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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 9 of 22

Device	Model / Reference	Registries	Class	Status
BPL ONE Respiratory Belt	BPL026	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Cushion	VL0022	EUDAMEDFDA UDI	Class II	Active
Uni-frame® Thermoplastic	MTAPUW	EUDAMEDFDA UDI	Class II	Active
Posicast® Thermoplastic	960030	FDA UDI	Class II	Unknown
Headrest - Timo Size A	MTTIMO2A	FDA UDI	Class II	Active
Assist Handles	622501	FDA UDI	Class II	Unknown
IPPS™ Overlay	MTIL6322	FDA UDI	Class II	Active
Posirest 2	106521	FDA UDI	Class II	Active
Palliative Solid Extension	MTIL6603	FDA UDI	Class II	Unknown
Headrest	MTSILVER2	EUDAMEDFDA UDI	Class II	Active
Fixing Knob	302064	FDA UDI	Class II	Unknown
Headrest	MTSILVER2D	EUDAMEDFDA UDI	Class II	Active
Couchtop Panel	MTIL301003	FDA UDI	Class II	Unknown
Lateral Stabilizer	MTIL630111	FDA UDI	Class II	Unknown
Uni-frame® Thermoplastic	MTVRTR	FDA UDI	Class II	Active
Fiducial Marker Kit	MTNW887836	EUDAMEDFDA UDI	Class II	Active
ProForm™ Pediatric Thermoplastic	PRO431IM1832	EUDAMEDFDA UDI	Class II	Active
Vac-Lok™ Vacuum Compressor	MTVPEXH	EUDAMEDFDA UDI	Class II	Active
Universal Couchtop™	MTIL7040	FDA UDI	Class II	Active
Positioning Cushion	301034	FDA UDI	Class II	Active
Transfer Guide	MTSBRT014	FDA UDI	Class II	Unknown
Docking Station	MTIL600412	FDA UDI	Class II	Active
IPPS™ Overlay	MTIL3000	FDA UDI	Class II	Unknown
Headrest	MTTIMOL	FDA UDI	Class II	Unknown
Shoulder Retractors	20SR02SUB2	EUDAMEDFDA UDI	Class II	Active
Spacer	107104	FDA UDI	Class II	Active
Vac-Lok™ Cushion	VLPLV01	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPSID2732	EUDAMEDFDA UDI	Class II	Active
Lok-Bar™	MTSBRT054	EUDAMEDFDA UDI	Class II	Active
Accessory Rail Locking Block	MTARB001	FDA UDI	Class II	Unknown
Universal Couchtop™	MTIL6920	FDA UDI	Class II	Active
Uni-frame® Baseplate	MT20103CF	EUDAMEDFDA UDI	Class II	Active
Combifix™	151005	FDA UDI	Class II	Unknown
Docking Station	MTIL600310	FDA UDI	Class II	Unknown
Vac-Lok™ Cushion	VLJ20	EUDAMEDFDA UDI	Class II	Active
Bolus	MTCB404010S	FDA UDI	Class I	Active
Fiducial Marker Kit	MTNW887840	EUDAMEDFDA UDI	Class II	Active
Arm Support	MTTAS2L	EUDAMEDFDA UDI	Class II	Active
AccuForm™ Cushion	MTACLTYPES1	EUDAMEDFDA UDI	Class II	Active
IPPS™ Overlay	MTIL6500	FDA UDI	Class II	Unknown
IPPS™ Overlay	MTIL6303	FDA UDI	Class II	Unknown
Uni-frame® Baseplate	MT20108	EUDAMEDFDA UDI	Class II	Active
Type-S™ Thermoplastic	MTAPSD3.2	EUDAMEDFDA UDI	Class II	Active
AccuForm™ Cushion	MTACL5865T	FDA UDI	Class II	Active
Posirest 2	106520	FDA UDI	Class II	Active
Positioning Cushion	301083	FDA UDI	Class II	Unknown
Couchtop Panel	MTIL300512	FDA UDI	Class II	Unknown
Shoulder Retractors	302072	EUDAMEDFDA UDI	Class II	Active
Kneefix™ 2	301047	FDA UDI	Class II	Unknown
IPPS Overlay	MTIL6560	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.