• Modèle / numéro de série
    Lot Codes: 512551364X 516051164X 521750164X
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US (nationwide) and to Canada.
  • Description du dispositif
    Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE || Item Code: PP18CSD || Castile soap towelettes are used to clean the genital area for male and female patients
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

76 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Lot Numbers: 161510095H, 161620089H, 161690203H, 161760132H, 161900091H,161970090H, 162040107H, 162110103H, 162320191H, 162390212H
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide. Foreign: Belgium Germany France Netherlands
  • Description du dispositif
    Covidien Nellcor SpO2 Forehead Sensor || Item Code: RS10; || The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: B000000164, B000000170, B000000173, B000000178
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
  • Description du dispositif
    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
  • Manufacturer
  • Modèle / numéro de série
    Lot number: B000000174
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
  • Description du dispositif
    SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
  • Manufacturer
  • Modèle / numéro de série
    Lot number: B000000166
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
  • Description du dispositif
    SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01
  • Manufacturer
  • Modèle / numéro de série
    Lot number: B000000167
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI; and countries of DK and DE
  • Description du dispositif
    BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01
  • Manufacturer
71 en plus