BEUDAMED
    4 results · 12ms · Sources: EU EUDAMED, US FDA

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    TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.

    FDA Enforcement
    Class II ·Terminated·Accuray Incorporated·January 3, 2018

    Velocity" Injection Port and Applier Product Code PT2XV, Lot #: 1110603, 10060505, 11160512, 02090601, 03220609, 03220610, 06270601, 07170601, 09210601, 09270601, 20003156, ZHKBBB, ZJFBDK, ZJFBF6, ZJJBLR, ZJMBCD, ZJNBKW, ZKBBJV, ZKBBLK, ZKDB0B, ZKFBDG, ZKFBDJ, ZKGBBM, ZKGBDW, ZKHBCC, ZKHBDH, ZKKBDZ, ZKLBD9, ZKMBK1, ZKNBD7, ZLBBBJ, ZLCBC4, ZLCBGB, ZLDBBC, ZLFBGL, ZLGBC9 & ZLHBBJ.

    FDA Recall
    Terminated ·Ethicon Endo-Surgery Inc·Product code LTI·September 27, 2010

    Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515

    FDA Recall
    Terminated ·Product code GBR·July 1, 2003

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015