Devices

Device Recall MC500 Multicolor Laser Photocoagulator

  • Modèle / numéro de série
    Part number: 173530U20 Serial numbers: 50010, 50127, 50136, 50277, 50310, 50311, 50330, 50331, 50357. 50358, 50359, 50382, 50383, 50408. 50417, 50418, 50426, 50439, 50445, 50446, 50471, 50514, 50552, 50558, 50573, 50600, 50610, 50611, 50651.
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including IL NE NY, NH, CD, MI, TX, CA, PA, FL, KS, UT, MN, WI,. MO. and OR.
  • Description du dispositif
    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
  • Manufacturer
    Nidek Inc
  • 1 Event

Fabricant

Nidek Inc
  • Adresse du fabricant
    Nidek Inc, 47651 Westinghouse Dr, Fremont CA 94539-7474
  • Société-mère du fabricant (2017)
    Nidek Co. Ltd.
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall MC500 Multicolor Laser Photocoagulator
  • Modèle / numéro de série
    Serial numbers: 20023,20039, 20040, 20042, 20047, 20049, 20050, 20051, 20052, 20062, 20063, 20064, 20066, 20067, 20068, 20076
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
  • Description du dispositif
    MC-500 Multicolor Laser Photocoagulator; || Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
  • Manufacturer
    Nidek Inc
Device Recall MC500 Multicolor Laser Photocoagulator
  • Modèle / numéro de série
    MC-500; Serial numbers: 50011, 50382, 50425, 50558, 50609
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution in the states of: CA, NE, and NY.
  • Description du dispositif
    MC-500 Multicolor Laser Photocoagulator using software version 2.20. || Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
  • Manufacturer
    Nidek Inc