHF135	EUDAMEDFDA UDI	Class II	Active
Posifix® Headrest	301026	EUDAMEDFDA UDI	Class II	Active
Locators	662060	FDA UDI	Class II	Unknown
ProForm™ Head and Neck Extension	MTIL6678	FDA UDI	Class II	Active
ProForm™ Head and Neck Extension	MTIL6683	FDA UDI	Class II	Active
IPPS Overlay	20IL430030	FDA UDI	Class II	Unknown
New Horizon Prone Breastboard	MTHPBB01	EUDAMEDFDA UDI	Class II	Active
Positioning Cushion	301091	FDA UDI	Class II	Active
Posirest 2	106522	FDA UDI	Class II	Active
Positioning Cushion	301051	FDA UDI	Class II	Unknown
Exact Lok-Bar	20IL430031	FDA UDI	Class II	Unknown
Uni-frame® Thermoplastic	MTAPU142.4	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPSID2732SG	FDA UDI	Class II	Active
IPPS™ Overlay	MTIL6022	FDA UDI	Class II	Active
Thermoplastic	MTRFX918	EUDAMEDFDA UDI	Class II	Active
Universal Couchtop™	MTIL6042	FDA UDI	Class II	Active
Body Pro-Lok™ Platform	MTSBRT070	FDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPSID2932	EUDAMEDFDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPUI26232	FDA UDI	Class II	Unknown
Vac-Lok Cushion	MTVLB40C	FDA UDI	Class II	Unknown
Universal Couchtop™	MTIL6343	FDA UDI	Class II	Active
ProForm™ Thermoplastic	PRO330	EUDAMEDFDA UDI	Class II	Active
Prodigy Lok-Bar	MTIL3654	FDA UDI	Class II	Unknown
Wrist Support	MT40010	FDA UDI	Class II	Unknown
Posicast® Thermoplastic	760030	FDA UDI	Class II	Unknown
AccuForm™ Cushion	MTACL2035U	EUDAMEDFDA UDI	Class II	Active
RediFoam™	MTFA41B	FDA UDI	Class II	Active
Hand Grip	MT2504	FDA UDI	Class II	Active
Latch	108011	FDA UDI	Class II	Unknown
Type-S™ Thermoplastic	MTAPUID1832SG	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Cushion	MTVLB40	FDA UDI	Class II	Unknown
Vac-Lok Cushion	MTVLG35C	FDA UDI	Class II	Unknown
Uni-frame® Thermoplastic	MTAPUI2024	FDA UDI	Class II	Unknown
Uni-frame® Thermoplastic	MTAPU	EUDAMEDFDA UDI	Class II	Active
Positioning Cushion	301003	FDA UDI	Class II	Unknown
Type-S™ Overlay	MTMRHNTYPES	EUDAMEDFDA UDI	Class II	Active
Immobilizer	MTDLI	FDA UDI	Class II	Unknown
Positioning Cushion	402422	FDA UDI	Class II	Active
Proutra™	MT6X300R	FDA UDI	Class II	Active
Universal Couchtop™	MTIL674015	FDA UDI	Class II	Active
Contura™ Belly Board	MTBBCF	FDA UDI	Class II	Active
Headrest - Timo size B with base	MTTIMO2BBB	EUDAMEDFDA UDI	Class II	Active
Headrest	MTTIMO	FDA UDI	Class II	Unknown
T-Pin Lok-Bar™	MTSBRT009	EUDAMEDFDA UDI	Class II	Active
Prone-Lok™ Positioning Cushion	MTPLC01	FDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPSID27NR24	EUDAMEDFDA UDI	Class II	Active
Universal Couchtop™	MTIL6040	FDA UDI	Class II	Active
Chabner XRT Radiation Bra	CRTBRA01	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.