BEUDAMED
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    MED-TEC, INC. BREAST BOARD, MT-250

    FDA 510(k)
    FDA Class 2 ·Radiology

    MED-TEC, INC. BREAST BOARD, MT-200

    FDA 510(k)
    FDA Class 2 ·Radiology

    MED-TEC

    FDA Adverse Event
    Other ·MED-TEC, INC.·Product code LHN·March 13, 2002

    MED-TEC, CARBON FIBER BREAST BOARD

    FDA Adverse Event
    Other ·MED-TEC, INC.·Product code IYE·August 27, 2003

    MED-TEC, TYPE-S SYSTEM

    FDA Adverse Event
    Other ·MED-TEC,INC.·Product code IWY·July 22, 2003

    MED-TEC MT-350 BREAST BOARD

    FDA Adverse Event
    Other ·MED-TEC, INC.·Product code IYE·March 6, 2001

    MED-TEC UNI-FRAME

    FDA Adverse Event
    Other ·MED-TEC,INC.·Product code IWY·January 24, 2001

    REDI-FOAM

    FDA Adverse Event
    Other ·MED-TEC INC.·Product code JAD·February 18, 1997

    MED-TEC CARBON FIBER COUCH INSERT

    FDA Adverse Event
    Other ·MED-TEC,INC.·Product code KXJ·September 9, 1999

    REDI-FOAM

    FDA Adverse Event
    Malfunction ·MED-TEC,INC.·Product code IWE·November 13, 1998

    Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.

    FDA Recall
    Terminated ·Med Tec Inc·Product code IXQ·March 6, 2009

    CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area.

    FDA Recall
    Terminated ·Med Tec Inc·Product code FMQ·August 19, 2015

    FISCHER CONE BIOP EX MED

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code HGI·May 26, 2020

    TYPE-S HEAD EXTENSION

    FDA Adverse Event
    Malfunction ·CIVCO MEDICAL SOLUTIONS, MED-TEC INC.·Product code IWY·April 20, 2007

    EXTENDED ACRYLIC WINGBOARD

    FDA Adverse Event
    Other ·CIVCO MEDICAL SOLUTIONS, MED-TEC INC.·Product code KXJ·January 4, 2008

    CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA. For use to support and aid in positioning a patient during radiologic and other medical procedures.

    FDA Recall
    Terminated ·Med Tec Inc·Product code IXQ·June 21, 2010

    CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.

    FDA Recall
    Terminated ·Med Tec Inc·Product code IYE·August 31, 2009

    Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.

    FDA Recall
    Terminated ·Med Tec Inc·Product code FMQ·December 11, 2014

    Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear accelerator (Linac) software systems, and/or image guidance systems and the Protura Couch. The system is intended to support a treatment table and add pitch and roll to normal X, Y, Z and yaw motions to provide 6-degree axis movement. The product includes an interface between the treatment planning system and the treatment table to direct the table motion based on coordinates supplied. These products connect or support a treatment table by use of various mounting plates.

    FDA Recall
    Terminated ·Med Tec Inc·Product code JAI·November 8, 2017

    CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.

    FDA Recall
    Terminated ·Med Tec Inc·Product code KXH·August 10, 2017