Gyrus ACMI, Inc

2 devices in the database

  • Model / Serial
    TS101DC, TS100S | JC929332 and below for product TS100S and JC924165 and below for product TS101DC
  • Product Description
    MD: ENT irrigation/aspiration pump
  • Model / Serial
    3103PK, 3104PK, 3105PK, 915000PK, 915005PK, 915010PK | all
  • Product Description
    MD: Endotherapy electrosurgical electrode, single-use

14 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
9 more