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Sign in to claim this brandMedtec 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
- —
- —
- [email protected]
- Phone
- +17127378688
- PRRC Contact
- Alena Newgren
- EUDAMED SRN
- US-MF-000002608
- FDA FEI Number
- 1000143606
- DUNS Number
- —
Catalogue (1098)
Page 22 of 22| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Medtec Autoblot 2000 | K951753 | FDA 510(k) | Class I | Active |
| Med-Tec Bellyboard, Models Mt-Bba-01 & Mt-Bba-02 | K023293 | FDA 510(k) | Class II | Active |
| Green Tec-2100 | K955236 | FDA 510(k) | Class I | Active |
| 360 Deg. Rotating 1/2 Beam Block | K941719 | FDA 510(k) | Class II | Active |
| Vac-Lok Immobilization System | K935300 | FDA 510(k) | Class II | Active |
| Med-Tec Redi-Foam | K951808 | FDA 510(k) | Class II | Active |
| Blocking Tray | K944315 | FDA 510(k) | Class II | Active |
| Carbon Fiber Couch Insert | K950068 | FDA 510(k) | Class II | Active |
| Med-Tec String Reticle Tray | K951601 | FDA 510(k) | Class I | Active |
| Matrix Mt-Mx3 | K974700 | FDA 510(k) | Class II | Active |
| Moldcare Head & Neck Cushion, Model # Mt-Acl-14242 | K982624 | FDA 510(k) | Class II | Active |
| Med-Tec 6 Degree Axis Couch, Model Mt-6dac | K031866 | FDA 510(k) | Class II | Active |
| Med-Tec Breast Support System | K942282 | FDA 510(k) | Class II | Active |
| Coated Tungsten Eyeshield | K945515 | FDA 510(k) | Class I | Active |
| Med-Tec Knee Crutch | K951717 | FDA 510(k) | Class II | Active |
| Uni-Frame Head Immobilization System | K933227 | FDA 510(k) | Class II | Active |
| Med-Tec Compensator Block Cutter Software | K013875 | FDA 510(k) | Class II | Active |
| Handi-Foam | K935021 | FDA 510(k) | Class II | Active |
| Tec 2100 (model Mt-Lplgd) | K935760 | FDA 510(k) | Class I | Active |
| Med-Tec Testicular Separator | K951679 | FDA 510(k) | Class II | Active |
| Thermoplastic Shield | K954456 | FDA 510(k) | Class I | Active |
| Carbon Fiber Breast Board | K974703 | FDA 510(k) | Class II | Active |
| Scintillating Fiber Dosimeter (sfd), Model Mt-Sfd-1000 | K021360 | FDA 510(k) | Class II | Active |
| Pro Series Couch Software, Model Mt-Pro100 | K034054 | FDA 510(k) | Class II | Active |
| Intra-Oral Thermoplastic Shield | K962622 | FDA 510(k) | Class I | Active |
| Field Abutment Wedge | K943343 | FDA 510(k) | Class II | Active |
| Med-Tec Radio Therapy Treatment Chair | K951947 | FDA 510(k) | Class II | Active |
| Carbon Fiber Conformal Couch Top | K973842 | FDA 510(k) | Class II | Active |
| Med-Tec Tray Adapter | K950075 | FDA 510(k) | Class II | Active |
| Head And Neck Immobilization System, Body Immobilization System | K111340 | FDA 510(k) | Class II | Active |
| Electron Wedge Model Mt-Ew-1000 | K981992 | FDA 510(k) | Class II | Active |
| Mri Patient Positioning Devices | K093738 | FDA 510(k) | Class II | Active |
| Acrysteel Blocking Tray | K954705 | FDA 510(k) | Class II | Active |
| Tec-2110 Green Laser Model Mt-Hng | K950293 | FDA 510(k) | Class I | Active |
| Painted Wedge & Rod Breast Board | K952729 | FDA 510(k) | Class II | Active |
| Med-Tec Rediset | K952189 | FDA 510(k) | Class II | Active |
| Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base Lock Replacement Kit | K132908 | FDA 510(k) | Class II | Active |
| Tec 2101 (model Mt-Hplgd) | K941169 | FDA 510(k) | Class I | Active |
| Insta-Flo | K935209 | FDA 510(k) | Class II | Active |
| Hip Fixation System | K950866 | FDA 510(k) | Class II | Active |
| Med-Tec, Inc. Breast Board, Mt-200 | K935412 | FDA 510(k) | Class II | Active |
| Motorized Depth Dose Apparatus | K943199 | FDA 510(k) | Class II | Active |
| Tungsten Eyeshield | K943011 | FDA 510(k) | Class I | Active |
| Med-Tec Hand Grip | K954225 | FDA 510(k) | Class II | Active |
| Med-Tec (medical Intelligence) Bodyfix System, Model Mt-Bfx | K001052 | FDA 510(k) | Class II | Active |
| Radiation Exit Verification System/Back Pointer System | K934519 | FDA 510(k) | Class I | Active |
| Med-Tec, Inc. Breast Board, Mt-250 | K935411 | FDA 510(k) | Class II | Active |
| Couchtop | MTM3305 | EUDAMEDFDA UDI | Class I | Active |
Related Companies
Authorised Representatives
- CEpartner4U NL
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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. |